Valsartan and amlodipine: Drug information

(For additional information see "Valsartan and amlodipine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

ALERT: US Boxed Warning

Fetal toxicity:

When pregnancy is detected, discontinue therapy as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

Brand Names: US

Exforge

Pharmacologic Category

Angiotensin II Receptor Blocker;
Antianginal Agent;
Antihypertensive;
Calcium Channel Blocker;
Calcium Channel Blocker, Dihydropyridine

Dosing: Adult

Note: Dose must be individualized.

Hypertension

Hypertension: Oral:

Initial therapy: Amlodipine 5 mg/valsartan 160 mg once daily; dose may be titrated after 1 to 2 weeks. Maximum dose: amlodipine 10 mg/valsartan 320 mg once daily

Add-on therapy: Amlodipine 5 to 10 mg/valsartan 160 to 320 mg once daily; dose may be titrated after 3 to 4 weeks of therapy. Maximum dose: amlodipine 10 mg/valsartan 320 mg once daily

Replacement therapy: Substitute for the individually titrated components. Maximum dose: amlodipine 10 mg/valsartan 320 mg once daily

Dosing: Kidney Impairment: Adult

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. Use with caution; titrate slowly. Not recommended for initial therapy in patients with hepatic impairment (recommended initial dose of amlodipine [2.5 mg/day] in these patients is not available in this combination product). Use with caution in patients with ascites due to cirrhosis (Ref).

Dosing: Older Adult

Not recommended for initial therapy (recommended initial dose of amlodipine [2.5 mg/day] in these patients is not available in this combination product). Use of lower doses should be considered. Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.

1% to 10%:

Cardiovascular: Peripheral edema (5%)

Central nervous system: Dizziness (2%)

Renal: Increased blood urea nitrogen (6%)

Respiratory: Nasopharyngitis (4%), upper respiratory tract infection (3%)

<1%: Hypotension, orthostatic dizziness, orthostatic hypotension, severe hypotension

Frequency not defined:

Central nervous system: Vertigo

Contraindications

Hypersensitivity to amlodipine, valsartan, or any component of the formulation; concomitant use with aliskiren in patients with diabetes mellitus

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• Angioedema: Angioedema has been reported rarely with some angiotensin II receptor antagonists (ARBs) and may occur at any time during treatment (especially following first dose). It may involve the head and neck (potentially compromising airway) or the intestine (presenting with abdominal pain). Patients with idiopathic or hereditary angioedema or previous angioedema associated with ACE-inhibitor therapy may be at an increased risk. Prolonged frequent monitoring may be required, especially if tongue, glottis, or larynx are involved, as they are associated with airway obstruction. Patients with a history of airway surgery may have a higher risk of airway obstruction. Discontinue therapy immediately if angioedema occurs. Aggressive early management is critical. Intramuscular (IM) administration of epinephrine may be necessary. Do not readminister to patients who have had angioedema with ARBs.

• Angina/MI: Increased angina and/or MI has occurred with initiation or dosage titration of dihydropyridine calcium channel blockers. Reflex tachycardia may occur resulting in angina and/or MI in patients with obstructive coronary disease, especially in the absence of concurrent beta-blockade.

• Hyperkalemia: May occur with valsartan use; risk factors include renal dysfunction, diabetes mellitus, concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salts. Use cautiously, if at all, with these agents and monitor potassium closely.

• Hypotension: Symptomatic hypotension may occur upon initiation in patients who are salt- or volume-depleted (eg, those treated with high-dose diuretics); correct volume depletion prior to administration. This transient hypotensive response is not a contraindication to further treatment with amlodipine/valsartan.

• Hypotension/syncope: Symptomatic hypotension with or without syncope can rarely occur; use caution during initiation of therapy, particularly in patients with heart failure, severe aortic stenosis, or in post-MI patients or those undergoing surgery or dialysis.

• Peripheral edema: The most common side effect of amlodipine is peripheral edema; occurs within 2-3 weeks of starting therapy.

