Amdocal Pro 2.5/5

Indications

Bisoprolol & Amlodipine combination is indicated for the treatment of hypertension as substitution therapy in patients adequately controlled with the individual products given concurrently at the same dose level as in the combination, but as separate tablets.

Pharmacology

This combination consists of Amlodipine and Bisoprolol Fumarate. Amlodipine inhibits calcium ion influx into vascular smooth muscle and cardiac muscle cells, reducing peripheral vascular resistance and blood pressure. Bisoprolol Fumarate is a beta1-selective adrenoceptor blocker that reduces heart rate and cardiac output without affecting lipid metabolism or airway resistance.

Dosage & Administration

One tablet once daily for patients adequately controlled with separately administered monocomponent products of the same doses as the recommended fixed-dose combination.

Interaction

Combinations not recommended include calcium antagonists (verapamil, diltiazem) and centrally-acting antihypertensive drugs. Use with caution with strong or moderate CYP3A4 inhibitors, CYP3A4 inducers, simvastatin, tacrolimus, cyclosporine, and others.

Contraindications

Acute heart failure, cardiogenic shock, AV block, severe bronchial asthma, untreated phaeochromocytoma, hypersensitivity to bisoprolol, amlodipine, or related components.

Side Effects

Common side effects include dizziness, headache, palpitations, gastrointestinal disturbances, and edema. Uncommon side effects may include insomnia, mood changes, visual disturbances, bronchospasm, skin reactions, and musculoskeletal symptoms.

Pregnancy & Lactation

Not recommended during pregnancy and lactation.

Precautions & Warnings

Caution in heart failure, hepatic impairment, and obstructive airways diseases. Gradual withdrawal advised; monitor during anesthesia.

Use in Special Populations

Geriatric use: Usual doses can be administered cautiously. Pediatric use: Safety and efficacy not established. Renal or hepatic impairment: Adjust dosages accordingly.

Overdose Effects

Symptoms may include bradycardia, hypotension, bronchospasm, acute cardiac insufficiency, and hypoglycemia. Supportive treatment recommended.

Therapeutic Class

Anti-hypertensive.

Storage Conditions

Store in a dry place below 30°C, protect from light, and keep out of reach of children.