Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
Dapsone
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Medicine Registered
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 Baca dokumen lengkapnya
1 AUSTRALIAN PRODUCT INFORMATION DAPSONE NAME OF THE DRUG: Dapsone DESCRIPTION: Tablets, 25mg and 100mg (white, scored): 100’s Active. Dapsone. Chemical Name: 4,4'-Sulfonylbisbenzenamine Formula: C 12 H 12 N 2 O 2 S CAS: 80-08-0 Mw: 248.31 Inactive. Starch-maize, cellulose-microcrystalline, magnesium stearate, silicon dioxide Tablets do not contain alcohol, gluten, lactose, parabens, sugar, sulfilte or tartrazine. PHARMACOLOGY: PHARMACOKINETICS: • Dapsone is almost completely absorbed from the gastrointestinal tract with peak plasma concentrations occurring 2 to 8 hours after a dose. Steady-state concentrations are not attained until after at least 8 days of daily administration, doses of 100 mg daily provide trough concentrations of 0.5 micrograms/mL, which are well in excess of the MIC for _M. leprae_. About 50 to 80% of dapsone in the circulation is bound to plasma proteins and nearly 100% of its monoacetylated metabolite is bound. • Dapsone undergoes enterohepatic recycling. It is widely distributed; it is present in saliva and breast milk and across the placenta. The half life ranges from 10 to 80 hours. • Dapsone is acetylated to monacetyldapsone, the major metabolite, and other mono and diacetyl derivatives. Acetylation exhibits genetic polymorphism. Hydroxylation is the other major metabolic pathway resulting in hydroxylamine dapsone, which may be responsible for dapsone-associated metahaemoglobinaemia haemolysis. • Dapsone is mainly excreted in the Urine, only 20% of a dose as unchanged drug. MICROBIOLOGY: • Dapsone is a sulfone active against a wide range of bacteria, but it is mainly used for its action against _Mycobacterium leprae_. Its mechanism of action is probably similar to that of the sulfonamides, which involves inh Baca dokumen lengkapnya