• Renal function deterioration: Valsartan may be associated with deterioration of renal function and/or increases in serum creatinine, particularly in patients with low renal blood flow (eg, renal artery stenosis, heart failure) whose glomerular filtration rate (GFR) is dependent on efferent arteriolar vasoconstriction by angiotensin II; deterioration may result in oliguria, acute renal failure, and progressive azotemia. Small increases in serum creatinine may occur following initiation; consider discontinuation only in patients with progressive and/or significant deterioration in renal function.

Disease-related concerns:

• Aortic stenosis: Use amlodipine with extreme caution in patients with severe aortic stenosis; may reduce coronary perfusion resulting in ischemia.

• Ascites: Generally, avoid use in patients with ascites due to cirrhosis or refractory ascites; if use cannot be avoided in patients with ascites due to cirrhosis, monitor BP and renal function carefully to avoid rapid development of renal failure (AASLD [Runyon 2013]).

• Heart failure: Use caution when initiating in heart failure; may need to adjust dose, and/or concurrent diuretic therapy.

• Hepatic impairment: Use with caution in patients with hepatic impairment; amlodipine and valsartan exposure increases with hepatic dysfunction.

• Hypertrophic cardiomyopathy (HCM) with outflow tract obstruction: Use amlodipine with caution in patients with HCM and outflow tract obstruction since reduction in afterload may worsen symptoms associated with this condition.

• Renal artery stenosis: Use valsartan with caution in patients with unstented unilateral/bilateral renal artery stenosis. When unstented bilateral renal artery stenosis is present, use is generally avoided due to the elevated risk of deterioration in renal function unless possible benefits outweigh risks.

• Renal impairment: Use with caution with preexisting renal insufficiency and severe renal impairment.

Concurrent drug therapy issues:

• Angiotensin-converting enzyme (ACE) inhibitors and renin inhibitors: Concomitant use of an ACE-inhibitor or renin inhibitor (eg, aliskiren) is associated with an increased risk of hypotension, hyperkalemia, and renal dysfunction. Concomitant use with aliskiren should be avoided in patients with GFR <60 mL/minute and is contraindicated in patients with diabetes mellitus (regardless of GFR).

Special populations:

• Older adult: Exposure to amlodipine is increased in the elderly; consider use of a lower initial dose.

• Pregnancy: [US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected.

• Surgical patients: In patients on chronic angiotensin receptor blocker (ARB) therapy, intraoperative hypotension may occur with induction and maintenance of general anesthesia; however, discontinuation of therapy prior to surgery is controversial. If continued preoperatively, avoidance of hypotensive agents during surgery is prudent (Hillis, 2011).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Exforge: Amlodipine 5 mg and valsartan 160 mg, Amlodipine 5 mg and valsartan 320 mg, Amlodipine 10 mg and valsartan 160 mg, Amlodipine 10 mg and valsartan 320 mg

Generic: Amlodipine 10 mg and valsartan 160 mg, Amlodipine 10 mg and valsartan 320 mg, Amlodipine 5 mg and valsartan 160 mg, Amlodipine 5 mg and valsartan 320 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (amLODIPine Besylate-Valsartan Oral)

5-160 mg (per each): $5.46 - $5.47

5-320 mg (per each): $6.93 - $6.94

10-160 mg (per each): $6.20

10-320 mg (per each): $7.86 - $7.87

Tablets (Exforge Oral)

5-160 mg (per each): $12.64

5-320 mg (per each): $16.04

10-160 mg (per each): $14.34

10-320 mg (per each): $18.21

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Administer with or without food.

Use: Labeled Indications

Hypertension: Management of hypertension (monotherapy or in combination with other antihypertensives). See individual monographs.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Aliskiren: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Aliskiren may enhance the hypotensive effect of Angiotensin II Receptor Blockers. Aliskiren may enhance the nephrotoxic effect of Angiotensin II Receptor Blockers. Management: Aliskiren use with ACEIs or ARBs in patients with diabetes is contraindicated. Combined use in other patients should be avoided, particularly when CrCl is less than 60 mL/min. If combined, monitor potassium, creatinine, and blood pressure closely. Risk D: Consider therapy modification

ALPRAZolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ALPRAZolam. Risk C: Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Angiotensin II: Receptor Blockers may diminish the therapeutic effect of Angiotensin II. Risk C: Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: Angiotensin II Receptor Blockers may enhance the adverse/toxic effect of Angiotensin-Converting Enzyme Inhibitors. Angiotensin II Receptor Blockers may increase the serum concentration of Angiotensin-Converting Enzyme Inhibitors. Management: Use of telmisartan and ramipril is not recommended. It is not clear if any other combination of an ACE inhibitor and an ARB would be any safer. Consider alternatives when possible. Monitor blood pressure, renal function, and potassium if combined. Risk D: Consider therapy modification

Antihepaciviral Combination Products: May increase the serum concentration of Valsartan. Management: Consider decreasing the valsartan dose and monitoring for evidence of hypotension and worsening renal function if these agents are used in combination. Risk D: Consider therapy modification

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy

Arginine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Asciminib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Atosiban: Calcium Channel Blockers may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination

Calcium Salts: May diminish the therapeutic effect of Calcium Channel Blockers. Risk C: Monitor therapy

CarBAMazepine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of CarBAMazepine. Risk C: Monitor therapy

Charcoal, Activated: May decrease the serum concentration of AmLODIPine. Risk C: Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Clopidogrel: Calcium Channel Blockers may diminish the therapeutic effect of Clopidogrel. Risk C: Monitor therapy

CycloSPORINE (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of AmLODIPine. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of AmLODIPine. Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of AmLODIPine. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of AmLODIPine. Risk C: Monitor therapy

Dabigatran Etexilate: AmLODIPine may diminish the therapeutic effect of Dabigatran Etexilate. Risk C: Monitor therapy

Dantrolene: May enhance the hyperkalemic effect of Calcium Channel Blockers. Dantrolene may enhance the negative inotropic effect of Calcium Channel Blockers. Risk X: Avoid combination

Dapoxetine: May enhance the orthostatic hypotensive effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Dapoxetine: May enhance the orthostatic hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Darolutamide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Drospirenone-Containing Products: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

Eltrombopag: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Encorafenib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Eplerenone: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Finerenone: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Finerenone. Risk C: Monitor therapy

Finerenone: Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Finerenone. Risk C: Monitor therapy

Flibanserin: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Flibanserin. Risk C: Monitor therapy

Flunarizine: May enhance the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Gemfibrozil: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Heparin: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Heparins (Low Molecular Weight): May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Herbal Products with Blood Pressure Increasing Effects: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Indoramin: May enhance the hypotensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Inhalational Anesthetics: May enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Ixabepilone: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Ixabepilone. Risk C: Monitor therapy

Leflunomide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Lemborexant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lemborexant. Management: The maximum recommended dosage of lemborexant is 5 mg, no more than once per night, when coadministered with weak CYP3A4 inhibitors. Risk D: Consider therapy modification

Leniolisib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Foslevodopa. Risk C: Monitor therapy

Lithium: Angiotensin II Receptor Blockers may increase the serum concentration of Lithium. Management: Initiate lithium at lower doses in patients receiving an angiotensin II receptor blocker (ARB). Consider lithium dose reductions in patients stable on lithium therapy who are initiating an ARB. Monitor lithium concentrations closely when combined. Risk D: Consider therapy modification

Lomitapide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be titrated up to a max adult dose of 30 mg/day. Risk D: Consider therapy modification

Lonafarnib: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lonafarnib. Management: Avoid concurrent use of lonafarnib with weak CYP3A4 inhibitors. If concurrent use is unavoidable, reduce the lonafarnib dose to or continue at a dose of 115 mg/square meter. Monitor for evidence of arrhythmia, syncope, palpitations, or similar effects. Risk D: Consider therapy modification

Loop Diuretics: May enhance the hypotensive effect of Angiotensin II Receptor Blockers. Loop Diuretics may enhance the nephrotoxic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Loop Diuretics: May enhance the hypotensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Lovastatin: AmLODIPine may increase the serum concentration of Lovastatin. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the adverse/toxic effect of Calcium Channel Blockers (Dihydropyridine). Specifically, the risk of hypotension or muscle weakness may be increased. Risk C: Monitor therapy

Melatonin: May diminish the antihypertensive effect of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Midazolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Midazolam. Risk C: Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Neuromuscular-Blocking Agents (Nondepolarizing): Calcium Channel Blockers may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

