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Amlovas VS
Amlodipine & Valsartan
Amlovas VS

AmlovasTM VS 5/80 mg Tablet: Each film coated tablet contains Amlodipine Besilate BP equivalent to 5 mg Amlodipine and 80 mg Valsartan USP. AmlovasTM VS 5/160 mg Tablet: Each film coated tablet contains Amlodipine Besilate BP equivalent to 5 mg Amlodipine and 160 mg Valsartan USP. AmlovasTM VS 10/160 mg Tablet: Each film coated tablet contains Amlodipine Besilate BP equivalent to 10 mg Amlodipine and 160 mg Valsartan USP.

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Pharmacology/Description

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Valsartan 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. Amlodipine and Valsartan have been shown to be effective in lowering blood pressure. Both Amlodipine and Valsartan lower blood pressure by reducing peripheral resistance, but calcium influx blockade and reduction of Angiotensin II vasoconstriction are complementary mechanisms.

Indication

Amlodipine and Valsartan combination is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension

Dosage And Administration

Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg-10 mg while Valsartan is effective in doses of 80 mg-320 mg. In clinical trials with Amlodipine and Valsartan combination using Amlodipine doses of 5 mg-10 mg and Valsartan doses of 160 mg-320 mg, the antihypertensive effects increased with increasing doses.

Side Effects

Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.peripheral edema (5.4% vs. 3.0%), nasopharyngitis (4.3% vs. 1.8%), upper respiratory tract infection (2.9% vs 2.1%) and dizziness (2.1% vs 0.9%). Orthostatic events (orthostatic hypotension and postural dizziness) were seen in less than 1% of patients.

Contraindications

Amlodipine and Valsartan combination is contraindicated in patients who are hypersensitive to any component of this product.

Drug Interactions

No drug interaction studies have been conducted with Amlodipine and Valsartan combination and other drugs, although studies have been conducted with the individual Amlodipine and Valsartan components

Precautions

Impaired Hepatic Function, Beta-Blocker Withdrawal: Amlodipine is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker. Nursing Mothers: It is not known whether Amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while Amlodipine is administered. Pediatric Use: Safety and effectiveness of Amlodipine and Valsartan combination in pediatric patients have not been established.

Over Dosage

Amlodipine: In humans, experience with intentional overdosage of Amlodipine is limited. If massive overdose should occur, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Intravenous Calcium gluconate may help to reverse the effects of calcium entry blockade. As Amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. Valsartan: Limited data are available related to overdosage in humans. The most likely effect of overdose with Valsartan would be peripheral vasodilation, hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension should occur, supportive treatment should be instituted. Valsartan is not removed from the plasma by hemodialysis.

Pharmaceutical Precautions

Store in a cool dry place protected from light. Keep out of reach of children.

Commercial Pack

AmlovasTM VS 5/80 mg Tablet: Each box contains 3x10 tablets in Alu-Alu blister pack. AmlovasTM VS 5/160 mg Tablet: Each box contains 3x10 tablets in Alu-Alu blister pack. AmlovasTM VS 10/160 mg Tablet: Each box contains 3x10 tablets in Alu-Alu blister pack.