Maxrin D 0.4mg+0.5mg Capsule

✔️ Dosage & Administration

Adults (including the elderly)

One capsule once daily, containing Tamsulosin Hydrochloride 0.4 mg and Dutasteride 0.5 mg

To be taken approximately 30 minutes after the same meal each day

Capsules should be swallowed whole and must not be chewed, crushed, or opened

This combination may be used to replace concomitant Dutasteride and Tamsulosin therapy to simplify treatment. Where clinically appropriate, patients may be switched directly from monotherapy to Maxrin D.

Renal Impairment

No dosage adjustment is expected, as pharmacokinetic effects have not been studied

Hepatic Impairment

Use with caution in mild to moderate hepatic impairment

Contraindicated in severe hepatic impairment

✔️ Maxrin D is contra-indicated in:

Women, children, and adolescents

Patients with hypersensitivity to Dutasteride, other 5-alpha reductase inhibitors, Tamsulosin, soya, peanut, or any excipients

History of orthostatic hypotension

Severe hepatic impairment

✔️ The most commonly reported adverse effects include:

• Erectile dysfunction
• Reduced libido
• Ejaculatory disorders
• Breast tenderness or enlargement
• Dizziness

✔️ Precautions & Warnings

Combination therapy should be prescribed after careful benefit–risk assessment

Slightly increased risk of cardiac failure has been reported with long-term combination therapy

PSA levels decrease by ~50% after 6 months; a new PSA baseline should be established and monitored regularly

Orthostatic hypotension may occur; patients should be advised to sit or lie down if symptoms develop

Caution when co-administered with PDE-5 inhibitors

Risk of Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery; inform ophthalmologist prior to surgery

Leaking capsules should not be handled by women or children

Rare cases of male breast cancer have been reported; patients should report breast changes promptly

✔️ Pregnancy & Lactation

Contraindicated in women

Dutasteride may affect semen parameters; pthe otential impact on male fertility cannot be excluded

Exposure of pregnant women to Dutasteride (including via semen) may affect male fetal genital development

Male patients should use condoms if their partner is pregnant or may become pregnant

It is unknown whether Dutasteride or Tamsulosin is excreted in human milk

✔️ Interaction

Dutasteride

Metabolized primarily via CYP3A4 and CYP3A5

Concomitant use with CYP3A4 or P-glycoprotein inhibitors (e.g., verapamil, diltiazem) may increase Dutasteride serum levels

Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) may further elevate exposure; dose frequency reduction may be considered if adverse effects occur

No significant interaction observed with warfarin, digoxin, or cholestyramine

Tamsulosin

Concurrent use with antihypertensives, PDE-5 inhibitors, anesthetics, or other alpha-blockers may enhance hypotensive effects

Use with cimetidine may increase Tamsulosin exposure; caution is advised

No clinically significant interactions reported with atenolol, enalapril, nifedipine, or theophylline

Diclofenac may increase the tamsulosin elimination rate

✔️ Storage

Store in a cool, dry place

Protect from light