RIFAMPIN capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Asclemed USA, Inc.

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 (e.g., RIFATER ® (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

Dettagli prodotto:

Rifampin capsules USP, 300 mg are red capsules, imprinted E 799 in black ink on both cap and body. They are available as follows: NDC 76420-060-14, bottles of 14 capsules (repackaged from NDC 0185-0799-xx) NDC 76420-060-30, bottles of 30 capsules (repackaged from NDC 0185-0799-xx) NDC 76420-060-60, bottles of 60 capsules (repackaged from NDC 0185-0799-xx) Store at 20º to 25º C (68º to 77º F) [See USP Controlled Room Temperature] Dispense contents in a tight light-resistant container as defined in the USP with a child resistant closure, as required. Store in a dry place. KEEP TIGHTLY CLOSED. Avoid excessive heat. KEEP OUT OF THE REACH OF CHILDREN. Rx only The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc. Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

RIFAMPIN- RIFAMPIN CAPSULE
ASCLEMED USA, INC.
----------
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-2,4,12,16,18, 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.
Its structural formula is:
Rifampin capsules, USP for oral administration, contain 300 mg
rifampin per capsule. The 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,
43
58
4
12
microcrystalline cellulose, propylene glycol, shellac glaze, sodium
benzoate, black iron oxide, talc, and
titanium dioxide.
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