RIFAMPIN capsule, coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

H.J. Harkins Company, Inc.

INN (Nome Internazionale):

RIFAMPIN

Composizione:

RIFAMPIN 300 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide (RIFATER® manufactured by sanofi-aventis U.S. LLC) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the

Dettagli prodotto:

Rifampin Capsules, USP, 150 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 150” and on the other half in radial print “VP/015” Bottles of 30 (NDC 61748-015-30) Unit Dose Boxes of 100 (NDC 61748-015-11) Rifampin Capsules, USP, 300 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 300” and on the other half in radial print “VP/018” Bottles of 30 (NDC 61748-018-30) Bottles of 60 (NDC 61748-018-60) Bottles of 100 (NDC 61748-018-01) Unit Dose Boxes of 100 (NDC 61748-018-11) Storage: Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Store in a dry place. Avoid excessive heat. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

RIFAMPIN - RIFAMPIN CAPSULE, COATED
H.J. HARKINS COMPANY, INC.
----------
RIFAMPIN CAPSULES, USP
RX ONLY
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 capsules, USP contain 150 mg or 300 mg rifampin per capsule.
The 150 mg and 300 mg
capsules also contain, as inactive ingredients: colloidal silicon
dioxide, corn starch, FD&C Blue No. 1,
FD&C Red No. 40, gelatin, lactose monohydrate, magnesium stearate,
sodium lauryl sulfate, talc, and
titanium dioxide.
The printing ink contains ammonium hydroxide, isopropyl alcohol,
n-butyl alcohol, pharmaceutical
glaze, propylene glycol, simethicone, and titanium dioxide
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-piper-
azinyl)formimidoyl]-2,7-(epoxypentadeca-[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione
21-
acetate. Its structural formula is:
CLINICAL PHARMACOLOGY
ORAL ADMINISTRATION
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 is ingested with food.
Rifampin is widely distributed throughout the body. It is present in
effective concentrations in many
organs and body fluids, incl