Prexxartan Oral Solution Dosage

2.1 General Considerations

PREXXARTAN is not therapeutically equivalent to the tablet formulation of Diovan. The peak concentration of valsartan with PREXXARTAN is higher than with Diovan [see Warnings and Precautions (5.2), Clinical Pharmacology (12.3)]. Follow dosing instructions given here.

2.2 Adult Hypertension

The recommended starting dose of PREXXARTAN is 40 mg or 80 mg twice daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions in blood pressure may be started at 80 mg administered twice a day. PREXXARTAN may be used over a total daily dose range of 80 mg to 320 mg.

The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the total daily dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.

No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Monitor closely patients with severe hepatic or renal impairment.

PREXXARTAN may be administered with other antihypertensive agents.

2.3 Pediatric Hypertension 6 to 16 Years of Age

The recommended starting dose is 0.65 mg/kg twice daily (up to 40 mg total daily dose). The dosage should be adjusted according to blood pressure response. Doses higher than 1.35 mg/kg twice daily (or >160 mg total daily dose) have not been studied in pediatric patients 6 to 16 years old.

No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73 m2[see Use in Specific Populations (8.4)].

PREXXARTAN is not recommended for patients under 6 years of age [see Adverse Reactions (6.1), Use in Specific Populations (8.4), Clinical Studies (14.1)].

2.4 Heart Failure

The recommended starting dose of PREXXARTAN is 40 mg twice daily. Titrate to 80 mg and 160 mg twice daily, as tolerated by the patient. Consider reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses.

2.5 Post-Myocardial Infarction

PREXXARTAN may be initiated as early as 12 hours after a myocardial infarction. The recommended starting dose of PREXXARTAN is 20 mg twice daily. Patients may be up titrated within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consider dosage reduction. PREXXARTAN may be given with other standard post-myocardial infarction treatment, including thrombolytics, aspirin, beta-blockers, and statins.