Medicine guide

Amlodipine and Valsartan

5 mg + 160 mg · Tablet, Film Coated

Prescription only
Angiotensin 2 Receptor Blocker

Active substance: Amlodipine and Valsartan
Used in: Heart, blood pressure and circulation
Made by: Mylan Pharmaceuticals Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2021-08-31

This product has FDA recalls (5)

Class II Ongoing · 2018-12-04 — GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Using the product could cause temporary or medically reversible harm.
Class II Ongoing · 2018-12-04 — GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Using the product could cause temporary or medically reversible harm.
Class II Ongoing · 2018-12-04 — GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.Using the product could cause temporary or medically reversible harm.

A recall usually covers specific lots. Check the lot number on your pack against the notice, and ask your pharmacist before you stop a medicine. FDA recalls

What it is

Angiotensin 2 Receptor Blocker

Used for

In patients not adequately controlled on monotherapy ( 1 )

The label’s usual adult dose

Initiate with 5/160 mg, then titrate upwards as necessary to a maximum of 10/320 mg once daily ( 2.4 ) 2.1 General Considerations Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320 mg tablet once daily as needed to control blood pressure. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose. Amlodipine and valsartan tablets may be administered with other antihypertensive agents. 2.2 Add-on Therapy A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine calcium-channel blocker) alone or with valsartan (or another ARB) alone may be switched to combination therapy with amlodipine and valsartan tablets. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to amlodipine and valsartan tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to amlodipine and valsartan tablets should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 10/320 mg. 2.3 Replacement Therapy For convenience, patients receiving amlodipine and valsartan from separate tablets may instead wish to receive tablets of amlodipine and valsartan containing the same component doses. 2.4 Initial Therapy A patient may be initiated on amlodipine and valsartan tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is amlodipine and valsartan tablets 5/160 mg once daily in patients who are not volume-depleted.

Full directions ↓

Serious warning

When pregnancy is detected, discontinue amlodipine and valsartan tablets as soon as possible. ( 5.1 )

All warnings ↓

Good to know

Prescription only

35other products contain Amlodipine and Valsartan — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Amlodipine and valsartan is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets 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 are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and valsartan tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine and valsartan tablets are indicated for the treatment of hypertension. Amlodipine and valsartan tablets may be used in patients whose blood pressure is not adequately controlled on either monotherapy. Amlodipine and valsartan tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of amlodipine and valsartan tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks including whether the patient is likely to tolerate the lowest dose of amlodipine and valsartan tablets. Patients with stage 2 hypertension (moderate or severe) are at a relatively higher risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high-dose multifactorial study [see Clinical Studies (14) ] provide estimates of the probability of reaching a blood pressure goal with amlodipine and valsartan tablets compared to amlodipine or valsartan monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with amlodipine and valsartan tablets 10/320 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 67% likelihood of achieving a goal of < 140 mmHg (systolic) and 80% likelihood of achieving < 90 mmHg (diastolic) on amlodipine alone, and the likelihood of achieving these goals on valsartan alone is about 47% (systolic) or 62% (diastolic). The likelihood of achieving these goals on amlodipine and valsartan tablets rises to about 80% (systolic) or 85% (diastolic). The likelihood of achieving these goals on placebo is about 28% (systolic) or 37% (diastolic). Amlodipine and Valsartan Figures 01 - 04

From the official label · 2021-08-31 · DailyMed

How it works

From this product’s own US prescribing label.

Amlodipine Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.
Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites.

Peak level after6–12 h

Half-life30–50 h

Mostly cleared after≈ 8 daysfive half-lives — our arithmetic

The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

How the body breaks it down

In vitro metabolism studies involving recombinant CYP 450 enzymes indicated that the CYP 2C9 isoenzyme is responsible for the formation of valeryl-4-hydroxy valsartan.

How it leaves the body

Amlodipine is extensively (about 90%) converted to inactive metabolites via hepatic metabolism with 10% of the parent compound and 60% of the metabolites excreted in the urine.

With food

The bioavailability of amlodipine is not altered by the presence of food.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2021-08-31

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

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. ( 5.1 )
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )

Quoted from the official label, section “Boxed Warning”.

