DAPSONE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

dapsone (UNII: 8W5C518302) (dapsone - UNII:8W5C518302)

Beszerezhető a:

Alvogen Inc.

INN (nemzetközi neve):

dapsone

Összetétel:

dapsone 25 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

Dapsone Tablets USP, 25 mg are available as white to off-white round tablets, debossed “F19” above and “25” below the score on one side. NDC 47781-333-31 30 Tablets (2x15 unit-of-use blisters). Dapsone Tablets USP, 100 mg are available as white to off-white round tablets, debossed “F20” above and “100” below the score on one side. NDC 47781-334-31 30 Tablets (2x15 unit-of-use blisters). 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

DAPSONE- DAPSONE TABLET
ALVOGEN INC.
----------
DAPSONE TABLETS, USP
25 MG AND 100 MG
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 insoluble 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: croscarmellose sodium, hydroxypropyl cellulose,
magnesium stearate,
microcrystalline cellulose, and silicon dioxide.
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 patient should be warned to respond to the presenc