Amlodipine and olmesartan: Drug information

For additional information see "Amlodipine and olmesartan: Patient drug information"

For abbreviations, symbols, and age group definitions 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: Liver 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 2024]).

• 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): $16.01

5-40 mg (per each): $20.20

10-20 mg (per each): $16.01

10-40 mg (per each): $20.20

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Aliskiren: May increase nephrotoxic effects of Angiotensin II Receptor Blockers. Aliskiren may increase hyperkalemic effects of Angiotensin II Receptor Blockers. Aliskiren may increase hypotensive effects 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 serum concentration of ALPRAZolam. Risk C: Monitor

Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects 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 decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Angiotensin II: Angiotensin II Receptor Blockers may decrease therapeutic effects of Angiotensin II. Risk C: Monitor

Angiotensin-Converting Enzyme Inhibitors: Angiotensin II Receptor Blockers may increase adverse/toxic effects of Angiotensin-Converting Enzyme Inhibitors. Angiotensin II Receptor Blockers may increase 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 increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor

Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

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

Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Brigatinib: May decrease antihypertensive effects of Antihypertensive Agents. Brigatinib may increase bradycardic effects of Antihypertensive Agents. Risk C: Monitor

Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid

Calcium Salts: May decrease therapeutic effects of Calcium Channel Blockers. Risk C: Monitor

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

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

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

Colesevelam: May decrease serum concentration of Olmesartan. Management: Administer olmesartan 4 hours prior to colesevelam. Risk D: Consider Therapy Modification

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

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

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

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

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

Dantrolene: May increase hyperkalemic effects of Calcium Channel Blockers. Dantrolene may increase negative inotropic effects of Calcium Channel Blockers. Risk X: Avoid

Dapoxetine: May increase orthostatic hypotensive effects of Angiotensin II Receptor Blockers. Risk C: Monitor

Dapoxetine: May increase orthostatic hypotensive effects of Calcium Channel Blockers. Risk C: Monitor

Dexmethylphenidate: May decrease therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Dipeptidyl Peptidase-IV Inhibitors: May increase adverse/toxic effects of Angiotensin II Receptor Blockers. Specifically, the risk for angioedema may be increased with this combination. Risk C: Monitor

Drospirenone-Containing Products: May increase hyperkalemic effects of Angiotensin II Receptor Blockers. Risk C: Monitor

DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor

Finerenone: Angiotensin II Receptor Blockers may increase hyperkalemic effects of Finerenone. Risk C: Monitor

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

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

Flunarizine: May increase therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Heparin: May increase hyperkalemic effects of Angiotensin II Receptor Blockers. Risk C: Monitor

Heparins (Low Molecular Weight): May increase hyperkalemic effects of Angiotensin II Receptor Blockers. Risk C: Monitor

Herbal Products with Blood Pressure Increasing Effects: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Indoramin: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Inhalational Anesthetics: May increase hypotensive effects of Calcium Channel Blockers. Risk C: Monitor

Isocarboxazid: May increase antihypertensive effects of Antihypertensive Agents. Risk X: Avoid

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

Lemborexant: CYP3A4 Inhibitors (Weak) may increase 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 increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor

Lithium: Angiotensin II Receptor Blockers may increase 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 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

Loop Diuretics: May increase hypotensive effects of Angiotensin II Receptor Blockers. Loop Diuretics may increase nephrotoxic effects of Angiotensin II Receptor Blockers. Risk C: Monitor

Loop Diuretics: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

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

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

Melatonin: May decrease antihypertensive effects of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor

Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor

Methylphenidate: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

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

Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Neuromuscular-Blocking Agents (Nondepolarizing): Calcium Channel Blockers may increase neuromuscular-blocking effects of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor

Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicorandil: May increase hyperkalemic effects of Angiotensin II Receptor Blockers. Risk C: Monitor

Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

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

Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor

Nonsteroidal Anti-Inflammatory Agents (Topical): May decrease therapeutic effects of Angiotensin II Receptor Blockers. Risk C: Monitor

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

Obinutuzumab: May increase hypotensive effects 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 increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Perazine: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor

Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

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

Polyethylene Glycol-Electrolyte Solution: Angiotensin II Receptor Blockers may increase nephrotoxic effects of Polyethylene Glycol-Electrolyte Solution. Risk C: Monitor

Potassium Salts: May increase hyperkalemic effects of Angiotensin II Receptor Blockers. Risk C: Monitor

Potassium-Sparing Diuretics: May increase hyperkalemic effects of Angiotensin II Receptor Blockers. Risk C: Monitor

Prazosin: Antihypertensive Agents may increase hypotensive effects of Prazosin. Risk C: Monitor

Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Ranolazine: May increase adverse/toxic effects of Angiotensin II Receptor Blockers. Risk C: Monitor

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

Sacubitril: Angiotensin II Receptor Blockers may increase adverse/toxic effects of Sacubitril. Risk X: Avoid

Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Simvastatin: AmLODIPine may increase 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 decrease therapeutic effects 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 serum concentration of Sirolimus (Conventional). Risk C: Monitor

Sirolimus (Protein Bound): CYP3A4 Inhibitors (Weak) may increase 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 increase nephrotoxic effects of Sodium Phosphates. Specifically, the risk of acute phosphate nephropathy may be enhanced. Risk C: Monitor

Sparsentan: May increase adverse/toxic effects of Angiotensin II Receptor Blockers. Risk X: Avoid

Tacrolimus (Systemic): Angiotensin II Receptor Blockers may increase hyperkalemic effects of Tacrolimus (Systemic). Risk C: Monitor

