Combomax 0.4 mg+0.5 mg

Description

Indications: Combomax capsule is indicated for:

• The treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).
• Reduction in the risk of acute urinary retention and the need for surgery in patients with moderate to severe symptoms of BPH.

Consult a registered doctor before using this medicine.

Pharmacology:

Combomax is a combination of two drugs with complementary mechanisms of action to improve symptoms in patients with BPH:

Tamsulosin:

• An alpha1-adrenoreceptor blocker that addresses the dynamic component of BPH.
• It works by inhibiting alpha1A-adrenoreceptors in the smooth muscle of the prostate and bladder neck, leading to relaxation of these muscles. This helps improve urine flow.
• Tamsulosin specifically targets the alpha1A and alpha1D subtypes, which are predominant in the prostate and bladder, contributing to symptom relief.

Dutasteride:

• A dual 5-alpha reductase inhibitor that affects the static component of BPH by preventing the conversion of testosterone into dihydrotestosterone (DHT), a potent androgen responsible for prostate growth.
• Dutasteride lowers DHT levels, reducing prostatic volume and treating the underlying cause of BPH.

Dosage & Administration:

Adults (including elderly):

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

Renal Impairment:

• No dosage adjustment is required for patients with renal impairment.

Hepatic Impairment:

• In patients with mild to moderate hepatic impairment, caution should be exercised.
• Contraindicated in severe hepatic impairment.

Interactions:

There have been no formal drug interaction studies for the Tamsulosin-Dutasteride combination.

Tamsulosin:

• May interact with drugs that lower blood pressure, such as PDE5 inhibitors and other alpha-1 blockers, leading to enhanced hypotensive effects.
• Caution is advised when combining with cimetidine (as it can increase Tamsulosin levels).
• No significant interactions have been seen with warfarin or other drugs such as nifedipine or theophylline.

Dutasteride:

• Concomitant use with strong CYP3A4 inhibitors (like ritonavir or ketoconazole) may increase Dutasteride serum levels. Adjusting the dose might be necessary if side effects occur.
• Dutasteride does not significantly alter the pharmacokinetics of Tamsulosin, terazosin, or other common drugs like warfarin.

Contraindications:

• Women, children, and adolescents.
• Hypersensitivity to any component of the formulation, including Dutasteride, Tamsulosin, soya, and peanuts.
• History of orthostatic hypotension.
• Severe hepatic impairment.

Side Effects:

The most common adverse reactions include:

• Impotence
• Decreased libido
• Breast disorders (including enlargement and tenderness)
• Ejaculation disorders
• Dizziness

Pregnancy & Lactation:

Pregnancy:

• Contraindicated for use in women, especially those who are pregnant or may become pregnant.
• Dutasteride may cause harm to a male fetus, inhibiting the development of external genitalia.

Lactation:

• It is not known whether Tamsulosin or Dutasteride are excreted in human milk.

Fertility:

• Dutasteride may affect sperm count, motility, and semen volume, potentially impacting male fertility.

Precautions & Warnings:

• Cardiac Failure: The incidence of cardiac failure is slightly higher with the combination therapy, though it remains rare.
• PSA Levels: Monitoring of serum prostate-specific antigen (PSA) is required, as Tamsulosin-Dutasteride can reduce PSA levels by around 50%.
• Prostate Cancer Risk: There is an increased incidence of high-grade prostate cancer in men treated with Dutasteride, although the relationship remains unclear.
• Hypotension: Orthostatic hypotension may occur, so patients should be cautious, especially at the start of treatment.
• Intraoperative Floppy Iris Syndrome (IFIS): Patients on Tamsulosin may experience complications during cataract surgery.

Overdose Effects:

• Dutasteride: No significant adverse effects observed with doses up to 40 mg/day (80x therapeutic dose). There is no specific antidote, so symptomatic and supportive treatment is recommended.

• Tamsulosin: Overdose may cause acute hypotension, vomiting, and diarrhea. Treatment involves fluid replacement and, if necessary, vasopressors.

Therapeutic Class:

• BPH/Urinary retention/Urinary incontinence

Storage Conditions:

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