Tamsin D 0.4 mg+0.5 mg (Capsule)

Indications

• Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH)
• Reduction in the risk of acute urinary retention and surgery in patients with moderate to severe symptoms of BPH

Pharmacology

• Combination of Tamsulosin Hydrochloride and Dutasteride for improving symptoms in patients with BPH
• Tamsulosin acts as an alpha1-adrenoreceptor blocking agent
• Dutasteride is a dual 5 alpha reductase inhibitor

Dosage & Administration

• Recommended dose is one capsule (Tamsulosin Hydrochloride 0.4 mg & Dutasteride 0.5 mg) taken orally approximately 30 minutes after the same meal each day
• Capsules should be swallowed whole and not chewed or opened

Interaction

• No formal drug interaction studies for Dutasteride-Tamsulosin combination
• Effects of other drugs on the pharmacokinetics of Dutasteride
• Effects of Dutasteride on the pharmacokinetics of other drugs

Contraindications

• Contra-indicated in women and children
• Contra-indicated in patients with hypersensitivity to Dutasteride or Tamsulosin
• Contra-indicated in patients with a history of orthostatic hypotension and severe hepatic impairment

Side Effects

• Most common adverse reactions include impotence, decreased libido, breast disorders, ejaculation disorders, and dizziness

Pregnancy & Lactation

• Contra-indicated for use by women
• No studies available on the effect of Tamsulosin-Dutasteride combination on pregnancy, lactation, and fertility
• Dutasteride has been reported to affect semen characteristics in healthy men

Precautions & Warnings

• Caution prescribed for the potential increased risk of adverse events including cardiac failure
• Effects on prostate specific antigen (PSA) and prostate cancer detection
• Regular evaluation for prostate cancer risk including PSA testing

Overdose Effects

• No data available for over dosage of Tamsulosin-Dutasteride combination
• In volunteer studies, single daily doses of Dutasteride up to 40 mg/day have been administered for 7 days without significant safety concerns
• Acute overdose with 5 mg Tamsulosin Hydrochloride has been reported

Therapeutic Class

• BPH/ Urinary retention/ Urinary incontinence

Storage Conditions

• Store in a cool and dry place, protected from light

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