Rifampicin

Indications

INDICATIONS AND USAGE 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. Tuberculosis 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Rifampin can be administered by the oral route (see INDICATIONS AND USAGE ). See CLINICAL PHARMACOLOGY for dosing information in patients with renal failure. Tuberculosis Adults 10 mg/kg, in a single daily administration, not to exceed 600 mg/day, orally. Pediatric Patients 10 to 20 mg/kg, not to exceed 600 mg/day, orally. It is recommended that oral rifampin be administered once daily, either 1 hour before or 2 hours after a meal with a full glass of water. Rifampin is indicated in the treatment of all forms of tuberculosis.

Contraindications

CONTRAINDICATIONS 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.

Warnings and precautions

WARNINGS Hepatotoxicity of hepatocellular, cholestatic, and mixed patterns has been reported in patients treated with rifampin. Severity ranged from asymptomatic elevations in liver enzymes, isolated jaundice/hyperbilirubinemia, symptomatic self-limited hepatitis to fulminant liver failure and death. Severe hepatic dysfunction including fatalities were reported in patients with liver disease and in patients taking rifampin with other hepatotoxic agents.

Pregnancy

Pregnancy–Teratogenic Effects Rifampin has been shown to be teratogenic in rodents. Congenital malformations, primarily spina bifida, were increased in the offspring of pregnant rats given rifampin during organogenesis at oral doses of 150 to 250 mg/kg/day (about 1 to 2 times the maximum recommended human dose based on body surface area comparisons…

Storage and supply

HOW SUPPLIED 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.

Source: Rifampin (Rifampin) — US FDA prescribing information, 2023-12-20, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.