NiMODipine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of NiMODipine. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: Angiotensin II Receptor Blockers may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Angiotensin II Receptor Blockers. The combination of these two agents may also significantly decrease glomerular filtration and renal function. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Topical): May diminish the therapeutic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Risk X: Avoid combination

Polyethylene Glycol-Electrolyte Solution: Angiotensin II Receptor Blockers may enhance the nephrotoxic effect of Polyethylene Glycol-Electrolyte Solution. Risk C: Monitor therapy

Potassium Salts: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Potassium-Sparing Diuretics: Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk C: Monitor therapy

Prazosin: Antihypertensive Agents may enhance the hypotensive effect of Prazosin. Risk C: Monitor therapy

Pretomanid: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Ranolazine: May enhance the adverse/toxic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Red Yeast Rice: AmLODIPine may increase the serum concentration of Red Yeast Rice. Risk C: Monitor therapy

Silodosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Simvastatin: AmLODIPine may increase the serum concentration of Simvastatin. Management: Dose of simvastatin should not exceed 20 mg daily if coadministering with amlodipine. If coadministering with simvastatin and amlodipine, close laboratory and clinical monitoring for signs and symptoms of rhabdomyolysis is warranted. Risk D: Consider therapy modification

Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification

Sirolimus (Conventional): CYP3A4 Inhibitors (Weak) may increase the serum concentration of Sirolimus (Conventional). Risk C: Monitor therapy

Sirolimus (Protein Bound): CYP3A4 Inhibitors (Weak) may increase the serum concentration of Sirolimus (Protein Bound). Management: Reduce the dose of protein bound sirolimus to 56 mg/m² when used concomitantly with a weak CYP3A4 inhibitor. Risk D: Consider therapy modification

Sodium Phosphates: Angiotensin II Receptor Blockers may enhance the nephrotoxic effect of Sodium Phosphates. Specifically, the risk of acute phosphate nephropathy may be enhanced. Risk C: Monitor therapy

Sparsentan: May enhance the adverse/toxic effect of Angiotensin II Receptor Blockers. Risk X: Avoid combination

Tacrolimus (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Tacrolimus (Systemic): Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Tacrolimus (Systemic). Risk C: Monitor therapy

Tacrolimus (Systemic): CYP3A4 Inhibitors (Weak) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Terazosin: Antihypertensive Agents may enhance the hypotensive effect of Terazosin. Risk C: Monitor therapy

Teriflunomide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Tolvaptan: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Triazolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Triazolam. Risk C: Monitor therapy

Trimethoprim: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Trofinetide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Management: Avoid concurrent use with OATP1B1/1B3 substrates for which small changes in exposure may be associated with serious toxicities. Monitor for evidence of an altered response to any OATP1B1/1B3 substrate if used together with trofinetide. Risk D: Consider therapy modification

Ubrogepant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Ubrogepant. Management: In patients taking weak CYP3A4 inhibitors, the initial and second dose (given at least 2 hours later if needed) of ubrogepant should be limited to 50 mg. Risk D: Consider therapy modification

Urapidil: Antihypertensive Agents may enhance the hypotensive effect of Urapidil. Risk C: Monitor therapy

Voclosporin: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Food Interactions

See individual agents.

Pregnancy Considerations

[US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected. See individual agents.

Breastfeeding Considerations

Amlodipine is present in breast milk (Naito 2015); excretion of valsartan is unknown.

Because of the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer. See individual agents.

Dietary Considerations

Avoid salt substitutes which contain potassium.

Monitoring Parameters

Blood pressure, heart rate; baseline and periodic electrolyte panels; renal and liver function; monitor for orthostasis, peripheral edema

Mechanism of Action

Amlodipine inhibits calcium ion from entering the “slow channels” or select voltage-sensitive areas of vascular smooth muscle and myocardium during depolarization, producing a relaxation of coronary vascular smooth muscle and coronary vasodilation; increases myocardial oxygen delivery in patients with vasospastic angina. Amlodipine directly acts on vascular smooth muscle to produce peripheral arterial vasodilation reducing peripheral vascular resistance and blood pressure.

