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Irbesartan and hydrochlorothiazide: Drug information

Irbesartan and hydrochlorothiazide: Drug information
(For additional information see "Irbesartan and hydrochlorothiazide: 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 use 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
  • Avalide
Brand Names: Canada
  • ACT Irbesartan/HCT;
  • Apo-Irbesartan/HCTZ;
  • Avalide;
  • Irbesartan-HCT;
  • Irbesartan-HCTZ;
  • JAMP-Irbesartan and Hydrochlorothiazide;
  • Mint-Irbesartan/HCTZ;
  • PMS-Irbesartan HCTZ;
  • Ran-Irbesartan HCTZ;
  • ratio-Irbesartan HCTZ;
  • Sandoz-Irbesartan HCT;
  • Teva-Irbesartan HCTZ
Pharmacologic Category
  • Angiotensin II Receptor Blocker;
  • Antihypertensive;
  • Diuretic, Thiazide
Dosing: Adult
Hypertension

Hypertension: Oral: Note: Maximum antihypertensive effects are attained within 2 to 4 weeks after initiation or a change in dose; however, if necessary, may carefully titrate dose as soon as after 1 week of treatment. Dose must be individualized.

Add-on therapy: A patient who is not controlled with either agent alone may be switched to the combination product. The lowest dosage available is irbesartan 150 mg/hydrochlorothiazide 12.5 mg.

Initial therapy: Irbesartan 150 mg/hydrochlorothiazide 12.5 mg once daily. If initial response is inadequate, may titrate dose after 1 to 2 weeks (maximum daily dose: Irbesartan 300 mg/hydrochlorothiazide 25 mg).

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: No dosage adjustment necessary; use with caution.

CrCl ≤30 mL/minute: Use not recommended (hydrochlorothiazide is likely to be ineffective).

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary; use with caution.

Dosing: Older Adult

Refer to adult dosing.

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 (3%), chest pain (2%), decreased blood pressure (excessive reduction in patients with uncomplicated hypertension: 1%), tachycardia (1%)

Central nervous system: Dizziness (8%; orthostatic: 1%), fatigue (6%)

Endocrine: Hypokalemia (≤8%)

Gastrointestinal: Nausea and vomiting (3%), dyspepsia (≤3%), heartburn (≤3%), abdominal pain (2%)

Genitourinary: Difficulty in micturition (2%)

Neuromuscular & skeletal: Musculoskeletal pain (6%)

Renal: Increased blood urea nitrogen (2%), increased serum creatinine (1%)

Miscellaneous: Flu-like symptoms (3%)

<1%, postmarketing, and/or case reports: Angioedema, hepatitis, hyperkalemia, tinnitus, urticaria

Contraindications

Hypersensitivity to irbesartan, hydrochlorothiazide, 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. See “Warnings/Precautions” for more detail.

Canadian labeling: Additional contraindications (not in US labeling): Concomitant use with aliskiren in patients with moderate-to-severe renal impairment (GFR <60 mL/minute/1.73 m2); concomitant use with ACE inhibitors in patients with diabetic nephropathy; pregnancy; breastfeeding; rare hereditary problems of galactose intolerance, the congenital lactase deficiency or glucose-galactose malabsorption.

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.

• Electrolyte disturbances: Hyperkalemia may occur with angiotensin II receptor antagonists; risk factors include renal dysfunction, 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.

• 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); correct volume depletion prior to administration. This transient hypotensive response is not a contraindication to further treatment with irbesartan/hydrochlorothiazide.

• Ocular effects: Hydrochlorothiazide may cause acute transient myopia and acute angle-closure glaucoma.

• Photosensitivity: Photosensitization may occur.

• Renal function deterioration: 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/mitral stenosis: Use with caution in patients with significant aortic/mitral stenosis.

• 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 caution in patients with severe hepatic impairment; in progressive or severe liver disease, avoid electrolyte and acid/base imbalances that might lead to hepatic encephalopathy/coma.

• 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.

• 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 irbesartan 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 irbesartan with caution with preexisting renal insufficiency. Cumulative effects of hydrochlorothiazide, including azotemia, may develop in patients with impaired renal function.

