Tuesday 31 July 2012

Nexavar


Pronunciation: soe-RAF-e-nib
Generic Name: Sorafenib
Brand Name: Nexavar


Nexavar is used for:

Treating advanced kidney cancer. It is also used to treat certain types of liver cancer. It may also be used for other conditions as determined by your doctor.


Nexavar is a multikinase inhibitor. It works by decreasing tumor growth and replication.


Do NOT use Nexavar if:


  • you are allergic to any ingredient in Nexavar

  • you have a certain type of irregular heartbeat (congenital long QT syndrome)

  • you have a certain type of lung cancer (squamous cell) and are taking carboplatin and paclitaxel

Contact your doctor or health care provider right away if any of these apply to you.



Before using Nexavar:


Some medical conditions may interact with Nexavar. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have heart failure or other heart problems (eg, disease of the blood vessels in the heart, a recent heart attack, slow or irregular heartbeat), chest pain, high blood pressure, bleeding problems, active bleeding, blood electrolyte problems (eg, low blood calcium, magnesium, or potassium levels), or liver or kidney problems

  • if you are on dialysis, or you have or are being treated for lung cancer

  • if you have had or will be having surgery or a dental procedure

  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Nexavar. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Warfarin because risk of bleeding may be increased

  • Docetaxel, doxorubicin, fluorouracil/leucovorin, or irinotecan because the risk of their side effects may be increased by Nexavar

  • Barbiturates (eg, phenobarbital, primidone), carbamazepine, dexamethasone, hydantoins (eg, fosphenytoin, phenytoin), nevirapine, oral neomycin, rifamycins (eg, rifabutin, rifampin), or St. John's wort because they may decrease Nexavar's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nexavar may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Nexavar:


Use Nexavar as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Nexavar. Talk to your pharmacist if you have questions about this information.

  • Take Nexavar on an empty stomach at least 1 hour before or 2 hours after eating.

  • Swallow Nexavar whole. Do not break, crush, or chew before swallowing.

  • Take Nexavar with a full glass of water (8 oz/240 mL).

  • Continue to take Nexavar even if you feel well. Do not miss any doses.

  • If you miss a dose of Nexavar, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Nexavar.



Important safety information:


  • Nexavar may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

  • Nexavar may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

  • Tell your doctor or dentist that you take Nexavar before you receive any medical or dental care, emergency care, or surgery.

  • Both men and women who are taking Nexavar should use effective contraception (birth control) during treatment with Nexavar and for at least 2 weeks after stopping treatment.

  • Lab tests, including blood pressure, blood electrolyte levels, and electrocardiograms (ECGs), may be performed while you use Nexavar. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Nexavar should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Nexavar may cause harm to the fetus. Avoid becoming pregnant while you are taking it and for at least 2 weeks after you stop taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Nexavar while you are pregnant. It is not known if Nexavar is found in breast milk. Do not breast-feed while taking Nexavar.


Possible side effects of Nexavar:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; diarrhea; dry skin; hair thinning or loss; headache; loss of appetite; mouth, bone, muscle, stomach, or joint pain; nausea; tiredness; vomiting; weakness; weight loss.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry stools; chest, jaw, or left arm pain; confusion; coughing or vomiting blood; decreased sexual ability; decreased urination; depression; fainting; fast or irregular heartbeat; fever, chills, or sore throat; mouth sores; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; redness, pain, swelling, numbness, tingling, ulcers, or blisters on the palms of hands or soles of feet; seizures; severe or persistent dizziness, headache, or light-headedness; severe stomach pain, vomiting, or nausea; shortness of breath; speech changes; sudden increased sweating; sudden weight gain; swelling of the ankles, hands, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, unusual tiredness, yellowing of the eyes or skin); unusual bruising or bleeding; unusual tiredness or weakness; vision changes; vomit that looks like coffee grounds.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Nexavar side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include rash, redness, swelling, blistering, or itching of skin; severe or persistent diarrhea.


Proper storage of Nexavar:

Store Nexavar at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nexavar out of the reach of children and away from pets.


General information:


  • If you have any questions about Nexavar, please talk with your doctor, pharmacist, or other health care provider.

  • Nexavar is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Nexavar. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nexavar resources


  • Nexavar Side Effects (in more detail)
  • Nexavar Use in Pregnancy & Breastfeeding
  • Nexavar Drug Interactions
  • Nexavar Support Group
  • 3 Reviews for Nexavar - Add your own review/rating


  • Nexavar Prescribing Information (FDA)

  • Nexavar Consumer Overview

  • Nexavar Monograph (AHFS DI)

  • Nexavar Advanced Consumer (Micromedex) - Includes Dosage Information

  • Sorafenib Professional Patient Advice (Wolters Kluwer)



Compare Nexavar with other medications


  • Hepatic Tumor
  • Hepatocellular Carcinoma
  • Renal Cell Carcinoma
  • Thyroid Cancer

Friday 27 July 2012

IsonaRif


Generic Name: rifampin and isoniazid (Oral route)


rif-AM-pin, eye-soe-NYE-a-zid


Oral route(Capsule)

Severe and sometimes fatal hepatitis has been reported with isoniazid therapy and may occur even after many months of treatment. The risk for hepatitis increases with advancing age and alcohol use. Monthly clinical evaluation and liver function tests should be performed .



Commonly used brand name(s)

In the U.S.


  • IsonaRif

  • Rifamate

Available Dosage Forms:


  • Capsule

  • Tablet

Therapeutic Class: Antitubercular Combination


Chemical Class: Rifamycin


Uses For IsonaRif


Rifampin and isoniazid is a combination antibiotic and anti-infective medicine. This combination medication is used to treat tuberculosis (TB). It may be taken alone or with one or more other medicines for TB.


To help clear up your tuberculosis (TB) infection completely, you must keep taking this medicine for the full time of treatment, even if you begin to feel better. This is very important. It is also important that you do not miss any doses.


Rifampin and isoniazid combination is available only with your doctor's prescription.


Before Using IsonaRif


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Rifampin and isoniazid combination is not recommended for use in children.


Geriatric


Liver problems are more likely to occur in patients over 50 years of age who are taking isoniazid-containing medicines.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Atazanavir