Do not take it if

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 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

General Considerations:
Majority of effect attained within 2 weeks ( 2.1 )
May be administered with other antihypertensive agents ( 2.1 ) Hypertension:
May be used as add-on therapy for patients not controlled on monotherapy ( 2.2 )
Patients who experience dose-limiting adverse reactions on monotherapy may be switched to amlodipine and valsartan tablets containing a lower dose of that component ( 2.2 )
May be substituted for titrated components ( 2.3 )
When used as initial therapy:
Initiate with 5/160 mg, then titrate upwards as necessary to a maximum of 10/320 mg once daily ( 2.4 ) 2.1 General Considerations Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320 mg tablet once daily as needed to control blood pressure. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose. Amlodipine and valsartan tablets may be administered with other antihypertensive agents. 2.2 Add-on Therapy A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine calcium-channel blocker) alone or with valsartan (or another ARB) alone may be switched to combination therapy with amlodipine and valsartan tablets. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to amlodipine and valsartan tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to amlodipine and valsartan tablets should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 10/320 mg. 2.3 Replacement Therapy For convenience, patients receiving amlodipine and valsartan from separate tablets may instead wish to receive tablets of amlodipine and valsartan containing the same component doses. 2.4 Initial Therapy A patient may be initiated on amlodipine and valsartan tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is amlodipine and valsartan tablets 5/160 mg once daily in patients who are not volume-depleted.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

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 renin-angiotensin 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. When pregnancy is detected, discontinue amlodipine and valsartan tablets as soon as possible [see Use in Specific Populations (8.1) ] . 5.2 Hypotension Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with amlodipine and valsartan tablets in placebo-controlled studies. 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 administration of amlodipine and valsartan tablets. Treatment with amlodipine and valsartan tablets 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. In controlled trials in heart failure patients, the incidence of hypotension in valsartan-treated patients was 5.5% compared to 1.8% in placebo-treated patients. In the Valsartan in Acute Myocardial Infarction Trial (VALIANT), hypotension in post-myocardial infarction patients led to permanent discontinuation of therapy in 1.4% of valsartan-treated patients and 0.8% of captopril-treated patients. Since the 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 amlodipine and valsartan tablets, place the 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. 5.3 Risk of Myocardial Infarction or Increased Angina Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease. 5.4 Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., 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 on amlodipine and valsartan tablets. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on amlodipine and valsartan tablets [see Drug Interactions (7) ] . 5.5 Hyperkalemia Drugs that inhibit the 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 amlodipine and valsartan tablets may be required [see Adverse Reactions (6.1) ] .

