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Amlodipine and olmesartan: Drug information

Amlodipine and olmesartan: Drug information
(For additional information see "Amlodipine and olmesartan: 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 amlodipine/olmesartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Brand Names: US
  • Azor
Pharmacologic Category
  • Angiotensin II Receptor Blocker;
  • Antianginal Agent;
  • Antihypertensive;
  • Calcium Channel Blocker;
  • Calcium Channel Blocker, Dihydropyridine
Dosing: Adult
Hypertension, chronic

Hypertension, chronic: Oral: Initial: Amlodipine 5 mg/olmesartan 20 mg once daily; increase dose as needed in 1- to 2-week intervals using available strength combinations. Maximum dose: Amlodipine 10 mg/olmesartan 40 mg per day.

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

Dosing: Kidney Impairment: Adult

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 (has not been studied); use with caution; amlodipine and olmesartan exposure is increased. Not recommended for initial therapy (appropriate combination dosage form is not available).

Dosing: Older Adult

Refer to adult dosing. Initial therapy is not recommended in patients ≥75 years.

Adverse Reactions

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

Frequency not defined:

Cardiovascular: Edema, hypotension, orthostatic hypotension, palpitations

Dermatologic: Pruritus, skin rash

Genitourinary: Nocturia, urinary frequency

Hematologic & oncologic: Decreased hematocrit, decreased hemoglobin

Postmarketing: Nervous system: Akathisia (tardive) (Hsieh 2017)

Contraindications

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: Angiotensin II receptor antagonists (ARBs) do not appear to elevate the risk of angioedema (Rasmussen 2019; Toh 2012). Patients with a history of angioedema due to an angiotensin-converting enzyme inhibitor must be educated that sometimes there can be recurrence within months following discontinuation (Beltrami 2011). No matter the cause of angioedema, prolonged frequent monitoring is required, especially if tongue, glottis, or larynx are involved, as they are associated with airway obstruction. Discontinue therapy immediately if angioedema occurs. Aggressive early management is critical. IM administration of epinephrine may be necessary. Do not readminister to patients who have had angioedema with ARBs.

• Angina/Myocardial infarction: Increased angina and/or myocardial infarction (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.

• Gastrointestinal effects: Symptoms of sprue-like enteropathy (ie, severe, chronic diarrhea with significant weight loss) has been reported with olmesartan; may develop months to years after treatment initiation with villous atrophy commonly found on intestinal biopsy. Once other etiologies have been excluded, discontinue treatment and consider other antihypertensive treatment. Clinical and histologic improvement was noted after treatment was discontinued in a case series of 22 patients (Rubio-Tapia 2012).

• Hyperkalemia: May occur with olmesartan use; risk factors include kidney 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); also may occur in patients with severe aortic stenosis; correct volume depletion prior to administration. This transient hypotensive response is not a contraindication to further treatment with amlodipine/olmesartan.

• Kidney function deterioration: Olmesartan may be associated with deterioration of kidney 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 kidney 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 kidney function.

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

Disease-related concerns:

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

• 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 kidney function carefully to avoid rapid development of kidney failure (AASLD [Runyon 2013]).

• Hepatic impairment: Use with caution in patients with hepatic impairment; amlodipine and olmesartan exposure is increased. Initial therapy is not recommended; the appropriate combination dosage form is not available.

• Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction: Use amlodipine with caution in patients with hypertrophic cardiomyopathy and left ventricular outflow tract obstruction since reduction in afterload may worsen symptoms associated with this condition (AHA/ACC [Ommen 2020]).

• Kidney impairment: Use with caution in patients with kidney impairment.

• Renal artery stenosis: Use olmesartan 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 kidney function unless possible benefits outweigh risks.

Special populations:

• Older adult: Initial therapy is not recommended in patients ≥75 years; the appropriate combination dosage form is not available.

