Valvex A (80/5)/Valvex A (160/5)/Valvex A (160/10) Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per 80 mg/5 mg tab Valsartan 80 mg, amlodipine besilate 5 mg. Per 160 mg/5 mg tab Valsartan 160 mg, amlodipine besilate 5 mg. Per 160 mg/10 mg tab Valsartan 160 mg, amlodipine besilate 10 mg

Indications/Uses

Treatment of essential HTN in adults whose BP is not adequately controlled on amlodipine or valsartan monotherapy.

Click to view Valvex A (80/5)/Valvex A (160/5)/Valvex A (160/10) detailed prescribing information

Dosage/Direction for Use

1 tab/day.

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Overdosage

View Valvex A (80/5)/Valvex A (160/5)/Valvex A (160/10) overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity to valsartan, amlodipine besilate & dihydropyridine derivatives. Severe hepatic impairment, biliary cirrhosis or cholestasis; renal impairment; hypotension; cardiogenic shock; obstruction of the outflow tract of the left ventricle (eg, hypertrophic obstructive cadiomyopathy & high grade aortic stenosis); hemodynamically unstable heart failure after acute MI.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Valvex A (80/5)/Valvex A (160/5)/Valvex A (160/10) detailed prescribing information

Special Precautions

Hypertensive crisis. Na &/or vol-depleted patients; hyperkalemia; renal artery stenosis; kidney transplantation; primary aldosteronism; angioedema; heart failure/post MI; aortic & mitral valve stenosis. Pregnancy. Childn <18 yr. Elderly ≥65 yr.

Use In Pregnancy & Lactation

Click to view Valvex A (80/5)/Valvex A (160/5)/Valvex A (160/10) detailed prescribing information

Adverse Reactions

Nasopharyngitis, influenza; hypokalemia.

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Drug Interactions

Increased antihypertensive effects w/ α-blockers, diuretics; TCAs. Amlodipine: Increased BP-lowering effects w/ grapefruit or grapefruit juice. Increased exposure w/ CYP3A4 inhibitors (PIs, azole antifungals, macrolides eg, erythromycin or clarithromycin, verapamil or diltiazem). Potential lowering of plasma conc w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Simvastatin; dantrolene. Valsartan: Lithium; NSAIDs including selective COX-2 inhibitors, acetylsalicylic acid (>3 g/day) & nonselective NSAIDs. Increased systemic exposure w/ uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir).

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Storage

View Valvex A (80/5)/Valvex A (160/5)/Valvex A (160/10) storage conditions for details to ensure optimal shelf-life.

Description

View Valvex A (80/5)/Valvex A (160/5)/Valvex A (160/10) description for details of the chemical structure and excipients (inactive components).

Action

View Valvex A (80/5)/Valvex A (160/5)/Valvex A (160/10) mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Angiotensin II Antagonists / Calcium Antagonists

ATC Classification

C09DB01 - valsartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.

Regulatory Classification

Presentation/Packing

Form

Valvex 80 mg/5 mg FC tab

Packing/Price

30's

Form

Valvex A 160 mg/10 mg FC tab

Packing/Price

30's

Form

Valvex A 160 mg/5 mg FC tab

Packing/Price

30's

Valvex A (80/5)/Valvex A (160/5)/Valvex A (160/10)

amlodipine + valsartan

Manufacturer:

Vexxa Lifesciences

Distributor:

VE Pharma