Alfumax-ER10 mg

Alfumax-ER is an alpha-1 adrenergic receptor antagonist indicated for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.

• Established/FDA-approved use: Relief of BPH-related lower urinary tract symptoms such as urinary hesitancy, weak or interrupted stream, straining, incomplete bladder emptying, urinary frequency, and nocturia.
• Guideline-supported adjunct use: Facilitation of voiding trial after catheter removal in men presenting with acute urinary retention associated with BPH, usually combined with catheterization.

Alfumax-ER is not indicated for the treatment of hypertension, and it is not intended for use in women or children.

Important: Alfumax-ER improves urinary symptoms but does not reduce the size of the prostate or halt progression of BPH.

Each tablet contains Alfuzosin Hydrochloride INN as the active ingredient, most commonly formulated as an extended-release (prolonged-release) 10 mg tablet for once-daily oral use. Inactive ingredients vary by manufacturer and typically include diluents, binders, and a film coat.

Alfumax-ER is a quinazoline-derivative, selective alpha-1 adrenergic receptor antagonist used to relieve the urinary symptoms associated with benign prostatic hyperplasia (BPH). It is formulated as a prolonged-release tablet designed to provide a smooth, sustained plasma concentration over 24 hours with once-daily dosing.

By relaxing smooth muscle in the prostate, prostatic capsule, bladder neck, and proximal urethra, Alfumax-ER improves urine flow and reduces bothersome voiding symptoms without significantly shrinking the prostate gland itself.

Alfumax-ER belongs to the therapeutic class of alpha-1 adrenergic receptor antagonists (alpha-blockers), specifically agents used for benign prostatic hyperplasia (BPH). It is often described as a "uroselective" alpha-blocker because of its relatively greater affinity for alpha-1 receptors in the lower urinary tract compared to the vasculature.

Alfuzosin Hydrochloride is a selective antagonist of post-synaptic alpha-1 adrenergic receptors, which are abundant in the smooth muscle of the prostate, prostate capsule, bladder neck, and proximal urethra.

By blocking these receptors, Alfuzosin Hydrochloride relaxes smooth muscle tone in the lower urinary tract, reducing bladder outlet resistance and improving urinary flow in men with BPH. Because it has relatively lower selectivity for vascular alpha-1 receptors compared with some other alpha-blockers, the vasodilatory (blood-pressure-lowering) effect is generally less pronounced, although orthostatic hypotension can still occur, particularly at the start of treatment or with concurrent antihypertensive therapy.

Alfuzosin Hydrochloride does not have any direct effect on prostate size or on the underlying hormonal drivers of BPH progression; its benefit is purely symptomatic.

Pharmacokinetically, Alfuzosin Hydrochloride is well absorbed after oral administration, undergoes extensive hepatic metabolism (largely via CYP3A4), and is eliminated mainly through the feces with a smaller fraction excreted renally.

Alfumax-ER extended-release tablets should be taken orally, once daily, immediately after a meal, and should be swallowed whole with a full glass of water. Do not crush, chew, or split the tablet. Taking it consistently after the same meal each day helps maintain steady drug levels.

Alfumax-ER is metabolized mainly by the CYP3A4 enzyme, so its interactions are largely related to this pathway and to additive blood-pressure-lowering effects.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): significantly increase plasma concentrations of Alfumax-ER, raising the risk of hypotension; concurrent use is contraindicated in patients with hepatic or renal impairment and should generally be avoided or used with caution and dose reduction in others.
• Other alpha-1 adrenergic blockers (e.g., doxazosin, terazosin, tamsulosin, silodosin): should not be used concurrently with Alfumax-ER due to the risk of additive hypotensive effects.
• Antihypertensive agents and nitrates: concurrent use with Alfumax-ER may increase the risk of symptomatic orthostatic hypotension; blood pressure should be monitored, especially when therapy is initiated.
• PDE5 inhibitors (e.g., sildenafil, tadalafil): concomitant use with Alfumax-ER can cause symptomatic hypotension in some patients; caution and dose spacing/monitoring are advised.
• Other drugs that prolong the QT interval: use with caution, as QT prolongation has been reported with Alfumax-ER in some studies.

