General Considerations

The recommended starting dose of PRESTALIA is 3.5/2.5 mg once daily.

Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. The maximum recommended dose is 14/10 mg once daily [see Clinical Pharmacology (12.3)].

PRESTALIA may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals.

Consider use in patients unable to achieve adequate antihypertensive effect with amlodipine monotherapy because of dose-limiting peripheral edema caused by amlodipine [see Adverse Reactions (6)].

Administered as monotherapy, perindopril erbumine is an effective treatment for hypertension in once-daily doses ranging from 4 mg to 16 mg daily. Amlodipine is effective in once-daily doses of 5 mg and 10 mg. Adverse reactions related to perindopril are generally uncommon and independent of dose, while those related to amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter [see Adverse Reactions (6)].

Dosage Adjustment in Renal Impairment

PRESTALIA is not recommended in patients with creatinine clearances <30 mL/min. For patients with creatinine clearance between 30 and 80 mL/min (mild or moderate renal impairment), do not exceed 7/5 mg [see Use in Specific Populations (8.6) and Warnings and Precautions (5.7)].

Monitoring in Elderly Patients (Over 65 Years of Age)

Monitor blood pressure for up to two weeks following titrations at dosages above 7/5 mg in patients over 65 years of age [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].