Sasolin D

• Benign Prostatic Hyperplasia (BPH):
  Approved for the treatment of moderate to severe symptoms of BPH in men with an enlarged prostate (typically prostate volume ≥30 mL). It improves urinary flow, reduces lower urinary tract symptoms (LUTS), and lowers the risk of acute urinary retention and BPH-related surgery.
• Off-label uses:
  Occasionally used in clinical practice to manage persistent LUTS related to BPH when monotherapy is inadequate.

• Adults:
  One oral capsule daily containing 0.4 mg tamsulosin hydrochloride and 0.5 mg dutasteride.
  Administer approximately 30 minutes after the same meal each day to optimize absorption and reduce variability.
• Pediatrics:
  Not indicated.
• Elderly:
  No dose adjustment required; monitor for adverse effects.
• Renal Impairment:
  Use with caution in severe renal impairment; no specific dose adjustment for mild to moderate cases.
• Hepatic Impairment:
  Caution advised in moderate to severe hepatic impairment; no formal dose adjustments recommended.
• Administration:
  Capsules should be swallowed whole without crushing or chewing.

Tamsulosin selectively blocks alpha-1A adrenergic receptors in prostatic and bladder neck smooth muscle, causing muscle relaxation and thereby reducing urinary outflow resistance. Dutasteride inhibits both type 1 and type 2 isoenzymes of 5-alpha reductase, preventing the conversion of testosterone to dihydrotestosterone (DHT), which is a key androgen promoting prostate enlargement. The combination thus offers both rapid symptomatic relief (via tamsulosin) and long-term reduction in prostate size and disease progression (via dutasteride).

• Tamsulosin:
• Rapidly absorbed; peak plasma levels at 4–5 hours.
• Bioavailability approximately 30–40%.
• Highly plasma protein-bound (~94–99%).
• Metabolized primarily via hepatic CYP3A4 and CYP2D6.
• Half-life: 9–15 hours.
• Excretion mainly through feces and urine as metabolites.
• Dutasteride:
• Well absorbed with peak plasma concentration at 2–3 hours post-dose.
• Highly lipophilic, extensively distributed in tissues.
• Metabolized by CYP3A4 to active metabolites.
• Half-life: approximately 5 weeks due to tissue accumulation.
• Eliminated primarily via feces.

• Pregnancy:
  Not indicated for use in women. Dutasteride is teratogenic and contraindicated in women of childbearing potential.
• Lactation:
  Safety unknown; breastfeeding not recommended due to potential for adverse effects.

• Tamsulosin: Selective Alpha-1 Adrenergic Receptor Blocker
• Dutasteride: 5-Alpha Reductase Inhibitor
• Combination: Treatment for Benign Prostatic Hyperplasia (Alpha Blocker + 5-Alpha Reductase Inhibitor)

• Known hypersensitivity to tamsulosin, dutasteride, or any excipients.
• Women who are or may become pregnant.
• Severe hepatic impairment (use cautiously).
• Pediatric patients.

• First-dose hypotension and orthostatic hypotension risk, particularly with tamsulosin.
• Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery associated with tamsulosin.
• Dutasteride lowers PSA levels; PSA monitoring should adjust for this effect.
• Possible increased risk of high-grade prostate cancer; patients should be monitored.
• Caution in hepatic impairment.
• Sexual dysfunction, including decreased libido and erectile dysfunction, may occur.

• Common:
  Dizziness, headache, nasal congestion, abnormal ejaculation, fatigue.
• Serious (rare):
  Severe hypotension, syncope, allergic reactions, breast tenderness or enlargement, priapism, and high-grade prostate cancer.

• CYP3A4 inhibitors (e.g., ketoconazole) may increase plasma concentrations of both drugs, increasing side effects.
• Additive hypotensive effects with other blood pressure–lowering agents or PDE5 inhibitors.
• Cimetidine may increase tamsulosin exposure.
• Alcohol can exacerbate hypotensive effects.

• Clinical guidelines endorse combination therapy in men with moderate to severe BPH and enlarged prostate to reduce progression risk.
• Updated warnings emphasize IFIS risk in cataract surgery patients treated with tamsulosin.
• PSA interpretation guidelines updated for patients on dutasteride due to suppressed levels.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Do not freeze.
• Keep capsules in the original container tightly closed.
• Handle capsules carefully; do not crush or chew.