Renal Dose Adjustment (Based on CrCl)
- CrCl
30 mL/min: Avoid use
Hepatic Dose Adjustment
- Mild-moderate impairment: Caution advised
- Severe impairment: Avoid use
See Supplemental Patient Information
- If pregnancy is detected during therapy, suspend the drug as early as possible [US Black Box warning]
- Drugs acting directly on the renin-angiotensin system (olmesartan medoxomil) can cause fetal and neonatal morbidity and death when administered to pregnant women. 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. Closely observe the infants with histories of in utero exposure to an angiotensin II receptor antagonist for hypotension, oliguria, and hyperkalemia. Support blood pressure and renal perfusion in cases of oliguria
- Symptomatic hypotension may occur after initiation of therapy in volume- or salt-depleted patients (such as those treated with high doses of diuretics). Start therapy under close medical supervision in such patients. If hypotension occurs, place the patient in supine position and give intravenous normal saline infusion
- Patients with a history of severe obstructive coronary artery disease may develop increased frequency, duration, or severity of angina or acute myocardial infarction on start of calcium channel blocker or at the time of dose titration
- Avoid therapy in patients with severe renal impairment (CrCl 30 ml/min). Consider withholding or discontinuing either diuretic or angiotensin receptor blocker therapies if progressive renal impairment becomes evident
- Olmesartan medoxomil has been associated with changes in renal function in some individuals due to inhibition of renin-angiotensin-aldosterone system. 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. Increase in serum creatinine or blood urea nitrogen (BUN) have been reported in studies of ACE inhibitors in patients with renal artery stenosis (unilateral/bilateral)
- 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
- Use with caution in patients with severely impaired hepatic function or progressive liver disease, as minor changes in fluid and electrolyte balance may precipitate hepatic coma
- 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. Interference with adequate oral electrolyte intake can contribute to hypokalemia, which may cause cardiac arrhythmia and may also sensitize or exaggerate the response of the heart to the toxic effects of digitalis
- Hyperuricemia may occur or frank gout may be precipitated in some patients receiving thiazide therapy
- Dosage adjustments of insulin or oral hypoglycemic agents may be required in diabetic patients. 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
- 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
- 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
- Increases in cholesterol and triglyceride levels may occur in patients receiving thiazide therapy
- Avoid concomitant lithium use
- 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
- 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
- CHF
- Aortic stenosis
- Mitral stenosis
- Volume or salt depletion
- Post MI
- Hypertrophic cardiomyopathy
- Surgery
- Metabolic acidosis
- Diabetes mellitus
- Post-sympathectomy
- Hypersensitivity reactions
- Hx of sulfonamide or penicillin allergy
- 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: No information is available regarding the use of amlodipine and olmesartan during breastfeeding; however, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. Hydrochlorothiazide doses of 50 mg daily or less are acceptable during lactation. Intense diuresis with large doses may decrease breastmilk production. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACTlast accessed 14 November 2011). As per the manufacturer's data, it is unknown whether amlodipine or olmesartan are excreted in human milk, although thiazides appear in human milk and olmesartan is secreted at low concentration in the milk of lactating rats. Due to the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, analyzing the importance of the drug to the mother.
US Trade Name(s)
US Availability
Tribenzor (amlodipine/hydrochlorothiazide/olmesartan)
- TABS:
- 5 mg/12.5 mg/20 mg
- 5 mg/12.5 mg/40 mg
- 5 mg/25 mg/40 mg
- 10 mg/12.5 mg/40 mg
- 10 mg/25 mg/40 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Sevikar HCT (amlodipine/hydrochlorothiazide/olmesartan)
- TABS:
- 5 mg/12.5 mg/20 mg
- 5 mg/12.5 mg/40 mg
- 5 mg/25 mg/40 mg
- 10 mg/12.5 mg/40 mg
- 10 mg/25 mg/40 mg
Australian Trade Name(s)
Australian Availability
Pricing data from www.DrugStore.com in U.S.A.
- Tribenzor 40-10-25 MG TABS [Bottle] (SANKYO)
30 mg = $152.14
90 mg = $433.29 - Tribenzor 20-5-12.5 MG TABS [Bottle] (SANKYO)
30 mg = $119.99
90 mg = $335.95 - Tribenzor 40-5-25 MG TABS [Bottle] (SANKYO)
30 mg = $154.49
90 mg = $444.01 - Tribenzor 40-5-12.5 MG TABS [Bottle] (SANKYO)
30 mg = $152.14
60 mg = $304.27
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.