RIFAMPIN capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

REMEDYREPACK INC.

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 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 capsules are 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 ).

Produkt oversigt:

Rifampin Capsules USP, 300 mg are size '1' capsules having dark red cap, imprinted with "LU" in white ink and light red body, imprinted with "E02" in white ink, containing reddish brown powder. NDC: 70518-2404-00 NDC: 70518-2404-01 NDC: 70518-2404-02 NDC: 70518-2404-03 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 30 in 1 BOX PACKAGING: 1 in 1 POUCH Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed. Store in a dry place. Avoid excessive heat. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

RIFAMPIN- RIFAMPIN CAPSULE
REMEDYREPACK INC.
----------
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 contains 150 mg or 300
mg rifampin per
capsule. The 150 mg and 300 mg capsules also contain, as inactive
ingredients: corn
starch, crospovidone, D & C Red no. 28, FD & C Blue no. 1, FD & C Red
no. 40, gelatin,
magnesium stearate, potassium hydroxide, pregelatinized starch,
propylene glycol,
shellac, sodium lauryl sulphate 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
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 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 the unbou