  • Boceprevir

  • Darunavir

  • Fosamprenavir

  • Lopinavir

  • Lurasidone

  • Nifedipine

  • Praziquantel

  • Ranolazine

  • Rilpivirine

  • Saquinavir

  • Telaprevir

  • Tipranavir

  • Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Abiraterone

  • Amiodarone

  • Amprenavir

  • Atovaquone

  • Cabazitaxel

  • Crizotinib

  • Cyclosporine

  • Dabigatran Etexilate

  • Dasatinib

  • Delavirdine

  • Dronedarone

  • Efavirenz

  • Erlotinib

  • Ethionamide

  • Etravirine

  • Everolimus

  • Imatinib

  • Indinavir

  • Irinotecan

  • Isoniazid

  • Itraconazole

  • Ixabepilone

  • Lapatinib

  • Levodopa

  • Linagliptin

  • Lorcainide

  • Maraviroc

  • Mycophenolate Mofetil

  • Nelfinavir

  • Nevirapine

  • Nilotinib

  • Pazopanib

  • Posaconazole

  • Pyrazinamide

  • Quetiapine

  • Quinine

  • Rifampin

  • Ritonavir

  • Rivaroxaban

  • Roflumilast

  • Romidepsin

  • Sirolimus

  • Sunitinib

  • Tacrolimus

  • Telithromycin

  • Temsirolimus

  • Ticagrelor

  • Tolvaptan

  • Vandetanib

  • Vemurafenib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acetaminophen

  • Acetyldigoxin

  • Aliskiren

  • Aminosalicylic Acid

  • Anisindione

  • Aprepitant

  • Atorvastatin

  • Betamethasone

  • Bexarotene

  • Bosentan

  • Buspirone

  • Carbamazepine

  • Carvedilol

  • Caspofungin

  • Chloramphenicol

  • Chlorpropamide

  • Citalopram

  • Clarithromycin

  • Clofibrate

  • Clozapine

  • Cortisone

  • Deferasirox

  • Desogestrel

  • Dexamethasone

  • Diazepam

  • Dicumarol

  • Dienogest

  • Digoxin

  • Diltiazem

  • Disopyramide

  • Disulfiram

  • Doxycycline

  • Drospirenone

  • Eltrombopag

  • Enalaprilat

  • Enalapril Maleate

  • Enflurane

  • Estradiol Cypionate

  • Estradiol Valerate

  • Ethinyl Estradiol

  • Ethionamide

  • Ethynodiol Diacetate

  • Etonogestrel

  • Fentanyl

  • Fesoterodine

  • Fluconazole

  • Fludrocortisone

  • Fosaprepitant

  • Fosphenytoin

  • Gefitinib

  • Gliclazide

  • Glyburide

  • Haloperidol

  • Isradipine

  • Ketoconazole

  • Lamotrigine

  • Leflunomide

  • Levomethadyl

  • Levonorgestrel

  • Levothyroxine

  • Linezolid

  • Losartan

  • Medroxyprogesterone Acetate

  • Mefloquine

  • Meperidine

  • Mestranol

  • Metformin

  • Methadone

  • Methylprednisolone

  • Metoprolol

  • Morphine

  • Morphine Sulfate Liposome

  • Moxifloxacin

  • Nisoldipine

  • Norelgestromin

  • Norethindrone

  • Norgestimate

  • Norgestrel

  • Oxycodone

  • Phenprocoumon

  • Phenytoin

  • Pioglitazone

  • Pirmenol

  • Pitavastatin

  • Prednisolone

  • Prednisone

  • Propafenone

  • Raltegravir

  • Repaglinide

  • Rofecoxib

  • Rosiglitazone

  • Ruxolitinib

  • Sertraline

  • Simvastatin

  • Tadalafil

  • Tamoxifen

  • Theophylline

  • Tocainide

  • Triazolam

  • Trimetrexate

  • Valproic Acid

  • Warfarin

  • Zaleplon

  • Zidovudine

  • Zolpidem

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • food

  • Tyramine Containing Food

Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Alcohol abuse (or history of) or

  • Liver disease—There may be an increased chance of getting hepatitis if you take this medicine and drink alcohol daily

  • Convulsive disorders such as seizures or epilepsy—Rifampin and isoniazid combination may increase the frequency of seizures (convulsions) in some patients

  • Kidney disease (severe)—There may be an increased chance of side effects in patients with severe kidney disease

Proper Use of rifampin and isoniazid

This section provides information on the proper use of a number of products that contain rifampin and isoniazid. It may not be specific to IsonaRif. Please read with care.


If this medicine upsets your stomach, take it with food. Antacids may also help. However, do not take aluminum-containing antacids within 1 hour of the time you take rifampin and isoniazid combination. They may keep this medicine from working properly.


To help clear up your tuberculosis (TB) completely, it is very important that you keep taking this medicine for the full time of treatment, even if you begin to feel better after a few weeks. You may have to take it every day for as long as 1 to 2 years or more. It is important that you do not miss any doses.


Your doctor may also want you to take pyridoxine (e.g., Hexa-Betalin, vitamin B 6) every day to help prevent or lessen some of the side effects of isoniazid. If it is needed, it is very important to take pyridoxine every day along with this medicine. Do not miss any doses.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For the oral dosage form (capsules):
    • For the treatment of tuberculosis:
      • Adults and older children—600 milligrams (mg) of rifampin and 300 mg of isoniazid once a day.

      • Children—This combination medicine is not recommended for use in children.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using IsonaRif


It is very important that your doctor check your progress at regular visits. In addition, you should check with your doctor immediately if blurred vision or loss of vision, with or without eye pain, occurs during treatment. He or she may want you to have your eyes checked by an ophthalmologist (eye doctor).


If your symptoms do not improve within 2 to 3 weeks, or if they become worse, check with your doctor.


Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking rifampin and isoniazid combination. Unplanned pregnancies may occur. You should use a different means of birth control while you are taking this medicine. If you have any questions about this, check with your health care professional.


Liver problems may be more likely to occur if you drink alcoholic beverages regularly while you are taking this medicine. Also, the regular use of alcohol may keep this medicine from working properly. Therefore, you should strictly limit the amount of alcoholic beverages you drink while you are taking this medicine.


Certain foods such as cheese (Swiss or Cheshire) or fish (tuna, skipjack, or Sardinella) may rarely cause reactions in some patients taking isoniazid-containing medicines. Check with your doctor if redness or itching of the skin, hot feeling, fast or pounding heartbeat, sweating, chills or clammy feeling, headache, or lightheadedness occurs after eating these foods while you are taking this medicine.


This medicine will cause the urine, stool, saliva, sputum, sweat, and tears to turn reddish-orange to reddish-brown. This is to be expected while you are taking this medicine. This effect may cause soft contact lenses to become permanently discolored. Standard cleaning solutions may not take out all the discoloration. Therefore, it is best not to wear soft contact lenses while taking this medicine. This condition will return to normal once you stop taking this medicine. Hard contact lenses are not discolored by this medicine. If you have any questions about this, check with your doctor.


If this medicine causes you to feel very tired or very weak; or causes clumsiness; unsteadiness; a loss of appetite; nausea; numbness, tingling, burning, or pain in the hands and feet; or vomiting, stop taking it and check with your doctor immediately. These may be early warning symptoms of more serious liver or nerve problems that could develop later.


Rifampin and isoniazid combination may cause blood problems. These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.


IsonaRif Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Clumsiness or unsteadiness

  • dark urine

  • loss of appetite

  • nausea and vomiting

  • numbness, tingling, burning, or pain in hands and feet

  • unusual tiredness or weakness

  • yellow eyes or skin

Less common
  • Chills

  • difficult breathing

  • dizziness

  • fever

  • headache

  • itching

  • muscle and bone pain

  • shivering

  • skin rash and redness

Rare
  • Bloody or cloudy urine

  • blurred vision or loss of vision, with or without eye pain

  • convulsions (seizures)

  • depression

  • greatly decreased frequency of urination or amount of urine

  • mood or mental changes

  • sore throat

  • unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Diarrhea

  • stomach pain or upset

Less common
  • Sore mouth or tongue

This medicine commonly causes reddish-orange to reddish-brown discoloration of urine, stool, saliva, sputum, sweat, and tears. This side effect does not usually require medical attention.


Dark urine and yellowing of the eyes or skin (signs of liver problems) are more likely to occur in patients 50 years of age and older.


Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: IsonaRif side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More IsonaRif resources


  • IsonaRif Side Effects (in more detail)
  • IsonaRif Use in Pregnancy & Breastfeeding
  • IsonaRif Drug Interactions
  • IsonaRif Support Group
  • 0 Reviews for IsonaRif - Add your own review/rating


  • Isonarif MedFacts Consumer Leaflet (Wolters Kluwer)

  • Rifamate Prescribing Information (FDA)

  • Rifamate Concise Consumer Information (Cerner Multum)



Compare IsonaRif with other medications


  • Tuberculosis, Active

Thursday 26 July 2012

Celestoderm-V



Generic Name: betamethasone valerate (Topical application route)


bay-ta-METH-a-sone VAL-er-ate


Commonly used brand name(s)

In the U.S.


