Rifaximin (ZAXINE)

05/23/2024
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Product Information

  • Name: ZAXINE
  • Active Ingredient: Rifaximin
  • Strength: 550 mg tablets
  • Manufacturer: Salix Pharmaceuticals, Inc.
  • Distributed by: Lupin Pharma Canada Ltd.

Therapeutic Classification

  • Class: Antibacterial Agent

Indications and Clinical Use

  • Irritable Bowel Syndrome with Diarrhea (IBS-D): For the treatment of IBS-D in adults.
  • Hepatic Encephalopathy (HE): For the reduction in risk of overt HE recurrence in patients ≥ 18 years of age.

Dosage and Administration

  • Hepatic Encephalopathy: 550 mg twice daily.
  • IBS-D: 550 mg three times a day for 14 days. Patients who experience a recurrence of symptoms and responded to the first treatment can be retreated for up to 2 times.

Contraindications

  • Hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any ingredients in ZAXINE.

Warnings and Precautions

  • Not for Systemic Infections: Acts locally in the gut and should not be used for systemic infections.
  • Tendinitis and Tendon Rupture: Rare but serious, especially in older patients.
  • Clostridium difficile-Associated Diarrhea (CDAD): May occur with antibacterial use.
  • Hypersensitivity Reactions: Includes anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
  • Hepatic Impairment: Increased systemic exposure; caution in severe hepatic impairment (Child-Pugh C).
  • Pregnancy: Use only if benefits justify risks.
  • Breastfeeding: Unknown if excreted in human milk; consider discontinuing drug or breastfeeding.
  • Pediatrics and Geriatrics: Safety and effectiveness not established in pediatric patients; no significant differences in safety or effectiveness in elderly.

Adverse Reactions

  • Common: Nausea, headache, abdominal pain, dizziness, rash, pruritus.
  • Serious: Severe hypersensitivity reactions, Clostridium difficile-associated diarrhea, hepatic encephalopathy.

Drug Interactions

  • CYP3A4 substrates: Rifaximin is metabolized by CYP3A4; may interact with other CYP3A4 substrates.
  • P-gp inhibitors: May increase systemic exposure of rifaximin.
  • Oral Contraceptives: Minimal effect on Cmax and AUC.

Pharmacokinetics

  • Absorption: Poorly absorbed, with low systemic availability.
  • Distribution: Moderately bound to plasma proteins.
  • Metabolism: Metabolized by CYP3A4 in vitro.
  • Excretion: Mainly excreted in feces, minimal renal excretion.
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Written By Paul Kim

Medical Director - APN, NSWOC, RNP

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