This combination is indicated for the treatment of hypertension, either as monotherapy or in combination with other antihypertensive agents. It may also be considered as an initial treatment option in patients who are expected to require multiple medications to achieve their target blood pressure levels.

This is a fixed-dose combination of telmisartan and amlodipine. Telmisartan is a non-peptide angiotensin II receptor blocker (ARB) that selectively antagonizes the AT1 receptor subtype. Angiotensin II is a key regulator of blood pressure, causing vasoconstriction, aldosterone release, cardiac stimulation, and sodium retention in the kidneys. By blocking AT1 receptors, telmisartan prevents these effects, leading to vasodilation and reduction of blood pressure without significantly affecting heart rate. It has a much higher affinity for AT1 receptors compared to AT2 receptors and does not interfere with other hormone receptors or ion channels involved in cardiovascular regulation.

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the influx of calcium ions into vascular smooth muscle and cardiac muscle cells. It primarily acts on vascular smooth muscle, causing peripheral arterial dilation, reducing vascular resistance, and lowering blood pressure.

Initial Therapy: Patient may be initiated on this tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started with 80/5 mg once daily. Initial therapy with this is not recommended in patients 575 years old or with hepatic impairment.

Add-on Therapy: Patients not adequately controlled with amiodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amiodipine who experience adverse reactions such as edema, may be switched to this 40/5 mg tablets once daily, বাংলায় দেখুন reducing the dose of amiodipine without reducing the overall expected antihypertensive response.

Replacement Therapy: Patients receiving amiodipine and telmisartan from separate tablets may instead receive this tablets containing the same component doses once daily. Dosage must be individualized and may be increased after at least 2 weeks. The maximum recommended dose of this tablet is 80/10 mg once daily

Co-administration of telmisartan has not shown clinically significant interactions with drugs such as acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen.

Telmisartan is not metabolized by the cytochrome P450 system and has minimal effect on these enzymes, except for a slight inhibition of CYP2C19. Therefore, it is unlikely to interact with drugs metabolized by cytochrome P450, although caution may be required with CYP2C19 substrates.

Amlodipine has been safely used with thiazide diuretics, beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, NSAIDs, antibiotics, and oral antidiabetic drugs.

No clinically significant pharmacokinetic interactions have been observed between amlodipine and cimetidine, grapefruit juice, or sildenafil. Additionally, amlodipine does not significantly affect the pharmacokinetics or pharmacodynamics of atorvastatin, digoxin, or warfarin.

• This combination is contraindicated in patients with known hypersensitivity to any of its components.
• It is also contraindicated in pregnancy,
• biliary obstructive disorders, severe hepatic impairment, hypotension, cardiogenic shock, and left ventricular outflow tract obstruction.

Common side effects include dizziness, peripheral edema, migraine, headache, paresthesia, vertigo, bradycardia, palpitations, hypotension, cough, abdominal pain, diarrhea, nausea, itching, muscle pain, spasms, erectile dysfunction, chest pain, fatigue, and swelling.

This combination falls under Pregnancy Category C (first trimester) and Category D (second and third trimesters). It is not known whether telmisartan or amlodipine is excreted in human breast milk. Due to potential risks to the infant, either breastfeeding should be discontinued or the drug should be stopped, depending on the clinical need.

• Avoid exposure during pregnancy due to fetal risk
• Correct volume or salt depletion before starting therapy to prevent hypotension
• Monitor for signs of low blood pressure
• Use cautiously in patients with hepatic or severe renal impairment; dose adjustment may be required
• Monitor patients with heart failure for worsening condition
• Avoid combining with ACE inhibitors or other ARBs
• In patients with severe coronary artery disease, initiation may rarely increase angina or precipitate myocardial infarction

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Initial therapy is not recommended in patients aged 75 years or older.

Hepatic Impairment: Not recommended as initial therapy in patients with liver impairment.

Telmisartan: Overdose may cause hypotension, dizziness, and tachycardia; bradycardia may also occur. Supportive care is required. Telmisartan is not removed by hemodialysis.

Amlodipine: Overdose may result in excessive vasodilation, marked hypotension, and reflex tachycardia. Management includes cardiac monitoring, fluid support, and use of vasopressors if necessary. Amlodipine is not removed by hemodialysis.

Combined antihypertensive preparations

Do not store above 30°C. Protect from light and high humidity. Keep out of reach of children.