• Pregnancy: [US Boxed Warning]: When pregnancy is detected, discontinue amlodipine/olmesartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

• 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). Based on current research and clinical guidelines in patients undergoing noncardiac surgery, continuing ARBs is reasonable in the perioperative period. If ARBs are held before surgery, it is reasonable to restart postoperatively as soon as clinically feasible (ACC/AHA [Fleisher 2014]).

Dosage Forms: US

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

Tablet, Oral:

Azor: Amlodipine 5 mg and olmesartan medoxomil 20 mg, Amlodipine 5 mg and olmesartan medoxomil 40 mg, Amlodipine 10 mg and olmesartan medoxomil 20 mg, Amlodipine 10 mg and olmesartan medoxomil 40 mg

Generic: Amlodipine 10 mg and olmesartan medoxomil 20 mg, Amlodipine 10 mg and olmesartan medoxomil 40 mg, Amlodipine 5 mg and olmesartan medoxomil 20 mg, Amlodipine 5 mg and olmesartan medoxomil 40 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (amLODIPine-Olmesartan Oral)

5-20 mg (per each): $7.83 - $7.84

5-40 mg (per each): $9.89 - $9.92

10-20 mg (per each): $7.83 - $7.84

10-40 mg (per each): $9.89 - $9.92

Tablets (Azor Oral)

5-20 mg (per each): $14.55

5-40 mg (per each): $18.36

10-20 mg (per each): $14.55

10-40 mg (per each): $18.36

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, chronic: Management of hypertension.

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

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

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

Colesevelam: May decrease the serum concentration of Olmesartan. Management: Administer olmesartan at least 4 hours prior to colesevelam. Risk D: Consider therapy modification

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

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

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

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

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

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

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

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

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

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. Refer to individual monographs for additional information.

Breastfeeding Considerations

Amlodipine is present in breast milk; excretion of olmesartan is unknown.

Due to the potential for serious adverse reactions in the breastfeeding infant, breastfeeding is not recommended by the manufacturer. Refer to individual monographs for additional information.

Dietary Considerations

Avoid salt substitutes which contain potassium.

Monitoring Parameters

BP, heart rate; electrolytes; kidney function; monitor for orthostasis, peripheral edema.

Mechanism of Action

Amlodipine: Directly acts on vascular smooth muscle to produce peripheral arterial vasodilation reducing peripheral vascular resistance and blood pressure.

Olmesartan: Blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II.

