Adult Dosing

Tubercular infection

• 2 tabs PO qd on empty stomach, 1 hr before or 2 hrs after food

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Pulmonary tuberculosis in which organisms are susceptible, and when the patient has been titrated on the individual components

• Hypersensitivity to any of the ingredients of the product
• Prior isoniazid associated hepatic injury
• Acute hepatic disease

• Therapy may cause severe hepatitis most commonly in 1st 3months
• Carefully monitor AST/ALT at baseline, then periodically in patients >35 yrs
• Suspend therapy if LFTs >3-5x ULN or if symptoms of hepatic injury occur, institute alternative therapy; if must restart wait until symptoms and LFTs resolve; restart at low dose, increase gradually, and immediately discontinue if any signs and symptoms of recurrent hepatic injury occur
• Avoid preventive therapy in patients with hepatic impairment
• Do not administer if there is concomitant alcohol use, chronic hepatic disease, and IV drug use
• There is increased risk with age (highest risk 50-64 yrs, risk decreases >65 yrs)
• Women are at increased risk during therapy, particularly black and Hispanic, and during post-partum period, consider more careful monitoring

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Contraindicated

• Therapy has been associated with liver dysfunction. Liver function tests should be performed prior to therapy and periodically during treatment
• Avoid preventive therapy in patients with hepatic impairment
• Do not administer if there is concomitant alcohol use, chronic hepatic disease, and IV drug use
• Suspend therapy if LFTs >3-5x ULN or if symptoms of hepatic injury occur, institute alternative therapy; if must restart wait until symptoms and LFTs resolve; restart at low dose, increase gradually, and immediately discontinue if any signs and symptoms of recurrent hepatic injury occur

Cautions: Use cautiously in

• Renal impairment
• Peripheral neuropathy
• HIV infection
• Alcohol abuse
• IV drug abuse
• Porphyria
• Patients >35 yrs

Pregnancy Category:C

Breastfeeding: Because of the low levels of isoniazid in breastmilk and safe administration directly to infants, it is unlikely to cause adverse reactions in infants, but infants should be monitored for rare instances jaundice. Limited information indicates that rifampin is excreted in breastmilk in low levels and thus would not be expected to adversely affect the breastfed infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT). According to the AAP, women with tuberculosis who have been treated for > 2 wks and who are not considered contagious may breastfeed. Rifampin and isoniazid is compatible and considered safe with breastfeeding based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 25 February 2011).

• CNS: Shock, peripheral neuropathy, toxic psychosis, seizures, porphyria exacerbation, paresthesias, headache, drowsiness, dizziness
• GI: Pseudomembranous colitis, anorexia, nausea, vomiting, abdominal pain, diarrhea
• EENT: Optic neuritis, visual changes, contact lens staining
• RESP: Dyspnea
• DERM: Severe skin reactions
• GU: Interstitial nephritis, renal failure
• HEPA: Fatal hepatotoxicity, elevated liver transaminases
• HEMA: Agranulocytosis, anemia, thrombocytopenia, leukopenia, hemorrhage
• MISC: Hypersensitivity reactions, anaphylaxis, reddish-orange body fluid, influenza-like symptoms, pyridoxine deficiency

Isoniazid

• Antitubercular; inhibits mycobacterial cell wall synthesis and interferes with metabolism
• 50% metabolized by the liver
• Excreted in urine (50% unchanged)
• Half-life: 1–4 hrs

Rifampin

• Rifamycin; inhibits RNA synthesis by blocking RNA transcription in susceptible organisms
• Extensively metabolized by the liver
• Excreted in urine; feces
• Half-life: 3 hrs

US Trade Name(s)

• Rifamate

US Availability

isoniazid/rifampin (generic)

• CAPS: 150 mg/300 mg

Rifamate

• CAPS: 150 mg/300 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Rifinah

UK Availability

Rifinah

• TABS:
• 150 mg/300 mg
• 100 mg/150 mg

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Antituberculosis Agents

Antituberculosis Combinations

Infectious Disease

Antituberculosis Agents

Antituberculosis Combinations

Pricing data from www.DrugStore.com in U.S.A.

• Rifamate 150-300 MG CAPS [Bottle] (SANOFI-AVENTIS U.S.)
  60 mg = $265.67
  180 mg = $777.53

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Rifamate 150 MG-300 MG Oral Capsule

Ingredient(s): Isoniazid mixture with Rifampin

Imprint: RIFAMATE

Color(s): Red

Shape: Capsule

Size (mm): 14.00

Score: 1

Inactive Ingredient(s): colloidal silicon dioxide / fd&c blue no. 1 / fd&c red no. 40 / gelatin / magnesium stearate / sodium starch glycolate / titanium dioxide.

Drug Label Author:
sanofi-aventis U.S. LLC

DEA Schedule:
Non-Scheduled