RIFAMPIN- rifampin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

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® 1) 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

Product summary:

Product: 50090-2633 NDC: 50090-2633-0 30 CAPSULE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIFAMPIN- RIFAMPIN CAPSULE
A-S MEDICATION SOLUTIONS
----------
RIFAMPIN CAPSULES, USP
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 contain 150 mg or 300
mg rifampin per capsule. The
150 mg and 300 mg capsules contain a powder that is brick-red in
color. The 150 mg and 300 mg
capsules also contain, as inactive ingredients: pregelatinized starch,
colloidal silicon dioxide, talc,
magnesium stearate, D&C Red # 28, FD&C Blue # 1, FD&C Red # 40,
gelatin, 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
Rifampin is readily absorbed from the gastrointestinal tract. Peak
serum concentrations in healthy adults
43
58
4
12
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 bound. Most of