RIFAMPIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

INN (International Name):

RIFAMPIN

Composition:

RIFAMPIN 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Rifampin capsules USP, 300 mg are red capsules, imprinted E 799 in black ink on both cap and body. They are available as follows: Carton of 100 capsules (10 capsules each blister pack x 10) NDC 0904-5282-61 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. Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 Rev.09/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIFAMPIN- RIFAMPIN CAPSULE
MAJOR PHARMACEUTICALS
----------
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:
43
58
4
12
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.
Rifampin is w