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: Olmedine | Sevikar;
  • (AT) Austria: Amelior | Reverantza | Sevikar;
  • (AU) Australia: Apo olmesartan/amlodipine | Olmekar | Olmesartan/amlodipine myl | Pharmacor olmesartan amlodipine | Sevikar;
  • (BD) Bangladesh: Amlosart | Bizoran | Calsart | Camlosart | Disartan | Duoblock | Duofast | Duovas | Olmedip | Olmepres plus | Olmesafe am | Olmesta m | Olmevas am | Olmezest AM | Olpres A | Orbapin | Ransys am | Tenivasc;
  • (BE) Belgium: Forzaten | Olmesartan amlodipine ab | Olmesartan/amlodipine krka | Olmesartan/amlodipine sandoz | Olmesartan/amlodipine teva | Sevikar;
  • (BG) Bulgaria: Amolcon | Olmedipin | Olmesartan medoxomil/amlodipin | Olmesta a | Olmezide am | Reverantza | Tansidor duo | Tespadan;
  • (BR) Brazil: Fluxocor anlo | Olmy anlo;
  • (CH) Switzerland: Olmesartan amlodipin mepha | Olmesartan amlodipin sandoz | Sevikar | Vascord;
  • (CL) Chile: Cardioplus AM;
  • (CN) China: Olmesartan medoxomil and amlodipine besylate | Sevikar;
  • (CO) Colombia: Olmedipin am | Olmedoxtan A | Olmetec anlo;
  • (CZ) Czech Republic: Sintonyn;
  • (DE) Germany: Olmeamlo | Olmedipin | Olmesartan Amlodipin Zentiva | Olmesartan/Amlodipin 1A Pharma | Olmesartan/Amlodipin AbZ | Olmesartan/Amlodipin AL | Olmesartan/amlodipin heumann | Olmesartan/Amlodipin hexal | Olmesartanmedoxomil amlodipin beta | Olmesartanmedoxomil/Amlodipin Accord | Olmesartanmedoxomil/Amlodipin Mylan | Sevikar | Vocado;
  • (DO) Dominican Republic: Benicar amlo | Olmedipin am | Olmedos a | Olmesar a | Sartax a;
  • (EC) Ecuador: Olmetec anlo;
  • (EE) Estonia: Olmesartan/amlodipin accord | Olmesartan/amlodipin zentiva | Olssa | Sanoral;
  • (EG) Egypt: Erastapex co | Improflow;
  • (ES) Spain: Albis | Balzak | Capenon | Olmesar amlodi pensa | Olmesartan/amlodipine TAD | Olmesartan/amlodipino alter | Olmesartan/amlodipino aurovitas | Olmesartan/amlodipino cinfa | Olmesartan/amlodipino kern | Olmesartan/amlodipino mabo | Olmesartan/amlodipino normon | Olmesartan/amlodipino ratiopharm | Olmesartan/amlodipino stada | Olmesartan/amlodipino teva | Sevikar;
  • (FI) Finland: Alea | Olmesartan medoxomil/amlodipine krka | Sevikar;
  • (FR) France: Axeler | Sevikar;
  • (GB) United Kingdom: Azor | Sevikar;
  • (GR) Greece: Comprelan | Olmedipin | Olmesartan+amlodipine/sandoz | Orizal | Polaplom | Sevikar | Topress;
  • (HK) Hong Kong: Azoren;
  • (HU) Hungary: Duactan;
  • (ID) Indonesia: Normetec;
  • (IE) Ireland: Konverge | Olmesartan medoxomil/amlodipine | Olmesartan/amlodipine clonmel | Olmesartan/amlodipine krka | Olmesartan/amlodipine mylan | Sevikar;
  • (IN) India: Amcard Om | Benitec A | Benitec a | Ol Vamlo | Olcure am | Olmark a | Olmat AM | Olmax am | Olmecip-am | Olmesafe am | Olmesar a | Olmesat AM | Olmetor AM | Olmetrack AM | Olmezest AM | Olmighty AM | Olmin a | Olmiryl am | Olmy-A | Olraas am | Olsar A | Olsavas AM | Olsertain am | Olvance am | Olways am | Omen am | Omesvio am | Ortan AM | Pinom A | Rasotan SA | Winbp AM | Xirtam am;
  • (IT) Italy: Bivis | Giant | Olmesartan e amlodipina aurobindo | Olmesartan e amlodipina eg | Olmesartan e amlodipina pensa | Olmesartan medoxomil e amlodipina | Olmesartan medoxomil e amlodipina accord | Olmesartan medoxomil e amlodipina krka | Olmesartan medoxomil e amlodipina mylan | Olmesartan medoxomil e amlodipina sandoz | Olmesartan medoxomil e amlodipina teva | Olmesartan medoxomil/amlodipina zentiva | Olsart | Sevikar;
