Zitromax may be available in the countries listed below.
Azithromycin is reported as an ingredient of Zitromax in the following countries:
Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Zitromax in the following countries:
International Drug Name Search
Nexadron may be available in the countries listed below.
Dexamethasone is reported as an ingredient of Nexadron in the following countries:
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Robaxacet may be available in the countries listed below.
Methocarbamol is reported as an ingredient of Robaxacet in the following countries:
Paracetamol is reported as an ingredient of Robaxacet in the following countries:
International Drug Name Search
Klallergine may be available in the countries listed below.
Loratadine is reported as an ingredient of Klallergine in the following countries:
International Drug Name Search
Virpex may be available in the countries listed below.
Idoxuridine is reported as an ingredient of Virpex in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
In the US, Papaverine (papaverine systemic) is a member of the drug class peripheral vasodilators.
US matches:
BAN
A03AD01,G04BE02
0000058-74-2
C20-H21-N-O4
339
Vasodilator
Antispasmodic agent
Treatment of erectile dysfunction
Isoquinoline, 1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
Ketidin may be available in the countries listed below.
Raloxifene hydrochloride (a derivative of Raloxifene) is reported as an ingredient of Ketidin in the following countries:
International Drug Name Search
Kefsid may be available in the countries listed below.
Cefaclor monohydrate (a derivative of Cefaclor) is reported as an ingredient of Kefsid in the following countries:
International Drug Name Search
Bambutol may be available in the countries listed below.
Bambuterol hydrochloride (a derivative of Bambuterol) is reported as an ingredient of Bambutol in the following countries:
International Drug Name Search
Diénogest may be available in the countries listed below.
Diénogest (DCF) is known as Dienogest in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
Salbulin may be available in the countries listed below.
UK matches:
Salbutamol is reported as an ingredient of Salbulin in the following countries:
Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Salbulin in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Telo may be available in the countries listed below.
Cefditoren pivoxil (a derivative of Cefditoren) is reported as an ingredient of Telo in the following countries:
International Drug Name Search
Haxifal may be available in the countries listed below.
Cefaclor monohydrate (a derivative of Cefaclor) is reported as an ingredient of Haxifal in the following countries:
International Drug Name Search
Roxar may be available in the countries listed below.
Roxithromycin is reported as an ingredient of Roxar in the following countries:
International Drug Name Search
Nifedigel may be available in the countries listed below.
Nifedipine is reported as an ingredient of Nifedigel in the following countries:
International Drug Name Search
Klaribros may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Klaribros in the following countries:
International Drug Name Search
Triocalcit may be available in the countries listed below.
Calcitriol is reported as an ingredient of Triocalcit in the following countries:
International Drug Name Search
Sanbe Tears may be available in the countries listed below.
Dextran average molecular weight about 70000 (a derivative of Dextran) is reported as an ingredient of Sanbe Tears in the following countries:
Hypromellose is reported as an ingredient of Sanbe Tears in the following countries:
International Drug Name Search
Kefa-Mastin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cefalexin monohydrate (a derivative of Cefalexin) is reported as an ingredient of Kefa-Mastin in the following countries:
Streptomycin sulfate (a derivative of Streptomycin) is reported as an ingredient of Kefa-Mastin in the following countries:
International Drug Name Search
Brandyl may be available in the countries listed below.
Terbutaline sulfate (a derivative of Terbutaline) is reported as an ingredient of Brandyl in the following countries:
International Drug Name Search
Trimetho-Diazin Ogris may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadiazine is reported as an ingredient of Trimetho-Diazin Ogris in the following countries:
Trimethoprim is reported as an ingredient of Trimetho-Diazin Ogris in the following countries:
International Drug Name Search
Prehistam may be available in the countries listed below.
Budesonide is reported as an ingredient of Prehistam in the following countries:
Formoterol is reported as an ingredient of Prehistam in the following countries:
International Drug Name Search
Fungizon may be available in the countries listed below.
Amphotericin B is reported as an ingredient of Fungizon in the following countries:
International Drug Name Search
Fudone may be available in the countries listed below.
Famotidine is reported as an ingredient of Fudone in the following countries:
International Drug Name Search
Oncocarbin may be available in the countries listed below.
Carboplatin is reported as an ingredient of Oncocarbin in the following countries:
International Drug Name Search
Zopiclone Sandoz may be available in the countries listed below.