Adverse effects reported with Alfumax-ER include:

• Common: Dizziness, headache, fatigue, upper respiratory tract infection symptoms, nausea, abdominal pain, and general weakness.
• Less common: Orthostatic hypotension, syncope (fainting), palpitations/tachycardia, diarrhea, dry mouth, and rash.
• Rare but serious: Priapism (a prolonged, painful erection requiring urgent medical attention), intraoperative floppy iris syndrome (IFIS) during cataract surgery, angioedema, and aggravation of angina in patients with pre-existing coronary artery disease.

Patients should seek prompt medical attention for fainting, prolonged erection, or signs of an allergic reaction while taking Alfumax-ER.

Alfumax-ER is indicated only for use in adult men and has no approved use in women. It is not intended for use during pregnancy or lactation, and no clinical data exist regarding its use in pregnant or breastfeeding women. There is no recognized clinical role for its use in this population; women who are pregnant or breastfeeding should not take Alfumax-ER.

The following precautions apply to the use of Alfumax-ER:

• Orthostatic hypotension: Symptomatic postural hypotension and syncope can occur, especially within a few hours of the first dose or when antihypertensive drugs, nitrates, or PDE5 inhibitors are used concurrently. Patients should be cautioned to sit or lie down at the first sign of dizziness and to use caution when driving or performing hazardous tasks, particularly when starting treatment.
• Intraoperative floppy iris syndrome (IFIS): A variant of small pupil syndrome has been observed during cataract surgery in some patients treated with alpha-1 blockers, including Alfumax-ER, even after discontinuation. Patients should inform their ophthalmologist about current or past use of Alfumax-ER before cataract surgery so the surgical team can prepare appropriately; the drug generally should not be initiated in patients with planned cataract surgery in the near term.
• QT interval prolongation: QT prolongation has been observed in some studies of Alfumax-ER. Use with caution in patients with congenital or acquired QT prolongation or in those taking other QT-prolonging drugs.
• Hepatic and renal impairment: See Contraindications and Dosage and Administration; systemic exposure to Alfumax-ER is increased in hepatic and severe renal impairment.
• Priapism and angina: Discontinue and seek urgent medical care if priapism occurs; discontinue if angina develops or worsens during treatment with Alfumax-ER.
• Not indicated for use in women or children; benefit is symptomatic only and does not prevent BPH progression or complications such as acute urinary retention requiring surgery.

Overdose with Alfumax-ER can cause profound hypotension, dizziness, and syncope due to excessive alpha-1 blockade. If overdose is suspected, seek immediate medical attention or contact a poison control center/emergency services right away. The patient should be placed in a supine (lying down) position with the legs raised to counter hypotension while awaiting emergency care. Management is supportive and symptomatic (e.g., cardiovascular support); since Alfumax-ER is highly protein-bound, dialysis is unlikely to be of benefit. Do not attempt home treatment beyond basic first-aid positioning - immediate professional medical evaluation is required.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly: No overall dose adjustment is required based on age alone, although plasma levels of Alfumax-ER can be somewhat higher in patients 75 years and older; these patients should be monitored for hypotension.

Renal impairment: Use with caution in severe renal impairment; see Dosage and Administration.

Hepatic impairment: Contraindicated in moderate-to-severe hepatic impairment; use with caution in mild impairment (see Contraindications).

Women and children: Alfumax-ER is not indicated for use in women or in pediatric patients; safety and efficacy in these populations have not been established.

Alfumax-ER is generally used as a long-term, ongoing therapy for chronic BPH symptom control, continued for as long as symptomatic benefit is maintained and the medicine is tolerated, under regular physician follow-up. When used as an adjunct after catheter removal for acute urinary retention, a short course (commonly around 3-4 days) is typical. The prescribing physician determines the appropriate duration based on response and tolerability.

Alpha-1 adrenergic receptor antagonist (alpha-blocker); agent for benign prostatic hyperplasia (BPH).

Alfuzosin Hydrochloride selectively blocks post-synaptic alpha-1 adrenergic receptors located in the smooth muscle of the prostate, prostatic capsule, bladder neck, and proximal urethra. This blockade relaxes smooth muscle tone in the lower urinary tract, decreasing resistance to urinary outflow and improving voiding symptoms in men with BPH, without a significant direct effect on prostate size.

Alfumax-ER is not indicated for use in children or adolescents. Safety and efficacy in pediatric patients have not been established, and the drug should not be used in this population.