olmesartan/hydrochlorothiazide (Rx)

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

Postmarketing Reports

Hydrochlorothiazide

• Non-melanoma skin cancer

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; 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 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 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.