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

Special populations:

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

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

Dosage Forms: US

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

Tablet, oral:

Avalide 150/12.5: Irbesartan 150 mg and hydrochlorothiazide 12.5 mg

Avalide 300/12.5: Irbesartan 300 mg and hydrochlorothiazide 12.5 mg

Generic: 150/12.5: Irbesartan 150 mg and hydrochlorothiazide 12.5 mg; 300/12.5: Irbesartan 300 mg and hydrochlorothiazide 12.5 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Avalide Oral)

150-12.5 mg (per each): $11.11

300-12.5 mg (per each): $12.10

Tablets (Irbesartan-hydroCHLOROthiazide Oral)

150-12.5 mg (per each): $0.67 - $3.73

300-12.5 mg (per each): $0.73 - $4.07

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.

Dosage Forms: Canada

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

Tablet, oral:

Avalide 150/12.5: Irbesartan 150 mg and hydrochlorothiazide 12.5 mg

Avalide 300/12.5: Irbesartan 300 mg and hydrochlorothiazide 12.5 mg

Generic: 150/12.5: Irbesartan 150 mg and hydrochlorothiazide 12.5 mg; 300/12.5: Irbesartan 300 mg and hydrochlorothiazide 12.5 mg

Administration: Adult

Oral: Administer with or without food.

Use: Labeled Indications

Hypertension: Management of hypertension

Medication Safety Issues
Sound-alike/look-alike issues:

Avalide may be confused with Avandia

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

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

Alcohol (Ethyl): May enhance the orthostatic hypotensive effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

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

Allopurinol: Thiazide and Thiazide-Like Diuretics may enhance the potential for allergic or hypersensitivity reactions to Allopurinol. 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

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

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

Anticholinergic Agents: May increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Antidiabetic Agents: Thiazide and Thiazide-Like Diuretics may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

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

Arsenic Trioxide: Thiazide and Thiazide-Like Diuretics may enhance the hypotensive effect of Arsenic Trioxide. Thiazide and Thiazide-Like Diuretics may enhance the QTc-prolonging effect 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

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

Beta2-Agonists: May enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Bile Acid Sequestrants: May decrease the absorption of Thiazide and Thiazide-Like Diuretics. The diuretic response is likewise decreased. Management: Consider separating administraton of bile acid sequestrants and 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 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: Thiazide and Thiazide-Like Diuretics may increase the serum concentration of Calcium Salts. Risk C: Monitor therapy

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

Corticosteroids (Systemic): May enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

CycloPHOSphamide: Thiazide and Thiazide-Like Diuretics may enhance the adverse/toxic effect of CycloPHOSphamide. Specifically, granulocytopenia may be enhanced. Risk C: Monitor therapy

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

Desmopressin: Hyponatremia-Associated Agents may enhance the hyponatremic effect of Desmopressin. Risk C: Monitor therapy

Dexketoprofen: May enhance the adverse/toxic effect of Sulfonamides. Risk C: Monitor therapy

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

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

Diazoxide: Thiazide and Thiazide-Like Diuretics may enhance the adverse/toxic effect of Diazoxide. Risk C: Monitor therapy

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

Dichlorphenamide: Thiazide and Thiazide-Like Diuretics may enhance the hypokalemic effect of Dichlorphenamide. Risk C: Monitor therapy

Dofetilide: HydroCHLOROthiazide may enhance the QTc-prolonging effect of Dofetilide. HydroCHLOROthiazide may increase the serum concentration of Dofetilide. Risk X: Avoid combination

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

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

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

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

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

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

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

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

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

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

Ivabradine: Thiazide and Thiazide-Like Diuretics may enhance the arrhythmogenic effect of Ivabradine. Risk C: Monitor therapy

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

Levosulpiride: Thiazide and Thiazide-Like Diuretics may enhance the adverse/toxic effect of Levosulpiride. Risk X: Avoid combination

Licorice: May enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Lithium: Thiazide and Thiazide-Like Diuretics may decrease the 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

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

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

Mecamylamine: Thiazide and Thiazide-Like Diuretics may enhance the adverse/toxic effect 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

Methenamine: Thiazide and Thiazide-Like Diuretics may diminish the therapeutic effect of Methenamine. Risk C: Monitor therapy

Methotrexate: HydroCHLOROthiazide may enhance the nephrotoxic effect of Methotrexate. Risk C: Monitor therapy

Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy

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

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

Multivitamins/Fluoride (with ADE): May enhance the hypercalcemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): Thiazide and Thiazide-Like Diuretics may enhance the hypercalcemic effect of Multivitamins/Minerals (with ADEK, Folate, Iron). Risk C: Monitor therapy

