RIFAMPIN capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 Elimina

Produkt oversigt:

Rifampin capsules USP, 150 mg are orange capsules, imprinted E 801 in black ink on both cap and body. They are available as follows: NDC 24658-801-30, bottles of 30 capsules 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 24658-802-60, bottles of 30 capsules Storage 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 Epic Pharma, LLC. Distributed by: PuraCap Laboratories, LLC DBA Blu Pharmaceuticals Greenvale, NY 11548 Rev. 11-2022-00 MF801BLUREV11/22 OS0015

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

RIFAMPIN- RIFAMPIN CAPSULE
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
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RIFAMPIN CAPSULES, USP
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 150 mg or 300
mg rifampin per
capsule. 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
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.
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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 bound. Most of the unbound fraction is not ionized
and, therefor