Classes
DEA Class; Rx
Common Brand Names; Benicar HCT
- ARB/HCTZ Combos
Description
Oral antihypertensive combination product containing an angiotensin II receptor antagonist and thiazide diuretic
Used for the management of hypertension in adults
Additive blood pressure reduction
Indications
Indicated for the treatment of hypertension in patients who do not respond to monotherapy.
Contraindications
Hypersensitivity to olmesartan, hydrochlorothiazide or sulfonamides
Acute transient myopia and acute angle-closure glaucoma in patients with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
Pregnancy (2nd/3rd trimesters)
Anuria
Coadministration with aliskiren in patients with diabetes mellitus
Adverse Effects
Adverse reactions with combination products and individual agents
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%)
- 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
- Non-melanoma skin cancer
Warnings
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history
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
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; instruct patients to protect skin from sun and undergo regular skin cancer screening
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 decrease urinary calcium excretion and may cause elevations of serum calcium; monitor calcium levels.
Thiazide diuretics reported to cause exacerbation or activation of systemic lupus erythematosus
Pregnancy and Lactation
Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters)
Lactation: discontinue drug or do not nurse
Maximum Dosage
40 mg/day PO olmesartan and 25 mg/day PO hydrochlorothiazide.
40 mg/day PO olmesartan and 25 mg/day PO hydrochlorothiazide.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Olmesartan/hydrochlorothiazide
tablet
- 20mg/12.5mg
- 40mg/12.5mg
- 40mg/25mg