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary Amlodipine and valsartan tablets can cause fetal harm when administered to a pregnant woman.
Use of drugs that act on the renin-angiotensin 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 renin-angiotensin system from other antihypertensive agents.
Published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (see Clinical Considerations ) .
When pregnancy is detected, discontinue amlodipine and valsartan tablets as soon as possible.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).
Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.
Pregnant women with hypertension should be carefully monitored and managed accordingly.
Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following:
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.
Patients and physicians should be aware, however, that 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 amlodipine and valsartan for hypotension, oliguria, and hyperkalemia.
In neonates with a history of in utero exposure to amlodipine and valsartan, 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.
Data Animal Data In rats, administered 20 mg/kg/day amlodipine plus 320 mg/kg/day valsartan, treatment-related maternal and fetal effects (developmental delays and alterations noted in the presence of significant maternal toxicity) were noted with the high dose combination.
This corresponds to dose multiples of 9 and 19.5 times, respectively, the maximum recommended human dose (MRHD) of 10 mg/day for amlodipine and 320 mg/day for valsartan (based on body surface area and considering a 60 kg patient).
IN SPECIFIC POPULATIONS Lactation:
Breastfeeding is not recommended ( 8.2 ) Geriatric Patients:
Not recommended for initial therapy ( 8.5 ) Hepatic Impairment:
Not recommended for initial therapy ( 8.7 )
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 renin-angiotensin 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 renin-angiotensin system from other antihypertensive agents.
Published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (see Clinical Considerations ) .
When pregnancy is detected, discontinue amlodipine and valsartan tablets as soon as possible.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).
Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.
Pregnant women with hypertension should be carefully monitored and managed accordingly.
Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following:
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.
Patients and physicians should be aware, however, that 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 amlodipine and valsartan for hypotension, oliguria, and hyperkalemia.
In neonates with a history of in utero exposure to amlodipine and valsartan, 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.
Data Animal Data In rats, administered 20 mg/kg/day amlodipine plus 320 mg/kg/day valsartan, treatment-related maternal and fetal effects (developmental delays and alterations noted in the presence of significant maternal toxicity) were noted with the high dose combination.
This corresponds to dose multiples of 9 and 19.5 times, respectively, the maximum recommended human dose (MRHD) of 10 mg/day for amlodipine and 320 mg/day for valsartan (based on body surface area and considering a 60 kg patient).
8.2 Lactation Risk Summary There is limited information regarding the presence of amlodipine and valsartan in human milk, the effects on the breastfed infant, or the effects 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, advise a nursing woman that breastfeeding is not recommended during treatment with amlodipine and valsartan tablets.
Data Valsartan was detected in the milk of lactating rats 15 minutes after oral administration of a 3 mg/kg dose.
8.4 Pediatric Use Safety and effectiveness of amlodipine and valsartan tablets in pediatric patients have not been established.
8.5 Geriatric Use In controlled clinical trials, 323 (22.5%) hypertensive patients treated with amlodipine and valsartan tablets were ≥ 65 years and 79 (5.5%) were ≥ 75 years.
No overall differences in the efficacy or safety of amlodipine and valsartan tablets were observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out.
Amlodipine The recommended starting dose of amlodipine 2.5 mg is not an available strength with amlodipine and valsartan tablets.
Clinical studies of amlodipine besylate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Elderly patients have decreased clearance of amlodipine with a resulting increase of area under the curve (AUC) of approximately 40% to 60%.
Valsartan In the controlled clinical trials of valsartan, 1214 (36.2%) of hypertensive patients treated with valsartan were ≥ 65 years and 265 (7.9%) were ≥ 75 years.
No overall difference in the efficacy or safety of valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out.
8.6 Renal Impairment Safety and effectiveness of amlodipine and valsartan tablets in patients with severe renal impairment (CrCl < 30 mL/min) have not been established.
No dose adjustment is required in patients with mild (CrCl 60 to 90 mL/min) or moderate (CrCl 30 to 60 mL/min) renal impairment.
8.7 Hepatic Impairment Amlodipine Exposure to amlodipine is increased in patients with hepatic insufficiency [see Clinical Pharmacology (12.3) ] .
The recommended initial dose of amlodipine in patients with hepatic impairment is 2.5 mg, which is not an available strength with amlodipine and valsartan tablets.
Valsartan No dose adjustment is necessary for patients with mild-to-moderate disease.
No dosing recommendations can be provided for patients with severe liver disease.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

