DAPSONE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Nostrum Laboratories, Inc.

Designació comuna internacional (DCI):

DAPSONE

Composición:

DAPSONE 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Dapsone Tablets USP, 25 mg are available as White to Off-white, Oval shaped Tablets Debossed with “ND2” on one side and scored on other side.     Bottle of 30 tablets    NDC 29033-036-30     Bottle of 100 tablets  NDC 29033-036-01 Dapsone Tablets USP, 100 mg are available as White to Off-white, Oval shaped Tablets Debossed with “ND1” on one side and scored on other side in a bottle of 30 tablets. NDC 29033-037-30. Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Protect from light. As with all medications, keep out of reach of children.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

DAPSONE- DAPSONE TABLET
NOSTRUM LABORATORIES, INC.
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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: Croscarmellose sodium, magnesium stearate and
silicified
microcrystalline cellulose.
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