Multivitamins/Minerals (with AE, No Iron): Thiazide and Thiazide-Like Diuretics may increase the 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 therapy

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

Neuromuscular-Blocking Agents (Nondepolarizing): Thiazide and Thiazide-Like Diuretics 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

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

Nonsteroidal Anti-Inflammatory Agents: Thiazide and Thiazide-Like Diuretics may enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Thiazide and Thiazide-Like Diuretics. 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

Nonsteroidal Anti-Inflammatory Agents (Topical): May diminish the therapeutic effect of Thiazide and Thiazide-Like Diuretics. 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

Opioid Agonists: May enhance the adverse/toxic effect of Diuretics. Opioid Agonists may diminish the therapeutic effect of Diuretics. Risk C: Monitor therapy

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

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

Polyethylene Glycol-Electrolyte Solution: Diuretics may enhance the nephrotoxic effect of Polyethylene Glycol-Electrolyte Solution. Risk C: Monitor therapy

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. 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

Promazine: Thiazide and Thiazide-Like Diuretics may enhance the QTc-prolonging effect of Promazine. Risk X: Avoid combination

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

Reboxetine: May enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Repaglinide: Irbesartan may increase the serum concentration of Repaglinide. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hyponatremic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

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

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

Sodium Phosphates: Diuretics 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): Angiotensin II Receptor Blockers may enhance the hyperkalemic effect 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

Topiramate: Thiazide and Thiazide-Like Diuretics may enhance the hypokalemic effect of Topiramate. Thiazide and Thiazide-Like Diuretics may increase the serum concentration of Topiramate. Risk C: Monitor therapy

Toremifene: Thiazide and Thiazide-Like Diuretics may enhance the hypercalcemic effect of Toremifene. Risk C: Monitor therapy

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

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

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin D Analogs: Thiazide and Thiazide-Like Diuretics may enhance the hypercalcemic effect of Vitamin D Analogs. Risk C: Monitor therapy

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

Thiazide diuretics are found in breast milk; excretion of irbesartan is not known.

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.

Monitoring Parameters

Blood pressure; serum electrolytes, BUN, creatinine; visual acuity, ocular pain.

Mechanism of Action

Irbesartan: Irbesartan is an angiotensin receptor antagonist. Angiotensin II acts as a vasoconstrictor. In addition to causing direct vasoconstriction, angiotensin II also stimulates the release of aldosterone. Once aldosterone is released, sodium as well as water are reabsorbed. The end result is an elevation in blood pressure. Irbesartan binds to the AT1 angiotensin II receptor. This binding prevents angiotensin II from binding to the receptor thereby blocking the vasoconstriction and the aldosterone secreting effects of angiotensin II.