No drug interaction studies have been conducted with amlodipine and valsartan tablets and other drugs, although studies have been conducted with the individual amlodipine and valsartan components. Amlodipine:
Impact of Other Drugs on Amlodipine:
CYP3A Inhibitors:
Coadministration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology (12.3) ] . CYP3A Inducers:
No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is coadministered with CYP3A inducers (e.g., rifampicin, St. John’s Wort). Sildenafil:
Monitor for hypotension when sildenafil is coadministered with amlodipine [see Clinical Pharmacology (12.2) ] . Impact of Amlodipine on Other Drugs:
Simvastatin:
Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily [see Clinical Pharmacology (12.3) ] . Immunosuppressants:
Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate [see Clinical Pharmacology (12.3) ] . Valsartan:
Agents Increasing Serum Potassium:
Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable. Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors):
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including valsartan, may be attenuated by NSAIDs including selective COX-2 inhibitors. Dual Blockade of the Renin-Angiotensin System (RAS):
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general,
avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on valsartan and other agents that affect the RAS. Do not coadminister aliskiren with amlodipine and valsartan tablets in patients with diabetes.
Avoid use of aliskiren with amlodipine and valsartan tablets in patients with renal impairment (GFR < 60 mL/min). Lithium:
Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use.
If simvastatin is coadministered with amlodipine,
do not exceed doses greater than 20 mg daily of simvastatin ( 7 )
Non-Steroidal Anti-Inflammatory Drug (NSAID) use may lead to increased risk of renal impairment and loss of anti-hypertensive effect ( 7 )
Dual inhibition of the renin-angiotensin system:
Increased risk of renal impairment, hypotension, and hyperkalemia ( 7 )
Lithium: Increases in serum lithium level and lithium toxicity ( 7 )
Sildenafil When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect [see Drug Interactions (7) ] .
Amlodipine In vitro data in human plasma indicate that amlodipine has no effect on the protein binding of digoxin, phenytoin, warfarin and indomethacin.
Impact of Other Drugs on Amlodipine Coadministered cimetidine, magnesium- and aluminum hydroxide antacids, sildenafil, and grapefruit juice have no impact on the exposure to amlodipine.
CYP3A Inhibitors Coadministration of a 180 mg daily dose of diltiazem with 5 mg amlodipine in elderly hypertensive patients resulted in a 60% increase in amlodipine systemic exposure.
Erythromycin coadministration in healthy volunteers did not significantly change amlodipine systemic exposure.
However, strong inhibitors of CYP3A (e.g., itraconazole, clarithromycin) may increase the plasma concentrations of amlodipine to a greater extent [see Drug Interactions (7) ] .
Impact of Amlodipine on Other Drugs Coadministered amlodipine does not affect the exposure to atorvastatin, digoxin, ethanol and the warfarin prothrombin response time.
Simvastatin Coadministration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone [see Drug Interactions (7) ] .
Cyclosporine A prospective study in renal transplant patients (N = 11) showed an average of 40% increase in trough cyclosporine levels when concomitantly treated with amlodipine [see Drug Interactions (7) ] .
Tacrolimus A prospective study in healthy Chinese volunteers (N = 9) with CYP3A5 expressers showed a 2.5- to 4-fold increase in tacrolimus exposure when concomitantly administered with amlodipine compared to tacrolimus alone.
This finding was not observed in CYP3A5 non-expressers (N = 6).
However, a 3-fold increase in plasma exposure to tacrolimus in a renal transplant patient (CYP3A5 non-expresser) upon initiation of amlodipine for the treatment of post-transplant hypertension resulting in reduction of tacrolimus dose has been reported.
Irrespective of the CYP3A5 genotype status, the possibility of an interaction cannot be excluded with these drugs [see Drug Interactions (7) ] .
Valsartan No clinically significant pharmacokinetic interactions were observed when valsartan was coadministered with amlodipine, atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin.
The valsartan-atenolol combination was more antihypertensive than either component, but it did not lower the heart rate more than atenolol alone.
Coadministration of valsartan and warfarin did not change the pharmacokinetics of valsartan or the time-course of the anticoagulant properties of warfarin.
Transporters The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and the hepatic efflux transporter MRP2.
Coadministration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Amlodipine:
Single oral doses of amlodipine maleate equivalent to 40 mg/kg and 100 mg/kg amlodipine in mice and rats, respectively, caused deaths.
Single oral doses equivalent to 4 or more mg/kg amlodipine in dogs (11 or more times the maximum recommended human dose on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension.
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension.
In humans, experience with intentional overdosage of amlodipine is limited.
Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
If massive overdose should occur, initiate active cardiac and respiratory monitoring.
Frequent blood pressure measurements are essential.
Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated.
If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output.
As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.
Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
Valsartan: Limited data are available related to overdosage in humans.
The most likely effect of overdose with valsartan would be peripheral vasodilation, hypotension, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation.
Depressed level of consciousness, circulatory collapse, and shock have been reported.
If symptomatic hypotension should occur, institute supportive treatment.
Valsartan is not removed from the plasma by hemodialysis.
Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for the salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 37 times, respectively, the MRHD on a mg/m 2 basis) (Calculations assume an oral dose of 320 mg/day and a 60 kg patient).

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness of amlodipine and valsartan tablets in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

In controlled clinical trials, 323 (22.5%) hypertensive patients treated with amlodipine and valsartan tablets were ≥ 65 years and 79 (5.5%) were ≥ 75 years.
No overall differences in the efficacy or safety of amlodipine and valsartan tablets were observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out.
Amlodipine The recommended starting dose of amlodipine 2.5 mg is not an available strength with amlodipine and valsartan tablets.
Clinical studies of amlodipine besylate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Elderly patients have decreased clearance of amlodipine with a resulting increase of area under the curve (AUC) of approximately 40% to 60%.
Valsartan In the controlled clinical trials of valsartan, 1214 (36.2%) of hypertensive patients treated with valsartan were ≥ 65 years and 265 (7.9%) were ≥ 75 years.
No overall difference in the efficacy or safety of valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out.

