Prestalia(perindopril arginine and amlodipine besylate) tablets
PRESTALIA Rx
Hypertension  Only 4 drugs may be compared at once
Generic Name and Formulations:
Perindopril arginine, amlodipine; 3.5mg/2.5mg, 7mg/5mg, 14mg/10mg; tabs.
Company:
Symplmed

Select therapeutic use: Hypertension
Indications for PRESTALIA:
Hypertension.

Adult:
Initially 3.5mg/2.5mg once daily. Adjust at 7–14 day intervals; max 14mg/10mg once daily. Renal impairment: (CrCl <30mL/min): not recommended; (CrCl 30–80mL/min): max 7mg/5mg. Elderly (>65yrs): if dose titrations >7mg/5mg, monitor BP for up to 2 weeks.

Children:
Not established.

Contraindications:
History of ACEI-associated or other angioedema. Concomitant aliskiren in patients with diabetes. Concomitant neprilysin inhibitor (eg, sacubitril); do not give within 36 hours of switching to or from sacubitril/valsartan.

Warnings/Precautions:
Fetal toxicity may develop; discontinue if pregnancy is detected. Discontinue if angioedema, laryngeal edema occurs. Severe obstructive coronary artery disease. Salt/volume depletion. Severe aortic stenosis. Surgery. Monitor for hyperkalemia. Diabetes. Renal artery stenosis. Severe CHF. Post-MI. Monitor renal function periodically during treatment; consider withholding or discontinuing if significant renal dysfunction occurs. Dialysis. Discontinue if jaundice or marked elevations of liver enzymes occur. Elderly (>65yrs). Pregnancy (Cat.D). Nursing mothers: not recommended.

Interactions:
See Contraindications. Increased risk of angioedema with concomitant neprilysin inhibitor or mTOR inhibitor (eg, temsirolimus). Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended. Hyperkalemia with K+ supplements, K+ sparing diuretics, K+ containing salt substitutes, others (eg, cyclosporine, indomethacin, heparin). Potentiated by diuretics. May increase lithium levels; monitor. May be antagonized by, and renal toxicity potentiated by, NSAIDs, including selective COX-2 inhibitors (monitor renal function periodically in elderly and/or volume depleted). Potentiates simvastatin; limit simvastatin dose to 20mg daily. Monitor cyclosporine levels. May be potentiated by moderate or strong CYP3A inhibitors (eg, diltiazem, itraconazole); monitor and may need dose adjustments. Monitor BP if coadministered with CYP3A4 inducers. Nitritoid reactions with concomitant injectable gold (eg, sodium aurothiomalate); rare.

Pharmacological Class:
ACE inhibitor + dihydropyridine calcium channel blocker (CCB).

Adverse Reactions:
Edema, cough, headache, dizziness; angioedema, hypotension, hyperkalemia.

Generic Availability:
NO

How Supplied:
Tabs—90