DAPSONE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

ANI Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

DAPSONE

Composição:

DAPSONE 25 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Dermatitis herpetiformis: (D.H.) Leprosy: All forms of leprosy except for cases of proven Dapsone resistance. Hypersensitivity to Dapsone and/or its derivatives.

Resumo do produto:

Dapsone Tablets USP, 25 mg are available as white to creamy white, uncoated round shaped tablets, debossed with “N” above the bisect and “135” below the bisect and plain on other side. Bottle of 30 tablets              NDC 70954-135-10 Bottle of 100 tablets            NDC 70954-135-20 Dapsone Tablets USP, 100 mg are available as white to creamy white, uncoated round shaped tablets, debossed with “N” above the bisect and “136” below the bisect and plain on other side. Bottle of 30 tablets              NDC 70954-136-10 Bottle of 100 tablets            NDC 70954-136-20

Status de autorização:

Abbreviated New Drug Application

Características técnicas

DAPSONE - DAPSONE TABLET
ANI PHARMACEUTICALS, INC.
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DAPSONE TABLETS USP, 25 MG AND 100 MG
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 to
yellow crystalline powder. Sparingly soluble in alcohol; Soluble in
acetone and in dilute
mineral acids; practically insoluble in water.
Dapsone is issued on prescription in tablets of 25 and 100 mg for oral
use.
Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch,
Magnesium Stearate and
Microcrystalline Cellulose.
USP Dissolution Test Pending.
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.
CONTRAINDICATIONS
Hypersensitivity to Dapsone and/or its derivatives.
WARNINGS
The pati