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Amlodipine, olmesartan, and hydrochlorothiazide: Drug information

Amlodipine, olmesartan, and hydrochlorothiazide: Drug information
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For additional information see "Amlodipine, olmesartan, and hydrochlorothiazide: Patient drug information"

For abbreviations, symbols, and age group definitions 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 death to the developing fetus.

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

Hypertension: Oral: Usual dosage: Olmesartan 20 to 40 mg/amlodipine 5 to 10 mg/hydrochlorothiazide 12.5 to 25 mg once daily; may titrate dose in 2-week intervals. Patients already taking one or more of these components may be switched to a combination product for individually titrated agents. Maximum dose: Olmesartan 40 mg/amlodipine 10 mg/hydrochlorothiazide 25 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

CrCl ≥30 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

CrCl <30 mL/minute: Avoid use; contraindicated in patients with anuria

Dosing: Liver Impairment: Adult

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Severe impairment: There are no specific dosage adjustments provided in the manufacturer’s labeling. Use with caution; titrate slowly. Recommended initial daily dose of amlodipine (2.5 mg) in these patients is not available in this combination product. Should be used with caution in patients with ascites due to cirrhosis (Ref).

Dosing: Older Adult

Refer to adult dosing. Use with caution. The recommended initial dose of amlodipine (2.5 mg/day) in patients ≥75 years is not available in this combination product.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reactions/percentages reported with combination product; also see individual agents.

1% to 10%:

Cardiovascular: Edema (8%), syncope (1%)

Central nervous system: Dizziness (6% to 9%), headache (6%), fatigue (4%)

Gastrointestinal: Diarrhea (3%), nausea (3%)

Genitourinary: Urinary tract infection (2%)

Neuromuscular & skeletal: Muscle spasm (3%), joint swelling (2%)

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

Contraindications

Hypersensitivity to olmesartan, amlodipine, hydrochlorothiazide, other sulfonamide-derived drugs, or any component of the formulation; concomitant use with aliskiren in patients with diabetes mellitus; anuria

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

Note: Although the FDA-approved product labeling states this medication is contraindicated in patients with hypersensitivity to sulfonamide-containing drugs, the scientific basis of this cross-sensitivity has been challenged.

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.

• Electrolyte disturbances: Hyperkalemia may occur with angiotensin II receptor antagonists; risk factors include renal impairment, diabetes mellitus, and 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. Thiazide diuretics may cause hypokalemia, hypochloremic alkalosis, hypomagnesemia, and hyponatremia.

• Gastrointestinal effects: Symptoms of sprue-like enteropathy (ie, severe, chronic diarrhea with significant weight loss) has been reported with olmesartan; may develop 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 (Ianiro 2014; Rubio-Tapia 2012).

• Gout: In certain patients with a history of gout, a familial predisposition to gout, or chronic renal failure, gout can be precipitated by hydrochlorothiazide. This risk may be increased with doses ≥25 mg (Gurwitz 1997).

• Hypersensitivity reactions: Hypersensitivity reactions may occur with hydrochlorothiazide. Risk is increased in patients with a history of allergy or bronchial asthma.

• 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 olmesartan/amlodipine/hydrochlorothiazide.

• Ocular effects: Hydrochlorothiazide may cause acute transient myopia and acute angle-closure glaucoma, typically occurring within hours to weeks following initiation; discontinue therapy immediately in patients with acute decreases in visual acuity or ocular pain. Additional treatments may be needed if uncontrolled intraocular pressure persists. Risk factors may include a history of sulfonamide or penicillin allergy.

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

• Photosensitivity: May occur with hydrochlorothiazide.

• Renal function deterioration: Olmesartan 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.

• Skin cancer, nonmelanoma: Prolonged use (≥3 years) may increase the risk for squamous cell carcinoma up to 4 times and increase the risk for basal cell carcinoma up to 1.25 times compared to patients not treated with hydrochlorothiazide (Pedersen 2018; Pottegård 2017).