  • Betamethacot

  • Beta-Val

  • Luxiq

  • Qualisone

  • Valisone

In Canada


  • Betacort Scalp Lotion

  • Betnovate

  • Betnovate-1/2

  • Celestoderm-V

  • Celestoderm-V/2

  • Ectosone Mild-Lotion

  • Ectosone Regular-Cream

  • Ectosone Regular-Lotion

  • Ectosone Scalp Lotion

  • Metaderm Mild

  • Metaderm Regular

  • Novo-Betamet

Available Dosage Forms:


  • Gel/Jelly

  • Ointment

  • Lotion

  • Cream

  • Foam

Therapeutic Class: Corticosteroid, Intermediate


Pharmacologic Class: Betamethasone


Uses For Celestoderm-V


Betamethasone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. Betamethasone foam is used for scalp problems. This medicine is a corticosteroid (cortisone-like medicine or steroid).


This medicine is available only with your doctor's prescription.


Before Using Celestoderm-V


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of betamethasone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. For the foam form, safety and efficacy have not been established.


Geriatric


No information is available on the relationship of age to the effects of betamethasone topical in geriatric patients.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Cushing's syndrome (adrenal gland disorder) or

  • Diabetes or

  • Hyperglycemia (high blood sugar) or

  • Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

  • Infection of the skin at or near the place of application or

  • Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of betamethasone

This section provides information on the proper use of a number of products that contain betamethasone. It may not be specific to Celestoderm-V. Please read with care.


It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.


This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.


This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.


To use cream, lotion, or ointment:


  • Wash your hands with soap and water before and after using this medicine.

  • Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.

  • With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.

  • Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

  • If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.

  • If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

To use the foam:


  • This medicine comes with a patient information insert. Read and follow the instructions carefully.

  • Wash your hands with soap and water before and after using this medicine.

  • Turn the can upside down and place a small amount of medicine in a saucer or any cool, clean surface. Do not put the foam directly in your hands. This will melt the foam immediately upon contact with warm skin.

  • Move the hair away and put a small amount of the foam on the affected areas of the scalp. Massage it in gently until the medicine has dried.

  • Do not wash or rinse the treated areas immediately after applying the medicine.

  • Do not use this medicine near heat, open flame, or while smoking.

Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For redness, itching, and swelling of the skin:
    • For topical dosage forms (cream and ointment):
      • Adults—Apply to the affected area of the skin one to three times per day.

      • Children—Use and dose must be determined by your doctor.


    • For topical dosage form (lotion):
      • Adults—Apply a few drops to the affected area of the skin two times per day (morning and evening).

      • Children—Use and dose must be determined by your doctor.



  • For scalp problems:
    • For topical dosage form (foam):
      • Adults—Apply to the affected area of the scalp two times per day (once in the morning and once at night).

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


Storage


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Store the can of the foam at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.


Precautions While Using Celestoderm-V


It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.


If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.


Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.


Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.


Do not use cosmetics or other skin care products on the treated areas.


Celestoderm-V Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Burning, itching, or stinging at the application site

Less common
  • Hair loss

  • thinning of the hair

Incidence not known
  • Blistering, burning, crusting, dryness, or flaking of the skin

  • irritation

  • itching, scaling, severe redness, soreness, or swelling of the skin

  • redness and scaling around the mouth

  • thinning of the skin with easy bruising, especially when used on where the skin folds together (e.g. between the fingers)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Acne or pimples

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

Incidence not known
  • Burning and itching of the skin with pinhead-sized red blisters

  • burning, itching, and pain in hairy areas, or pus at the root of the hair

  • increased hair growth on the forehead, back, arms, and legs

  • lightening of normal skin color

  • lightening of treated areas of dark skin

  • reddish purple lines on the arms, face, legs, trunk, or groin

  • softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Celestoderm-V resources


  • Celestoderm-V Use in Pregnancy & Breastfeeding
  • Celestoderm-V Drug Interactions
  • Celestoderm-V Support Group
  • 13 Reviews for Celestoderm-V - Add your own review/rating


Compare Celestoderm-V with other medications


  • Atopic Dermatitis
  • Dermatitis
  • Dermatological Disorders
  • Lichen Planus
  • Lichen Sclerosus

Azilect 1 mg Tablets






AZILECT 1 mg tablets


Rasagiline



Read all of this leaflet carefully before you start taking this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




In this leaflet:


  • 1. What AZILECT is and what it is used for

  • 2. Before you take AZILECT

  • 3. How to take AZILECT

  • 4. Possible side effects

  • 5. How to store AZILECT

  • 6. Further information




What Azilect Is And What It Is Used For


AZILECT is used for the treatment of Parkinson’s disease. It can be used together with or without levodopa (another medicine that is used to treat Parkinson’s disease).


With Parkinson’s disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a chemical in the brain involved in movement control. AZILECT helps to increase and sustain levels of dopamine in the brain.




Before You Take Azilect




Do not take AZILECT


  • if you are allergic (hypersensitive) to rasagiline or any of the other ingredients of AZILECT.

  • if you have severe liver problems.


Do not take the following medicines while taking AZILECT:


  • monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson’s disease, or used for any other indication), including medicinal and natural products without prescription e.g. St. John's Wort.

  • pethidine (a strong pain killer).

You must wait at least 14 days after stopping AZILECT treatment and starting treatment with MAO inhibitors or pethidine.




Take special care with AZILECT


  • if you have mild to moderate liver problems

  • You should speak with your doctor about any suspicious skin changes.


Children


AZILECT is not recommended for use under the age of 18.




Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription or if you are smoking or intend to stop smoking.



Ask your doctor for advice before taking any of the following medicines together with AZILECT:


  • Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants)

  • the antibiotic ciprofloxacin used against infections

  • the cough suppressant dextromethorphan

  • sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine

The use of AZILECT together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.


If you are starting treatment with AZILECT, you should wait at least 5 weeks after stopping fluoxetine treatment.


If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping AZILECT treatment.




Taking AZILECT with food and drink


AZILECT may be taken with or without food.




Pregnancy and breast-feeding


Ask your doctor or pharmacist for advice before taking any medicine.




Driving and using machines


No studies on the effects on the ability to drive and use machines have been performed. Ask your doctor for advice prior to driving or using machines.





How To Take Azilect


Always take AZILECT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.


The usual dose of AZILECT is 1 tablet of 1 mg taken by mouth once daily. AZILECT may be taken with or without food.



If you take more AZILECT than you should


If you think that you may have taken too many AZILECT tablets, contact your doctor or pharmacist immediately. Take the AZILECT carton/bottle with you to show the doctor or pharmacist.




If you forget to take AZILECT


Do not take a double dose to make up for a forgotten dose. Take the next dose normally, when it is time to take it.




If you stop taking AZILECT


Do not stop taking AZILECT without first talking to your doctor.



If you have any further questions on the use of this product, ask your doctor or pharmacist.




Possible Side Effects


Like all medicines, AZILECT can cause side effects, although not everybody gets them.