Valsartan produces direct antagonism of the angiotensin II (AT2) receptors, unlike the ACE inhibitors. It displaces angiotensin II from the AT1 receptor and produces its blood pressure-lowering effects by antagonizing AT1-induced vasoconstriction, aldosterone release, catecholamine release, arginine vasopressin release, water intake, and hypertrophic responses. This action results in more efficient blockade of the cardiovascular effects of angiotensin II and fewer side effects than the ACE inhibitors.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Imprida | Lodiva | Lotevan | Wamlox;
(AR) Argentina: Diapresan a | Diovan A | Disarval | Exforge | Noster | Noster 10/160 | Simultan a;
(AT) Austria: Amlodipin / Valsartan Zentiva | Amlodipin/valsartan 1a pharma | Amlodipin/Valsartan Actavis | Amlodipin/valsartan genericon | Amlodipin/valsartan krka | Amlodipin/valsartan sandoz | Amlodipin/valsartan stada | Amlovalsax;
(AU) Australia: Exforge | Valsart/amlodipine sandoz | Valsartan/amlodipine novartis;
(BD) Bangladesh: Amlosartan | Amlovas Vs | Camoval | Co disys | Co valtin | Exforge;
(BE) Belgium: Amlodipine/valsartan EG | Amlodipine/valsartan krka | Amlodipine/valsartan sandoz | Exforge;
(BG) Bulgaria: Amlodipine/valsartan sandoz | Amvalcon | Asbima | Dipperam | Valsavil am | Valtensam | Wamlox;
(BR) Brazil: Brasart bcc | Cosartan alp | Diovan amlo | Valsartana + anlodipino;
(CH) Switzerland: Amlodip valsartan mylan | Amlodipin valsartan sandoz | Amlodipin Valsartan Zentiva | Exforge | Valsartan amlo spirig hc;
(CI) Côte d'Ivoire: Valamlo;
(CL) Chile: Exforge | Valaxam | Vartalan am;
(CN) China: Bei bo te | Valsartan and amlodipine;
(CO) Colombia: Alpex duoval | Amlodipino + valsartan | Ampliron | Duoval | Exforge | Garmisch duoval | Valsartan+amlodipino | Valsartan/Amlodipino;
(CZ) Czech Republic: Wamlox;
(DE) Germany: Amlo valsacor | Amlodipin valsartan beta | Amlodipin Valsartan Zentiva | Amlodipin/valsartan 1 a pharma | Amlodipin/valsartan abz | Amlodipin/valsartan accord | Amlodipin/Valsartan AL | Amlodipin/valsartan denk | Amlodipin/valsartan heumann | Amlodipin/valsartan mylan | Amlodipin/valsartan puren | Amlodipin/Valsartan ratiopharm | Copalia | Dafiro | Epiaosan | Exforge | Valsimia;
(DO) Dominican Republic: Amapine v | Aremis | Atdos a | Diloben | Forzapress | Gioten a | Lysamol a | Valdiber a | Valodipin | Valodipin plus | Valsar A | Valsartec a | Valscard a | Vartalan am;
(EC) Ecuador: Exforge | Hiperval am | Simultan a | Valaxam;
(EE) Estonia: Amlodipine/valsartan sandoz | Exforge | Wamlox;
(EG) Egypt: Alkapress Plus | Amilo plus | Avivavasc | Blokatens | Exforge | Kemiforge | Molivart | Nexpress;
(ES) Spain: Amlodipin/valsartan tecnigen | Amlodipino/Valsartan Aurovitas | Amlodipino/valsartan cinfamed | Amlodipino/valsartan kern pharma | Amlodipino/valsartan krka | Amlodipino/valsartan Mylan | Amlodipino/valsartan ratiopharm | Amlodipino/valsartan sandoz | Amlodipino/valsartan stada | Amlodipino/valsartan teva | Dafiro | Imprida | Valsimia;
(ET) Ethiopia: Amlodipine and valsartan | Exforge;
