Combomax 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 & Dutasteride
• Mechanism of action to improve symptoms in patients with BPH
• Tamsulosin action as an alpha1-adrenoreceptor blocking agent
• Dutasteride action as a dual 5 alpha reductase inhibitor (5ARI)
• Effects of Tamsulosin on dynamic component of BPH
• Effects of Dutasteride on static component of BPH
• Inhibition of conversion of Testosterone to Dihydrotestosterone by Dutasteride

Dosage & Administration

• Recommended dose for adults
• Instructions for oral intake
• Use as a substitute for concomitant Tamsulosin Hydrochloride and Dutasteride
• Renal impairment dosage
• Hepatic impairment precautions

Interaction

• Lack of 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
• Concomitant administration precautions

Contraindications

• Contra-indicated in women and children and adolescents
• Hypersensitivity to Dutasteride or Tamsulosin
• Contra-indicated in patients with severe hepatic impairment

Side Effects

• Common adverse reactions in subjects receiving combination therapy
• Reported adverse reactions like impotence, decreased libido, breast disorders, ejaculation disorders, dizziness

Pregnancy & Lactation

• Contra-indicated for use by women
• Effect of Dutasteride on male fertility
• Effects on pregnancy and lactation
• Recommendation for avoiding exposure to semen by pregnant partners

Precautions & Warnings

• Careful benefit-risk assessment for combination therapy
• Adverse event risk assessment
• Effect on prostate specific antigen (PSA) and prostate cancer detection
• Evaluation for prostate cancer risk
• Renal impairment caution
• Orthostatic and symptomatic hypotension precautions
• Intraoperative Floppy Iris Syndrome and leaking capsule precautions
• Hepatic impairment caution
• Breast neoplasia risk

Overdose Effects

• No data available on overdose effects of Tamsulosin-Dutasteride combination
• Safety concerns of Dutasteride overdose
• Reported acute Tamsulosin Hydrochloride overdose and treatment

Therapeutic Class

• BPH/ Urinary retention/ Urinary incontinence

Storage Conditions

• Recommended storage conditions

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