The following side effects have been reported in placebo controlled clinical trials:



The frequency of possible side effects listed below is defined using the following convention:



  • Very common (affects more than 1 user in 10)


  • Common (affects 1 to 10 users in 100)


  • Uncommon (affects 1 to 10 users in 1,000)


  • Rare (affects 1 to 10 users in 10,000)


  • Very rare (affects less than 1 user in 10,000)


  • Not known (frequency cannot be estimated from the available data)

Very common


  • abnormal movements (dyskinesia)

  • headache

Common:


  • abdominal pain

  • fall

  • allergy

  • fever

  • flu (influenza)

  • general feeling of being unwell (malaise)

  • neck pain

  • chest pain (angina pectoris)

  • low blood pressure when rising to a standing position with symptoms like dizziness/light-headedness (orthostatic hypotension)

  • decreased appetite

  • constipation

  • dry mouth

  • nausea and vomiting

  • flatulence

  • abnormal results of blood tests (leucopenia)

  • joint pain (arthralgia)

  • musculoskeletal pain

  • joint inflammation (arthritis)

  • numbness and muscle weakness of the hand (carpal tunnel syndrome)

  • decreased weight

  • abnormal dreams

  • difficulty in muscular co-ordination (balance disorder)

  • depression

  • dizziness (vertigo)

  • prolonged muscle contractions (dystonia)

  • runny nose (rhinitis)

  • irritation of the skin (dermatitis)

  • rash

  • bloodshot eyes (conjunctivitis)

  • urinary urgency

Uncommon:


  • stroke (cerebrovascular accident)

  • heart attack (myocardial infarction)

  • blistering rash (vesiculobullous rash)

In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials.


Nevertheless, scientific evidence suggests that Parkinson’s disease, and not any medicine in particular, is associated with a higher risk of skin cancer (not exclusively melanoma). You should speak with your doctor about any suspicious skin changes.


Parkinson's disease is associated with symptoms of hallucinations and confusion.


In post marketing experience these symptoms have also been observed in Parkinson's disease patients treated with AZILECT.


If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




How To Store Azilect


Keep out of the reach and sight of children.


Do not use AZILECT after the expiry date which is stated on the carton, bottle or blister. The expiry date refers to the last day of that month.


Do not store above 25°C.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information



What AZILECT contains


  • The active substance is rasagiline. Each tablet contains 1 mg rasagiline (as mesilate).

  • The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid, talc.



What AZILECT looks like and contents of the pack


AZILECT tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.


The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets or in a bottle containing 30 tablets.


Not all pack sizes may be marketed.




Marketing Authorisation Holder and Manufacturer


Marketing Authorisation Holder



Teva Pharma GmbH

Kandelstrasse 10

D-79199 Kirchzarten

Germany


Manufacturer



Teva Pharmaceuticals Europe B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands



For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
































United Kingdom

Lundbeck Limited

Lundbeck House

Caldecotte Lake Business Park

Caldecotte

Milton Keynes

MK7 8LG

UK

Tel:+44 1908 64 9966




This leaflet was last approved in November 2009





Survanta





Survanta



Beractant



IMPORTANT INFORMATION




Read all of this leaflet carefully before this medicine is used.



Keep this leaflet; you may want to read it again later.



If you have any questions, please ask your doctor or pharmacist (chemist).



This medicine has been prescribed for your child. It should not be given to anyone else. It may harm them, even if their symptoms are similar to those of your child.





In this leaflet:



1. Why does this medicine need to be used?

2. How does this medicine work?

3. Before Survanta is used

4. How Survanta is used

5. Possible side effects

6. Storing Survanta

7. What is in Survanta?

8. Addresses






Why does this medicine need to be used?



Your baby will be/has been given Survanta because he or she is at risk of developing, or is suffering from, a condition called Respiratory Distress Syndrome (hyaline membrane disease) which may cause severe breathing difficulties.



Survanta is indicated for treatment of Respiratory Distress Syndrome (RDS) in newborn premature infants with a birth weight of 700 g or greater and who have had a tube inserted and are on a mechanical ventilator to help them breathe.



Survanta is also used for the treatment of premature babies, when the pregnancy has lasted for less than 32 weeks, at risk of developing RDS.





How does this medicine work?



Respiratory Distress Syndrome occurs in some babies, particularly premature babies, who lack a substance usually produced in the lungs known as surfactant. This surfactant lines the inside of the lungs, stopping them from sticking together, so that the baby can breathe normally.



Survanta is a natural surfactant extracted from cows lungs (See Section 7) and it acts in a similar way to your baby's own surfactant, helping your baby to breathe normally.





Before Survanta is used



Your baby will only be given Survanta if the equipment for ventilation and monitoring babies with Respiratory Distress Syndrome is available.





How Survanta is used



The dosage of Survanta varies for each child depending on their body weight. The usual dose is 100 mg Survanta per kg body weight. The doctor will calculate the right dose. Usually the first dose will be given as soon as possible after birth (usually within 15 minutes) or as soon as possible after Respiratory Distress Syndrome has been diagnosed (usually within 8 hours of birth).



The dose of Survanta will be administered to your baby via a tube already in place in your baby's windpipe. Do not be concerned if your baby is disconnected from its ventilator while Survanta is being administered. To make sure that Survanta reaches all parts of your baby’s lungs, the dose is split into smaller doses and your baby’s position altered before each part of the dose is given.



The dose may be repeated up to three times at six hourly intervals within 48 hours. Survanta will be warmed to room temperature before administration to your baby.





Survanta Side Effects



Like all medicines, Survanta can cause side effects although not everybody gets them. Some side effects that have been seen with Survanta are as follows:



  • Cases of bleeding in the lungs have been reported with Survanta.

  • Bleeding in the brain has been observed in babies who received Survanta but the occurrence of this is no different from what would be expected in untreated babies of the same age.

  • Blockage of the breathing tube that has been inserted into your baby's windpipe, has been reported.

If you have any questions about your baby's treatment which are not answered by this leaflet, ask the doctor.



During the dosing procedure, occasional episodes of slow heartbeat (bradycardia) and/or oxygen reduction in the circulation have been reported. If these occur, dosing will be stopped and appropriate measures to relieve the condition will be started. After stabilisation, the dosing procedure will be resumed.





Storing Survanta



  • Survanta should not be used after the expiry date shown on the label.

  • Survanta should have been stored in a refrigerator and protected from light; however before it is given to your baby it will be warmed to room temperature.

  • Survanta must not be frozen. Any product that has been frozen by mistake should be thrown away.

  • Each vial of Survanta is for single use only. Used vials with medicine left in them should be thrown away.

  • If any vial is not used within 8 hours of re-warming to room temperature it should be thrown away. Vials should not be returned to the refrigerator once warmed.




What is in Survanta?



Survanta contains the active ingredient beractant which is a mixture containing phospholipids (25 mg/ml), free fatty acids (1.4 -3.5 mg/ml), triglycerides (0.5 -1.75 mg/ml) and protein (0.1 -1.0 mg/ml). In addition to the active ingredient Survanta also contains sodium chloride, sodium hydroxide, hydrochloric acid, palmitic acid, dipalmitoyl phosphatidylcholine, tripalmitin and water.



Survanta is a sterile suspension and is supplied in a single use glass vial containing 8 ml (200 mg phospholipids). Packs of l, 3, and 10 vials are available.*



*Not all pack sizes may be marketed.





Addresses



Marketing Authorisation Holder:




Abbott Laboratories Ltd.

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

Berkshire
SL6 4XE

UK



The company responsible for manufacture is




Abbott Logistics, BV

Meeuwenlaan 4

8011 BZ

Zwolle

Netherlands




This leaflet was last approved in: July 2010



List 1039-53





03-A372






Wednesday 25 July 2012

Actos



Pronunciation: PYE-oh-GLI-ta-zone
Generic Name: Pioglitazone
Brand Name: Actos

Thiazolidinedione antidiabetics such as Actos may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Actos should not be used to treat patients with moderate to severe heart failure. You will be monitored for signs of heart failure when you start Actos and when your dose increases. Contact your doctor at once if you develop swelling of the hands, ankles, or feet; shortness of breath; or sudden, unexplained weight gain. Your doctor may need to stop your medicine or change your dose.





Actos is used for:

Treating type 2 diabetes in certain patients. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.


Actos is a thiazolidinedione antidiabetic. It works by lowering blood sugar by making the cells of the body more sensitive to the action of insulin.


