Aprovasc

Aprovasc

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Concise Prescribing Info
Contents
Per 150 mg/5 mg FC tab Irbesartan 150 mg, amlodipine 5 mg. Per 150 mg/10 mg FC tab Irbesartan 150 mg, amlodipine 10 mg. Per 300 mg/5 mg FC tab Irbesartan 300 mg, amlodipine 5 mg. Per 300 mg/10 mg FC tab Irbesartan 300 mg, amlodipine 10 mg
Indications/Uses
Essential HTN in adult patients whose BP is not adequately controlled on irbesartan or amlodipine monotherapy.
Dosage/Direction for Use
Usual initial & maintenance dose: 1 tab daily. Max recommended dose: 300 mg/10 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to irbesartan, amlodipine or dihydropyridines. Cardiogenic shock, clinically significant aortic stenosis, unstable angina (excluding Prinzmetal's angina). Not to be co-administered w/ aliskiren-containing medicines in patients w/ diabetes or moderate to severe renal insufficiency (GFR <60 mL/min/1.73 m2); ACE inhibitors in patients w/ diabetic nephropathy. Pregnancy & lactation.
Special Precautions
NYHA III & IV heart failure; hypertensive crisis; hypertensive patients w/ renal artery stenosis in 1 or both kidneys or severe CHF. Correct vol & Na depletion prior to initiation therapy. Not recommended in concomitant use w/ aliskiren-containing medicines in patients w/ diabetes or moderate to severe renal insufficiency (GFR <60 mL/min/1.73 m2); ACE inhibitors in patients w/ diabetic nephropathy. Hepatic impairment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy. Ped patients.
Adverse Reactions
Dizziness, headache, somnolence; nausea; fatigue; edema, peripheral edema; palpitations; postural hypotension; gingival swelling; proteinuria. Irbesartan: Vertigo; upper abdominal pain; tongue disorder. Amlodipine: Hot flush; glossodynia; cough; contact dermatitis.
Drug Interactions
Irbesartan: Increased K levels w/ K-sparing diuretics, K supplements or K-containing salt substitutes. Renal function deterioration w/ NSAIDs including selective COX-2 inhibitors; angiotenisin II receptor antagonists. Attenuated antihypertensive effect w/ NSAIDs including selective COX-2 inhibitors. Increased serum lithium conc & toxicity.
MIMS Class
Angiotensin II Antagonists / Calcium Antagonists
ATC Classification
C09DB05 - irbesartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Aprovasc 150 mg/5 mg FC tab
Packing/Price
28's
Form
Aprovasc 150 mg/10 mg FC tab
Packing/Price
28's
Form
Aprovasc 300 mg/5 mg FC tab
Packing/Price
28's
Form
Aprovasc 300 mg/10 mg FC tab
Packing/Price
28's
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