Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
dapsone, Quantity: 100 mg
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Dapsone
Tablet, uncoated
Excipient Ingredients: maize starch; magnesium stearate; silicon dioxide; microcrystalline cellulose
Oral
100 tablets
(S4) Prescription Only Medicine
Dermatitis herpetiformis. Leprosy. Actinomycotic mycetoma.
Visual Identification: White, round, scored tablet, debossed '100' above the score and '101' below the score on one side, and 'JACOBUS' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2004-07-20
Page 1 of 3 DAPSONE _Dapsone 25, 100 mg tablet _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about Dapsone. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Dapsone against the benefits they expect it will have for you. Keep this leaflet with the medicine. You may need to read it again. WHAT DAPSONE IS USED FOR? Dapsone is used to treat leprosy (Hansen’s disease) and to help control a skin problem called dermatitis and a fungal disease called _Actinomycotic mycetoma_ . When it is used to treat leprosy, Dapsone may be given with one or more other medicines. Mechanism of action: Dapsone (DAP-sone), a sulfone, belongs to the family of medicines called anti-infectives. Dapsone works by killing the bacteria or fungi causing your infection or by stopping its growth. Dapsone will not work against infections caused by viruses such as colds or the flu. Dapsone is available only with a doctor's prescription. There is no evidence that Dapsone is addictive. BEFORE TAKING DAPSONE _WHEN YOU MUST NOT TAKE IT? _ _WHEN YOU MUST NOT BE GIVEN IT? _ Do not take/use Dapsone if: you have ever had an allergic reaction to Dapsone or any other sulpha drugs or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, which is always present, fever, jaundice, and eosinophilia. _TAMPERING _ _AND _ _EXPIRY _ _DATE _ _WARNINGS: _ Do not use Dapsone if the packaging is torn or shows signs of tampering. If you are not sure whether you should start taking Dapsone, contact your doctor. _BEFORE YOU START TO TAKE IT _ _BEFORE YOU ARE GIVEN IT _ Tell your doctor if: 1. _YOU _ _HAVE _ _ANY _ _TYPE _ _OF _ _ALLERGIC _ _REACTION _ _TO _ _SULPHA _ _DRUGS _ _(SULFONAMIDE MEDICINES):_ You may have an increased chance of being allergic to Dapsone if you are allergic to sulpha dru Baca dokumen lengkap
1 AUSTRALIAN PRODUCT INFORMATION DAPSONE (DAPSONE) TABLETS 1. NAME OF THE MEDICINE Dapsone. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dapsone tablets are available in strengths of 25 mg and 100 mg round, white, scored tablets. Dapsone tablets do not contain alcohol, gluten, lactose, parabens, sugar, sulfites or tartrazine. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dermatitis herpetiformis. Leprosy. Actinomycotic mycetoma. 4.2 DOSE AND METHOD OF ADMINISTRATION To be taken with or after food. Tablets should be taken whole and small doses should be made up from 25 mg tablets. Do not split the tablet. DERMATITIS HERPETIFORMIS: _ADULTS: _The usual maintenance dosage is 50 to 100 mg daily, but as little as 50 mg weekly may be adequate. Dosages of up to 300 mg daily may be considered, but efforts should be made to reduce this to the minimal maintenance dosage as soon as possible. _ _ LEPROSY: _ADULTS: _The standard dose is 100 mg daily (1 to 2 mg/kg bodyweight). _CHILDREN: _Dosage should be adjusted according to bodyweight. The modern treatment of leprosy involves the use of multiple drug regimens to avoid the development of resistant strains. The World Health Organization has made the following recommendations for standard adult treatment regimens (with dosage adjustments according to bodyweight). MULTIBACILLARY LEPROSY:_ _ Rifampicin 600 mg once monthly supervised; dapsone 100 mg daily, self- administered; clofazimine 300 mg once monthly, supervised; and 50 mg daily self-administered. 2 PAUCIBACILLARY LEPROSY:_ _ Rifampicin 600 mg once monthly for 6 months, supervised; dapsone 100 mg daily for 6 months, self-administered. ACTINOMYCOTIC MYCETOMA: _ADULTS: _Published reports suggest that a dose of 100 mg should be given twice daily and continued for some months after the clinical symptoms have disappeared. Streptomycin at 14 mg/kg daily for the first month and alternate days thereafter (or the equivalent) sho Baca dokumen lengkap