Maa: Armenia
Kieli: englanti
Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
dapsone
Arpimed LLC
J04BA02
dapsone
100mg
tablets
(50/5x10/) in blister
Prescription
Registered
2022-05-03
SUMMARY PRODUCT CHARACTERISTIC DAPSONE 100 MG TABLETS 1.1. TRADE NAME - Dapsone 1.2. INTERNATIONAL NON-PROPERTY NAME – Dapsone 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: _ACTIVE INGREDIENT:_ Dapsone – 100 mg; _For a full list of excipients, see section 6.1. _ _ _ 3. PHARMACEUTICAL FORM White or off-white biconvex, scored tablets with a few small darker spots. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS 1. As part of a multi-drug regimen in the treatment of all forms of leprosy. 2. Treatment of dermatitis herpetiformis and other dermatoses. 3. Prophylaxis of malaria in combination with pyrimethamine. 4. Prophylaxis of Pneumocystis carinii pneumonia in immunodeficient subjects, especially AIDS patients. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ _ADULTS AND CHILDREN OVER 12 YEARS:_ _Multibacillary leprosy (3-drug regimen):_ 100mg daily for at least two years. _Paucibacillary leprosy (2-drug regimen):_ 100mg daily for at least six months. _Malaria prophylaxis:_ 100mg weekly with 12.5mg pyrimethamine. _Dermatitis herpetiformis:_ Initially 50mg daily, gradually increased to 300mg daily if required. Once lesions have begun to subside, the dose should be reduced to a minimum as soon as possible, usually 25-50mg daily, which may be continued for a number of years. Maintenance dosage can often be reduced in patients receiving a gluten-free diet. _Pneumocystis carinii pneumonia:_ In combination with trimethoprim, 50-100mg daily; 100mg twice weekly or 200mg once weekly. _CHILDREN 6-12 YEARS:_ _Multibacillary leprosy (3-drug regimen):_ 50mg daily for at least two years. _Paucibacillary leprosy (2-drug regimen):_ 50mg daily for at least six months. _ELDERLY:_ Dosage should be reduced in the elderly where there is an impairment of hepatic function. _Method of Administration_ For oral administration. 4.3. CONTRAINDICATIONS Known hypersensitivity to sulfonamides, sulfones, or any of the excipients; severe anaemia; porphyria; severe glucose-6-phosphate dehydrogenase deficiency. 4.4. Lue koko asiakirja