Zopiclone is reported as an ingredient of Zopiclone Sandoz in the following countries:
International Drug Name Search
Spiracin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Spiramycin is reported as an ingredient of Spiracin in the following countries:
International Drug Name Search
Warfarin Sodium Clathrate may be available in the countries listed below.
Warfarin Sodium Clathrate (BANM) is known as Warfarin in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
Imipramina MK may be available in the countries listed below.
Imipramine hydrochloride (a derivative of Imipramine) is reported as an ingredient of Imipramina MK in the following countries:
International Drug Name Search
Rec.INN
J01MB04
0051940-44-4
C14-H17-N5-O3
303
Antiinfective, quinolin-derivative
Pyrido[2,3-d]pyrimidine-6-carboxylic acid, 8-ethyl-5,8-dihydro-5-oxo-2-(1-piperazinyl)-
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Calciopiù may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Calciopiù in the following countries:
International Drug Name Search
Providing fluids containing various amounts of sugars and electrolytes to your body when you are not able to drink enough liquids or when additional fluids are needed. It may also be used as a way to give other injectable medicines. It may also be used for other conditions as determined by your doctor.
Dextrose and Ringer's is a sterile solution injected intravenously (IV, into the vein).
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Dextrose and Ringer's. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Dextrose and Ringer's. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Dextrose and Ringer's 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.
Use Dextrose and Ringer's as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Dextrose and Ringer's.
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:
Increased urination; redness, pain, or swelling at the injection site.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; infection at the injection site; muscle twitching; seizures; swelling of the hands and feet; 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: Dextrose ander's side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Dextrose and Ringer's is usually handled and stored by a health care provider. If you are using Dextrose and Ringer's at home, store Dextrose and Ringer's as directed by your pharmacist or health care provider. Keep Dextrose and Ringer's out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Dextrose and Ringer's. 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.
Ophtasone may be available in the countries listed below.
Betamethasone 21-(disodium phosphate) (a derivative of Betamethasone) is reported as an ingredient of Ophtasone in the following countries:
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Ophtasone in the following countries:
International Drug Name Search
Moverdin may be available in the countries listed below.
Selegiline hydrochloride (a derivative of Selegiline) is reported as an ingredient of Moverdin in the following countries:
International Drug Name Search
Azactam is a brand name of aztreonam, approved by the FDA in the following formulation(s):
Yes. The following products are equivalent to Azactam:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Azactam. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Azactam.
Faximin may be available in the countries listed below.
Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Faximin in the following countries:
International Drug Name Search
Algiderm may be available in the countries listed below.
Erythromycin ethylsuccinate (a derivative of Erythromycin) is reported as an ingredient of Algiderm in the following countries:
International Drug Name Search
Azitromicina Mepha may be available in the countries listed below.
Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Azitromicina Mepha in the following countries:
International Drug Name Search
Generic Name: brompheniramine and pseudoephedrine (BROM fen EER a meen and SOO doe ed FED rin)
Brand Names: Andehist NR Syrup, Bidhist-D, Bromaline, Bromhist Pediatric Drops, Bromhist-NR, BroveX PD, BroveX PSE, Brovex SR, Di-Bromm, Histex SR, J-TanD PD, Lodrane 12D, Lodrane 24D, Lodrane D, Lodrane Liquid, LoHist-12D, LoHist-PD, Q-Tapp, Sildec, Touro Allergy, Ultrabrom, Ultrabrom PD
Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of brompheniramine and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.
Brompheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.
There are many brands and forms of this medicine available and not all brands are listed on this leaflet.
Ask a doctor or pharmacist if it is safe for you to take brompheniramine and pseudoephedrine if you have:
diabetes;
glaucoma;
heart disease or high blood pressure;
diabetes;
a thyroid disorder;
an enlarged prostate; or
problems with urination.
Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, pounding, or uneven heartbeat;
confusion, hallucinations, unusual thoughts or behavior;
severe dizziness, anxiety, restless feeling, or nervousness;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
confusion, hallucinations, unusual thoughts or behavior;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
urinating less than usual or not at all.
Less serious side effects may include:
blurred vision;
dry mouth;
nausea, stomach pain, constipation;
mild loss of appetite, stomach upset;
warmth, tingling, or redness under your skin;
sleep problems (insomnia);
restless or excitability (especially in children);
skin rash or itching;
dizziness, drowsiness;
problems with memory or concentration; or
ringing in your ears.
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.
Tell your doctor about all other medications you use, especially:
medicines to treat high blood pressure;
a diuretic (water pill);
medication to treat irritable bowel syndrome;
bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This list is not complete and there may be other drugs that can interact with brompheniramine and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: B-Vex PD side effects (in more detail)
Muvera may be available in the countries listed below.
Meloxicam is reported as an ingredient of Muvera in the following countries:
International Drug Name Search
Romazicon is a brand name of flumazenil, approved by the FDA in the following formulation(s):
Yes. The following products are equivalent to Romazicon:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Romazicon. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Romazicon.
Fluoxetina Combix may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetina Combix in the following countries:
International Drug Name Search
Novocillin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Benzylpenicillin is reported as an ingredient of Novocillin in the following countries:
International Drug Name Search
Aplacasse may be available in the countries listed below.
Lorazepam is reported as an ingredient of Aplacasse in the following countries:
International Drug Name Search
Azathioprina Carrion may be available in the countries listed below.
Azathioprine is reported as an ingredient of Azathioprina Carrion in the following countries:
International Drug Name Search
Opra may be available in the countries listed below.
Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Opra in the following countries:
International Drug Name Search
Gentamicina + Betametasone Almus may be available in the countries listed below.
Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Gentamicina + Betametasone Almus in the following countries:
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Gentamicina + Betametasone Almus in the following countries:
International Drug Name Search
Klebrocid may be available in the countries listed below.
Leuprorelin acetate (a derivative of Leuprorelin) is reported as an ingredient of Klebrocid in the following countries:
International Drug Name Search
Zibren may be available in the countries listed below.
Acetylcarnitine is reported as an ingredient of Zibren in the following countries:
Acetylcarnitine hydrochloride (a derivative of Acetylcarnitine) is reported as an ingredient of Zibren in the following countries:
International Drug Name Search
Milbidine may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Povidone-Iodine is reported as an ingredient of Milbidine in the following countries:
International Drug Name Search
Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically in-soluble in water and insoluble in fixed and vegetable oils.
Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use.
Inactive Ingredients: Colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose and corn starch.
Actions: The mechanism of action in Dermatitis herpetiformis has not been established. By the kinetic method in mice, Dapsone is bactericidal as well as bacteriostatic against Mycobacterium leprae.
Absorption and Excretion: Dapsone, when given orally, is rapidly and almost completely absorbed. About 85 percent of the daily intake is recoverable from the urine mainly in the form of water-soluble metabolites. Excretion of the drug is slow and a constant blood level can be maintained with the usual dosage.
Blood Levels: Detected a few minutes after ingestion, the drug reaches peak concentration in 4-8 hours. Daily administration for at least eight days is necessary to achieve a plateau level. With doses of 200 mg daily, this level averaged 2.3 μg/ml with a range of 0.1-7.0 μg/ml. The half-life in the plasma in different individuals varies from ten hours to fifty hours and averages twenty-eight hours. Repeat tests in the same individual are constant. Daily administration (50 - 100 mg) in leprosy patients will provide blood levels in excess of the usual minimum inhibitory concentration even for patients with a short Dapsone half-life.
Dermatitis herpetiformis: (D.H.)
Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.
Hypersensitivity to Dapsone and/or its derivatives.
The patient should be warned to respond to the presence of clinical signs such as sore throat, fever, pallor, purpura or jaundice. Deaths associated with the administration of Dapsone have been reported from agranulocytosis, aplastic anemia and other blood dyscrasias. Complete blood counts should be done frequently in patients receiving Dapsone. The FDA Dermatology Advisory Committee recommended that, when feasible, counts should be done weekly for the first month, monthly for six months and semi-annually thereafter. If a significant reduction in leucocytes, platelets or hemopoiesis is noted, Dapsone should be discontinued and the patient followed intensively. Folic acid antagonists have similar effects and may increase the incidence of hematologic reactions; if co-administered with Dapsone the patient should be monitored more frequently. Patients on weekly pyrimethamine and Dapsone have developed agranulocytosis during the second and third month of therapy.
Severe anemia should be treated prior to initiation of therapy and hemoglobin monitored. Hemolysis and methemoglobin may be poorly tolerated by patients with severe cardiopulmonary disease.
Cutaneous reactions, especially bullous, include exfoliative dermatitis and are probably one of the most serious, though rare, complications of sulfone therapy. They are directly due to drug sensitization. Such reactions include toxic erythema, erythema multiforme, toxic epidermal necrolysis, morbilliform and scarlatiniform reactions, urticaria and erythema nodosum. If new or toxic dermatologic reactions occur, sulfone therapy must be promptly discontinued and appropriate therapy instituted. Leprosy reactional states, including cutaneous, are not hypersensitivity reactions to Dapsone and do not require discontinuation. See special section.
General: Hemolysis and Heinz body formation may be exaggerated in individuals with a glucose-6-phosphate dehydrogenase (G6PD) deficiency, or methemoglobin reductase deficiency, or hemoglobin M. This reaction is frequently dose-related. Dapsone should be given with caution to these patients or if the patient is exposed to other agents or conditions such as infection or diabetic ketosis capable of producing hemolysis. Drugs or chemicals which have produced significant hemolysis in G6PD or methemoglobin reductase deficient patients include Dapsone, sulfanilamide, nitrite, aniline, phenylhydrazine, napthalene, niridazole, nitro-furantoin and 8-amino-antimalarials such as primaquine.
Toxic hepatitis and cholestatic jaundice have been reported early in therapy. Hyperbilirubinemia may occur more often in G6PD deficient patients. When feasible, baseline and subsequent monitoring of liver function is recommended; if abnormal, Dapsone should be discontinued until the source of the abnormality is established.
Drug Interactions: Rifampin lowers Dapsone levels 7 to 10-fold by accelerating plasma clearance; in leprosy this reduction has not required a change in dosage. Folic acid antagonists such as pyrimethamine may increase the likelihood of hematologic reactions.
A modest interaction has been reported for patients receiving 100 mg Dapsone daily in combination with trimethoprim 5 mg/kg q6h. On Day 7, the serum Dapsone levels averaged 2.1 ± 1.0 μg/mL in comparison to 1.5 ± 0.5 μg/mL for Dapsone alone. On Day 7, trimethoprim levels averaged 18.4 ± 5.2 μg/mL in comparison to 12.4 ± 4.5 μg/mL for patients not receiving Dapsone. Thus, there is a mutual interaction between Dapsone and trimethoprim in which each raises the level of the other about 1.5 times.
A crossover study1 designed to assess the potential of a drug interaction between Dapsone, 100 mg/day and trimethoprim, 200 mg every 12 hours, in eight asymptomatic HIV positive volunteers (average CD4 count 524 cells/mm3) demonstrated that there was not a significant drug intreraction between Dapsone and trimethoprim. However, an earlier report2 also by Lee et al, in 78 HIV infected patients with acute Pneumocystis carinii pneumonia, receiving Dapsone, 100 mg/day and higher trimethoprim dose, 20 mg/kg/day, demonstrated that the serum levels of Dapsone were increased by 40% and trimethoprim levels were increased by 48% when the drugs were administered concurrently.
Carcinogenesis, mutagenesis: Dapsone has been found carcinogenic (sarcomagenic) for male rats and female mice causing mesenchymal tumors in the spleen and peritoneum, and thyroid carcinoma in female rats. Dapsone is not mutagenic with or without microsomal activation in S. typhimurium tester strains 1535, 1537, 1538, 98, or 100.
Pregnancy: Teratogenic Effects. Pregnancy Category C: Animal reproduction studies have not been conducted with Dapsone. Extensive, but uncontrolled experience and two published surveys on the use of Dapsone in pregnant women have not shown that Dapsone increases the risk of fetal abnormalities if administered during all trimesters of pregnancy or can affect reproduction capacity. Because of the lack of animal studies or controlled human experience, Dapsone should be given to a pregnant woman only if clearly needed. In general, for leprosy, USPHS at Carville recommends maintenance of Dapsone. Dapsone has been important for the management of some pregnant D.H. patients.
Nursing Mothers: Dapsone is excreted in breast milk in substantial amounts. Hemolytic reactions can occur in neonates. See section on hemolysis. Because of the potential for tumorgenicity shown for Dapsone in animal studies a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of drug to the mother.
Pediatric Use: Pediatric patients are treated on the same schedule as adults but with correspondingly smaller doses. Dapsone is generally not considered to have an effect on the later growth, development and functional development of the pediatric patient.
In addition to the warnings listed above, the following syndromes and serious reactions have been reported in patients on Dapsone.
