LOLO TAMSULOSIN USP 0.4mg CAPSULES(Each hard gelatin capsule contains Tamsulosin 0.4mg)

Indications

• Benign prostatic hyperplasia (BPH)

Dosage

Adults: The typical adult dose of amsulosin is 0.4 mg once daily, taken after the same meal each day. In some cases, the dose may be increased to 0.8 mg once daily based on clinical response and tolerability.

Mechanism of action

Amsulosin selectively inhibits alpha-1A adrenergic receptors, primarily found in the prostate and bladder neck. This leads to smooth muscle relaxation, resulting in decreased resistance to urinary flow and alleviation of symptoms associated with BPH, such as difficulty in urination and increased urinary frequency.

Pharmacodynamics

The pharmacodynamic effects of amsulosin are characterized by its ability to reduce the tone of the prostate and bladder neck smooth muscles, resulting in an improved urinary stream. The specific targeting of the alpha-1A subtype reduces the incidence of systemic side effects commonly associated with non-selective alpha blockers.

Pharmacokinetics

Amsulosin is rapidly absorbed following oral administration, with peak plasma concentrations occurring approximately 4 to 6 hours after dosing. It has a high bioavailability due to a low first-pass effect. The drug is extensively metabolized in the liver, primarily via cytochrome P450 3A4. The elimination half-life is approximately 5 to 9 hours, with renal excretion of metabolites being the main route of elimination. Dose adjustments may be necessary in patients with significant renal or hepatic impairment.

Contra-indications

• Severe hepatic impairment
• Hypersensitivity to amsulosin or any of its components
• Concurrent use with strong CYP3A4 inhibitors

Adverse effects

• Dizziness
• Headache
• Hypotension
• Nasal congestion
• Retrograde ejaculation
• Fatigue

Interactions

• Increased risk of hypotension with other antihypertensive agents
• Caution with PDE5 inhibitors due to potential additive effects on blood pressure
• CYP3A4 inhibitors may increase amsulosin levels

Precautions

• Caution in patients with a history of orthostatic hypotension
• Monitor renal function in patients with moderate to severe renal impairment
• Not recommended for use in women

Pregnancy

Amsulosin is not indicated in pregnancy; safety during pregnancy has not been established.

Breast-feeding

Amsulosin is not recommended during breastfeeding due to lack of data on excretion in human milk.

Storage

Store below 25°C. Protect from moisture.

Formulations

• Amsulosin hydrochloride 0.4 mg capsules