Alkapress Plus 5/160 mg 14 tablets

Alkapress Plus 5/160 mg 14 tablets

Composition
Active ingredients:
- Amlodipine besylate 6.9 mg (equivalent to amlodipine 5 mg)
- Valsartan 160 mg.
Excipients:
Crospovidone, Sodium starch glycolate, Microcrystalline cellulose (Avicel PH101), Microcrystalline cellulose (Avicel PH102), Colloidal silicon dioxide (Aerosil 200), Magnesium stearate.
Description:
Alkapress Plus is a fixed-dose combination antihypertensive product containing amlodipine, a dihydropyridine calcium-channel blocker, and valsartan, an angiotensin II receptor antagonist.
The combination lowers blood pressure by reducing peripheral vascular resistance, inhibiting angiotensin II–mediated vasoconstriction, and promoting vasodilation.
It is used to achieve blood pressure control in patients who require combination therapy.
Indications for Use:
- Hypertension. 
Alkapress Plus is indicated for the treatment of hypertension to lower blood pressure, which reduces the risk of cardiovascular events such as stroke and myocardial infarction.
Used in:
- Patients not adequately controlled on amlodipine or valsartan monotherapy;
- Patients likely to require multiple antihypertensive agents to reach target blood pressure goals.
Dosage and Method of Administration:
General dosing:
- Once daily administration.
- