Telmacal 5/40

Indications

Telmacal is designed for managing hypertension in adults, either as a standalone treatment or alongside other antihypertensive medications. It is also suitable as an initial therapy for patients likely to need multiple drugs to achieve effective blood pressure control.

Pharmacology

• Telmisartan: This non-peptide angiotensin receptor blocker (ARB) selectively targets the AT1 receptor, blocking the action of angiotensin II. This action helps dilate blood vessels and lower blood pressure without affecting heart rate.
• Amiodipine: A dihydropyridine calcium-channel blocker (CCB) that inhibits calcium influx into vascular and cardiac muscles, resulting in vasodilation and reduced peripheral vascular resistance.

Dosage & Administration

• Initial Therapy: Start with Telmacal 40/5 mg once daily. For more significant blood pressure reduction, the dose may be increased to 80/5 mg daily. Not recommended for patients aged 75 or older or those with hepatic impairment.
• Add-on Therapy: For patients not adequately controlled with amiodipine or telmisartan alone, switch to Telmacal 40/5 mg once daily. The dose can be adjusted based on response.
• Replacement Therapy: For those transitioning from separate amiodipine and telmisartan tablets, use Telmacal once daily, with a maximum dose of 80/10 mg.

Interactions

Telmacal generally does not interact significantly with other common medications, though caution is advised with drugs like aliskiren and NSAIDs. It does not impact the cytochrome P450 system significantly, except for some effects on CYP2C19.

Contraindications

Avoid use in patients with known hypersensitivity to Telmacal components, those with severe hepatic impairment, biliary obstruction, hypotension, or left ventricular outflow tract obstruction. Not recommended during pregnancy or lactation.

Side Effects

Common adverse effects include dizziness, edema, headache, and abdominal pain. Severe reactions may involve hypotension, fatigue, and muscle cramps.

Pregnancy & Lactation

• Pregnancy: Category C in the first trimester and D in the second and third trimesters. Use only if absolutely necessary and discontinue upon pregnancy confirmation.
• Lactation: The safety in breastfeeding is uncertain; consider the drug’s importance to the mother when deciding on continuation.

Precautions & Warnings

Monitor for signs of hypotension, correct any volume or salt depletion before starting therapy, and avoid using with ACE inhibitors. Use caution in patients with heart failure or severe coronary artery disease.

Use in Special Populations

• Pediatric Use: Safety and effectiveness in children have not been established.
• Geriatric Use: Not recommended for initial therapy in those aged 75 or older.
• Hepatic Impairment: Avoid in patients with severe liver impairment.

Overdose Effects

• Telmisartan: Likely symptoms include hypotension and dizziness. Hemodialysis is not effective.
• Amiodipine: Excessive vasodilation and hypotension may occur. Treatment involves supportive care and possibly vasopressors.

Therapeutic Class

Combined Antihypertensive Preparations

Storage Conditions

Store at or below 30°C, away from light and high humidity. Keep out of reach of children.