RIFAMPIN capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

RIFAMPIN (UNII: VJT6J7R4TR) (RIFAMPIN - UNII:VJT6J7R4TR)

Disponível em:

Cardinal Health

DCI (Denominação Comum Internacional):

RIFAMPIN

Composição:

RIFAMPIN 300 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

Abbreviated New Drug Application

Características técnicas

RIFAMPIN- RIFAMPIN CAPSULE
CARDINAL HEALTH
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RIFAMPIN CAPSULES, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of rifampin
capsules USP and other antibacterial drugs, rifampin should be used
only to treat or prevent infections
that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Rifampin is a semisynthetic antibiotic derivative of rifamycin SV.
Rifampin is a red-brown crystalline
powder very slightly soluble in water at neutral pH, freely soluble in
chloroform, soluble in ethyl
acetate and in methanol. Its molecular weight is 822.95 and its
chemical formula is C
H N O . The
chemical name for rifampin is either: 3-[[(4-Methyl-1-piperazinyl)
imino]-methyl] rifamycin or
5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-
piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)
naphtho [2,1-_b_]furan-1,11(2H)-dione
21-acetate.
The structural formula is:
Rifampin capsules for oral administration contain 150 mg or 300 mg
rifampin per capsule. In addition,
the 150 mg and 300 mg capsules also contain the following inactive
ingredients: colloidal silicon
dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium,
FD&C blue #1, FD&C blue #1
aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40
aluminum lake, gelatin,
magnesium stearate, microcrystalline cellulose, pharmaceutical glaze,
silicon dioxide, sodium benzoate,
sodium lauryl sulfate, synthetic black iron oxide, talc, and titanium
dioxide. The 150 mg capsules also
contain, D&C yellow #10, D&C Red #28.
CLINICAL PHARMACOLOGY
ORAL ADMINISTRATION
43
58
4
12
Rifampin is readily absorbed from the gastrointestinal tract. Peak
serum concentrations in healthy adults
and pediatric populations vary widely from individual to individual.
Following a single 600 mg oral
dose of rifampin in healthy adults, the peak serum concentration
averages 7 mcg/mL but may vary from 4
to 32 mcg/mL. Absorption of rifampin is reduced by about 30% when the
drug