Amlodipine And Valsartan

1 INDICATIONS & USAGE Amlodipine and valsartan tablets, USP are the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure: • In patients not adequately controlled on monotherapy ( 1 ) • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals ( 1 ). Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Hypertension Amlodipine and valsartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure.

6 ADVERSE REACTIONS In placebo-controlled clinical trials, discontinuation due to side effects occurred in 1.8% of patients in the amlodipine and valsartan tablets-treated patients and 2.1% in the placebo-treated group. The most common reasons for discontinuation of therapy with amlodipine and valsartan tablets were peripheral edema and vertigo. The adverse experiences that occurred in clinical trials (≥2% of patients) at a higher incidence than placebo included peripheral edema, nasopharyngitis, upper respiratory tract infection, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary Amlodipine and valsartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the reninangiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the reninangiotensin system from other antihypertensive agents.

WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue amlodipine and valsartan tablets as soon as possible. ( 5.1 ) • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue amlodipine and valsartan tablets as soon as possible. 5 WARNINGS AND PRECAUTIONS • Hypotension: Correct volume depletion prior to initiation ( 5.2 ) • Increased angina and/or myocardial infarction ( 5.3 ) • Monitor renal function and potassium in susceptible patients ( 5.4 , 5.5 ) 5.1 Fetal Toxicity Amlodipine and valsartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the reninangiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. 4 CONTRAINDICATIONS Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with amlodipine and valsartan tablets in patients with diabetes [see Drug Interactions ( 7 )]. Known hypersensitivity to any component; Do not coadminister aliskiren with amlodipine and valsartan tablets in patients with diabetes ( 4 )