Zatral

 10 mg Tablet (Extended Release)
Eskayef Pharmaceuticals Ltd.

Unit Price: ৳ 10.00 (3 x 10: ৳ 300.00)

Strip Price: ৳ 100.00

Indications
  • Treatment of Benign Prostatic Hyperplasia (BPH):
    Alfuzosin is indicated for the relief of symptoms of BPH including urinary frequency, urgency, nocturia, weak stream, and incomplete bladder emptying.
  • Off-label uses: Occasionally used to aid in the passage of ureteral stones by relaxing ureteral smooth muscle, though not formally approved for this indication.
Dosage & Administration
  • Adults:
    • Usual dose: 10 mg once daily immediately after the same meal each day to enhance absorption.
    • The extended-release formulation is preferred for once-daily dosing.
  • Elderly: Same as adults; no dose adjustment required.
  • Pediatrics: Safety and efficacy not established; not recommended.
  • Renal Impairment:
    • Mild to moderate impairment: no dose adjustment necessary.
    • Severe impairment: use with caution; limited data available.
  • Hepatic Impairment: Contraindicated in severe hepatic impairment.
  • Administration: Oral use, swallow extended-release tablets whole; do not crush or chew.
Mechanism of Action (MOA)

Alfuzosin is a selective alpha-1 adrenergic receptor antagonist with relative uroselectivity. It binds to and blocks alpha-1 receptors located in the smooth muscle of the prostate, bladder neck, and urethra, leading to relaxation of these muscles. This reduces resistance to urinary outflow and improves symptoms of BPH without significantly affecting blood pressure due to limited vascular alpha-1 blockade at therapeutic doses.

Pharmacokinetics
  • Absorption: Well absorbed; bioavailability approximately 49%. Food enhances absorption and reduces variability.
  • Distribution: Highly protein bound (~82–90%).
  • Metabolism: Extensively metabolized in the liver primarily by CYP3A4 enzymes.
  • Half-life: Approximately 10 hours, allowing once-daily dosing.
  • Elimination: Mainly excreted in feces (about 70%) and urine (~30%) as metabolites and unchanged drug.
Pregnancy Category & Lactation
  • Pregnancy: Not indicated for use in women; no adequate studies in pregnant women.
  • Lactation: Unknown if excreted in human milk; use caution if administered to breastfeeding mothers.
Therapeutic Class
  • Primary Class: Alpha-1 adrenergic receptor antagonist
  • Subclass: Selective uroselective alpha-1 blocker
Contraindications
  • Known hypersensitivity to alfuzosin or any formulation excipients
  • Severe hepatic impairment
  • Concurrent use with potent CYP3A4 inhibitors (e.g., ketoconazole)
  • History of orthostatic hypotension or syncope related to alpha-blockers
Warnings & Precautions
  • Hypotension and Syncope: Risk of orthostatic hypotension, especially at therapy initiation or dose escalation; caution in patients with low blood pressure or volume depletion.
  • Intraoperative Floppy Iris Syndrome (IFIS): Possible in patients undergoing cataract surgery; inform ophthalmologists if patient is on or has taken alfuzosin.
  • Hepatic Impairment: Contraindicated in severe cases; monitor mild/moderate impairment.
  • Renal Impairment: Use caution; monitor renal function.
  • Elderly Patients: Higher sensitivity to hypotensive effects; monitor blood pressure closely.
Side Effects

Common:

  • Dizziness, headache
  • Fatigue
  • Upper respiratory tract infections
  • Gastrointestinal complaints (nausea, abdominal pain)

Less common:

  • Hypotension, postural dizziness
  • Palpitations
  • Rhinitis

Rare/Serious:

  • Syncope, angina pectoris
  • Prolonged QT interval (rare)
  • Allergic reactions including rash and angioedema
Drug Interactions
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): Increase alfuzosin plasma concentrations, raising risk of hypotension. Avoid combination.
  • Other antihypertensives or PDE5 inhibitors: Additive blood pressure lowering effects; monitor for hypotension.
  • Strong CYP3A4 inducers: May reduce alfuzosin efficacy.
  • Alcohol: May enhance hypotensive effects; caution advised.
Recent Updates or Guidelines
  • Guidelines recommend alfuzosin as a first-line pharmacologic treatment for symptomatic BPH due to its efficacy and tolerability profile.
  • Recent safety communications emphasize caution with concurrent CYP3A4 inhibitors and awareness of IFIS risk in cataract surgery.
  • Dose optimization and patient education on postural hypotension have been highlighted to reduce adverse events.
Storage Conditions
  • Store at 20°C to 25°C (68°F to 77°F).
  • Protect from moisture and light.
  • Keep tablets in original packaging until use.
  • Do not freeze or expose to excessive heat.
Available Brand Names