Indications

Eziflo-D is a combination of Tamsulosin and Dutasteride indicated for the treatment of benign prostatic hyperplasia (BPH). Its main uses are:

• Treating moderate to severe symptoms of BPH.
• Reducing the risk of acute urinary retention and the need for surgery in patients with BPH symptoms.

Pharmacology

Eziflo-D contains two active ingredients that work together to treat BPH:

• Tamsulosin: An alpha1-adrenoreceptor blocker. It works by relaxing the smooth muscles in the prostate and bladder neck, improving urine flow and reducing BPH symptoms (the dynamic component).
• Dutasteride: A dual 5-alpha reductase inhibitor. It works by blocking the conversion of testosterone to dihydrotestosterone (DHT), a hormone that causes prostate enlargement. This reduces the size of the prostate over time, addressing the underlying cause of BPH (the static component).

Dosage & Administration

• Adults (including elderly): One capsule (0.4 mg Tamsulosin and 0.5 mg Dutasteride) taken orally once daily, 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 needed for patients with kidney problems.
• Hepatic impairment: Use with caution in patients with mild to moderate liver impairment. It is contraindicated in patients with severe liver impairment.

Interaction

• CYP3A4 inhibitors (e.g., ritonavir, indinavir, ketoconazole, oral erythromycin): These drugs can increase the concentration of Dutasteride in the blood.
• Blood pressure-lowering drugs (including other alpha-blockers and PDE5 inhibitors): Co-administration can lead to enhanced hypotensive (low blood pressure) effects.
• Cimetidine: Can increase the concentration of Tamsulosin in the blood.
• Warfarin: Caution should be exercised with concomitant use, as results from interaction studies are inconclusive.
• Grapefruit juice: Should not be taken with Rupatadine (a component mentioned in previous texts, but not in this one).

Contraindications

Eziflo-D is contraindicated in:

• Women, children, and adolescents.
• Patients with hypersensitivity to Dutasteride, other 5-alpha reductase inhibitors, Tamsulosin, soya, or peanut.
• Patients with a history of orthostatic hypotension (dizziness upon standing).
• Patients with severe liver impairment.

Side Effects

The most common side effects reported were:

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

Pregnancy & Lactation

This drug is contraindicated for use by women. It can inhibit the development of male external genitalia if a woman carrying a male fetus is exposed to it. Patients should use a condom to prevent semen exposure to a pregnant or potentially pregnant partner. It is not known if the drugs are excreted in human milk.

Precautions & Warnings

• Cardiac Failure: Combination therapy may be associated with an increased risk of cardiac failure.
• Prostate Cancer Detection: The drug lowers PSA levels, which can interfere with prostate cancer detection. A new PSA baseline should be established after 6 months of treatment.
• High-grade Tumors: There is a potential link between Dutasteride and a higher incidence of high-grade prostate cancers, so patients should be regularly evaluated.
• Hypotension: Tamsulosin can cause a drop in blood pressure. Patients should be cautious about dizziness or fainting.
• Intraoperative Floppy Iris Syndrome (IFIS): This can occur during cataract surgery in patients on Tamsulosin. Therapy initiation is not recommended for patients scheduled for cataract surgery.
• Leaking Capsule: Women and children should avoid contact with leaking capsules as Dutasteride is absorbed through the skin.
• Breast Neoplasia: Male breast cancer has been reported in men taking Dutasteride. Any changes in breast tissue should be reported to a physician.

Overdose Effects

Overdose data for the combination is unavailable. Overdose symptoms for the individual components include:

• Dutasteride: Doses up to 40 mg/day have been administered without significant safety concerns.
• Tamsulosin: Overdose may cause acute hypotension, vomiting, and diarrhea. Treatment is supportive.

Therapeutic Class

Eziflo-D is classified as a medication for BPH/Urinary retention.

Storage Conditions

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