(FI) Finland: Amlodipin/valsartan krka | Amlodipin/valsartan orion | Amlodipin/Valsartan ratiopharm | Amlodipin/valsartan stada | Amlodipine/valsartan Mylan | Exforge;
(FR) France: Amlodipine/Valsartan accord | Amlodipine/valsartan arrow | Amlodipine/valsartan cristers | Amlodipine/valsartan EG | Amlodipine/valsartan evolugen | Amlodipine/valsartan krka | Amlodipine/valsartan Mylan | Amlodipine/valsartan sandoz | Amlodipine/valsartan teva | Amlodipine/valsartan zentiva | Amlodipine/valsartan zydus;
(GB) United Kingdom: Exforge;
(GR) Greece: Alvoda | Copalia | Covadir | Exforge | Valsimia;
(HK) Hong Kong: Nikp amlodipine/valsartan | Norvan;
(HR) Croatia: Amlodipin/valsartan Pliva | Amlodipin/valsartan sandoz | Exforge | Vainas | Wamlox;
(HU) Hungary: Amlodipine/valsartan sandoz | Wamlox;
(ID) Indonesia: Exforge | Lapiva | Vardipin;
(IE) Ireland: Amlodipine/valsartan clonmel | Amlodipine/valsartan krka | Amlodipine/valsartan Mylan | Amlodipine/valsartan Rowex | Exforge;
(IL) Israel: Duplex | Exforge;
(IN) India: Amlopres VL | Exforge | Valembic am;
(IT) Italy: Asbima | Cantensio | Dipperam;
(JO) Jordan: Exforge | Lotevan | Newstar | Senergy;
(JP) Japan: Amvalo | Exforge Combination;
(KE) Kenya: Amva denk | Avsar | Exforge | Starval am | Valembic am | Valvas;
(KR) Korea, Republic of: Aforge | Alfaforge | Amdisar | Amiforge | Amlosartan | Amlotan | Amlovaltan | Amlovan | Amortan | Amvalsan | Amvalt | Amvaltan | Amvartan | Amvasartan | Anafurge | Anoforge | Anyforge | Arb xg | Avaltan | Avartan | Avastar | Besforge | Biforge | Cadenza | Cardiforge | Cesmutan | Citforge | Combiforge | Conex | Corforge | Crb | Ctforge | Diodipine | Dionova | Diroforge | Disforge | Doubleforge | Dual down | Dual x | Dualforge | Duoforge | Ex v | Exadipine | Excombi | Exdipin | Exduo | Exfall | Exforge | Exforte | Exfos | Exivitan | Exlopine | Exnin | Exone | Exparall | Expin | Expine | Expintan | Expo g | Exrobin | Exvaltan | Glofoge | Gloforge | Hiforge | Huniz valsarpin | Imprida | J tension | Jeiforge | Jforge | Logis | Lowforge | Maxforge | Mediloten | Megaforge | Mr forge | Necfo | Necpo | Neoforge | New dqforce | Newdqforce | Newgenforge | Norvasc v | Novaltan | Novasartan | Np forge | Onoforge | Orosartan | Rexfage q | S sartan | Sardipine | Staforge | Stafozy | Synect | Tds sartan | Twotwoforge | Unasartan | Uniforge | Uroforge | V dipine | Valadipine | Valdipine | Valsadipine | Valsaforce | Valsapine | Valsarex | Valsarodin | Valtan x | Vardipine | Varoforge | Vasalpine | Vdipine | Vforge | Visforge | Wenex g | Winexge | X detension | X lotan | Xlow | Xpera | Yuyuforge;
(KW) Kuwait: Exforge | Lotevan;
(LB) Lebanon: Angiosar | Exforge | Lotevan | Povam | Simultan a | Viostan am;
(LT) Lithuania: Amlodipine/valsartan | Amlodipine/valsartan inteli | Amlodipine/valsartan teva | Dipperam | Exforge | Valsartan/amlodipine teva pharma | Wamlox;
(LU) Luxembourg: Amlodipine/valsartan EG | Exforge;
(LV) Latvia: Amlodipine/valsartan teva | Dipperam | Exforge | Wamlox;
(MA) Morocco: Exforge | Lotevan | Suliat;
(MX) Mexico: Exforge;
(MY) Malaysia: Amval | Exforge;
(NG) Nigeria: Amlosartan | Avsar | Carvals am | Dioplus | Exforge | Lastavin am | Nordexa plus | Odizat | Poccosart | Potenza | Senergy | Valsar am | Valsartan and amlodipine;
