RIFAMPIN capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Rebel Distributors Corp

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 capsule 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 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, the American T

Termék összefoglaló:

Rifampin Capsules, USP 300 mg are supplied as red capsules, imprinted E 799 and are available in bottles of 15, 20 and 30. Store at 20º - 25º C (68º - 77º F) [See USP Controlled Room Temperature]. Store in a dry place. Keep tightly closed. Avoid excessive heat. Dispense contents with a child resistant closure (as required) and in a tight light-resistant container as defined in the USP/NF. 1. National Committee for Clinical Laboratory Standards, Antimycobacterial Susceptibility Testing. Proposed Standard NCCLS Document M24-P, Vol. 10, No. 10, NNCLS, Villanova, PA, 1990. 2. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically — Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December 1993. 3. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibly Tests — Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December 1993. 4. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing; Fifth Informational Supplement, NCCLS Document M100-S5, Vol. 14, No. 16, NCCLS, Villanova, PA, December 1994. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for Sandoz Inc., Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 Rev. 11/08 MF0799REV11/08 0S7204 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

RIFAMPIN- RIFAMPIN CAPSULE
REBEL DISTRIBUTORS CORP
----------
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, calcium
stearate, D&C yellow #10 aluminum lake, 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