Temcard-A is a fixed dose combination of Telmisartan and Amlodipine.
Temcard-A is a fixed dose combination of Telmisartan and Amlodipine. Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. Because Telmisartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Telmisartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Amlodipine, a dihydropyridine calcium-channel blocker (CCB), inhibits the transmembrane influx of calcium ion into vascular smooth muscle and cardiac muscle. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Temcard-A 40/5 Tablet: Each tablet contains Telmisartan USP 40 mg and Amlodipine Besilate BP equivalent to Amlodipine 5 mg.
Temcard-A 80/5 Tablet: Each tablet contains Telmisartan USP 80 mg and Amlodipine Besilate BP equivalent to Amlodipine 5 mg.
Initial Therapy: Patient may be initiated on Temcard-A 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 Temcard-A 80/5 mg once daily. Initial therapy with Temcard-A is not recommended in patients >75 years old or with hepatic impairment.
Add-on Therapy: Temcard-A may be used to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with Telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amlodipine who experience adverse reactions such as edema, may be switched to Temcard-A 40/5 mg tablets once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.
Replacement Therapy: Patients receiving Amlodipine and Telmisartan from separate tablets may instead receive Temcard-A 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 Temcard-A tablet is 80/10 mg once daily.
Telmisartan and amlodipine combination tablet is contraindicated in patients with known hypersensitivity to Telmisartan, amlodipine or any other component of this product.
Fetal toxicity: Use of Telmisartan increases fetal and neonatal morbidity and death. Hypotension: Symptomatic hypotension may occur after initiation of Telmisartan in patients treated with high dose of diuretics. Amlodipine may also cause symptomatic hypotension particularly in patients with severe aortic stenosis. Hyperkalemia: Hyperkalemia may occur in patients on ARBs, particularly in patients with advanced renal impairment, heart failure, on renal replacement therapy or on other drugs that increase potassium levels. Impaired hepatic function: As majority of Telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorder or hepatic insufficiency can be expected to have reduced clearance. Initiate Telmisartan at low dose and titrates slowly in these patients. For patients with hepatic impairment, start Amlodipine or add Amlodipine at 2.5 mg as these patients have decreased clearance of Amlodipine. Impaired renal function: As Telmisartan inhibits renin-angiotensin-aldosterone system, changes in renal function in susceptible patients can be
anticipated.
Dizziness, peripheral edema, migraine, headache, paraesthesia, vertigo, bradycardia, palpitations, hypotension, cough, abdominal pain, diarrhea, nausea, pruritus, myalgia, spasm, erectile dysfunction, chest pain, fatigue, edema etc.
DRUG INTERACTION
Aliskerin: Avoid use of aliskerin with Telmisartan in patients with renal impairment (GFR<60 mL/min). Digoxin: When Telmisartan is co-administered with digoxin, increase in digoxin plasma concentration is observed. Lithium: Increase in serum lithium concentration is observed when lithium is co-administered with Telmisartan. NSAIDs: Antihypertensive effect of Telmisartan may be attenuated with NSAIDs. Simvastatin: Limit the dose of simvastatin in patients on Amlodipine to 20 mg daily. CYP3A4 inhibitors: Co-administration of diltiazem with amlodipine may result in increase in Amlodipine systemic exposure. CYP3A4 inducers: No information is available on the effects of CYP3A4 inducers (e.g: carbamazepine, phenobarbitol, phenytoin, rifampicin etc.) on Amlodipine.
Temcard-A 40/5 Tablet: Each box contains 30 tablets in Alu-Alu blister pack.
Temcard-A 80/5 Tablet: Each box contains 30 tablets in Alu-Alu blister pack.
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