Renal Dose Adjustment (Based on CrCl)
- <30 mL/min: Not recommended
Hepatic Dose Adjustment
- Hepatic impairment: No dose adjustments
See Supplemental Patient Information
- If pregnancy is detected during therapy, suspend the drug as early as possible [US Black Box warning]
- Therapy may cause fetal and neonatal injury including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure and death when used during second and third trimesters of pregnancy
- Oligohydramnios, prematurity, intrauterine growth retardation, and patent ductus arteriosus have been reported with the use of this therapy during pregnancy. Discontinue therapy if oligohydramnios is observed unless it is considered life-saving for the mother
- Symptomatic hypotension may occur after initiation of therapy in volume- or salt-depleted patients (e.g., those treated with high doses diuretics). Start therapy under close medical supervision. If hypotension occurs, place the patient in supine position and give intravenous normal saline infusion
- Use with caution in patients with impaired hepatic function or progressive liver disease, as minor changes in fluid and electrolyte balance may precipitate hepatic coma
- Hypersensitivity reactions to hydrochlorothiazide may occur more likely in patients with a history of allergy or bronchial asthma
- Therapy with thiazide diuretics may cause exacerbation or activation of systemic lupus erythematosus
- Avoid concomitant lithium use
- Idiosyncratic reaction resulting in acute transient myopia and acute angle-closure glaucoma may occur with the use of hydrochloride-containing drugs. Discontinue therapy if such events occur and consider prompt medical or surgical treatments if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy
- Periodically determine serum electrolytes to detect possible electrolyte imbalance at appropriate intervals. Closely observe all patients receiving thiazide therapy for clinical signs of fluid or electrolyte imbalance including hyponatremia, hypochloremic alkalosis, and hypokalemia
- Prolonged therapy may lead to hypokalemia, especially with brisk diuresis
- Hyperuricemia may occur or frank gout may be precipitated in some patients receiving thiazide therapy
- Hyperglycemia may occur with thiazide therapy; latent diabetes mellitus may become manifest during thiazide therapy
- Increased urinary excretion of magnesium leading to hypomagnesemia has been reported in patients receiving thiazide therapy
- Thiazide-containing products may decrease urinary calcium excretion and cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Discontinue therapy before carrying out tests for parathyroid function
- Increases in cholesterol and triglyceride levels may occur in patients receiving thiazide therapy
- Hydrochlorothiazide may precipitate azotemia in patients with renal disease. Therefore, use with caution in severe renal disease. Cumulative effects of the drug may develop in patients with impaired renal function
- Hydrochlorothiazide associated hypokalemia may be avoided or treated by use of potassium sparing diuretics or potassium supplements such as foods with a high potassium content
- Carefully adjust dosage of insulin or oral hypoglycemic agents when administering hydrochlorothiazide in diabetic patients
- Suspend hydrochlorothiazide before carrying out tests for parathyroid function because marked hypercalcemia may be evidence of hidden hyperparathyroidism
- Patients with renal artery stenosis may experience acute renal failure. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment may be associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Use with caution in patients with severe CHF
- Intestinal problems (ie, sprue-like enteropathy) reported; symptoms may include severe, chronic diarrhea with substantial weight loss, hence consider discontinuation of therapy in cases where no other etiology is identified
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Renal artery stenosis
- Hyponatremia
- Volume depletion
- Progressive hepatic disease
- Post-sympathectomy
- Diabetes mellitus
- Hx of gout
- Hx of pancreatitis
- Major surgery
- Elderly patients
Supplemental Patient Information
- Apprise female patients of childbearing age about the adverse effects of the drug on the fetus; discuss other treatment options with female patients planning to become pregnant
- Caution patients that lightheadedness may occur during therapy, especially during the first few days of therapy; advise patients to promptly consult their physician should lightheadedness occur
Pregnancy Category:C (first trimester), D (second and third trimesters)
Breastfeeding: Hydrochlorothiazide doses of 50 mg daily or less are acceptable during lactation. Intense diuresis with large doses may decrease breastmilk production. No information is available regarding the use of olmesartan during breastfeeding; however, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 31 May 2011). As per the manufacturer's data, thiazides appear in human milk and it is not known whether olmesartan is excreted in human milk, but is secreted at low concentration in the milk of lactating rats, hence, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
Benicar HCT (hydrochlorothiazide/olmesartan)
- TABS:
- 12.5 mg/20 mg
- 12.5 mg/40 mg
- 25 mg/40 mg
Canadian Trade Name(s)
Canadian Availability
Olmetec Plus (hydrochlorothiazide/olmesartan)
- TABS:
- 12.5 mg/20 mg
- 12.5 mg/40 mg
- 25 mg/40 mg
UK Trade Name(s)
UK Availability
Olmetec Plus (hydrochlorothiazide/olmesartan)
- TABS:
- 12.5 mg/40 mg
- 12.5 mg/20 mg
- 25 mg/20 mg
Australian Trade Name(s)
Australian Availability
Olmetec Plus (hydrochlorothiazide/olmesartan)
- TABS:
- 12.5 mg/20 mg
- 12.5 mg/40 mg
- 25 mg/40 mg
Pricing data from www.DrugStore.com in U.S.A.
- Benicar HCT 20-12.5 MG TABS [Bottle] (SANKYO)
30 mg = $96.99
90 mg = $275.96 - Benicar HCT 40-12.5 MG TABS [Bottle] (SANKYO)
30 mg = $135.99
90 mg = $391.96 - Benicar HCT 40-25 MG TABS [Bottle] (SANKYO)
30 mg = $135.99
90 mg = $376.98
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.