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(amlodipine and valsartan)
- Patient Information:
Details with Side Effects
AVOID USE IN PREGNANCY
When pregnancy is detected, discontinue Exforge as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. [See WARNINGS AND PRECAUTIONS]
Exforge is a fixed combination of amlodipine and valsartan.
Exforge contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is
Its empirical formula is C20H25ClN2O5•C6H6O3S and its molecular weight is 567.1.
Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan's chemical name is N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4yl]methyl]-L-valine; its structural formula is
Its empirical formula is C24H29N5O3 and its molecular weight is 435.5.
Exforge tablets are formulated in four strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.
The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Additionally the 5/320 mg and 10/320 mg strengths contain iron oxide yellow and sodium starch glycolate. The film coating contains hypromellose, iron oxides, polyethylene glycol, talc and titanium dioxide.
What are the possible side effects of amlodipine and valsartan (Exforge)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
In rare cases, amlodipine and valsartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.
Call your doctor at once if you have any other serious side effects, such...
What are the precautions when taking amlodipine and valsartan (Exforge)?
Before taking this product, tell your doctor or pharmacist if you are allergic to either amlodipine or valsartan; or to other calcium channel blockers (e.g., nifedipine); or to other angiotensin receptor blockers (e.g., losartan); or to ACE inhibitors (e.g., lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (e.g., renal artery stenosis), liver disease, bile duct blockage, heart/blood vessel disease (e.g., heart attack, heart failure, aortic stenosis), high levels of potassium in the blood (hyperkalemia), severe loss of body water...
Last reviewed on RxList: 1/3/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Exforge Information
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