Adult Dosing
Hypertension
- Add on therapy
- Patients not controlled on monotherapy: Start with 12.5 mg/150mg mg PO daily. If needed titrate to 12.5 mg/300 mg PO daily then 25 mg/300 mg PO daily, allow 2 to 4 weeks to achieve antihypertensive effect
- Max: [25 mg/300 mg]/day
- Replacement therapy: Substitute hydrochlorothiazide/irbesartan for the titrated components
- Initial therapy
- Start 12.5 mg/150 mg PO daily, increase q2-4 wks to achieve antihypertensive effect
- Max: [25 mg/300 mg]/day
Notes: Avoid using as initial therapy in patients with intravascular volume depletion
Pediatric Dosing
- Safety and effectiveness in pediatric patients has not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
Hepatic Dose Adjustment
- Hepatic impairment: No dose adjustments
See Supplemental Patient Information
- Fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death has occurred in developing fetuses when using this drug in pregnancy during the second and third trimesters [US Black Box Warning]
- Risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions are associated with usage of thiazides in adults during pregnancy
- Rare occasions of excessive reduction of blood pressure have occurred in treating patients with this combination drug for uncomplicated hypertension. Patients with intravascular volume or sodium depletion are susceptible to symptomatic hypotension. Correct such volume depletion in patients treated vigorously with diuretics or in patients on dialysis prior to initiation of antihypertensive therapy. On occurrence of hypotension, place the patient in the supine position and if essential administer IV infusion of normal saline
- Hydrochlorothiazide component is associated with hypersensitivity reactions in patients with or without a history of allergy or bronchial asthma; patients having such a history are more prone
- Exacerbation or activation of systemic lupus erythematosus is associated with thiazide component of this drug
- Electrolyte and metabolic imbalances may occur. A higher doses of irbesartan ameliorates the hypokalemic response to hydrochlorothiazide. At appropriate intervals periodically determine serum electrolytes to detect possible electrolyte imbalance. Observe patients receiving thiazide therapy for clinical signs of fluid or electrolyte imbalance. Determine serum and urine electrolyte when the patient is vomiting excessively or receiving parenteral fluids. Hypokalemia with brisk diuresis has occurred in the presence of severe cirrhosis or after long term therapy. Cardiac arrhythmia has occurred in association with hypokalemia resulting in sensitization or exaggeration of the response of the heart to the toxic effects of digitalis. Chloride replacement may be essential for the treatment of metabolic alkalosis. Dilutional hyponatremia has occurred in edematous patients in hot weather; Impose water restriction rather than administration of salt except in rare occasions when the hyponatremia is fatal. In actual salt depletion provide appropriate replacement therapy. Thiazide component is associated with hyperuricemia or precipitation of frank gout in certain patients
- If required adjust doses of insulin or oral hypoglycemic agents in diabetic patients. Antihypertensive effects of this drug is enhanced in the post-sympathectomy patient
- On evidence of progressive renal impairment consider withholding or discontinuing diuretic therapy
- Thiazide component is associated with increasing the urinary excretion of magnesium, decreasing urinary excretion of calcium and increasing cholesterol and triglyceride levels
- Minor alterations of fluid and electrolyte balance is associated with precipitation of hepatic coma in patients with impaired hepatic function or progressive liver disease
- Anticipate changes in renal function in susceptible individuals. A patients whose renal function is depending on the activity of the renin-angiotensin-aldosterone system treatment with ACE inhibitors is associated with oliguria and/or progressive azotemia and rarely with acute renal failure or death. Increase in serum creatinine or BUN have occurred in hypertensive patients with unilateral or bilateral renal artery stenosis. Thiazide component is associated with precipitation of azotemia in patients with renal disease. Cumulative effects have developed in patients with impaired renal function
Cautions: Use cautiously in:
- Renal impairment
- Renal artery stenosis
- Hepatic impairment
- Progressive hepatic disease
- Diabetes mellitus
- Volume depletion
- Hyponatremia
- CHF
- Post-sympathectomy
- History of gout
- Major surgery
- SLE
- Geriatrics
Supplemental Patient Information
- Apprise female patients of childbearing potential that use this combination drug during the second or third trimesters of pregnancy is associated with serious problems in the fetus and infant including low blood pressure, poor development of skull bones, kidney failure, and death
- Advise patients to inform their physician if they feel lightheaded or faintness; advise them to stop using this therapy and contact the prescribing doctor
- Advise patients to take adequate amount of fluids
Pregnancy Category:D
Breastfeeding: Prefer an alternative drug during breastfeeding as appropriate literature on the use of irbesartan is unavailable. Hydrochlorothiazide doses of 
50 mg/day are acceptable during lactation. Intense diuresis with higher doses may decrease breastmilk production. This information is (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 22 February 2011). Unknown whether irbesartan is excreted in human milk, thiazides are excreted in human milk. Exhibits potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
hydrochlorothiazide/irbesartan (generic)
- TABS:
- 12.5 mg/150 mg
- 12.5 mg/300 mg
Avalide (hydrochlorothiazide/irbesartan)
- TABS:
- 12.5 mg/150 mg
- 12.5 mg/300 mg
Canadian Trade Name(s)
Canadian Availability
Avalide (hydrochlorothiazide/irbesartan)
- TABS:
- 12.5 mg/150 mg
- 12.5 mg/300 mg
- 25 mg/300 mg
UK Trade Name(s)
UK Availability
Coaprovel (hydrochlorothiazide/irbesartan)
- TABS:
- 12.5 mg/150 mg
- 12.5 mg/300 mg
- 25 mg/300 mg
Australian Trade Name(s)
Australian Availability
Avapro HCT, Karvezide (hydrochlorothiazide/irbesartan)
- TABS:
- 12.5 mg/150 mg
- 12.5 mg/300 mg
- 25 mg/300 mg
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Avalide 150-12.5 MG TABS [Bottle] (B-M SQUIBB U.S. (PRIMARY CARE))
30 mg = $117.99
90 mg = $336.99 - Avalide 300-12.5 MG TABS [Bottle] (B-M SQUIBB U.S. (PRIMARY CARE))
30 mg = $131.99
90 mg = $378.98 - Avalide 300-25 MG TABS [Bottle] (B-M SQUIBB U.S. (PRIMARY CARE))
30 mg = $122.95
90 mg = $345.09
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.