DAPSONE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Marlex Pharmaceuticals Inc

INN（国际名称）:

DAPSONE

组成:

DAPSONE 25 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

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 Bottle of 100 tablets NDC 10135-0654-30 NDC 10135-0654-01 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 Bottle of 100 tablets NDC 10135-0655-30 NDC 10135-0655-01

授权状态:

Abbreviated New Drug Application

产品特点

DAPSONE- DAPSONE TABLET
MARLEX PHARMACEUTICALS INC
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DAPS ONE
DAPSONE - DAPS ONE TABLET
MARLEX 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.
CONTRAINDICA