• Sulfonamide (“sulfa”) allergy: The FDA-approved product labeling for many medications containing a sulfonamide chemical group includes a broad contraindication in patients with a prior allergic reaction to sulfonamides. There is a potential for cross-reactivity between members of a specific class (eg, two antibiotic sulfonamides). However, concerns for cross-reactivity have previously extended to all compounds containing the sulfonamide structure (SO2NH2). An expanded understanding of allergic mechanisms indicates cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur or at the very least this potential is extremely low (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004). In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are unlikely to occur with nonantibiotic sulfonamides. T-cell-mediated (type IV) reactions (eg, maculopapular rash) are less well understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians choose to avoid exposure to these classes.

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

• Bariatric surgery: Dehydration: Avoid diuretics in the immediate postoperative period after bariatric surgery; electrolyte disturbances and dehydration may occur. Diuretics may be resumed, if indicated, once oral fluid intake goals are met (Ziegler 2009).

• Diabetes: Use hydrochlorothiazide with caution in patients with prediabetes or diabetes mellitus; may see a change in glucose control.

• Hepatic impairment: Use with caution in patients with severe hepatic impairment; titrate slowly. Recommended initial daily dose of amlodipine (2.5 mg) in patients with severe hepatic impairment is not available in this combination product.

• Hypercalcemia: Thiazide diuretics may decrease renal calcium excretion; consider avoiding use in patients with hypercalcemia.

• Hypercholesterolemia: Use with caution in patients with moderate or high cholesterol concentrations; increased cholesterol and triglyceride levels have been reported with thiazides.

• 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]).

• Parathyroid disease: Thiazide diuretics reduce calcium excretion; pathologic changes in the parathyroid glands with hypercalcemia and hypophosphatemia have been observed with prolonged use; should be discontinued prior to testing for parathyroid function.

• 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 renal function unless possible benefits outweigh risks.

• Renal impairment: Use with caution in patients with renal impairment. Cumulative effects of hydrochlorothiazide may develop, including azotemia. Avoid use in patients with CrCl <30 mL/minute. Contraindicated in patients with anuria.

• Systemic lupus erythematosus (SLE): Hydrochlorothiazide can cause SLE exacerbation or activation.

Special populations:

• Older adult: In patients ≥75 years the recommended initial daily dose of amlodipine (2.5 mg) is not available in this combination product.

• Pregnancy: [US Boxed Warning]: When pregnancy is detected, discontinue 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). If given the morning of surgery, hydrochlorothiazide may render the patient volume depleted and blood pressure may be labile during general anesthesia.

Dosage Forms: US

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

Tablet, oral:

Tribenzor :Olmesartan medoxomil 20 mg, amlodipine 5 mg, and hydrochlorothiazide 12.5 mg

Tribenzor: Olmesartan medoxomil 40 mg, amlodipine 5 mg, and hydrochlorothiazide 12.5 mg

Tribenzor: Olmesartan medoxomil 40 mg, amlodipine 5 mg, and hydrochlorothiazide 25 mg

Tribenzor: Olmesartan medoxomil 40 mg, amlodipine 10 mg, and hydrochlorothiazide 12.5 mg

Tribenzor: Olmesartan medoxomil 40 mg, amlodipine 10 mg, and hydrochlorothiazide 25 mg

Generic: Olmesartan medoxomil 40 mg, amlodipine 5 mg, and hydrochlorothiazide 25 mg; olmesartan medoxomil 40 mg, amlodipine 10 mg, and hydrochlorothiazide 25 mg; olmesartan medoxomil 20 mg, amlodipine 5 mg, and hydrochlorothiazide 12.5 mg; olmesartan medoxomil 40 mg, amlodipine 5 mg, and hydrochlorothiazide 12.5 mg; olmesartan medoxomil 40 mg, amlodipine 10 mg, and hydrochlorothiazide 12.5 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Olmesartan-amLODIPine-HCTZ Oral)

20-5-12.5 mg (per each): $7.84

40-5-12.5 mg (per each): $9.90

40-5-25 mg (per each): $9.90

40-10-12.5 mg (per each): $9.90

40-10-25 mg (per each): $9.90

Tablets (Tribenzor Oral)

20-5-12.5 mg (per each): $16.01

40-5-12.5 mg (per each): $20.20

40-5-25 mg (per each): $20.20

40-10-12.5 mg (per each): $20.20

40-10-25 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: Management of hypertension.