Do NOT use Actos if:


  • you are allergic to any ingredient in Actos

  • you have bladder cancer or moderate to severe heart failure

  • you have type 1 diabetes or diabetic ketoacidosis (a certain, severe problem associated with diabetes)

  • you have a history of liver problems, including jaundice (yellowing of the skin or eyes), during therapy with a similar medicine called troglitazone

Contact your doctor or health care provider right away if any of these apply to you.



Before using Actos:


Some medical conditions may interact with Actos. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of liver problems, abnormal liver function tests, heart problems (eg, congestive heart failure [CHF]), bladder cancer, or eye or vision problems (eg, macular edema)

  • if you have swelling problems (edema)

Some MEDICINES MAY INTERACT with Actos. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Gemfibrozil, insulin, or oral antidiabetic medicines (eg, glipizide) because the risk of low blood sugar may be increased

  • Rifampin because it may decrease Actos's effectiveness, resulting in high blood sugar

  • Anticoagulants (eg, warfarin) because the risk of their side effects may be increased or their effectiveness may be decreased by Actos

This may not be a complete list of all interactions that may occur. Ask your health care provider if Actos may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Actos:


Use Actos as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Actos comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Actos refilled.

  • Take Actos by mouth with or without food.

  • Continue to take Actos even if you feel well. Do not miss any doses.

  • Taking Actos at the same time each day will help you remember to take it.

  • If you miss a dose of Actos, skip the missed dose and go back to your regular dosing schedule, unless your doctor directs you otherwise. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Actos.



Important safety information:


  • Carry an ID card at all times that says you have diabetes.

  • Proper diet, regular exercise, and regular blood sugar testing are important for best results with Actos. Follow the diet and exercise program given to you by your health care provider.

  • Check your blood sugar levels as directed by your doctor. If they are often higher than they should be and you take Actos exactly as prescribed, tell your doctor.

  • It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.

  • It may take 2 to 3 months to get the full effect from Actos. Do NOT take more than the recommended dose without checking with your doctor.

  • Actos may cause low blood sugar levels when it is used along with insulin or other oral diabetic medicines. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.

  • Actos may cause ovulation in women who have not reached menopause but do not ovulate. Be sure to use effective birth control while using Actos.

  • Tell your doctor or dentist that you take Actos before you receive any medical or dental care, emergency care, or surgery.

  • Actos may be associated with an increased risk of bladder cancer. Tell your doctor right away if you notice symptoms that could be associated with bladder cancer (eg, a red color or blood in the urine, difficult or painful urination, an increased need to urinate). Discuss any questions or concerns with your doctor.

  • An increased incidence of bone fracture has been reported in women who take Actos. Tell your doctor if you have a history of bone fracture, low calcium intake, or weak bones (eg, osteoporosis). Tell your doctor right away if you experience any unusual bone pain.

  • Lab tests, including fasting blood sugar, hemoglobin A1c, eye examinations, and liver function, may be performed while you use Actos. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Actos should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Actos while you are pregnant. It is not known if Actos is found in breast milk. Do not breast-feed while taking Actos.


Possible side effects of Actos:


All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Cold-like symptoms; headache; muscle aches; sinus pain; sore throat; weight gain.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; swelling of the hands, ankles, or feet; symptoms of heart failure (eg, shortness of breath; sudden, unexplained weight gain); symptoms of liver problems (eg, dark urine; stomach pain; unexplained nausea, vomiting, or loss of appetite; yellowing of the skin or eyes); symptoms of low blood sugar (eg, anxiety; chills, increased hunger, headache; increased dizziness or drowsiness; tremors); unusual bone pain; unusual tiredness or weakness.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Actos side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Actos:

Store Actos between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Actos out of the reach of children and away from pets.


General information:


  • If you have any questions about Actos, please talk with your doctor, pharmacist, or other health care provider.

  • Actos is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Actos. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Actos resources


  • Actos Side Effects (in more detail)
  • Actos Use in Pregnancy & Breastfeeding
  • Drug Images
  • Actos Drug Interactions
  • Actos Support Group
  • 26 Reviews for Actos - Add your own review/rating


  • Actos Prescribing Information (FDA)

  • Actos Monograph (AHFS DI)

  • Actos Advanced Consumer (Micromedex) - Includes Dosage Information

  • Actos Consumer Overview



Compare Actos with other medications


  • Diabetes, Type 2
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Monday 23 July 2012

Provera



Generic Name: medroxyprogesterone (oral) (me DROX ee proe JES ter one)

Brand Names: Provera


What is medroxyprogesterone?

Medroxyprogesterone is a progestin (a form of progesterone), a female hormone that helps regulate ovulation (the release of an egg from an ovary) and menstrual periods.


Medroxyprogesterone is used to treat conditions such as absent or irregular menstrual periods, or abnormal uterine bleeding. Medroxyprogesterone is also used to decrease the risk of endometrial hyperplasia (a condition that may lead to uterine cancer) while taking estrogens.


Medroxyprogesterone is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.


Medroxyprogesterone may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about medroxyprogesterone?


You should not use this medication if you are pregnant, or if you have liver disease, a hormone-related cancer such as breast or uterine cancer, a history of stroke or blood clot, or abnormal vaginal bleeding that has not been checked by a doctor. Medroxyprogesterone will not prevent heart disease, breast cancer, or dementia, and may actually increase the risk of developing these conditions in post-menopausal women. Medroxyprogesterone may also increase the risk of uterine or ovarian cancer in some women. Long-term treatment with estrogens and progestins (such as medroxyprogesterone) may also increase your risk of heart attack, blood clot, or stroke.

Talk to your doctor about your specific risks and benefits of taking this medication, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.


What should I discuss with my healthcare provider before taking medroxyprogesterone?


FDA pregnancy category X. Medroxyprogesterone can cause birth defects. Do not use if this medication you are pregnant. Tell your doctor right away if you become pregnant during treatment. You should not use this medication if you are allergic to medroxyprogesterone, or if you have:

  • abnormal vaginal bleeding that has not been diagnosed;




  • a hormone-related cancer such as breast or uterine cancer;




  • liver disease; or




  • a history of stroke or blood clot.



If you have any of these other conditions, you may need a dose adjustment or special tests to safely take medroxyprogesterone:



  • heart disease, congestive heart failure, recent stroke or heart attack




  • high blood pressure;




  • high cholesterol or triglycerides;




  • low levels of calcium in your blood;




  • severe pelvic pain;




  • recent miscarriage or abortion;




  • epilepsy;




  • asthma;




  • migraine headaches;




  • a thyroid disorder;



  • kidney disease,


  • diabetes; or




  • lupus.




Medroxyprogesterone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Medroxyprogesterone will not prevent heart disease, breast cancer, or dementia, and may actually increase the risk of developing these conditions in post-menopausal women. Medroxyprogesterone may also increase the risk of uterine or ovarian cancer in some women. Long-term treatment with estrogens and progestins (such as medroxyprogesterone) may also increase your risk of heart attack, blood clot, or stroke.

Talk to your doctor about your specific risks and benefits of taking this medication, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.


How should I take medroxyprogesterone?


Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.


Medroxyprogesterone is usually given for only a few days in a row each month. You may need to start taking the medication on a certain day of your menstrual cycle, depending on why you are taking medroxyprogesterone. Follow your doctor's instructions.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using medroxyprogesterone.


This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are taking medroxyprogesterone.


Store medroxyprogesterone at room temperature away from moisture and heat.

See also: Provera dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, breast tenderness, dizziness, drowsiness, or vaginal bleeding.


What should I avoid while taking medroxyprogesterone?


Avoid smoking while you are taking this medication. Smoking greatly increases your risk of blood clots.