Hematologic Effects: Dose-related hemolysis is the most common adverse effect and is seen in patients with or without G6PD deficiency. Almost all patients demonstrate the inter-related changes of a loss of 1-2g of hemoglobin, an increase in the reticulocytes (2-12%), a shortened red cell life span and a rise in methemoglobin. G6PD deficient patients have greater responses.
Nervous System Effects: Peripheral neuropathy is a definite but unusual complication of Dapsone therapy in non-leprosy patients. Motor loss is predominant. If muscle weakness appears, Dapsone should be withdrawn. Recovery on withdrawal is usually substantially complete. The mechanism of recovery is reported by axonal regeneration. Some recovered patients have tolerated retreatment at reduced dosage. In leprosy this complication may be difficult to distinguish from a leprosy reactional state.
Body As A Whole: In addition to the warnings and adverse effects reported above, additional adverse reactions include: nausea, vomiting, abdominal pains, pancreatitis, vertigo, blurred vision, tinnitus, insomnia, fever, headache, psychosis, phototoxicity, pulmonary eosinophilia, tachycardia, albuminuria, the nephrotic syndrome, hypoalbuminemia without proteinuria, renal papillary necrosis, male infertility, drug-induced Lupus erythematosus and an infectious mononucleosis-like syndrome. In general, with the exception of the complications of severe anoxia from overdosage (retinal and optic nerve damage, etc.) these adverse reactions have regressed off drug.
Nausea, vomiting, hyperexcitability can appear a few minutes up to 24 hours after ingestion of an overdosage. Methemoglobin induced depression, convulsions or severe cyanosis requires prompt treatment. In normal and methemoglobin reductase deficient patients, methylene blue, 1-2 mg/kg of body weight, given slowly intravenously, is the treatment of choice. The effect is complete in 30 minutes, but may have to be repeated if methemoglobin reaccumulates. For non-emergencies, if treatment is needed, methylene blue may be given orally in doses of 3-5 mg/kg every 4-6 hours. Methylene blue reduction depends on G6PD and should not be given to fully expressed G6PD deficient patients.
Dermatitis herpetiformis: The dosage should be individually titrated starting in adults with 50 mg daily and correspondingly smaller doses in children. If full control is not achieved within the range of 50-300 mg daily, higher doses may be tried. Dosage should be reduced to a minimum maintenance level as soon as possible. In responsive patients there is a prompt reduction in pruritus followed by clearance of skin lesions. There is no effect on the gastrointestinal component of the disease. Dapsone levels are influenced by acetylation rates. Patients with high acetylation rates, or who are receiving treatment affecting acetylation may require an adjustment in dosage.
A strict gluten free diet is an option for the patient to elect, permitting many to reduce or eliminate the need for Dapsone; the average time for dosage reduction is 8 months with a range of 4 months to 2 1/2 years and for dosage elimination 29 months with a range of 6 months to 9 years.
Leprosy: In order to reduce secondary Dapsone resistance, the WHO Expert Committee on Leprosy and the USPHS at Carville, LA, recommended that Dapsone should be commenced in combination with one or more anti-leprosy drugs. In the multidrug program Dapsone should be maintained at the full dosage of 100 mg daily without interruption (with corresponding smaller doses for children) and provided to all patients who have sensitive organisms with new or recrudescent disease or who have not yet completed a two year course of Dapsone monotherapy. For advice and other drugs, the USPHS at Carville, LA (1-800-642-2477) should be contacted. Before using other drugs consult appropriate product labeling.
In bacteriologically negative tuberculoid and indeterminate disease, the recommendation is the coadministration of Dapsone 100 mg daily with six months of Rifampin 600 mg daily. Under WHO, daily Rifampin may be replaced by 600 mg Rifampin monthly, if supervised. The Dapsone is continued until all signs of clinical activity are controlled - usually after an additional six months. Then Dapsone should be continued for an additional three years for tuberculoid and indeterminate patients and for five years for borderline tuberculoid patients.
In lepromatous and borderline lepromatous patients, the recommendation is the co-administration of Dapsone 100 mg daily with two years of Rifampin 600 mg daily. Under WHO daily Rifampin may be replaced by 600 mg Rifampin monthly, if supervised. One may elect the concurrent administration of a third anti-leprosy drug, usually either Clofazamine 50-100 mg daily or Ethionamide 250-500 mg daily. Dapsone 100 mg daily is continued 3-10 years until all signs of clinical activity are controlled with skin scrapings and biopsies negative for one year. Dapsone should then be continued for an additional 10 years for borderline patients and for life for lepromatous patients.
