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rifampin/isoniazid/pyrazinamide (Rifater)

 

Classes: Antitubercular Agents

Dosing and uses of Rifater (rifampin-isoniazid-pyrazinamide)

 

Adult dosage forms and strengths

isoniazid/pyrazinamide/rifampin

tablet

  • 50mg
  • 300mg
  • 120mg

 

Tuberculosis

<44 kg: 4 tablets PO qd

44-54 kg: 5 tablets PO qd

>55 kg: 6 tablets PO qd

 

Administration

Take on empty stomach with full glass of water

 

Pediatric dosage forms and strengths

<15 years old: safety & efficacy not established

 

Warnings

Contraindications

Hypersensitivity to isoniazid, pyrazinamide, rifamycins

Acute liver dz, severe hepatic damage, acute gout

Rifampin contraindicated in patients receiving ritonavir-boosted saquinavir due to an increased risk of severe hepatocellular toxicity

Rifampin contraindicated in patients 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

 

Cautions

Anaphylaxis

Rifampin is not recommended for intermittent therapy; caution patient against intentional or accidental interruption of daily dosage regimen since rare renal hypersensitivity reactions have been reported when therapy was resumed in such cases

Rifampin has enzyme induction properties that can enhance the metabolism of endogenous substrates including adrenal hormones, thyroid hormones, and vitamin d

 

Pregnancy and lactation

Pregnancy: C

Rifampin: Effects unknown; reported to cross placental barrier and appear in cord blood; increased congenital malformations, primarily spina bifida and cleft palate reported in offspring of rodents given oral doses of 150-250 mg/kg/day during pregnancy; case reports of postnatal hemorrhage in mother and infant when administered during last few weeks of pregnancy

Isoniazid: Embryocidal effects reported in both rats and rabbits, although no congenital abnormalities observed in mammalian offspring when given during pregnancy

Pyrazinamide: Animal reproductive studies have not been conducted

Lactation: Isoniazid is known to be secreted into breast milk; caution advised

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.