Medication Safety Issues
Older Adult: High-Risk Medication:

Beers Criteria: Diuretics (hydrochlorothiazide) are identified in the Beers Criteria as potentially inappropriate medications to be used with caution in patients 65 years and older due to the potential to cause or exacerbate syndrome of inappropriate antidiuretic hormone secretion (SIADH) or hyponatremia; monitor sodium concentration closely when initiating or adjusting the dose in older adults (Beers Criteria [AGS 2023]).

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.

Agents with Clinically Relevant Anticholinergic Effects: May increase serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Ajmaline: Sulfonamides may increase adverse/toxic effects of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor

Alcohol (Ethyl): May increase orthostatic hypotensive effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

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

Allopurinol: Thiazide and Thiazide-Like Diuretics may increase hypersensitivity effects of Allopurinol. Risk C: Monitor

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

Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid

Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor

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

Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor

Antidiabetic Agents: Thiazide and Thiazide-Like Diuretics may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor

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

Arsenic Trioxide: Thiazide and Thiazide-Like Diuretics may increase hypotensive effects of Arsenic Trioxide. Thiazide and Thiazide-Like Diuretics may increase QTc-prolonging effects of Arsenic Trioxide. Management: When possible, avoid concurrent use of arsenic trioxide with drugs that can cause electrolyte abnormalities, such as the thiazide and thiazide-like diuretics. Risk D: Consider Therapy Modification

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

Beta2-Agonists: May increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Bile Acid Sequestrants: May decrease absorption of Thiazide and Thiazide-Like Diuretics. Management: Separate administration of bile acid sequestrants and oral thiazide diuretics by at least 4 hours. Monitor for decreased therapeutic effects of thiazide diuretics if coadministered with a bile acid sequestrant. Risk D: Consider Therapy Modification

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

Calcium Salts: Thiazide and Thiazide-Like Diuretics may increase serum concentration of Calcium Salts. Risk C: Monitor

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

Cardiac Glycosides: Thiazide and Thiazide-Like Diuretics may increase adverse/toxic effects of Cardiac Glycosides. Specifically, cardiac glycoside toxicity may be enhanced by the hypokalemic and hypomagnesemic effect of thiazide diuretics. 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

Corticosteroids (Systemic): May increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

CycloPHOSphamide: Thiazide and Thiazide-Like Diuretics may increase adverse/toxic effects of CycloPHOSphamide. Specifically, granulocytopenia may be enhanced. Risk C: Monitor

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

Desmopressin: Hyponatremia-Associated Agents may increase hyponatremic effects of Desmopressin. Risk C: Monitor

Dexketoprofen: May increase adverse/toxic effects of Sulfonamides. Risk C: Monitor

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

Diacerein: May increase therapeutic effects of Diuretics. Specifically, the risk for dehydration or hypokalemia may be increased. Risk C: Monitor

Diazoxide Choline: May increase adverse/toxic effects of Thiazide and Thiazide-Like Diuretics. Specifically, the hyperglycemic and hyperuricemic effects may be increased. Risk C: Monitor

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

Diazoxide: Thiazide and Thiazide-Like Diuretics may increase adverse/toxic effects of Diazoxide. Risk C: Monitor

Dichlorphenamide: Thiazide and Thiazide-Like Diuretics may increase hypokalemic effects of Dichlorphenamide. 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