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: Andaran plus | Avansart H | Co Irbea | Coaprovel | Gizlan plus | Irbigen H | Irvel h;
  • (AR) Argentina: Avapro hct | Co aprovel;
  • (AT) Austria: Irbesartan hct G.L;
  • (AU) Australia: Abisart hct | Apo irbesartan HCTZ | Avapro hct | Avsartan hct | Chemmart irbesartan hctz | Irbesartan HCT | Irbesartan HCT Actavis | Irbesartan hct gh | Irbesartan HCT Winthrop | Irbesartan hctz an | Irbesartan/hctz ga | Irbesartan/hctz ranbaxy | Karvezide | Ksart hct | Terry white chemists irbesartan hctz;
  • (BD) Bangladesh: Arbitan plus | Cavazide;
  • (BE) Belgium: Co aprovel | Irbesartan hct eg | Irbesartan/hct teva | Irbesartan/hydrochlorothiazide apotex | Irbesartan/Hydrochlorothiazide mylan;
  • (BF) Burkina Faso: Andaran hct | Coaprovel;
  • (BG) Bulgaria: Co irbec | Co irbesan | Co irbesso | Converide | Irbecon co | Irprezide;
  • (BR) Brazil: Aprozide | Bart h | Irbesartana + hidroclorotiazida;
  • (CH) Switzerland: Co irbesartan | Coaprovel | Irbesartan HCT Actavis | Irbesartan hct mepha | Irbesartan hct zentiva;
  • (CI) Côte d'Ivoire: Andaran hct | Co aradex | Coaprovel | Coaprozar;
  • (CL) Chile: Coaprovel | Irtana h;
  • (CN) China: An bo nuo | Coaprovel | Irbesartan and hydrochlorothiazide | Yi lun ping;
  • (CO) Colombia: Araplus H | Bezart h | Coaprovel | Girenoxin plus | Hidroclorotiazida + irbesartan | Iberten H | Irbeprex h | Irbesartan + Hidroclorotiazida mk | Irbesartan/hct | Irbesartan/hidroclorotiazida | Irbetiazid | Irbevitae plus | Irbigen H;
  • (CZ) Czech Republic: Coaprovel | Converide | Ifirmacombi | Irbesartan HCT | Irbesartan Hydrochlorothiazide Winthrop;
  • (DE) Germany: Co irbenobel | Coaprovel | Dazirok | Irbecor comp | Irbepress hct | Irbesartan comp | Irbesartan comp. | Irbesartan hct aurobindo | Irbesartan hctz fair med | Irbesartan hydrochlorothiazide heumann | Irbesartan Hydrochlorothiazide Zentiva | Irbesartan plus HCT Hennig | Irbesartan/hct AL | Irbesartan/HCT stada | Irbesartan/hydrochlorothiazid heumann | Irbesartan/hydrochlorothiazid micro labs | Karvezide;
  • (DO) Dominican Republic: Aramax d | Bart h | Carditran h | Co Acepress | Co aprovel | Ibersafel h | Ibersar h | Iberterol h | Iberyl d | Irbecor H | Irbesartan+hidroclorotiazida | Irbesartan/Hidroclorotiazida mk | Iveprax h | Keotan h | Tensiber hct | Vassluten H;
  • (EC) Ecuador: Besarzid | Co aprovel | Coacepress | Irbesartan/hct | Irbesartan/hidroclorotiazida | Irbetiazid;
  • (EE) Estonia: Coaprovel;
  • (EG) Egypt: Co irbesartan | Coaprovel | Irbedrin Diu | Irbefutal co | Irbevasc plus | Irbezide | Kansartan Plus | Vezidane | X Tension Plus;
  • (ES) Spain: Coaprovel | Converide | Ifirmacombi | Irbesartan Hidroclorotiazida alter | Irbesartan/Hidroclorotiazida Actavis | Irbesartan/Hidroclorotiazida Almus | Irbesartan/hidroclorotiazida aristo | Irbesartan/hidroclorotiazida aurobindo | Irbesartan/hidroclorotiazida cinfa | Irbesartan/hidroclorotiazida combix | Irbesartan/hidroclorotiazida kern | Irbesartan/hidroclorotiazida mylan pharmaceut | Irbesartan/Hidroclorotiazida Normon | Irbesartan/hidroclorotiazida pensa | Irbesartan/hidroclorotiazida Qualigen | Irbesartan/hidroclorotiazida ranbaxy | Irbesartan/hidroclorotiazida ratio | Irbesartan/Hidroclorotiazida Sandoz | Irbesartan/Hidroclorotiazida Stada | Irbesartan/Hidroclorotiazida Tecnigen | Karvezide;
  • (ET) Ethiopia: Coaprovel | Converide | Hydrochlorothiazide + irbesartan | Irbesartan and hydrochlorothiazide;
