Olmesartan Medoxomil / Hydrochlorothiazide
Pronouncation: (ol-me-SAR-tan me-DOX-oh-mil/HYE-droe-KLOR-oh-THYE-a-zide)Class: Antihypertensive combination
Trade Names:
Benicar HCT
- Tablets olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg
- Tablets olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg
- Tablets olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg
Indications and Usage
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Treatment of hypertension.
Contraindications
Anuria; hypersensitivity to sulfonamide-derivatives or any component of the product.
Dosage and Administration
AdultsPO Titrate the dose based on individual response to each component as monotherapy. The dosage range for olmesartan/hydrochlorothiazide is 10 mg/12.5 mg to 40 mg/25 mg once daily.
Olmesartan: The usual starting dosage of olmesartan is 20 mg once daily as monotherapy. If further reduction of BP is needed after 2 wk of therapy, the dose may be increased to 40 mg. If BP is not controlled by olmesartan alone, hydrochlorothiazide may be added, starting with 12.5 mg and then titrating to 25 mg once daily.
Hydrochlorothiazide: If a patient is taking hydrochlorothiazide, olmesartan may be added, starting with 20 mg once daily and titrating to 40 mg. Consider reducing larger doses of hydrochlorothiazide to 12.5 mg before adding olmesartan.
Renal Function ImpairmentAdults
PO If CrCl is over 30 mL/min, the usual regimens of olmesartan/hydrochlorothiazide may be followed. In more severe renal function impairment, olmesartan/hydrochlorothiazide is not recommended.
General Advice
- May be given with other antihypertensive agents.
- May be given with or without food.
- Depending on the BP, the dose may be titrated at 2‐ to 4‐wk intervals.
Storage/Stability
Store at 68° to 77°F.
Drug Interactions
Alcohol, barbiturates, narcoticsPotentiation of orthostatic hypotension may occur.
Antidiabetic agents (oral agents and insulin)Dosage adjustments of the antidiabetic agent may be needed.
Antihypertensive agentsEffects may be additive or potentiated.
Cholestyramine, colestipolHydrochlorothiazide absorption may be reduced up to 85%.
CorticosteroidsIncreased risk of electrolyte depletion (eg, hypokalemia).
LithiumIncreased risk of lithium toxicity caused by reduced clearance. Do not coadminister.
Nondepolarizing skeletal muscle relaxants (eg, tubocurarine)Effect of muscle relaxant may be enhanced.
NSAIDs (eg, ibuprofen)The antihypertensive effect of hydrochlorothiazide may be reduced.
Pressor amines (eg, norepinephrine)Effect of pressor amine may be reduced.
Laboratory Test Interactions
Hydrochlorothiazide may decrease serum protein-bound iodine levels without signs of thyroid disturbance; may cause diagnostic interference of serum electrolyte levels, blood and urine glucose levels, serum bilirubin levels, and serum uric acid levels; may cause intermittent and slight elevations in serum calcium without known disorders of calcium metabolism.
Adverse Reactions
CNS
Dizziness (9%); vertigo (greater than 1%); asthenia (postmarketing).
Dermatologic
Rash (greater than 1%); alopecia, pruritus, urticaria (postmarketing).
GI
Nausea (3%); abdominal pain, diarrhea, dyspepsia, gastroenteritis (greater than 1%); vomiting (postmarketing).
Genitourinary
Hematuria (greater than 1%); acute renal failure, increased blood creatinine levels (postmarketing).
Hepatic
Increased AST, ALT, and glucose tolerance test (greater than 1%).
Lab Tests
Increased BUN and serum creatinine (1%).
Metabolic-Nutritional
Hyperuricemia (4%); increased creatine phosphokinase, hyperglycemia, hyperlipidemia (greater than 1%).
Musculoskeletal
Arthralgia, arthritis, back pain, myalgia (greater than 1%); rhabdomyolysis (postmarketing).
Respiratory
Upper respiratory tract infection (7%); coughing (greater than 1%).
Miscellaneous
Chest pain, peripheral edema (greater than 1%); angioedema (postmarketing).
Precautions
WarningsCan cause injury and death to the developing fetus when used during the second and third trimester of pregnancy. |
MonitorPerform periodic determinations of serum electrolytes to detect possible electrolyte imbalance. |
Pregnancy
Category C (first trimester); Category D (second and third trimesters).
Lactation
Undetermined.
Children
Safety and efficacy not established.
Elderly
Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.
Hypersensitivity
May occur in patients with or without a history of allergy or bronchial asthma.
Renal Function
Not recommended in patients with severe renal function impairment; cumulative effects may develop in patients with impaired renal function.
Hepatic Function
Use with caution in patients with impaired hepatic function or progressive liver disease.
Hyperglycemia
Hyperglycemia may occur; latent diabetes mellitus may become manifest.
Hyperuricemia
Hyperuricemia or frank gout may be precipitated.
Lipid disorders
Increases in cholesterol and triglyceride levels may occur.
Systemic lupus erythematosus
Activation or exacerbation may occur.
Volume or salt depletion
Symptomatic hypotension may occur after initiation of treatment in patients with an activated renin-angiotensin system (eg, volume- or salt-depleted patients).
Overdosage
Symptoms
Bradycardia, dehydration, electrolyte depletion (ie, hypochloremia, hypokalemia, hyponatremia), hypotension, tachycardia.
Patient Information
- Advise patient to read the patient information material before using product for the first time and with each refill.
- Instruct patient regarding how to store, administer, and dispose of outdated medication.
- Caution patients to inform health care provider if light-headedness occurs. If syncope occurs, the drug should be stopped until the health care provider is contacted.
- Instruct patient to take exactly as prescribed and not to change the dose or discontinue therapy unless advised by health care provider.
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