Medroxyprogesterone side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;




  • sudden headache, confusion, problems with vision, speech, or balance;




  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate;




  • pain or swelling in one or both legs;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;




  • vaginal bleeding if you have already gone through menopause;




  • feeling like you might pass out;




  • a breast lump;




  • symptoms of depression (sleep problems, dizziness, mood changes, headache);




  • fever;




  • jaundice (yellowing of the skin or eyes); or




  • swelling in your hands, ankles, or feet.



Less serious side effects may include:



  • spotting or breakthrough bleeding;




  • changes in your menstrual periods;




  • vaginal itching or discharge;




  • breast tenderness or discharge;




  • mild itching or skin rash;




  • increased acne, hair growth, loss of scalp hair;




  • sleep problems (insomnia);




  • changes in appetite or weight,




  • mild stomach pain, bloating, nausea; or




  • skin color changes.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect medroxyprogesterone?


There may be other drugs that can interact with medroxyprogesterone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More Provera resources


  • Provera Side Effects (in more detail)
  • Provera Dosage
  • Provera Use in Pregnancy & Breastfeeding
  • Drug Images
  • Provera Drug Interactions
  • Provera Support Group
  • 21 Reviews for Provera - Add your own review/rating


  • Provera Prescribing Information (FDA)

  • Provera MedFacts Consumer Leaflet (Wolters Kluwer)

  • Provera Advanced Consumer (Micromedex) - Includes Dosage Information

  • Depo-Provera Prescribing Information (FDA)

  • Depo-Provera Injectable Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Depo-Provera Consumer Overview

  • Depo-Provera Advanced Consumer (Micromedex) - Includes Dosage Information

  • Depo-SubQ Provera 104 Prescribing Information (FDA)

  • Medroxyprogesterone Prescribing Information (FDA)

  • Medroxyprogesterone Acetate Monograph (AHFS DI)

  • depo-subQ provera 104 Injectable Suspension (Subcutaneous) MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Provera with other medications


  • Abnormal Uterine Bleeding
  • Amenorrhea
  • Birth Control
  • Endometrial Cancer
  • Endometrial Hyperplasia, Prophylaxis
  • Endometriosis
  • Renal Cell Carcinoma


Where can I get more information?


  • Your pharmacist can provide more information about medroxyprogesterone.

See also: Provera side effects (in more detail)


Sunday 22 July 2012

Clindamycin Phosphate topical



Class: Antibacterials
VA Class: DE101
CAS Number: 24729-96-2
Brands: BenzaClin, Cleocin, Cleocin T, Clinda-Derm, Clindagel, Clindesse, Clindets, Duac

Introduction

Antibacterial; broad-spectrum antibiotic derived from lincomycin.5 6 7 100


Uses for Clindamycin Phosphate


Acne Vulgaris


Treatment of inflammatory acne vulgaris; used alone or in conjunction with benzoyl peroxide.1 178 179 186 187


Generally effective for treatment of mild to moderate inflammatory acne.a 186 187


May induce bacterial resistance when used as monotherapy;186 187 resistance associated with decreased clinical efficacy.186


Particularly useful when used in combination with benzoyl peroxide or topical retinoids;186 187 reduction in total lesion count of 50–70% reported when combination therapy used.186


Bacterial Vaginosis


Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).100 101 102 103 104 105 107 109 114 115 120 131 132 133 145 176 177 180


CDC recommends treatment of bacterial vaginosis in all symptomatic women (including pregnant women).101 In addition, asymptomatic pregnant women at high risk for complications of pregnancy should be screened (preferably at the first prenatal visit) and treatment initiated if needed.101


Treatment recommendations for bacterial vaginosis in HIV-infected women are the same as those for women without HIV infection.101


Regimens of choice in nonpregnant women are a 7-day regimen of oral metronidazole; a 5-day regimen of intravaginal metronidazole gel; or a 7-day regimen of intravaginal clindamycin cream;101 alternative regimens are a 7-day regimen of oral clindamycin or 3-day regimen of intravaginal clindamycin suppositories.101 The preferred regimens for pregnant women are a 7-day regimen of oral metronidazole or oral clindamycin.101


Regardless of regimen used, relapse or recurrence is common;101 102 114 115 132 136 an alternative regimen (e.g., oral therapy when topical was used initially) may be used in such situations.101 120


Routine treatment of asymptomatic male sexual contacts of women who have relapsing or recurrent bacterial vaginosis not recommended.101


Clindamycin Phosphate Dosage and Administration


Administration


Administer topically to the skin1 178 179 or intravaginally100 176 180 in appropriate formulations.


Topical skin preparations are for external use only and should not be used orally, intravaginally, or near or in eyes or mucous membranes.178 179


Intravaginal preparations are for intravaginal administration only and should not be used orally, topically on the skin, or near or in eyes.a


Topical Administration


Apply topically to the skin as a gel, lotion, or solution containing clindamycin 1%1 or as a gel containing clindamycin 1% in combination with benzoyl peroxide 5%.178 179 Apply to all areas of skin prone to acne.186


Do not use near eyes, nose, mouth, or other mucous membranes.178 179


Shake lotion well immediately prior to use.1


Remove solution-containing pledgets from their foil immediately before use; do not use if seal is broken.1 Use each pledget only once and then discard; may use more than 1 pledget for each application if needed to cover the affected area.1


Reconstitution

BenzaClin

Prepare BenzaClin topical gel containing clindamycin and benzoyl peroxide at the time of dispensing.179


Reconstitute vial containing clindamycin powder by adding 5 mL of purified water and shaking immediately to completely dissolve the drug; if needed, add additional purified water to bring level up to the mark on the vial.179


Add the reconstituted clindamycin solution to the benzyl peroxide gel provided by the manufacturer; stir until homogenous in appearance (1 to 1.5 minutes).179


Duac

Duac topical gel containing clindamycin and benzoyl peroxide does not need reconstitution and is used as provided by the manufacturer.178


Intravaginal Topical Administration


Administer intravaginally as a cream containing clindamycin 2% or as 100-mg vaginal suppositories.100 101 103 104 105 107 114 131 145 180


Dosage


Pediatric Patients


Acne Vulgaris

Maintenance therapy needed to prevent recurrence.186


Single-entity Clindamycin Preparations

Topical

Children ≥12 years of age: apply a thin film of gel, lotion, or solution to the cleansed affected area twice daily.1


Clindamycin and Benzoyl Peroxide Combination Preparations

Topical

Children ≥12 years of age: apply a thin film of BenzaClin gel to the cleansed affected area twice daily (morning and evening) or as directed by clinician.179


Children ≥12 years of age: apply a thin film of Duac gel to the cleansed affected areas once daily in the evening or as directed by clinician.178


Bacterial Vaginosis

Treatment in Nonpregnant Postmenarchal Females

Intravaginal

Clindesse vaginal cream: One applicatorful (single dose).180


Vaginal suppositories: 1 suppository daily (preferably at bedtime) for 3 days.176


Adults


Acne Vulgaris

Maintenance therapy needed to prevent recurrence.186


Treatment with Single-entity Clindamycin Preparations

Topical

Apply a thin film of gel, lotion, or solution to the cleansed affected area twice daily.1


Treatment with Clindamycin and Benzoyl Peroxide Combination Preparations

Topical

BenzaClin gel: apply a thin film to the cleansed affected area twice daily (morning and evening) or as directed by clinician.179


Duac gel: apply a thin film to the cleansed affected areas once daily in the evening or as directed by clinician.178


Bacterial Vaginosis

Treatment in Nonpregnant Women

Intravaginal

Cleocin vaginal cream: 1 applicatorful once daily (preferably at bedtime) for 3 or 7 consecutive days.100 101 104 105 107 CDC recommends a 7-day regimen.101