  • (FR) France: Coaprovel | Ifirmacombi | Irbesartan/hydrochlorothiazide alter | Irbesartan/hydrochlorothiazide arrow generiqu | Irbesartan/hydrochlorothiazide biogaran | Irbesartan/hydrochlorothiazide cristers | Irbesartan/hydrochlorothiazide eg | Irbesartan/hydrochlorothiazide Evolugen | Irbesartan/Hydrochlorothiazide mylan | Irbesartan/hydrochlorothiazide ranbaxy | Irbesartan/hydrochlorothiazide sandoz | Irbesartan/hydrochlorothiazide teva | Irbesartan/hydrochlorothiazide zentiva | Irbesartan/hydrochlorothiazide zydus;
  • (GB) United Kingdom: Coaprovel | Irbesart and hydrochlorothiazide | Irbesartan hydrochlorothiazide actavis | Irbesartan hydrochlorothiazide brown & burk | Irbesartan/Hydrochlorothiazide;
  • (GR) Greece: Coaprovel | Converide | Irbegen plus | Irbepress plus | Irbesartan HCT Actavis | Irbesartan+hydrochlorothiazide/mylan | Irbesartan/hydrochlorothiazide teva | Irbotens Plus | Karvezide | Lartokaz | Lucidel plus | Piesiton r | Roverin plus;
  • (HK) Hong Kong: Co aprovel | Coaprovel | Irbesartan HCT Actavis | Irbesartan hct sandoz;
  • (HR) Croatia: Coaprovel;
  • (HU) Hungary: Abonda plus | Co Irabel | Coaprovel | Ebrit HCT | Irbesartan HCT | Irbesartan hct sandoz | Irbesartan Hydrochlorothiazide Winthrop | Irprestan HCT;
  • (ID) Indonesia: Co aprovel | Co irvell | Irtan Plus;
  • (IE) Ireland: Coaprovel | Ifirmacombi | Irprezide;
  • (IL) Israel: Irban Plus;
  • (IN) India: Insat H | Irovel h | Xarb-h;
  • (IT) Italy: Coabesart | Coaprovel | Cobesar | Ifirmacombi | Irbediur | Irbesartan e idroclorotiazide alter | Irbesartan e idroclorotiazide aurobindo | Irbesartan e idroclorotiazide doc generici | Irbesartan e Idroclorotiazide eg | Irbesartan e idroclorotiazide mylan | Irbesartan e idroclorotiazide ranbaxy | Irbesartan e idroclorotiazide tecnimede | Irbesartan idroclorotiazide zentiva | Irbesartan/Hydrochlorothiazide mylan | Irbesartan/hydrochlorothiazide sandoz | Irbesartan/hydrochlorothiazide teva | Karvezide | Ratipred | Sykrazide;
  • (JO) Jordan: Coaprovel | Gizlan plus | Irbegen plus | Procard plus | Vivazac plus;
  • (KE) Kenya: Andaran hct | Co aprovel | Corycardon | Irbatal h | Irbetan h | Irovel h | Medisart 300h | Medisart h;
  • (KR) Korea, Republic of: Abell plus | Abeltan Plus | Bestan plus | Cellprovel plus | Coaprovel | Coaprtan | Coibesdil | Coizabeltan | Coizarbelltan | I sartan plus | Ibef | Ibertan Duo | Ibertan plus | Ibesa plus | Inno.n abeltan plus | Irbera plus | Irbetan plus | Irbetan plus f | Irsartan plus | Izatan Plus;
  • (KW) Kuwait: Coaprovel;
  • (LB) Lebanon: Coaprovel | Gizlan plus | Ibecard plus | Irbavel plus | Ziorel Plus;
  • (LT) Lithuania: Converide;
  • (LU) Luxembourg: Coaprovel | Irbesartan/hct eg;
  • (LV) Latvia: Coaprovel;
  • (MA) Morocco: Co aprovel | Co arapro | Co avepro | Co irvel | Co vepran | Coavacor | Coirbesar sun | Covezar | Irphi plus | Novortan plus;
  • (MX) Mexico: Avalide | Co aprovel | Co dulastat | Coaprovel | Diogena dra | Ibarzid | Irbesartan and hidroclorotiazida | Irbesartan and hidroclorotiazida bayer | Irbesartan and hidroclorotiazida bruluart | Irbesartan and hidroclorotiazida iqfa | Irbesartan and hidroclorotiazida ultra | Irbesartan, hidroclorotiazida | Irbesartan/hidroclorotiazida | Irmeglol d | Irmeglol duo | Pabesorag | Tificom;
  • (MY) Malaysia: Coaprovel | Irbemac h;
  • (NG) Nigeria: Coaprovel;
