Alkapress Trio 5/160/25 mg 14 tablets

Description:

Alkapress Trio is a fixed-dose combination of a calcium channel blocker (amlodipine), an angiotensin II receptor blocker (valsartan), and a thiazide diuretic (hydrochlorothiazide). It is used in patients whose blood pressure is not adequately controlled with any two of these components. Lowering blood pressure helps reduce the risk of strokes and heart attacks.

Indications for Use:

Treatment of hypertension in adults.
For patients not adequately controlled on two antihypertensive components (ARB, CCB, diuretic)

Dosage and Method of Administration:

Take once daily by mouth, swallow whole tablet without splitting
Dosage may be increased after 2 weeks if needed
Maximum recommended dose: 10 mg / 320 mg / 25 mg
Not intended for initial therapy
May be used with other antihypertensive agents

Contraindications:

-Hypersensitivity to any component
-Anuria
-Concomitant use with aliskiren in patients with diabetes or renal impairment (GFR < 60 ml/min/1.73m²)
-Pregnancy

Precautions:

Fetal toxicity: discontinue immediately if pregnancy is detected
Hypotension: correct volume or salt depletion before starting
Renal impairment: monitor function; discontinue if acute kidney injury occurs
Electrolyte imbalance: monitor potassium, magnesium, sodium, and calcium
Angina/myocardial infarction: may worsen with amlodipine initiation or dose increase
Glaucoma risk: hydrochlorothiazide may induce acute angle-closure
Other risks: hypersensitivity, gout, increased lipids, altered glucose tolerance

Pregnancy and Breastfeeding
Contraindicated during pregnancy
Not recommended during breastfeeding
May affect fertility

Side Effects:

Common: dizziness, edema, fatigue, muscle cramps, headache
GI: dyspepsia, nausea
Vascular: hypotension, orthostatic hypotension
Renal: impaired renal function, acute renal failure
Nervous system: syncope
Rare: gynecomastia, hepatitis, rash, angioedema, rhabdomyolysis, alopecia

Storage Conditions:

Store at a temperature not exceeding 30°C in a dry, light-protected place.

Packaging:

Carton box containing 1 blister of 14 film-coated tablets and a package insert.