Clindesse vaginal cream: One applicatorful (single dose).180


Vaginal suppositories: 1 suppository once daily (preferably at bedtime) for 3 consecutive days.101 176


Treatment in Pregnant Women

Intravaginal

Vaginal cream: 1 applicatorful once daily (preferably at bedtime) for 7 consecutive days.163 164


Cautions for Clindamycin Phosphate


Contraindications



  • Hypersensitivity to clindamycin, lincomycin, or any ingredient in the formulations.1 100 178 179




  • History of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.1 100 176 178 179



Warnings/Precautions


Warnings


Clostridium difficile-associated Diarrhea

Treatment with anti-infectives may permit overgrowth of Clostridium difficile.1 100 176 178 179 180 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with use of topical or systemic clindamycin.1 100 176 178 179 180 Consider CDAD if diarrhea develops during or following topical or intravaginal clindamycin therapy and manage accordingly.1 100 176 178 179 180 181 182 183 184 185


Some mild cases of CDAD may respond to discontinuance alone.1 100 176 178 179 180 181 182 183 184 185 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.1 100 176 178 179 180 181 182 183 184 185


Sensitivity Reactions


Contact dermatitis has been reported following use of topical clindamycin.a


Consider possibility that patients who become sensitized to topical clindamycin also may be sensitive to systemic clindamycin or lincomycin.a


Urticaria, rash, application-site pain, and pruritus occur rarely.100 145 176


Use topical gel, lotion, and solution with caution in atopic individuals.1


General Precautions


Superinfection

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.176 178 179


Vaginal and nonvaginal candidiasis (moniliasis) and vaginitis have occurred with intravaginal clindamycin.176


Gram-negative folliculitis has been reported rarely following topical clindamycin.a


If suprainfection or superinfection occurs, discontinue the drug and institute appropriate therapy.a 178 179


Vaginal Intercourse and Use of Vaginal Products

Patients receiving intravaginal clindamycin should not engage in vaginal intercourse and should refrain from use of vaginal products (e.g., douches, tampons) during the entire course of therapy.100 103 105 107 131 176


Efficacy of clindamycin could be reduced (e.g., by dislodgment and/or dilution, by increased vaginal pH secondary to deposition of semen).120 147


Latex or rubber products (e.g., condoms, vaginal contraceptive diaphragms) are weakened by oleaginous bases (e.g., mineral oil) in vaginal cream and suppositories and may not be effective as contraceptives and/or microbial barriers if used within 72 hours following intravaginal Cleocin or within 5 days following intravaginal Clindesse.100 176 180


Systemic Adverse Effects

Clindamycin is absorbed following topical or intravaginal application,1 100 176 178 179 and can be absorbed in sufficient amounts to produce systemic effects.1 100 176 (See Clostridium difficile-associated Colitis under Cautions.)


Administration Precautions

Vaginal cream may cause ocular burning and irritation; avoid contact with the eyes, and irrigate eyes with copious amounts of cool water if contact occurs.100 150


Topical solution contains alcohol which can burn and irritate sensitive surfaces (e.g., eyes, abraded skin, mucous membranes); bathe surfaces with copious amounts of cool water if contact occurs.1


Topical solution has an unpleasant taste; use caution when applying around the mouth.a


Specific Populations


Pregnancy

Category B (topical and vaginal single-entity clindamycin preparations).a 1 100 180


Category C (topical combination preparations containing clindamycin and benzoyl peroxide).178 179


CDC states clindamycin vaginal preparations should be used only during the first half of pregnancy.101


Lactation

Distributed into milk following systemic administration; not known whether clindamycin is distributed into milk following topical or intravaginal administration.1 100


Discontinue nursing or the drug.1 100 178 179


Pediatric Use

Safety and efficacy of single-entity topical gel, lotion, or solution containing clindamycin not established in children <12 years of age.1


Safety and efficacy of topical gels containing clindamycin in combination with benzoyl peroxide not established in children <12 years of age.178 179


Safety and efficacy of vaginal cream (Cleocin) not established in children <16 years of age.100 150


Safety and efficacy of vaginal suppositories (Cleocin) and vaginal cream (Clindesse) established in postmenarchal females based on extrapolation of data from adult women; safety and efficacy not established in premenarchal females.176 180


Geriatric Use

Insufficient experience with vaginal or topical clindamycin preparations in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.1 100 176 180


Common Adverse Effects


Topical application to the skin: burning, pruritus, dryness, erythema, oily skin, peeling.1 178 179


Intravaginal administration: vaginal candidiasis, vulvovaginitis, vulvovaginal disorder, trichomonal vaginitis, vaginal pain, body moniliasis, fungal infection.100 176 180


Interactions for Clindamycin Phosphate


Because clindamycin can be absorbed systemically following topical application to the skin or following intravaginal administration, the possibility that drug interactions could occur with these routes should be considered.100 108


Specific Drugs



























Drug



Interaction



Comments



Alcohol (e.g., in astringents, after-shave lotions)



Possible cumulative irritant or drying effecta



Erythromycin



In vitro evidence of antagonisma 179



Do not use concomitantlya 178 179



Neuromuscular blocking agents (e.g., ether, tubocurarine, pancuronium)



Systemically absorbed clindamycin after intravaginal administration has potential for enhanced neuromuscular blocking action100 125 126 176



Use intravaginal clindamycin with caution in patients receiving neuromuscular blocking agents; observe for neuromuscular blockade prolongation 100 125 126 176



Salicylic acid



Possible cumulative irritant effecta



Use with cautiona



Soap (abrasive, medicated)



Possible cumulative irritant or drying effecta



Sulfur



Possible cumulative irritant effecta



Use with cautiona



Tretinoin



Possible cumulative irritant effecta



Use with cautiona


Clindamycin Phosphate Pharmacokinetics


Absorption


Bioavailability


Absorbed systemically following topical or intravaginal administration.1 100 108 176


Approximately 5% of an intravaginal dose of clindamycin 2% vaginal cream (Cleocin) is absorbed systemically; peak serum concentrations attained approximately 14 hours after the intravaginal dose.100


Systemic absorption following intravaginal administration of Clindesse vaginal cream is reported to be lower than that following administration of Cleocin vaginal cream.180


Following intravaginal administration of vaginal suppository (100-mg vaginal suppository once daily for 3 days), almost 30% of the dose is absorbed systemically.176


Distribution


Not fully characterized following intravaginal administration.150


Elimination


Not fully characterized following intravaginal administration.150


Half-life


1.5–2.6 hours following intravaginal administration of vaginal cream (Cleocin).100


11 hours (range: 4–35 hours) following intravaginal administration of vaginal suppository.176


Stability


Storage


Topical


Gel, Lotion, or Solution

Tight container at 20–25°C; do not freeze.1


Clindamycin and Benzoyl Peroxide Gel Combinations

BenzaClin: room temperature ≤25°C before or after dispensing.179 Stable for 3 months following reconstitution of clindamycin powder and mixture with benzoyl peroxide gel.179


Duac: 2–8°C before dispensing.178 Stable at room temperature ≤25°C for 60 days after dispensing; do not freeze.178


Intravaginal


Cream

Cleocin: 20–25°C; do not freeze.1


Clindesse: 25°C (may be exposed to 15–30°C).180 Avoid temperatures >30°C.180


Suppositories

25°C (may be exposed to 15–30°C).176 Avoid temperatures >30°C and avoid high humidity.176


Actions and SpectrumActions



  • May be bactericidal or bacteriostatic in action, depending on concentration attained at site of infection and susceptibility of the infecting organism.a




  • Inhibits protein synthesis in susceptible organisms by reversible binding 50S ribosomal subunits.a




  • Clindamycin phosphate is inactive until hydrolyzed in vivo to free clindamycin.1




  • Exact mechanisms of action in treatment of acne vulgaris not fully elucidated; antibacterial activity may result in reduction of acne vulgaris lesions, but other mechanisms also appear to be involved.a




  • Inhibits skin surface growth of susceptible organisms (primarily Propionibacterium acnes), reduces formation and concentration of comedogenic (and possibly inflammatory lesion-inducing) free fatty acid in sebum.a




  • In vitro, inhibits leukocyte chemotaxis; if this occurs in vivo, may be another mechanism for suppression of inflammatory acne vulgaris lesions.a




  • In vitro spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and many gram-positive and -negative anaerobic bacteria.5 6 10 Inactive against fungi and viruses.




