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Alfuzosin Hydrochloride

ALFUZOSIN HYDROCHLORIDE

Manufacturer: Sun Pharmaceutical Industries, Inc.

Score: 141.0

Quick Summary

Alfuzosin hydrochloride is an alpha adrenergic antagonist indicated for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH). It is not indicated for the treatment of hypertension or for use in the pediatric population. The recommended dosage is one 10 mg tablet once daily, taken with food and with the same meal each day. The tablets should not be chewed or crushed. Alfuzosin hydrochloride is contraindicated in patients with moderate or severe hepatic impairment, and in patients taking potent CYP3A4 inhibitors. Common adverse reactions include dizziness, upper respiratory tract infection, headache, and fatigue.

Key Clinical Findings and Indications

  • Treatment of signs and symptoms of benign prostatic hyperplasia (BPH)
  • Selective antagonist of post-synaptic alpha 1-adrenoreceptors
  • Improves urine flow and reduces symptoms of BPH

Important Safety Information

Warning

Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists can potentially cause symptomatic hypotension

Contraindications

  • Moderate or severe hepatic impairment
  • Co-administration with potent CYP3A4 inhibitors
  • Known hypersensitivity to alfuzosin or any component of alfuzosin hydrochloride tablets

Adverse Reactions

  • Dizziness
  • Upper respiratory tract infection
  • Headache
  • Fatigue

Dosing Recommendations

General Guidance

No dose adjustment is necessary for patients with renal impairment

Benign prostatic hyperplasia (BPH)

Adult Dose

10 mg once daily with food

Pediatric Dose

Not indicated for use in pediatric population

Special Population Considerations

Pregnancy

  • Not indicated for use in women
  • No adequate data on developmental risk associated with use during pregnancy

Nursing Mothers

  • Not indicated for use in nursing mothers

Pediatric Use

  • Not indicated for use in pediatric population
  • Efficacy not demonstrated in clinical trials

Geriatric Use

  • No overall differences in safety or effectiveness observed between geriatric and younger subjects
  • Greater sensitivity of some older individuals cannot be ruled out

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