RIFAMPIN capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

American Health Packaging

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 ® *) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis,

Dettagli prodotto:

Rifampin Capsules USP, 150 mg are size '2' capsules having dark red cap, imprinted with "LU" in white ink and light red body, imprinted with "E01" in white ink, containing reddish brown powder. Unit dose packages of 30 (3 x 10) NDC 60687-575-21 Rifampin Capsules USP, 300 mg are size '1' capsules having dark red cap, imprinted with "LU" in white ink and light red body, imprinted with "E02" in white ink, containing reddish brown powder. Unit dose packages of 100 (10 x 10) NDC 60687-586-01 Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Store in a dry place. Avoid excessive heat. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

RIFAMPIN- RIFAMPIN CAPSULE
AMERICAN HEALTH PACKAGING
----------
RIFAMPIN CAPSULES USP
8457521/0622
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 for oral administration contains 150 mg or 300
mg rifampin per
capsule. The 150 mg and 300 mg capsules also contain, as inactive
ingredients: corn
starch, crospovidone, D & C Red no. 28, FD & C Blue no. 1, FD & C Red
no. 40, gelatin,
magnesium stearate, potassium hydroxide, pregelatinized starch,
propylene glycol,
shellac, sodium lauryl sulphate 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-2,4,12,16,18,20,22–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:
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 is ingested with food.
Rifampin is widely distributed throughout the body. It is present in
effective
concentrations in many organs and body fluids, including cerebrospinal
fluid. Rifampin is
about 80% protein bou