Dofetilide: HydroCHLOROthiazide may increase QTc-prolonging effects of Dofetilide. HydroCHLOROthiazide may increase serum concentration of Dofetilide. Risk X: Avoid

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

EPINEPHrine (Systemic): Diuretics may increase arrhythmogenic effects of EPINEPHrine (Systemic). Diuretics may decrease vasopressor effects of EPINEPHrine (Systemic). 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

Ipragliflozin: May increase adverse/toxic effects of Thiazide and Thiazide-Like Diuretics. Specifically, the risk for intravascular volume depletion may be increased. Risk C: Monitor

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

Isocarboxazid: May increase hypotensive effects of Diuretics. Risk X: Avoid

Ivabradine: Thiazide and Thiazide-Like Diuretics may increase arrhythmogenic effects of Ivabradine. Risk C: Monitor

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

Levosulpiride: Thiazide and Thiazide-Like Diuretics may increase adverse/toxic effects of Levosulpiride. Risk X: Avoid

Licorice: May increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. 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

Lithium: Thiazide and Thiazide-Like Diuretics may decrease excretion of Lithium. Management: Reduce the lithium dose if coadministered with thiazide or thiazide-like diuretics. Monitor serum lithium levels during coadministration with thiazide and thiazide-like diuretics. 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

Mecamylamine: Thiazide and Thiazide-Like Diuretics may increase adverse/toxic effects of Mecamylamine. Management: Consider avoiding the use of mecamylamine and thiazide diuretics. If combined, mecamylamine prescribing information suggests reducing the mecamylamine dose by 50% in order to avoid excessive hypotension. Risk D: Consider Therapy Modification

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

Methenamine: Thiazide and Thiazide-Like Diuretics may decrease therapeutic effects of Methenamine. Risk C: Monitor

Methotrexate: HydroCHLOROthiazide may increase nephrotoxic effects of Methotrexate. Risk C: Monitor

Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). 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

Multivitamins/Fluoride (with ADE): May increase hypercalcemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

Multivitamins/Minerals (with ADEK, Folate, Iron): Thiazide and Thiazide-Like Diuretics may increase hypercalcemic effects of Multivitamins/Minerals (with ADEK, Folate, Iron). Risk C: Monitor

Multivitamins/Minerals (with AE, No Iron): Thiazide and Thiazide-Like Diuretics may increase serum concentration of Multivitamins/Minerals (with AE, No Iron). Specifically, thiazide diuretics may decrease the excretion of calcium, and continued concomitant use can also result in metabolic alkalosis. 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

Neuromuscular-Blocking Agents (Nondepolarizing): Thiazide and Thiazide-Like Diuretics 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 (Topical): May decrease therapeutic effects of Thiazide and Thiazide-Like Diuretics. 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

Nonsteroidal Anti-Inflammatory Agents: May decrease therapeutic effects of Thiazide and Thiazide-Like Diuretics. Thiazide and Thiazide-Like Diuretics may increase nephrotoxic effects of Nonsteroidal Anti-Inflammatory Agents. 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

Opioid Agonists: May increase adverse/toxic effects of Diuretics. Opioid Agonists may decrease therapeutic effects of Diuretics. Risk C: Monitor

Palopegteriparatide: Thiazide and Thiazide-Like Diuretics may increase therapeutic effects of Palopegteriparatide. Thiazide and Thiazide-Like Diuretics may decrease therapeutic effects of Palopegteriparatide. Risk C: Monitor

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

Piperacillin: May increase hypokalemic effects of Diuretics. Risk C: Monitor

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

Polyethylene Glycol-Electrolyte Solution: Diuretics may increase nephrotoxic effects of Polyethylene Glycol-Electrolyte Solution. Risk C: Monitor

Porfimer: Photosensitizing Agents may increase photosensitizing effects of Porfimer. Risk X: Avoid

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

Promazine: Thiazide and Thiazide-Like Diuretics may increase QTc-prolonging effects of Promazine. Risk X: Avoid

