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warnings
WARNINGS Rifampin has been shown to produce liver dysfunction. There have been fatalities associated with jaundice in patients with liver disease or receiving rifampin concomitantly with other hepatotoxic agents. Since an increased risk may exist for individuals with liver disease, benefits must be weighed carefully against the risk of further liver damage. Periodic liver function monitoring is mandatory. The possibility of rapid emergence of resistant meningococci restricts the use of rifampin to short-term treatment of the asymptomatic carrier state. Rifampin is not to be used for the treatment of meningococcal disease. Several studies of tumorigenicity potential have been done in rodents. In one strain of mice known to be particularly susceptible to the spontaneous development of hepatomas, rifampin given at a level 2-10 times the maximum dosage used clinically resulted in a significant increase in the occurrence of hepatomas in female mice of this strain after one year of administration. There was no evidence of tumorigenicity in the males of this strain, in males or females of another mouse strain, or rats. Usage In Pregnancy Although rifampin has been reported to cross the placental barrier and appear in cord blood, the effect of rifampin, alone or in combination with other antituberculous drugs, on the human fetus is not known. An increase in congenital malformations, primarily spina bifida and cleft palate, has been reported in the offspring of rodents given oral doses of 150-250 mg/kg/day of rifampin during pregnancy. The possible teratogenic potential in women capable of bearing children should be carefully weighed against the benefits of therapy.
ADVERSE REACTIONS Gastrointestinal disturbances such as heartburn, epigastric distress, anorexia, nausea, vomiting, gas, cramps, and diarrhea have been noted in some patients. Rarely, pseudomembranous enterocolitis has been reported. Headache, drowsiness, fatigue, ataxia, dizziness, inability to concentrate, mental confusion, visual disturbances, muscular weakness, fever, pains in extremities, generalized numbness, and menstrual disturbances have also been noted. Hypersensitivity reactions have been reported. Encountered occasionally have been pruritus, urticaria, rash, pemphigoid reaction, eosinophilia, sore mouth, sore tongue, and exudative conjunctivitis. Rarely, hepatitis or a shock-like syndrome with a hepatic involvement and abnormal liver function tests have been reported. Transient abnormalities in liver function tests (e.g., elevations in serum bilirubin, BSP, alkaline phosphatase, serum transaminases) have also been observed. The BSP test should be performed prior to the morning dose of rifampin to avoid false-positive results. Thrombocytopenia, transient leukopenia, hemolytic anemia, and decreased hemoglobin have been observed. Thrombocytopenia has occurred when rifampin and ethambutol were administered concomitantly according to an intermittent dose schedule twice weekly and in high doses. Elevations in BUN and serum uric acid have occurred. Rarely, hemolysis, hemoglobinuria, hematuria, renal insufficiency or acute renal failure have been reported and are generally considered to be hypersensitivity reactions. These have usually occurred during intermittent therapy or when treatment was resumed following intentional or accidental interruption of a daily dosage regimen and were reversible when rifampin was discontinued and appropriate therapy instituted. Although rifampin has been reported to have an immunosuppressive effect in some animal experiments, available human data indicate that this has no clinical significance.