(NL) Netherlands: Amlodipine and valsartan | Amlodipine/valsartan | Amlodipine/valsartan aurobindo | Amlodipine/valsartan teva | Copalia | Exforge;
(NO) Norway: Bevacomb | Exforge;
(PE) Peru: Exforge | Valsiprel a;
(PH) Philippines: Amloval | Hybip | Trivan plus | Valazyd AM | Valcamp | Valianz | Valnorm duo | Valsadex | Valsar plus | Valsaram | Valtam | Valvex a;
(PK) Pakistan: A v | Address | Alvan | Alvostan | Alvostan ds | Am salvan | Amdosart plus | Amlodine | Amloplus | Amlortan | Amloval | Amlovastan | Amlove | Amlowell | Amodip-v | Amsart | Amsartan | Amstan | Amval | Amvart | Amvart ds | Av sartan | Avaam | Avsar | Biforge | Caloc v | Co redupres | Co valzaar | Co velker | Covam | Covance | Di valsar | Dioplus | Diovasc | Dipval | Dipval plus | Distan | Emhart | Exotan | Exval a | Listan am | Newday | Onato v | Plonim | Valam | Valcard | Valday | Valdipine | Valken a | Valmax am | Valmo | Valpin | Valsar m | Valsarpin | Valta am | Valtan m | Valtec am | Valturna a | Velvet am | Walpine | Zeglopin v;
(PL) Poland: Avasart plus | Dipperam | Exforge | Wamlox;
(PR) Puerto Rico: Amlodipine and valsartan | Amlodipine besylate and valsartan | Exforge;
(PT) Portugal: Amlodipina + Valsartan Ciclum | Amlodipina + valsartan Mylan | Amlodipina + valsartan pentafarma | Amlodipina + valsartan ratiopharm | Amlodipina + Valsartan Teva | Amlodipine+ Valsartan Aurovitas | Copalia | Dafiro;
(PY) Paraguay: Valaxam;
(QA) Qatar: Angiosar | Exforge | Newstar | Senergy;
(RO) Romania: Amlodipina/valsartan aurobindo | Amlodipina/valsartan stada | Amlodipina/valsartan zentiva | Dipperam | Exforge;
(RU) Russian Federation: Amlodipine valsartan richter | Amlodipine-valsartan | Amlodipine/valsartan Richter | Artinova am | Disartan | Exforge | Exfotanz | Narunel | Valz combi | Vamloset;
(SA) Saudi Arabia: Amlor plus | Amstar | Senergy | Vittoria;
(SE) Sweden: Amlodipin/valsartan 2care4 | Amlodipin/valsartan ebb | Amlodipin/valsartan krka | Amlodipin/valsartan stada | Exforge;
(SG) Singapore: Exforge;
(SI) Slovenia: Wamlox;
(SK) Slovakia: Amlodipin/valsartan sandoz | Wamlox;
(TH) Thailand: Dafiro;
(TN) Tunisia: Amlosartan zentiva | Amlovar | Duofor | Exforge | Icatens | Neaforge | Tensiovals duo | Value plus;
(TR) Turkey: Cardofix | Combisar | Valcodin | Valtan a;
(TW) Taiwan: Am daianxo | Am-daiwen | Amoten | Amvlo | Asartan | Dafiro | Estengy | Exfopine | Exforge | Exnortan | Valsoon;
(UA) Ukraine: Adeniz am | Amlosartan | Difors | Difors 160 | Difors 80 | Difors xl | Exforge | Kombisart | Valembik | Valodip | Vasar A;
(UG) Uganda: Exforge | Valsar am;
(UY) Uruguay: Exforge | Simultan a | Tensofin vl;
(VE) Venezuela, Bolivarian Republic of: Exforge | Vasanor;
(ZA) South Africa: Arlozyb | Calsar | Copalia | Dafiro | Exforge | Forgevasc | Gemvalaz | Tensoforj | Valduo | Valvasc;
(ZM) Zambia: Exforge;
(ZW) Zimbabwe: Exforge | Starval am

Exforge (amlodipine/valsartan) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; April 2021.
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Topic 8659 Version 353.0

خرید پکیج

Valsartan and amlodipine: Drug information