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

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

Terazosin: Antihypertensive Agents may increase hypotensive effects of Terazosin. Risk C: Monitor

Tolvaptan: May increase hyperkalemic effects of Angiotensin II Receptor Blockers. Risk C: Monitor

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

Trimethoprim: May increase hyperkalemic effects of Angiotensin II Receptor Blockers. Risk C: Monitor

Ubrogepant: CYP3A4 Inhibitors (Weak) may increase 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 increase hypotensive effects of Urapidil. Risk C: Monitor

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: Arbolt a | Olmedine | Sevikar;
(AT) Austria: Amelior | Reverantza | Sevikar;
(AU) Australia: Apo olmesartan/amlodipine | Olmekar | Olmesartan/amlodipine myl | Olmesartan/amlodipine sandoz | Pharmacor olmesartan amlodipine | Sevikar;
(BD) Bangladesh: Amlosart | Bizoran | Calnor | Calsart | Camlosart | Disartan | Duoblock | Duofast | Duovas | Lovapres plus | Olmedip | Olmefast am | Olmepin | Olmepres am | Olmepres plus | Olmesafe am | Olmesta m | Olmevas am | Olmezest AM | Olpres A | Orbapin | Ransys am | Rezor max | 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 | Olmesartan Amlodipin Zentiva | 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 | Hybreed am | 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 | Olzox 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: Abipre | Allduo | Amdiol | Amdivikar | Amevica | Amoditan | Amolvikar | Celevica | Cellevica | Duvikar | Emdivikar | Esca | Hanbika | Havikar | J vika | Jvica | Livikar | Lometan | Lowvikar | Macsevikar | Newvikar | Ol duo | Olbeca duo | Oldip | Olesc | Olmebesyl | Olmecforce | Olmedipin | Olmediqual | Olmeduo | Olmekar | Olmepine | Olmeropine | Olmesapin | Olobica | Olodipine | Olotension | Olovicar | Olsdipine | Olsebitan | Olvica | Pamikar | Parmica | Samvika | Sebaco | Serokar | Seviact | Seviduo | Sevikar | Seviloten | Seviol | Sevione | Sevisartan | Sevistar | Sevitec | Sevitension | Twovikar | 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 | Erastapex co | Olcontro plus | Olmevasc | Olneda | 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

Azor (amlodipine/olmesartan) [prescribing information]. South Plainfield, NJ: Cosette Pharmaceuticals Inc; February 2022.
Beltrami L, Zanichelli A, Zingale L, Vacchini R, Carugo S, Cicardi M. Long-term follow-up of 111 patients with angiotensin-converting enzyme inhibitor-related angioedema. J Hypertens. 2011;29(11):2273-2277. doi:10.1097/HJH.0b013e32834b4b9b [PubMed 21970934]
Fleisher LA, Fleischmann KE, Auerbach AD, et al. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;130(24):2215-2245. doi:10.1161/CIR.0000000000000105 [PubMed 25085962]
Gersh BJ, Maron BJ, Bonow RO, et al. 2011 ACCF/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011;124(24):e783-831. [PubMed 22068434]
Hillis LD, Smith PK, Anderson JL, et al. 2011 ACCF/AHA guideline for coronary artery bypass surgery: A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation, 2011, 124 (23):2610-42. [PubMed 22064600]
Hsieh MT, Lin PY, Tsai CJ, Chang CC, Lee Y. Tardive akathisia related to the anti-hypertensive agent Sevikar-a case report. BMC Pharmacol Toxicol. 2017;18(1):41. doi:10.1186/s40360-017-0148-3 [PubMed 28583166]
Jorgensen MG, “Prevalence of Amlodipine-Related Gingival Hyperplasia,” J Periodontol, 1997, 68(7):676-8. [PubMed 9249639]
Ommen SR, Ho CY, Asif IM, et al. 2024 AHA/ACC/AMSSM/HRS/PACES/SCMR guideline for the management of hypertrophic cardiomyopathy: a report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2024;149(23):e1239-e1311. doi:10.1161/CIR.0000000000001250 [PubMed 38718139]
Rasmussen ER, Pottegård A, Bygum A, von Buchwald C, Homøe P, Hallas J. Angiotensin II receptor blockers are safe in patients with prior angioedema related to angiotensin-converting enzyme inhibitors - a nationwide registry-based cohort study. J Intern Med. 2019;285(5):553-561. doi:10.1111/joim.12867 [PubMed 30618189]
Rubio-Tapia A, Herman ML, Ludvigsson JF, et al, "Severe Spruelike Enteropathy Associated With Olmesartan," Mayo Clin Proc, 2012. [PubMed 22728033]
Runyon BA; American Association for the Study of Liver Diseases Practice Guidelines Committee. Management of adult patients with ascites due to cirrhosis: Update 2012. Hepatology. https://www.aasld.org/sites/default/files/2019-06/141020_Guideline_Ascites_4UFb_2015.pdf. Accessed September 16, 2022. [PubMed Runyon.1]
Toh S, Reichman ME, Houstoun M, et al. Comparative risk for angioedema associated with the use of drugs that target the renin-angiotensin-aldosterone system. Arch Intern Med. 2012;172(20):1582-1589. doi:10.1001/2013.jamainternmed.34 [PubMed 23147456]
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]
Wynn RL, "Calcium Channel Blockers and Gingival Hyperplasia-An Update," Gen Dent, 2009, 57(2):105-7. [PubMed 19552357]

Topic 8845 Version 376.0

خرید پکیج

Amlodipine and olmesartan: Drug information