Quoted from the official label, section “Geriatric Use”.

Side effects

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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Studies with Amlodipine and Valsartan Tablets Amlodipine and valsartan tablets have been evaluated for safety in over 2600 patients with hypertension; over 1440 of these patients were treated for at least 6 months and over 540 of these patients were treated for at least 1 year.
Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
The hazards [see Warnings and Precautions (5) ] of valsartan are generally independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter.
The overall frequency of adverse reactions was neither dose-related nor related to gender, age, or race.
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 (0.4%), and vertigo (0.2%).
The adverse reactions that occurred in placebo-controlled clinical trials in at least 2% of patients treated with amlodipine and valsartan tablets but at a higher incidence in amlodipine/valsartan patients (n = 1437) than placebo (n = 337) included peripheral edema (5.4% vs 3.0%), nasopharyngitis (4.3% vs 1.8%), upper respiratory tract infection (2.9% vs 2.1%) and dizziness (2.1% vs 0.9%).
Orthostatic events (orthostatic hypotension and postural dizziness) were seen in less than 1% of patients.
Studies with Valsartan Diovan ® has been evaluated for safety in more than 4000 hypertensive patients in clinical trials.
In trials in which valsartan was compared to an angiotensin-converting enzyme (ACE) inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%).
In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, HCTZ, or lisinopril were 20%, 19%, and 69% respectively (p < 0.001).
Clinical Lab Test Findings Creatinine In heart failure patients, greater than 50% increases in creatinine were observed in 3.9% of valsartan-treated patients compared to 0.9% of placebo-treated patients.
In post-myocardial infarction patients, doubling of serum creatinine was observed in 4.2% of valsartan-treated patients and 3.4% of captopril-treated patients.
Blood Urea Nitrogen (BUN) In hypertensive patients, greater than 50% increases in BUN were observed in 5.5% of amlodipine and valsartan tablets-treated patients compared to 4.7% of placebo-treated patients.
In heart failure patients, greater than 50% increases in BUN were observed in 16.6% of valsartan-treated patients compared to 6.3% of placebo-treated patients [see Warnings and Precautions (5.4) ] .
Neutropenia Neutropenia was observed in 1.9% of patients treated with Diovan and 0.8% of patients treated with placebo.
6.2 Postmarketing Experience The following additional adverse reactions have been reported in postmarketing experience.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Amlodipine Gynecomastia has been reported infrequently and a causal relationship is uncertain.
Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.
Valsartan The following additional adverse reactions have been reported in postmarketing experience with valsartan:
Hypersensitivity:
Angioedema has been reported.
Some of these patients previously experienced angioedema with other drugs including ACE inhibitors.
Diovan should not be re-administered to patients who have had angioedema.
Digestive:
Elevated liver enzymes and reports of hepatitis Musculoskeletal :
Rhabdomyolysis Renal:
Impaired renal function, renal failure Dermatologic:
Alopecia, bullous dermatitis Blood and Lymphatic:
Thrombocytopenia Vascular:
Vasculitis

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Information for Patients:
Advise the patient to read the FDA-approved patient labeling ( Patient Information ).
Pregnancy:
Advise female patients of childbearing age about the consequences of exposure to amlodipine and valsartan tablets during pregnancy.
Discuss treatment options with women planning to become pregnant.
Ask patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ] .
Lactation:
Advise women not to breastfeed during treatment with amlodipine and valsartan tablets [see Use in Specific Populations (8.2) ] .
Symptomatic Hypotension:
Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to their healthcare provider.
Tell patients that if syncope occurs to discontinue amlodipine and valsartan tablets until the physician has been consulted.
Caution all patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope [see Warnings and Precautions (5.2) ] .
Hyperkalemia:
Advise patients not to use salt substitutes without consulting their healthcare provider [see Drug Interactions (7) ] .
FDA-APPROVED PATIENT LABELING

