Dosing and uses of Benicar HCT (olmesartan-hydrochlorothiazide)
Adult dosage forms and strengths
olmesartan/hydrochlorothiazide
tablet
- 20mg/12.5mg
- 40mg/12.5mg
- 40mg/25mg
Hypertension
Initial: 20 mg/12.5 mg PO qDay
May increase to 40 mg/25 mg after 2 weeks
Renal Impairment
CrCl <30 mL/min: Not recommended
Hepatic Impairment
Dose adjustment not necessary
Pediatric dosage forms and strengths
Safety and efficacy not established
Benicar HCT (olmesartan-hydrochlorothiazide) adverse (side) effects
Adverse reactions with combination products and individual agents
1-10%
Olmesartan
- Dizziness (3%)
- Headache (1%)
- Fatigue
- Diarrhea (1%)
- Hyperglycemia (1%)
- Hypertriglyceridemia (1%)
- Back pain (1%)
- Bronchitis (1%)
- Flu-like symptoms (1%)
- Pharyngitis (1%)
- Rhinitis (1%)
- Sinusitis (1%)
- URI (1%)
Frequency not defined
Chest pain
Peripheral edema
Rash
Hyperuricemia
Dizziness
Hyperlipidemia
Diarrhea
Hyperuricemia
Hematuria
Hyperglycemia
Upper respiratory infections
Increased transaminases
Gastroenteritis
Dyspepsia
Arthralgia
Arthritis
Myalgia
Back pain
Increased CPK
Hydrochlorothiazide
- Anorexia
- Epigastric distress
- Hypotension
- Orthostatic hypotension
- Photosensitivity
- Anaphylaxis
- Anemia
- Confusion
- Erythema multiforme
- Stevens-Johnson syndrome
- Exfoliative dermatitis including toxic epidermal necrolysis
- Dizziness
- Hypokalemia and/or hypomagnesemia
- Hyperuricemia
- Headache
Warnings
Black box warnings
Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death
Contraindications
Hypersensitivity to olmesartan, hydrochlorothiazide or sulfonamides
Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
Pregnancy (2nd/3rd trimesters): Significant risk of fetal and neonatal morbidity & mortality
Anuria
Do not coadminister with aliskiren in patients with diabetes mellitus
Not for initial treatment
Cautions
Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
Hyperkalemia, particularly when coadministered with potassium-sparing diuretics, potassium supplements, or salt substitutes; concurrent therapy with hydrochlorothiazide may reduce the frequency of this effect
Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for renal function changes (including acute renal failure) compared to monotherapy; closely monitor blood pressure
Hypotension may occur in patients who are salt or volume depleted (correct the volume depletion especially in patients receiving high dose diuretics)
Intestinal problems (ie, sprue-like enteropathy) reported with olmesartan; symptoms may include severe, chronic diarrhea with substantial weight loss
Hydrochlorothiazide can cause hypokalemia and hyponatremia; hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion
Drugs that inhibit the renin-angiotensin system can cause hyperkalemia; monitor serum electrolytes periodically
Electrolyte disturbances may occur
Photosensitivity may occur
Hyperuricemia may occur or gout may be precipitated in certain patients receiving thiazide therapy
Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides
Thiazides may decrease urinary calcium excretion
Caution in aortic mitral stenosis, hepatic impairment, hypercholesterolemia, hypercalcemia, parathyroid disease, pre-existing renal insufficiency, systemic lupus erythematosus, bilateral renal artery stenosis or anuria
Pregnancy and lactation
Pregnancy category: C (1st trimester); D (2nd & 3rd trimesters)
Lactation: discontinue drug or do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
