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Amlovas VS
Amlodipine & Valsartan
 Amlovas VS

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

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

Amlovas 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 has 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.

Indications

Amlodipine and Valsartan combination is indicated for the treatment of hypertension, to lower blood pressure:
  • In patients not adequately controlled on monotherapy.
  • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

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.
General Considerations
Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320 mg tablet once daily as needed to control blood pressure. Amlovas VS may be administered with or without food. Amlovas VS may be administered with other antihypertensive agents.
Add-on Therapy
A patient whose blood pressure is not adequately controlled with amlodipine alone or with valsartan alone may be switched to combination therapy with Amlovas VS.
Replacement Therapy
For convenience,patients receiving amlodipine and valsartan from separate tablets may instead wish to receive tablets of Amlovas VS containing the same component doses.
Initial Therapy
A patient may be initiated on Amlovas VS if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is Amlovas VS 5/160 mg once daily in patients who are not volume depleted.

Side Effects

Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The adverse experiences that occured in placebo-controlled clinical trials included 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

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