Valsartan-Amlodipine

Valsartan-Amlodipine is a combination of prescription medications used for the treatment of hypertension. 

• Valsartan-Amlodipine is available under the following different brand names: Exforge

Adult dosage

Tablet

• 5 mg/160 mg
• 5 mg/320 mg
• 10 mg/160 mg
• 10 mg/320 mg

Hypertension

Adult dosage

• 1Initiate with 5 mg/160 mg orally every day  OR
• Substitute for individually titrated components
• May increase dose after at least 2 weeks, not to exceed 10 mg/day amlodipine and 320 mg/day valsartan

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Valsartan-Amlodipine include:

• dizziness, and
• spinning sensation, or lightheadedness as the body adjusts to the medication

Serious side effects of Valsartan-Amlodipine include:

• swelling hands/ankles/feet,
• fainting,
• fast heartbeat,
• unusual change in the amount of urine,
• symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), or
• signs of infection (such as fever, chills, persistent sore throat)

Rare side effects of Valsartan-Amlodipine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Valsartan/hydrochlorothiazide has severe interactions with the following drugs:
  • aliskiren
  • dantrolene
• Valsartan/hydrochlorothiazide has serious interactions with at least 29 other drugs.
• Valsartan/hydrochlorothiazide has moderate interactions with at least 259 other drugs.
• Valsartan/hydrochlorothiazide has minor interactions with at least 50 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to valsartan, amlodipine, or excipients
• Concomitant administration with aliskiren in patients with diabetes mellitus

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Valsartan-Amlodipine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Valsartan-Amlodipine?”

Cautions

• Drugs that inhibit renin-angiotensin system can cause hyperkalemia; monitor serum electrolytes periodically; some patients with heart failure have developed increases in potassium with valsartan therapy; these effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment; dosage reduction and/or discontinuation of therapy may be required
• Worsening angina and acute MI may occur after starting or increasing amlodipine dose, particularly with severe obstructive CAD
• Peripheral edema may occur within 2-3 weeks of starting therapy (amlodipine)
• Use caution in heart failure, severe aortic stenosis (amlodipine), hepatic impairment, renal artery stenosis, or hypertrophic cardiomyopathy
• Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy; closely monitor blood pressure
• Impaired renal function
  • Changes in renal function including acute renal failure can be caused by drugs that inhibit renin-angiotensin system and by diuretics; patients whose renal function may depend in part on activity of renin­ angiotensin system (eg, patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure with therapy
  • Monitor renal function periodically in these patients; consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function
• Hypotension
  • In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur in patients receiving angiotensin receptor blockers; volume depletion should be corrected prior to therapy administration; treatment should start under close medical supervision
  • Initiate therapy cautiously in patients with heart failure or recent myocardial infarction and in patients undergoing surgery or dialysis; patients with heart failure or post-myocardial infarction patients given valsartan commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed
  • Since vasodilation induced by amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration; nonetheless, caution, as with any other peripheral vasodilator, should be exercised when administering amlodipine, particularly in patients with severe aortic stenosis
  • If excessive hypotension occurs with therapy, place patient in a supine position and, if necessary, give intravenous normal saline; a transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized
• Fetal toxicity
  • Use during the 2nd or 3rd trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Black Box Warnings)
  • 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; when pregnancy detected, discontinue therapy as soon as possible

Pregnancy & Lactation

• The drug combination can cause fetal harm when administered to a pregnant woman; use of drugs that act on renin-angiotensin system during 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 first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents
• When pregnancy is detected, discontinue therapy as soon as possible
• Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, and post-partum hemorrhage)
• Hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly
• Fetal/neonate adverse reactions
• Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in second and third trimesters of pregnancy can result in reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death
• Perform serial ultrasound examinations to assess the intra-amniotic environment; fetal testing may be appropriate, based on the week of gestation; oligohydramnios may not appear until after the fetus has sustained irreversible injury
• If oligohydramnios is observed, consider alternative drug treatment; closely observe neonates with histories of in utero exposure to the drug combination for hypotension, oliguria, and hyperkalemia; in neonates with a history of in utero exposure to the drug combination, if oliguria or hypotension occurs, support blood pressure and renal perfusion
• Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function
• Lactation
  • There is limited information regarding presence of drug combination in human milk, effects on breastfed infant, or on milk production; valsartan is present in rat milk; limited published studies report that amlodipine is present in human milk
  • Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with this drug combination