Alfasin XR Tablet (Extended Release)

Introduction

Alfasin XR Tablet (Extended Release) 10 mg is an alpha-1 adrenergic receptor antagonist used primarily to treat the symptoms of benign prostatic hyperplasia (BPH), which is the enlargement of the prostate gland in men. It helps relax the muscles in the prostate and bladder neck, making it easier to urinate.

Uses

Alfuzosin is used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH), such as difficulty urinating, painful urination, and urinary frequency and urgency. It does not shrink the prostate but works by relaxing the muscles in the prostate and bladder neck.

Brand Name	Alfasin XR
Type	Tablet (Extended Release)
Weight	10 mg
Generic	Alfuzosin Hydrochloride
Manufacturer	Incepta Pharmaceuticals Ltd.
Available in	English বাংলা

Mechanism of Action

Alfuzosin selectively blocks alpha-1 adrenergic receptors found in the lower urinary tract, including the prostate, bladder, and urethra. By blocking these receptors, Alfuzosin causes relaxation of smooth muscle in the bladder neck and prostate, which leads to improved urine flow and reduced symptoms of BPH.

How Long Does It Take to Work?

Alfuzosin usually starts working within a few hours of the first dose. Most patients notice a significant improvement in urinary symptoms within a week of starting treatment. However, it may take several weeks of consistent use for the full benefits to be realized.

Absorption

Alfuzosin is well absorbed after oral administration. Its absorption is enhanced when taken with food, particularly a meal. Peak plasma concentrations are typically reached within 8 hours after administration.

Route of Elimination

Alfuzosin is primarily metabolized by the liver and is excreted in both urine and feces. Approximately 69% of the drug is excreted in feces, and about 24% is excreted via urine, with less than 10% of the dose excreted as unchanged drug in urine.

Dosage

Benign prostatic hyperplasia (BPH): The recommended dose is 10 mg to be taken once daily after a meal.

Acute urinary retention (AUR): In patients 65 years and older, 10 mg daily after a meal to be taken from the first day of catheterisation. The treatment should be administered for 3-4 days, 2-3 days during catheterisation and 1 day after its removal. In this indication no benefit has been established in patients under 65 years of age or if treatment is extended beyond 4 days.

The usual dose of Alfuzosin is 10 mg once daily, taken immediately after the same meal each day. It should not be chewed or crushed, as this may affect the drug's absorption and efficacy. Dosage adjustments may be needed in patients with liver or kidney impairments.

Administration

Alfuzosin is administered orally and should be taken with food, ideally after the same meal each day to ensure consistent absorption. It is available in extended-release tablets and should be swallowed whole without crushing or chewing.

Side Effects

Common side effects include dizziness, headache, fatigue, upper respiratory infections, and hypotension (low blood pressure). In some cases, it can cause postural hypotension, where blood pressure drops upon standing, leading to dizziness or fainting.

Toxicity

Alfuzosin toxicity is rare but can occur in the case of an overdose. Symptoms may include severe hypotension, dizziness, or syncope. Supportive measures such as fluids and vasopressors may be required in cases of significant overdose.

Precautions

Alfuzosin should be used with caution in patients with severe hepatic impairment or a history of hypotension. It is not recommended for use in patients with moderate to severe liver disease. Caution should also be exercised in patients taking medications that lower blood pressure.

Interaction

Alfuzosin can interact with other medications that lower blood pressure, such as antihypertensives and phosphodiesterase type 5 inhibitors (e.g., sildenafil), increasing the risk of hypotension. It should also be used cautiously with potent CYP3A4 inhibitors, such as ketoconazole and ritonavir, as they can increase the plasma concentration of Alfuzosin.

Disease Interaction

Patients with liver disease, especially moderate to severe hepatic impairment, should avoid using Alfuzosin. It may also interact with cardiovascular diseases, particularly those related to blood pressure regulation. Caution is advised in patients with severe renal impairment.

Drug Interaction

Alfuzosin can interact with several drugs, including antihypertensive agents, which may cause additive hypotensive effects. It may also interact with potent inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir), leading to increased levels of Alfuzosin in the bloodstream.

Food Interactions

Alfuzosin should be taken with food to enhance absorption. Taking it on an empty stomach may reduce its efficacy. A consistent meal schedule is advised to ensure optimal drug absorption and therapeutic effect.

Pregnancy Use

Alfuzosin is not indicated for use in women and should not be used during pregnancy. No studies have been conducted on its safety during pregnancy.

Lactation Use

Alfuzosin is not indicated for use in women and should not be used during lactation. It is unknown if Alfuzosin is excreted in breast milk, but its use is contraindicated in nursing mothers.

Acute Overdose

In cases of acute overdose, symptoms such as severe hypotension and syncope may occur. Treatment involves symptomatic and supportive care, including the administration of fluids and vasopressors if necessary to maintain blood pressure.

Contraindication

Alfuzosin is contraindicated in patients with a known hypersensitivity to the drug or any of its components. It is also contraindicated in patients with moderate to severe hepatic impairment and those with a history of orthostatic hypotension.

Use Direction

Alfuzosin should be taken once daily, immediately after the same meal each day. The tablet should be swallowed whole, without crushing or chewing, to maintain the integrity of the extended-release formulation.

Storage Conditions

Alfuzosin should be stored at room temperature, away from moisture and heat. It should be kept in its original container and out of reach of children.

Volume of Distribution

The volume of distribution of Alfuzosin is approximately 2.5 L/kg, suggesting extensive distribution into body tissues.

Half Life

The elimination half-life of Alfuzosin is approximately 10 hours, which allows for once-daily dosing in an extended-release form.

Clearance

Alfuzosin is primarily cleared by the liver, with less than 10% of the dose excreted unchanged in the urine. It is metabolized by the CYP3A4 enzyme system, and caution is advised when using drugs that inhibit this pathway.

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