Silimed D
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Silimed D

Contains:

    • Silodosin IP 8 mg

    • Dutasteride IP 0.5 mg
      Therapeutic Class: α₁A-Adrenergic Receptor Antagonist + 5α-Reductase Inhibitor
      Schedule: Schedule H (Prescription Drug)

Silimed D offers dual-action management of Benign Prostatic Hyperplasia (BPH) by combining:

  • Silodosin, a selective α₁A-adrenoceptor blocker, which rapidly relieves lower urinary tract symptoms (LUTS) by relaxing smooth muscles in the prostate and bladder neck.

  • Dutasteride, a dual 5α-reductase inhibitor that shrinks prostate volume over time by blocking the conversion of testosterone to dihydrotestosterone (DHT), the key hormone driving prostate growth.

This combination provides rapid symptomatic relief and long-term disease modification, reducing the need for surgery and preventing BPH progression.

Usage of Silimed D

  • Moderate to severe BPH with enlarged prostate (>30 mL)

  • Patients with both symptoms (LUTS) and increased prostate size

  • For those at risk of BPH progression or urinary retention

  • Long-term management to prevent acute urinary retention (AUR) and need for surgery

Common Side Effects

  • Retrograde ejaculation (Silodosin-related)

  • Decreased libido

  • Erectile dysfunction

  • Breast tenderness or enlargement (rare)

  • Dizziness or postural hypotension

  • GI discomfort (nausea, mild diarrhea)

Side effects are generally dose-dependent and reversible on discontinuation.

Precautions

  • Women and children should not handle crushed or opened capsules (Dutasteride may absorb through skin)

  • Use with caution in hepatic impairment

  • Not recommended in severe renal impairment (CrCl <30 mL/min)

  • May mask rising PSA levels—PSA testing must be doubled for accurate prostate cancer screening

  • Intraoperative Floppy Iris Syndrome (IFIS) risk in patients undergoing cataract surgery – inform the surgeon

  • Avoid blood donation during and for 6 months after stopping Dutasteride

Drug Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole): May increase Silodosin levels

  • Alpha-blockers: Do not combine with other α-blockers

  • Phosphodiesterase-5 inhibitors (e.g., tadalafil): Caution—risk of hypotension

  • Finasteride/Dutasteride: Avoid duplicate 5-ARI therapy

  • Antihypertensives: May enhance hypotensive effects

Dosage and Administration

  • One capsule once daily, preferably with food

  • Swallow whole—do not crush or open

  • Onset of action:

    • Silodosin: within 2–3 days (symptom relief)

    • Dutasteride: within 2–4 weeks (prostate shrinkage), full effect by 3–6 months

Storage

  • Store below 25°C, in a dry, cool place

  • Keep out of reach of children

  • Avoid exposure of capsule contents to skin

Patient Counselling Tips

  • Take at the same time each day with meals

  • Inform about possible ejaculation disorders—harmless and reversible

  • May take several weeks to months for full prostate-shrinking benefits

  • Do not stop abruptly without consulting your physician

  • Inform your doctor about any plans for blood donation or eye surgery

  • Report signs of breast enlargement or nipple discharge

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