  • (NL) Netherlands: Coaprovel | Converide | Irbesartan/HCT Actavis | Irbesartan/Hydrochloorthiazide Aurobindo | Irbesartan/Hydrochloorthiazide Mylan | Irbesartan/Hydrochloorthiazide Sandoz | Irbesartan/Hydrochloorthiazide Teva | Irbesartan/hydrochloorthiazide xiromed;
  • (NO) Norway: Coaprovel | Ifirmacombi | Irbesartan/hydrochlorothiazide sandoz | Irbesartan/hydroklortiazid actavis;
  • (NZ) New Zealand: Karvezide;
  • (PE) Peru: Araplus H | Bart h | Chestinor plus | Co irbis | Coaprovel | Comesartin | Irbelab duo | Irbesel hc | Irbetiazid | Irbevitae plus | Probertan HCT | Velapro plus;
  • (PH) Philippines: Aprovaz | Co ivyzar | Coaprovel | Irbemed Plus | Irbezyd H | Winthrop Irbesartan + Hydrochlorothiazide;
  • (PK) Pakistan: Arbi d | B sart plus | Besart plus | Co aprovel | Irbest plus | Irecon h | Maxten plus | Sebri plus | Zepose plus;
  • (PL) Poland: Coaprovel | Irprezide;
  • (PR) Puerto Rico: Avalide | Irbesartan and hydrochlorothiazide | Irbesartan hctz | Irbesartan/Hydrochlorothiazide;
  • (PT) Portugal: Coaprovel | Irbesartan + hidroclorotiazida actavis | Irbesartan + Hidroclorotiazida Arudel | Irbesartan + Hidroclorotiazida Aurobindo | Irbesartan + Hidroclorotiazida Azevedos | Irbesartan + hidroclorotiazida basi | Irbesartan + hidroclorotiazida bluepharma | Irbesartan + hidroclorotiazida ciclum | Irbesartan + hidroclorotiazida farmoz | Irbesartan + hidroclorotiazida fisiofen | Irbesartan + hidroclorotiazida jaba | Irbesartan + hidroclorotiazida krka | Irbesartan + hidroclorotiazida mepha | Irbesartan + Hidroclorotiazida Pharmakern | Irbesartan + Hidroclorotiazida Sandoz | Irbesartan + hidroclorotiazida tecnilor | Irbesartan + hidroclorotiazida tetrafarma | Irbesartan + Hidroclorotiazida toLife | Irbesartan Hydrochlorothiazide | Irbesartan Hydrochlorothiazide Zentiva | Irbesartan+Hidroclorotiazida Teva;
  • (PY) Paraguay: Co aprovel;
  • (QA) Qatar: CoAprovel | Gizlan Plus | Vivazac Plus;
  • (RO) Romania: Coaprovel | Converide | Irbesartan hidroclorotiazida ranbaxy | Irbesartan Hydrochlorothiazide Zentiva | Irprezide;
  • (RU) Russian Federation: Coaprovel | Firmasta h 150 | Firmasta h 300 | Firmasta hd 300 | Ibertan plus;
  • (SA) Saudi Arabia: Apo irbesartan HCTZ | Arena plus | Co aprovel | Co irbetel | Coaprovel | Irbegen plus | Irovel plus | Vivazac plus;
  • (SE) Sweden: Coaprovel | Ifirmacombi | Irbesartan Hydrochlorothiazide Zentiva | Irbesartan/hydrochlorothiazide sandoz | Irbesartan/hydrochlorothiazide stada | Irbesartan/hydrochlorothiazide teva | Irbesartan/hydroklortiazid actavis;
  • (SG) Singapore: Coaprovel;
  • (SI) Slovenia: Coaprovel | Irbesartan HCT Actavis;
  • (SK) Slovakia: Coaprovel | Converide | Ifirmacombi | Irbesartan Hydrochlorothiazide Winthrop | Irbesartan/Hydrochlorothiazid Teva;
  • (TH) Thailand: Aprovel hct | Coaprovel;
  • (TN) Tunisia: Co irbesar | Co irbesartan | Co irby | Co irivel | Coaprovel | Coaprozar | Coaraven | Irbegen plus;
  • (TR) Turkey: Arbesta plus | Co irda | Irbecor Plus | Irprestan Plus | Karvezide | Rebevea Plus;
  • (TW) Taiwan: Coaprovel;
  • (UA) Ukraine: Co irbesan | Coaprovel | Irbetan h;
  • (UG) Uganda: Andaran hct | Irbesartan/hydrochlorothiazide sandoz;
  • (UY) Uruguay: Co aprovel | Noasartan d;
  • (VE) Venezuela, Bolivarian Republic of: Ariven hct | Coaprovel | Irbesartan HCT | Irbetiazid | Irtana h | Vassluten H;
  • (VN) Viet Nam: Apibestan 150 h | Co dovel | Co ibedis | Ihybes h | Sunirovel h;
  • (ZA) South Africa: Co irbewin | Coaprovel | Trobet co
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