USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, ROVIL PLUS should be discontinued as soon as possible.
INDICATIONS AND USAGE:
ROVIL PLUS (irbesartan-hydrochlorothiazide) tablets are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy.
ROVIL PLUS is contraindicated in patients who are hypersensitive to any component of this product.
Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
Body as a Whole: chest pain, fatigue, influenza.
Cardiovascular: edema, tachycardia.
Gastrointestinal: abdominal pain, dyspepsia/heartburn, nausea/vomiting.
Musculoskeletal: musculoskeletal pain.
Nervous System: dizziness, dizziness orthostatic.
The following adverse events were also reported at a rate of 1% or greater, but were as, or more, common in the placebo group: headache, sinus abnormality, cough, URI, pharyngitis, diarrhea, rhinitis, urinary tract infection, rash, anxiety/nervousness, and muscle cramp.
Adverse events occurred at about the same rates in men and women, older and younger patients, and black and non-black patients.
DOSAGE AND ADMINISTRATION:
The recommended initial dose of irbesartan is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.
A lower initial dose of irbesartan (75 mg) is recommended in patients with depletion of intravascular volume. Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.
Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily.
To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
ROVIL PLUS may be administered with other antihypertensive agents.
ROVIL PLUS may be administered with or without food.
The usual dose of ROVIL PLUS is one tablet once daily. More than two tablets once daily is not recommended. The maximal antihypertensive effect is attained about 2-4 weeks after initiation of therapy.
Use in Patients with Renal Impairment
The usual regimens of therapy with ROVIL PLUS may be followed as long as the patient' creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so ROVIL PLUS is not recommended.
Patients with Hepatic Impairment
No dosage adjustment is necessary in patients with hepatic impairment.
Boxes of 30 tablets.