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

Reboxetine: May increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. 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

Selective Serotonin Reuptake Inhibitor: May increase hyponatremic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor

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

Sodium Phosphates: Diuretics may increase nephrotoxic effects of Sodium Phosphates. Specifically, the risk of acute phosphate nephropathy may be enhanced. Risk C: Monitor

Sotagliflozin: HydroCHLOROthiazide may decrease therapeutic effects of Sotagliflozin. Sotagliflozin may decrease serum concentration of HydroCHLOROthiazide. 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

Topiramate: Thiazide and Thiazide-Like Diuretics may increase hypokalemic effects of Topiramate. Thiazide and Thiazide-Like Diuretics may increase serum concentration of Topiramate. Risk C: Monitor

Toremifene: Thiazide and Thiazide-Like Diuretics may increase hypercalcemic effects of Toremifene. 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

Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor

Vitamin D Analogs: Thiazide and Thiazide-Like Diuretics may increase hypercalcemic effects of Vitamin D Analogs. Risk C: Monitor

Pregnancy Considerations

[US Boxed Warning]: When pregnancy is detected, discontinue as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Refer to individual monographs for additional information.

Breastfeeding Considerations

Amlodipine and hydrochlorothiazide are present in breast milk; it is not known if olmesartan is excreted in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer. Refer to individual monographs for additional information.

Dietary Considerations

Avoid salt substitutes containing potassium.

Monitoring Parameters

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

Mechanism of Action

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

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

Hydrochlorothiazide: Inhibits sodium reabsorption in the distal tubules causing increased excretion of sodium and water as well as potassium and hydrogen ions.

