Generic name: perindopril arginine 3.5mg, amlodipine besylate 2.5mg
Dosage form: tablet
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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.
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 (6.1)].
PRESTALIA may be taken with or without food [see Clinical Pharmacology (12.3)].
Administered as monotherapy, perindopril erbumine is an effective treatment for hypertension in once-daily doses ranging from 4 mg to 16 mg daily but data are lacking to link these doses of perindopril erbumine to doses of PRESTALIA. 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
Perindoprilat elimination is decreased in renally impaired patients. PRESTALIA is not recommended in patients with creatinine clearances <30 mL/min. For patients with lesser degrees of impairment, the dose of PRESTALIA should not exceed 7/5 mg. [see Warnings and Precautions (5.7)]
Dosing in Specific Populations
Hepatic Impairment: The bioavailability of perindoprilat is increased in patients with impaired hepatic function [see Clinical Pharmacology (12.3)]. Therefore, PRESTALIA should be administered with caution to such patients. [see Warnings and Precautions (5.8)]
Renal Impairment: Pharmacokinetic data indicate that perindoprilat elimination is decreased in renally impaired patients. At creatinine clearances of 30 mL/min to 80 mL/min, AUC is about double that at 100 mL/min. When creatinine clearance drops below 30 mL/min, AUC increases more markedly. [see Warnings and Precautions (5.7)]
During dialysis, perindopril is removed with the same clearance as in patients with normal renal function. Amlodipine is highly protein bound and largely unaffected by hemodialysis.
PatientsOlder than 65 Years of Age: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, and cardiac function, and of concomitant disease and other drug therapy. In patients older than 65 years of age, PRESTALIA should usually be started at the lowest dose and should be titrated slowly.
Plasma concentrations of both perindopril and perindoprilat in elderly patients (>65 years) are approximately twice those observed in younger patients, reflecting both increased conversion of perindopril to perindoprilat and decreased renal excretion of perindoprilat. Clearance of amlodipine is decreased in elderly patients, resulting in an increased area under the plasma concentration curve (AUC) of approximately 40% to 60%. [see Use in Specific Populations (8.5)]
Use with Diuretics: In patients who are currently being treated with a diuretic, symptomatic hypotension can occur following the initial dose of PRESTALIA. Consider reducing the dose of diuretic prior to starting PRESTALIA. [see Drug Interactions (7)]