RIFAMPIN- rifampin capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Mylan Institutional Inc.

INN (Tarptautinis Pavadinimas):

RIFAMPIN

Sudėtis:

RIFAMPIN 300 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 for the Elimin

Produkto santrauka:

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 51079-890-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). NDC 51079-890-19 – Robot Ready blister packages of 25 (25 cards of 1 capsule each). Store at 20º to 25º C (68º to 77º F). [See USP Controlled Room Temperature.] Store in a dry place. Avoid excessive heat. Protect from light. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured for: Sandoz Inc. Princeton, NJ 08540 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12200 4/15

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

RIFAMPIN- RIFAMPIN CAPSULE
MYLAN INSTITUTIONAL 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-2,4,12,16,20,22-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, 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, propylene glycol,
shellac glaze, sodium benzoate,
black iron oxide, talc, and titanium dioxide. The 150 mg capsules also
contain D&C yellow #10, and
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 is ingested with food.
R