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:

AvKARE, 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.

產品總結:

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 90 tablets. NDC 42291-298-90. 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 90 tablets. NDC 42291-299-90. 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.

授权状态:

Abbreviated New Drug Application

产品特点

DAPSONE- DAPSONE TABLET
AVKARE, INC.
----------
DAPSONE TABLETS, USP
RX ONLY
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, fever