Irbesartan / Hydrochlorothiazide
Pronunciation: (IR-be-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide)Class: Antihypertensive combination
Trade Names:
Avalide
- Tablets irbesartan 150 mg and hydrochlorothiazide 12.5 mg
- Tablets irbesartan 300 mg and hydrochlorothiazide 12.5 mg
- Tablets irbesartan 300 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 Dose should be titrated based on individual response to each component as monotherapy. The usual dosage is 1 tablet once daily.
Irbesartan: Usual starting dosage of irbesartan is 150 mg once daily as monotherapy. If further reduction of BP is needed, dosage may be titrated to 300 mg once daily. A dosage of irbesartan 75 mg once daily is recommended in patients with depletion of intravascular volume (eg, hemodialysis patients, patients vigorously treated with diuretics).
Hydrochlorothiazide is effective in dosages of 12.5 to 50 mg once daily.
Renal Function ImpairmentAdults
PO If CrCl is more than 30 mL/min, the usual regimens of irbesartan/hydrochlorothiazide may be followed. With more severe renal function impairment, irbesartan/hydrochlorothiazide is not recommended.
General Advice
- May be administered with other antihypertensive agents.
- May be administered with or without food.
- It takes 2 to 4 wk for BP to stabilize after a dose change.
- A patient whose BP is inadequately controlled by irbesartan or hydrochlorothiazide alone may be switched to once-daily irbesartan/hydrochlorothiazide.
Storage/Stability
Store at 59° to 86°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
Cardiovascular
Edema (3%); tachycardia (1%).
CNS
Dizziness (8%); fatigue (7%); orthostatic dizziness (1%).
Dermatologic
Urticaria (postmarketing).
GI
Nausea, vomiting (3%); abdominal pain, dyspepsia/heartburn (2%).
Genitourinary
Abnormal urination (2%).
Hepatic
Jaundice (postmarketing).
Hypersensitivity
Allergy (1%).
Lab Tests
Increased BUN (2%); increased serum creatinine (1%); hyperkalemia (postmarketing).
Musculoskeletal
Musculoskeletal pain (7%).
Miscellaneous
Influenza (3%); chest pain (2%); angioedema involving swelling of face, lips, pharynx, and/or tongue (postmarketing).
Precautions
WarningsCan cause injury and death to developing fetus when used during 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 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 disease; 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 disturbances
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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