Amlodipine/Valsartan Teva

Amlodipine/Valsartan Teva

amlodipine + valsartan

Manufacturer:

Teva

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per 5/80 mg tab Amlodipine besilate 5 mg, valsartan 80 mg. Per 5/160 mg tab Amlodipine besilate 5 mg, valsartan 160 mg. Per 10/160 mg tab Amlodipine besilate 10 mg, valsartan 160 mg
Indications/Uses
HTN in adults whose BP is not adequately controlled w/ either amlodipine or valsartan monotherapy.
Dosage/Direction for Use
1 tab daily, preferably taken at the same time each day.
Administration
May be taken with or without food: Swallow w/ a glass of water.
Contraindications
Hypersensitivity to amlodipine, valsartan, or other Ca channel blockers. Severe liver problems or bile problems eg, biliary cirrhosis or cholestasis; severe hypotension; aortic stenosis or cardiogenic shock; heart failure after a heart attack. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). 2nd or 3rd trimester of pregnancy.
Special Precautions
Patients experiencing vomiting or diarrhoea; patients w/ hepatic or renal impairment; kidney transplant or narrowing of kidney arteries; primary hyperaldosteronism; history of heart failure or heart attack; aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy; history of swelling, particularly of the face & throat, w/ other medicines including ACE inhibitors. Concomitant use w/ aliskiren. Dual blockade of renin-angiotensin-aldosterone system through combined use of ACE inhibitors, ARBs or aliskiren is not recommended. ACE inhibitors & ARBs should not be used concomitantly in patients w/ diabetic nephropathy. Monitor kidney function, BP & electrolyte levels in the blood at regular intervals. Avoid grapefruit or grapefruit juice. Can cause dizziness which may affect ability to drive & use machines. Not recommended during the 1st trimester of pregnancy & during lactation. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Flu; blocked nose, sore throat & discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; tiredness; asthenia; redness & warm feeling of the face &/or neck. Allergic reaction.
Drug Interactions
Higher frequency of adverse events w/ ACE inhibitors, ARBs or aliskiren. Potential interaction w/ diuretics; lithium; K-sparing diuretics, K supplements, salt substitutes containing K & other substances that may increase K levels; NSAIDs or selective COX-2 inhibitors; anticonvulsants (eg, carbamazepine, phenobarb, phenytoin, fosphenytoin, primidone); St. John's wort; nitroglycerin & other nitrates, or other vasodilators; medicines for HIV/AIDS (eg, ritonavir, indinavir, nelfinavir); antifungals (eg, ketoconazole, itraconazole); antibacterials (eg, rifampicin, erythromycin, clarithromycin, telithromycin); verapamil, diltiazem; simvastatin; dantrolene; ciclosporin. Increased blood levels of amlodipine w/ grapefruit or grapefruit juice.
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.
Presentation/Packing
Form
Amlodipine/Valsartan Teva 10/160 mg tab
Packing/Price
28's
Form
Amlodipine/Valsartan Teva 5/160 mg tab
Packing/Price
28's
Form
Amlodipine/Valsartan Teva 5/80 mg tab
Packing/Price
28's
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