Secondary Dapsone resistance should be suspected whenever a lepromatous or borderline lepromatous patient receiving Dapsone treatment relapses clinically and bacteriologically, solid staining bacilli being found in the smears taken from the new active lesions. If such cases show no response to regular and supervised Dapsone therapy within three to six months or good compliance for the past 3-6 months can be assured, Dapsone resistance should be considered confirmed clinically. Determination of drug sensitivity using the mouse footpad method is recommended and, after prior arrangement, is available without charge from the USPHS, Carville, LA. Patients with proven Dapsone resistance should be treated with other drugs.
Abrupt changes in clinical activity occur in leprosy with any effective treatment and are known as reactional states. The majority can be classified into two groups. The “Reversal” reaction (Type 1) may occur in borderline or tuberculoid leprosy patients often soon after chemotherapy is started. The mechanism is presumed to result from a reduction in the antigenic load: the patient is able to mount an enhanced delayed hypersensitivity response to residual infection leading to swelling (“Reversal”) of existing skin and nerve lesions. If severe, or if neuritis is present, large doses of steroids should always be used. If severe, the patient should be hospitalized. In general anti-leprosy treatment is continued and therapy to suppress the reaction is indicated such as analgesics, steroids, or surgical decompression of swollen nerve trunks. USPHS at Carville, LA should be contacted for advice in management.
Erythema nodosum leprosum (ENL) (lepromatous reaction) (Type 2 reaction) occurs mainly in lepromatous patients and small numbers of borderline patients. Approximately 50% of treated patients show this reaction in the first year. The principal clinical features are fever and tender erythematous skin nodules sometimes associated with malaise, neuritis, orchitis, albuminuria, joint swelling, iritis, epistaxis or depression. Skin lesions can become pustular and/or ulcerate. Histologically there is a vasculitis with an intense polymorphonuclear infiltrate. Elevated circulating immune complexes are considered to be the mechanism of reaction. If severe, patients should be hospitalized. In general, anti-leprosy treatment is continued. Analgesics, steroids, and other agents available from USPHS, Carville, LA, are used to suppress the reaction.
Dapsone Tablets USP, 25 mg are available as round white scored tablets, debossed “25” above and “102” below the score and on the obverse “JACOBUS” in a Unit of Use carton of 30 tablets (2 x 15). The blisters are light and child-resistant. NDC 49938-102-30.
Dapsone Tablets USP, 100 mg are available as round white scored tablets, debossed “100” above and “101” below the score and on the obverse “JACOBUS” in a Unit of Use carton of 30 tablets (2 x 15).The blisters are light and child-resistant. NDC 49938-101-30.
Dapsone Tablets USP, 25 mg are available as round white scored tablets, debossed “25” above and “102” below the score and on the obverse “JACOBUS” in a Unit of Use carton of 28 tablets (2 x 14). The blisters are light and child-resistant. NDC 49938-102-28.
Dapsone Tablets USP, 100 mg are available as round white scored tablets, debossed“100" above and “101” below the score and on the obverse “JACOBUS” in a Unit of Use carton of 28 tablets (2 x 14). The blisters are light and child-resistant. NDC 49938-101-28.
Store at 20°- 25° C (68°- 77°F). [see USP Controlled Room Temperature]. Protect from light.
Rx only. Keep this and all medication out of the reach of children.
JACOBUS PHARMACEUTICAL CO., INC.
P.O. Box 5290
Princeton, NJ 08540
Revised August 2009
0826A09
Principal Display Panel – 25 mg Carton Label
NDC 49938-102-30
Dapsone
Tablets USP
25 mg
30 Tablets (2 x 15 unit of use)
Rx Only
To be sold as a single unit
Principal Display Panel – 100 mg Carton Label
NDC 49938-101-30
Dapsone
Tablets USP
100 mg
30 Tablets (2 x 15 unit of use)
Rx Only
To be sold as a single unit
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA086842 | 08/15/2008 | |
| Dapsone Dapsone tablet | ||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA086841 | 08/15/2008 | |
| Labeler - Jacobus Pharmaceutical Company, Inc. (088805734) |
