Dapsone tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

dapsone

Available from:

Arpimed LLC

ATC code:

J04BA02

INN (International Name):

dapsone

Dosage:

100mg

Pharmaceutical form:

tablets

Units in package:

(50/5x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-05-03

Summary of Product characteristics

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.