  • Clindamycin-resistant P. acnes have been reported.178




  • Complete cross-resistance occurs between clindamycin and lincomycin; partial cross-resistance occurs between clindamycin, lincomycin, and erythromycin.a



Advice to Patients



  • Importance of discontinuing use and notifying clinician if GI symptoms (e.g., diarrhea) occur.1 100 178 179




  • Importance of notifying clinician if local reactions or any other adverse reactions occur.178 179




  • Instruct patients regarding vaginal applicator use, and provide a copy of the manufacturer's instructions.100




  • Advise patients using topical gels containing clindamycin and benzyl peroxide that these preparations may bleach hair or colored fabric.178 179




  • Advise women using intravaginal cream or suppositories not to engage in vaginal intercourse and to refrain from use of vaginal products (e.g., douches or tampons) during the entire course of therapy.100 103 105 107 131 176 180




  • Advise women using Cleocin intravaginal cream or suppositories not to rely on latex or rubber products (e.g., condoms, vaginal contraceptive diaphragms) as contraceptives and/or microbial barriers if used within 72 hours following administration of the vaginal cream or suppository.100 176




  • Advise women using Clindesse intravaginal cream not to rely on latex or rubber products (e.g., condoms, vaginal contraceptive diaphragms) as contraceptives and/or microbial barriers if used within 5 days following administration of the vaginal cream.180




  • If using topical skin preparations, importance of avoiding contact with eyes, abraded skin, or mucous membranes; need to bathe area with copious amounts of cool water if contact occurs.1 178 179




  • If using vaginal cream, importance of avoiding contact of the cream with eyes; need to irrigate eyes with copious amounts of cool water if contact occurs.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name




































































Clindamycin Phosphate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Topical



Gel



1% (of clindamycin)*



Cleocin T



Pfizer



Clindagel



Galderma



Lotion



1% (of clindamycin)



Cleocin T



Pfizer



Pledgets (saturated with solution)



1% (of clindamycin)*



Cleocin T Pledgets



Pfizer



Clindamycin Phosphate Pledgets



Clindets Pledgets



Stiefel



Solution



1% (of clindamycin)*



Cleocin T 1%



Pfizer



Clinda-Derm



Paddock



Clindamycin Phosphate Topical Solution



Vaginal



Cream



2% (of clindamycin)



Cleocin (with 7 disposable vaginal applicators)



Pfizer



Clindesse (available in prefilled, disposable applicators)



Ther-Rx



Suppositories



100 mg (of clindamycin)



Cleocin Vaginal Ovules (with vaginal applicator)



Pfizer


















Clindamycin Phosphate Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Topical



For gel



300 mg (of clindamycin phosphate to prepare a clindamycin 1% gel) with Benzoyl Peroxide 5%



BenzaClin (with 1 or 2 vials containing clindamycin phosphate [300 mg of clindamycin] powder and container of benzoyl peroxide gel 5%)



Dermik



Gel



1% (of clindamycin) with Benzoyl Peroxide 5%



Duac



Stiefel


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Acanya 1.2-2.5% Gel (VALEANT): 50/$200 or 150/$577.99


BenzaClin 1-5% Gel (DERMIK): 25/$125.99 or 50/$239.97


BenzaClin with Pump 1-5% Gel (DERMIK): 50/$203.99 or 150/$575.95


Cleocin 100MG Suppositories (PFIZER U.S.): 3/$87.99 or 9/$230.97


Cleocin 2% Cream (PFIZER U.S.): 40/$85.99 or 120/$249.97


Cleocin-T 1% Gel (PFIZER U.S.): 30/$62.99 or 90/$175.96


Cleocin-T 1% Gel (PFIZER U.S.): 60/$110.24 or 180/$304.26


Cleocin-T 1% Lotion (PFIZER U.S.): 60/$90.4 or 180/$249.17


Cleocin-T 1% Solution (PFIZER U.S.): 60/$69.99 or 180/$198.96


Clindagel 1% Gel (GALDERMA): 40/$245.98 or 120/$696


Clindagel 1% Gel (GALDERMA): 75/$380 or 225/$1097.96


ClindaMax 1% Lotion (PHARMADERM): 60/$75.4 or 180/$211.71


Clindamax 2% Cream (PHARMADERM): 40/$59.99 or 120/$169.97


Clindamycin Phos-Benzoyl Perox 1-5% Gel (MYLAN): 50/$149.99 or 150/$429.96


Clindamycin Phosphate 1% Foam (PERRIGO PHARMACEUTICALS): 50/$159.98 or 150/$445.97


Clindamycin Phosphate 1% Foam (PERRIGO PHARMACEUTICALS): 100/$259.97 or 300/$725.94


Clindamycin Phosphate 1% Gel (FOUGERA): 30/$27.99 or 90/$65.97


Clindamycin Phosphate 1% Gel (FOUGERA): 60/$45.99 or 180/$105.97


Clindamycin Phosphate 1% Lotion (FOUGERA): 60/$45.99 or 180/$119.97


Clindamycin Phosphate 1% Solution (GREENSTONE): 30/$14.99 or 90/$38.99


Clindamycin Phosphate 1% Solution (GREENSTONE): 60/$45.99 or 180/$119.97


Clindamycin Phosphate 2% Cream (GREENSTONE): 40/$54.99 or 120/$155.98


Duac CS 1-5% Kit (GLAXO SMITH KLINE): 1/$196.99 or 3/$565.96


Evoclin 1% Foam (GLAXO SMITH KLINE): 100/$322 or 300/$914


Evoclin 1% Foam (GLAXO SMITH KLINE): 50/$205.99 or 150/$575.99


Ziana 1.2-0.025% Gel (MEDICIS): 30/$222.4 or 90/$654.05


Ziana 1.2-0.025% Gel (MEDICIS): 60/$405.99 or 180/$1155.97



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References


Only references cited for selected revisions after 1984 are available electronically.



1. Pharmacia & Upjohn. Cleocin T (clindamycin phosphate topical solution, topical gel, and topical lotion) prescribing information. New York, NY; 2005 Nov.



5. Kucers A, Bennett N. The use of antibiotics. 3rd ed. Philadelphia: JB Lippincott; 1979:470-95.



6. Kagan BM. Antimicrobial therapy. 3rd ed. Philadelphia: WB Saunders; 1980:97-116.



7. Grenzach HS. Antibiotics and chemotherapy. Vol 25. New York: S Karger; 1978:204-9.



10. Sutter VL. In vitro susceptibility of anaerobes: comparison of clindamycin and other antimicrobial agents. J Infect Dis. 1977; 135:7-12.



13. Wang WL, Everett ED, Johnson M et al. Susceptibility of Propionibacterium acnes to seventeen antibiotics. Antimicrob Agents Chemother. 1977; 11:171-3. [IDIS 83682] [PubMed 836012]



14. Rosenthal SL, Freundlich LF, Gilardi GL et al. In vitro antibiotic sensitivity of Moraxella species. Chemotherapy. 1978; 24:360-3. [IDIS 106292] [PubMed 699676]



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