DAPSONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Dapsone Tablets USP, 25 mg are available as round white scored tablets, debossed "25" above and "102" below the score and on the obverse "JACOBUS" in light and child-resistant bottles. Bottle of 100: NDC 42291-008-01 Dapsone Tablets USP, 100 mg are available as round white scored tablets, debossed "100" above and "101" below the score and on the obverse "JACOBUS" in light and child-resistant bottles.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DAPSONE- DAPSONE TABLET
AVKARE
----------
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 insoluble in water and
in-soluble in fixed and
vegetable oils.
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.
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 presence of clinical
signs such as sore
throat, fever, pa