DAPSONE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302)

Tersedia dari:

Virtus Pharmaceuticals

INN (Nama Internasional):

Dapsone

Komposisi:

Dapsone 25 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Dermatitis herpetiformis: (D.H.) Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.

Ringkasan produk:

Dapsone Tablets USP, 25 mg are available as round white to off-white scored tablets, debossed "25" above and "102" below the score and on the obverse "NCP" in bottles of 30 tablets. NDC 69543-150-30. Dapsone Tablets USP, 100 mg are available as round white to off-white scored tablets, debossed "100" above and "101" below the score and on the obverse "NCP" in bottles of 30 tablets. NDC 69543-151-30. Store at 20°to 25° C (68°to 77°F). [see USP Controlled Room Temperature]. Protect from light. Keep this and all medication out of the reach of children.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DAPSONE- DAPSONE TABLET
VIRTUS PHARMACEUTICALS
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DAPSONE TABLETS USP
DESCRIPTION
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.
CLINICAL PHARMACOLOGY
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 to 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 mcg/mL with a range of 0.1 to 7.0
mcg/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 to 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.
INDICATIONS AND USAGE
Dermatitis herpetiformis: (D.H.)
Leprosy: All forms of leprosy except for cases of proven Dapsone
resistance.
CONTRAINDICATION
Hypersensitivity to Dapsone and/or its derivatives.
WARNINGS
The patient should be warned to respond to the presence of clinical
signs such as sore throat, feve