  • (JO) Jordan: Combitran | Vocado;
  • (KE) Kenya: Olmat AM;
  • (KR) Korea, Republic of: Allduo | Amdiol | Amdivikar | Amevica | Amoditan | Amolvikar | Celevica | Cellevica | Duvikar | Emdivikar | Esca | Hanbika | Havikar | J vika | Jvica | Livikar | Lometan | Lowvikar | Macsevikar | Newvikar | Ol duo | Oldip | Olesc | Olmebesyl | Olmecforce | Olmedipin | Olmediqual | Olmeduo | Olmepine | Olmesapin | Olodipine | Olotension | Olovicar | Olsdipine | Olsebitan | Olvica | Pamikar | Parmica | Samvika | Sebaco | Serokar | Seviact | Seviduo | Sevikar | Seviloten | Seviol | Sevione | Sevisartan | Sevistar | Sevitec | Sevitension | Vikaronce | Vivas;
  • (KW) Kuwait: Sevikar;
  • (LB) Lebanon: Sevikar | Vocado;
  • (LT) Lithuania: Olmesartan medoxomil/amlodipine | Olmesartan medoxomil/amlodipine sandoz | Olmesartan medoxomil/amlodipine teva | Olmira | Sanoral;
  • (LU) Luxembourg: Forzaten | Olmesartan/Amlodipine EG | Sevikar;
  • (LV) Latvia: Olmesartan medoxomil/ amlodipine zentiva | Olmesartan medoxomil/amlodipine krka | Olmesartan/amlodipin accord | Olmesartan/amlodipin teva | Olssa | Sanoral | Sevikar;
  • (MA) Morocco: Sevikar;
  • (MX) Mexico: Duoalmetec | Maxopress;
  • (MY) Malaysia: Azoren;
  • (NG) Nigeria: Besquad;
  • (NL) Netherlands: Belfor | Olmesartan medoxomil/Amlodipine Aurobindo | Olmesartan medoxomil/amlodipine teva | Olmesartanmedoxomil/Amlodipine Accord | Sevikar;
  • (NO) Norway: Alea | Sevikar;
  • (PE) Peru: Cardioplus AM;
  • (PH) Philippines: Alzor ccb | Normetec | Olmestal A | Olmezar a;
  • (PK) Pakistan: Amtan | Baritec a | Benicar plus | Benzor am | Olesta am | Olmeday plus | Olmis a | Olmisan am | Olra am | Olsarb a | Omsana AM | Onato om | Pacivan a | Sofvasc Olm;
  • (PL) Poland: Elestar;
  • (PR) Puerto Rico: Amlodipine and olmesartan medoxomil | Azor;
  • (PT) Portugal: Amlodipina + Olmesartan medoxomilo Bluepharma | Amlodipina + olmesartan medoxomilo ciclum | Amlodipina + olmesartan medoxomilo cinfa | Amlodipina + olmesartan medoxomilo generis | Amlodipina + Olmesartan medoxomilo krka | Amlodipina + olmesartan medoxomilo mylan | Amlodipina + olmesartan medoxomilo ratiopharm | Amlodipina + olmesartan medoxomilo sandoz | Amlodipina + olmesartan medoxomilo teva | Amlodipina + olmesartan medoxomilo tolife | Amlodipina + Olmesartan medoxomilo Zentiva | Sevikar | Zolnor;
  • (PY) Paraguay: Caditar am;
  • (QA) Qatar: Olmedine | Sevikar;
  • (RO) Romania: Inovum | Olmesartan medoxomil/amlodipina accord | Olmesartan medoxomil/amlodipina zentiva | Olssa | Salvo;
  • (RU) Russian Federation: Attento;
  • (SA) Saudi Arabia: Bitens | Olcontro plus | Sevikar | Sevitense;
  • (SG) Singapore: Azoren;
  • (SI) Slovenia: Olectan;
  • (SK) Slovakia: Folgan;
  • (TH) Thailand: Normetec;
  • (TN) Tunisia: Sevikar;
  • (TR) Turkey: Excaliba | Imlo | Olmecomb | Sevikar;
  • (TW) Taiwan: Sevikar;
  • (UA) Ukraine: Attento | Sevikar;
  • (VE) Venezuela, Bolivarian Republic of: Benicar amlo | Dropten amlo
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  13. Sipahi I, Debanne SM, Rowland DY, et al, “Angiotensin-Receptor Blockade and Risk of Cancer: Meta-Analysis of Randomised Controlled Trials,” Lancet Oncol, 2010, 11(7):627-36. [PubMed 20542468]
  14. Wynn RL, "Calcium Channel Blockers and Gingival Hyperplasia-An Update," Gen Dent, 2009, 57(2):105-7. [PubMed 19552357]
Topic 8845 Version 346.0

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