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Amlodipine and Valsartan Tablets, USP are available containing amlodipine besylate, USP (6.94 mg or 13.88 mg, equivalent to 5 mg or 10 mg of amlodipine respectively) with 160 mg or 320 mg of valsartan, USP providing for the following available combinations:
5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg or 10 mg/320 mg.
The 5 mg/160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with MX1 on one side of the tablet and blank on the other side.
The 10 mg/160 mg tablets are tan, film-coated, oval, unscored tablets debossed with MX2 on one side of the tablet and blank on the other side.
The 5 mg/320 mg tablets are orange, film-coated, capsule-shaped, unscored tablets debossed with MX43 on one side of the tablet and blank on the other side.
The 10 mg/320 mg tablets are light orange, film-coated, capsule-shaped, unscored tablets debossed with MX44 on one side of the tablet and blank on the other side. Tablets (amlodipine/valsartan mg):
5/160, 10/160, 5/320, 10/320 ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Amlodipine and Valsartan Tablets, USP are available containing amlodipine besylate, USP (6.94 mg or 13.88 mg, equivalent to 5 mg or 10 mg of amlodipine respectively) with 160 mg or 320 mg of valsartan, USP providing for the following available combinations:
5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg or 10 mg/320 mg.
The 5 mg/160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with MX1 on one side of the tablet and blank on the other side.
They are available as follows:
NDC 0378-1721-93 bottles of 30 tablets The 10 mg/160 mg tablets are tan, film-coated, oval, unscored tablets debossed with MX2 on one side of the tablet and blank on the other side.
They are available as follows:
NDC 0378-1722-93 bottles of 30 tablets The 5 mg/320 mg tablets are orange, film-coated, capsule-shaped, unscored tablets debossed with MX43 on one side of the tablet and blank on the other side.
They are available as follows:
NDC 0378-1723-93 bottles of 30 tablets The 10 mg/320 mg tablets are light orange, film-coated, capsule-shaped, unscored tablets debossed with MX44 on one side of the tablet and blank on the other side.
They are available as follows:
NDC 0378-1724-93 bottles of 30 tablets
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Quoted from the official label, section “How Supplied”.

What is in it

Amlodipine and valsartan tablets, USP are a fixed combination of amlodipine and valsartan. Amlodipine and valsartan tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate, USP is a white or almost white powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-ethyl-5-methyl (4 RS )-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate; its structural formula is:
Its molecular formula is C 20 H 25 ClN 2 O 5
C 6 H 6 O 3 S and its molecular weight is 567.1. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT 1 receptor subtype. Valsartan, USP is a white to almost white amorphous powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N -[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]- N -valeryl- L -valine; its structural formula is:
Its molecular formula is C 24 H 29 N 5 O 3 and its molecular weight is 435.52. Amlodipine and valsartan tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate (6.94 mg or 13.88 mg, equivalent to 5 mg or 10 mg of amlodipine respectively), 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, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, red iron oxide, sodium starch glycolate (potato), talc, titanium dioxide and yellow iron oxide. Meets USP Dissolution Test 3. Amlodipine Besylate Structural Formula Valsartan Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (10)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 10 of 10

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (5)

Details

Made by	Mylan Pharmaceuticals Inc.
Active substance	Amlodipine and Valsartan
Used in	Heart, blood pressure and circulation
Strength	5 mg + 160 mg
Form	Tablet, Film Coated
Route	Oral
Packs	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
NDC	0378-1721

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

36 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet20 products
- 5 mg + 160 mg5
  5 mg + 160 mg · 5 companies
- 5 mg + 320 mg5
  5 mg + 320 mg · 5 companies
- 10 mg + 160 mg5
  10 mg + 160 mg · 5 companies
- 10 mg + 320 mg5
  10 mg + 320 mg · 5 companies
Tablet, Film Coated16 products
- 5 mg + 160 mg4
  5 mg + 160 mg · 4 companies
  - Alembic Pharmaceuticals Inc.
  - Alembic Pharmaceuticals Limited
  - Aurobindo Pharma Limited
  - Mylan Pharmaceuticals Inc. · this page
- 5 mg + 320 mg4
  5 mg + 320 mg · 4 companies
- 10 mg + 160 mg4
  10 mg + 160 mg · 4 companies
- 10 mg + 320 mg4
  10 mg + 320 mg · 4 companies

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Amlodipine and Valsartan