CoAprovel Dosage/Direction for Use

General: In patients whose blood pressure is not adequately controlled with irbesartan 300 mg monotherapy, CoAprovel (irbesartan 300 mg/hydrochlorothiazide 12.5 mg) once daily may be administered, with or without food.
CoAprovel (irbesartan 150 mg/hydrochlorothiazide 12.5 mg) may be initiated in patients who are not adequately controlled with hydrochlorothiazide, or irbesartan 150 mg alone.
Patients not responding adequately to CoAprovel (irbesartan 150 mg/hydrochlorothiazide 12.5 mg) can have the dose increased to CoAprovel (irbesartan 300 mg/ hydrochlorothiazide 12.5 mg). Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide are not recommended.
If blood pressure is not adequately controlled with CoAprovel alone, another antihypertensive drug (eg, beta-adrenergic blocking agent, long-acting calcium channel blocking agent) may be added.
Initial Therapy: The usual starting dose for initial therapy with CoAprovel is 150 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 300 mg/25 mg tablet once daily as needed to control blood pressure.
Special Populations: Pediatric patients: Safety and effectiveness in pediatric patients have not been established.
Elderly patients: No dosage reduction is generally necessary in the elderly.
Among patients who received CoAprovel in clinical studies, no overall differences in efficacy or safety were observed between older patients (65 years or older) and younger patients.
Hepatic impairment: No dosage reduction is generally necessary in patients with mild to moderate hepatic impairment. Due to the hydrochlorothiazide component, CoAprovel should be used with caution in patients with severe hepatic impairment. (See Warnings).
Renal impairment: No dosage reduction is generally necessary in patients with mild-to-moderate renal impairment (creatinine clearance >30 mL/min). However, due to the hydrochlorothiazide component, CoAprovel is not recommended for patients with severe renal impairment (creatinine clearance ≤ 30 mL/min). (See Warnings).
Patients with intravascular volume depletion: In severely volume-depleted and/or sodium-depleted patients, such as those treated vigorously with diuretics, the condition should be corrected prior to administration of CoAprovel. (See Warnings).