Rifater (Rifampin / Isoniazid / Pyrazinamide)

Rifater Review

Rifater is indicated in the treatment of pulmonary tuberculosis.

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Rifater Drug Class and Mechanism

Rifampin inhibits DNA-dependent RNA polymerase activity in susceptible Mycobacterium tuberculosis organisms. Specifically, it interacts with bacterial RNA polymerase, but does not inhibit the mammalian enzyme. Organisms resistant to rifampin are likely to be resistant to other rifamycins. Isoniazid Isoniazid kills actively growing tubercle bacilli by inhibiting the biosynthesis of mycolic acids which are major components of the cell wall of Mycobacterium tuberculosis.

Rifater Uses

RIFATER (rifampin/isoniazid/pyrazinamide) tablets are combination tablets containing 120 mg rifampin, 50 mg isoniazid, and 300 mg pyrazinamide for use in antibacterial therapy. The tablets also contain as inactive ingredients: povidone, carboxymethylcellulose sodium, calcium stearate, sodium lauryl sulfate, sucrose, talc, acacia, titanium dioxide, kaolin, magnesium carbonate, colloidal silicon dioxide, dried aluminum hydroxide gel, ferric oxide, black iron oxide, carnauba wax, white beeswax, colophony, hard paraffin, lecithin, shellac, and propylene glycol. The RIFATER triple therapy combinaion was developed for dosing convenience. Adults: Patients should be given the following single daily dose of RIFATER either 1 hour before or 2 hours after a meal with a full glass of water. Patients weighing ?44 kg - 4 tablets Patients weighing between 45-54 kg - 5 tablets Patients weighing ?55 kg - 6 tablets Pediatric Patients: The ratio of the drugs in RIFATER may not be appropriate in pediatric patients under the age of 15 (eg, higher mg/kg doses of isoniazid are usually given in pediatric patients than adults).

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Rifater Side Effects

No serious adverse events were reported in the patients receiving RIFATER tablets. Three serious adverse events were reported in the patients given isoniazid, rifampin, and pyrazinamide as separate tablets and capsules. The three serious adverse events were two general hypersensitivity reactions and one jaundice reaction. There were no significant differences between the two treatment groups in standard liver function, renal function and hematological laboratory test values measured at baseline and after 8 weeks of treatment. As would be expected for these drugs, there were alterations in liver enzymes (SGOT, SGPT) and serum uric acid levels. The adverse reactions reported during therapy with RIFATER are consistent with those described below for the individual components. Adverse Reactions Reported for Individual Components Rifampin, Gastrointestinal: Heartburn, epigastric distress, anorexia, nausea, vomiting, jaundice, flatulence, cramps, and diarrhea have been noted in some patients. Although Clostridium difficile has been shown in vitro to be sensitive to rifampin, pseudomembranous colitis has been reported with the use of rifampin (and other broad spectrum antibiotics). Therefore, it is important to consider this diagnosis in patients who develop diarrhea in association with antibiotic use. Rarely, hepatitis or a shocklike syndrome with hepatic involvement and abnormal liver function tests has been reported. Hematologic: Thrombocytopenia has occurred primarily with high dose intermittent therapy, but has also been noted after resumption of interrupted treatment. It rarely occurs during well-supervised daily therapy. This effect is reversible if the drug is discontinued as soon as purpura occurs. Cerebral hemorrhage and fatalities have been reported when rifampin administration has been continued or resumed after the appearance of purpura.

Rifater Pregnancy

Rifater Overdose

Rifater There is no human experience with Rifater overdosage. Rifampin Non-fatal overdoses with as high as 12 g of rifampin have been reported. One case of fatal overdose is known: A 26-year-old man died after self-administering 60 g of rifampin. Isoniazid Untreated or inadequately treated cases of gross isoniazid overdosage can be fatal, but good response has been reported in most patients treated within the first few hours after drug ingestion. Ingested acutely, as little as 1.5 g isoniazid may cause toxicity in adults. Doses of 35 to 40 mg/kg have resulted in seizures. Ingestion of 80 to 150 mg/kg isoniazid has been associated with severe toxicity and, if untreated, significant mortality.

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