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: Sevikar hct;
  • (AR) Argentina: Tribenzor;
  • (AT) Austria: Amelior plus hct | Excaliba plus | Sevikar hct;
  • (AU) Australia: Apo olmesartan/amlodipine/hctz | Olmekar hct | Sevikar hct;
  • (BE) Belgium: Forzaten/HCT | Olmesartan/amlodipin/hct mylan | Olmesartan/amlodipine/hct eg | Olmesartan/amlodipine/hctz krka | Sevikar/HCT;
  • (BG) Bulgaria: Olmesta a plus | Olmezide trio | Tespadan hct;
  • (BR) Brazil: Benicar triplo;
  • (CH) Switzerland: Co olmesartan amlo spirig hc | Olmesartan amlodipin hct mepha | Olmesartan amlodipin hct zentiva | Sevikar hct | Vascord hct;
  • (CO) Colombia: Olmetan plus;
  • (CZ) Czech Republic: Sintonyn combi;
  • (DE) Germany: Olmeamlo hct | Olmesardipin mylan plus | Olmesartan amlodipin hct beta | Olmesartan amlodipin hct zentiva | Olmesartan/amlodipin/ hct accord | Olmesartan/amlodipin/hct al | Olmesartan/amlodipin/hct heumann | Olmesartan/amlodipin/Hydrochlorothiazid glenmark | Olmesartan/amlodipine/hct ratiopharm | Sevikar hct | Vocado hct;
  • (DO) Dominican Republic: Eukene plus;
  • (EC) Ecuador: Bistenzid;
  • (EE) Estonia: Gaduar | Olmesartan medoxomil/amlodipine/hydrochlorothiazide teva | Olsitri | Sanoral hct;
  • (EG) Egypt: Amlosazide | Averothiazide | Erastapex trio | Lezberg trio | Marvitense | Tribatens;
  • (ES) Spain: Albis plus | Balzak plus | Capenon hct | Gaduar | Olmesartan/Amlodipino/Hidroclorotiazida Cinfamed | Olmesartan/Amlodipino/Hidroclorotiazida combix | Olmesartan/Amlodipino/Hidroclorotiazida kern pharma | Olmesartan/amlodipino/hidroclorotiazida krka | Olmesartan/Amlodipino/Hidroclorotiazida Normon | Olmesartan/amlodipino/hidroclorotiazida stadapharma | Sevikar hct;
  • (FI) Finland: Alea comp;
  • (GB) United Kingdom: Sevikar hct;
  • (GR) Greece: Comprelan plus | Olmedipin plus | Orizal Plus | Polaplom hct | Sevikar hct | Topress plus | Zyteba;
  • (HR) Croatia: Omelia;
  • (HU) Hungary: Duactan hct;
  • (IE) Ireland: Konverge plus | Olmesartan medoxomil/amlodipine/hydrochlorothiazide accord | Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel | Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Krka | Sevikar Plus;
  • (IN) India: O relate ah | Olcure amh | Olmark Ah | Olmat Amh | Olmecip Trio | Olmetime Amh | Olmin Ah | Olmiswift ha | Olmy Ah | Olsar ah | Olsavas 3 | Olzox trio | Omesvio 3d | Tri olmetor | Triolmesar | Triolmezest | Tripin om | Tripinom | Trisertain | Winbp Trio | Zeosartan a2;
  • (IT) Italy: Gaduar | Olmesartan medoxomil/amlodipina/idroclorotiazide doc | Olmetrivart | Sevitrex;
  • (JO) Jordan: Combitran plus | Vocado hct;
  • (KE) Kenya: Olmat Amh | Olme ah | Sevikar hct;
  • (KR) Korea, Republic of: Amlovika hct | Amolvikar hct | Amrovikar hct | Esca hct | J vika hct | Lowvikar hct | Newvikar plus | Oldip hct | Oldipi | Olmecforce h | Olmedikar hct | Olmedil hct | Olmediqual hct | Olmelopine hct | Olmesalpine hct | Olmevikar hct | Olodipine hct | Olotension hct | Olsebitan hct | Samvika hct | Sebaco hct | Sebitan HCT | Seracan hct | Sevi m hct | Seviact hct | Seviduo hct | Sevikar hct | Sevione hct | Sevithera hct;
  • (KW) Kuwait: Sevikar hct;
  • (LB) Lebanon: Vocado hct;
  • (LT) Lithuania: Gaduar | Olsitri | Sanoral hct;
  • (LU) Luxembourg: Forzaten/HCT | Olmesartan/amlodipin/hct mylan | Olmesartan/amlodipine/hct eg | Sevikar hct;
  • (LV) Latvia: Gaduar | Olmesartan medoxomil/amlodipine/hydrochlorothiazide accord | Olmesartan medoxomil/amlodipine/hydrochlorothiazide teva | Olsitri | Sanoral hct;
  • (MX) Mexico: Almetec tri | Avirena;
  • (NL) Netherlands: Olmesartan medoxomil/amlodipine/hct accord | Olmesartan medoxomil/amlodipine/hct teva | Sevikar hct;
  • (NO) Norway: Alea comp;
  • (PE) Peru: Iltuxam hct | Olmetecamlo hct;
  • (PH) Philippines: Tri Alzor;
  • (PL) Poland: Elestar hct;
  • (PR) Puerto Rico: Olmesartan medoxomil, amlodipine and hydrochlorothiazide | Tribenzor;
  • (PT) Portugal: Amlodipina + Olmesartan medoxomilo + Hidroclorotiazida Alter | Amlodipina + Olmesartan medoxomilo + Hidroclorotiazida Krka | Amlodipine + olmesartan medoxomylum + Hydrochlorothiazide ratiopharm | Zolnor hct;
  • (QA) Qatar: Olmedine HCT;
  • (RO) Romania: Inovum hct;
  • (SA) Saudi Arabia: Sevikar hct | Sevitense plus | Trioltan;
  • (SI) Slovenia: Olectan hct;
  • (SK) Slovakia: Folgan hct;
  • (TR) Turkey: Olmecomb plus;
  • (TW) Taiwan: Sevikar hct;
  • (UA) Ukraine: Sevikar hct
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