Zamplify 40/5/Zamplify 40/10/Zamplify 80/5/Zamplify 80/10 Dosage & Drug Information

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

Concise Prescribing Info

Contents

Per Zamplify 40/5 tab Telmisartan 40 mg, amlodipine besilate 5 mg. Per Zamplify 40/10 tab Telmisartan 40 mg, amlodipine besilate 10 mg. Per Zamplify 80/5 tab Telmisartan 80 mg, amlodipine besilate 5 mg. Per Zamplify 80/10 tab Telmisartan 80 mg, amlodipine besilate 10 mg

Indications/Uses

Treatment of HTN as monotherapy or w/ other antihypertensive agents. Initial therapy in patients who are likely to need multiple drugs to achieve BP goals.

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Dosage/Direction for Use

Individualized dosage. Max daily dose: 80 mg/10 mg. Replacement therapy 1 tab once daily containing same component doses. Add-on therapy May be switched to 40 mg/5 mg once daily in patients treated w/ amlodipine 10 mg who experience any dose limiting adverse reactions eg, edema. Initial therapy 40 mg/5 mg once daily. Patient requiring larger BP reduction Initially 80 mg/5 mg once daily. Patient w/ hepatic impairment, elderly ≥75 yr Initially 2.5 mg amlodipine then slowly titrate dose.

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Overdosage

View Zamplify 40/5/Zamplify 40/10/Zamplify 80/5/Zamplify 80/10 overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity.

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Special Precautions

Patients w/ hepatic or renal impairment. Discontinue immediately during pregnancy. Not recommended during lactation. Elderly ≥75 yr. Telmisartan: Symptomatic hypotension may occur in patients w/ an activated renin-angiotensin system eg, vol- or salt-depleted patients. Hyperkalemia may occur in patients w/ advanced renal impairment, heart failure, on renal replacement therapy, or on K supplements, K-sparing diuretics, K-containing salt substitutes or other drugs that increase K levels. Reduced clearance in patients w/ biliary obstructive disorders. Amlodipine: Symptomatic hypotension in patients w/ severe aortic stenosis. Increased frequency, duration or severity of angina or acute MI in patients w/ severe obstructive CAD on starting Ca channel blocker therapy or at the time of dosage increase. Closely monitor patients w/ heart failure.

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Use In Pregnancy & Lactation

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Adverse Reactions

Peripheral edema; dizziness, back pain; headache; hypotension; fatigue; abdominal pain. Telmisartan: URTI; sinusitis; diarrhea; pharyngitis. Flu-like symptoms; dyspepsia; myalgia; UTI; pain; coughing; HTN; chest pain; nausea. Amlodipine: Nausea; somnolence.

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Drug Interactions

Telmisartan: Median increases in peak plasma conc & trough conc of digoxin. Reversible increase in serum lithium conc & toxicity. Deterioration of renal function including possible acute renal failure & reduced antihypertensive effect w/ NSAIDs. Co-administration w/ ramipril is not recommended. Amlodipine: Increased exposure to simvastatin.

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Storage

View Zamplify 40/5/Zamplify 40/10/Zamplify 80/5/Zamplify 80/10 storage conditions for details to ensure optimal shelf-life.

Description

View Zamplify 40/5/Zamplify 40/10/Zamplify 80/5/Zamplify 80/10 description for details of the chemical structure and excipients (inactive components).

Action

View Zamplify 40/5/Zamplify 40/10/Zamplify 80/5/Zamplify 80/10 mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Angiotensin II Antagonists / Calcium Antagonists

ATC Classification

C09DB04 - telmisartan 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

Zamplify 40/10 tab

Packing/Price

30's

Form

Zamplify 40/5 tab

Packing/Price

30's

Form

Zamplify 80/10 tab

Packing/Price

30's

Form

Zamplify 80/5 tab

Packing/Price

30's

Zamplify 40/5/Zamplify 40/10/Zamplify 80/5/Zamplify 80/10

telmisartan + amlodipine

Manufacturer:

Zydus Healthcare

Distributor:

Zydus Healthcare