RIFAMPIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

EPIC PHARMA, LLC

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 Elimination of Tuberculosis, the American Thoracic Society, and Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive. Rifampin IV is indicated for the initial treatment and retreatment of tuberculosis when the drug cannot be taken by mouth. Rifampin is indicated for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. Rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. (See WARNINGS.) Rifampin should not be used indiscriminately, and, therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. So that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high. To reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Rifampin is contraindicated in patients with a history of hypersensitivity to rifampin or any of the components, or to any of the rifamycins. (See WARNINGS.) Rifampin is contraindicated in patients who are also receiving ritonavir-boosted saquinavir due to an increased risk of severe hepatocellular toxicity. (See PRECAUTIONS, Drug Interactions.) Rifampin is contraindicated in patients who are also receiving atazanavir, darunavir, fosamprenavir, saquinavir, or tipranavir due to the potential of rifampin to substantially decrease plasma concentrations of these antiviral drugs, which may result in loss of antiviral efficacy and/or development of viral resistance. Rifampin is contraindicated in patients receiving praziquantel since therapeutically effective blood levels of praziquantel may not be achieved. In patients receiving rifampin who need immediate treatment with praziquantel alternative agents should be considered. However, if treatment with praziquantel is necessary, rifampin should be discontinued 4 weeks before administration of praziquantel. Treatment with rifampin can then be restarted one day after completion of praziquantel treatment. Rifampin is contraindicated in patients receiving lurasidone. Concomitant use of lurasidone with strong CYP3A4 inducers (e.g., rifampin) decreased the exposure of lurasidone compared to the use of lurasidone alone. (See PRECAUTIONS, Drug Interactions).

Product summary:

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 42806-801-30, bottles of 30 capsules NDC 42806-801-01, bottles of 100 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 42806-799-30, bottles of 30 capsules NDC 42806-799-60, bottles of 60 capsules NDC 42806-799-01, bottles of 100 capsules NDC 42806-799-05, bottles of 500 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: Epic Pharma, LLC Laurelton, NY 11413 Rev. 07-2023-01 MF801REV07/23 OS0004

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIFAMPIN- RIFAMPIN CAPSULE
EPIC PHARMA, LLC
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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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12
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, therefore,
diffuses freely into tissues.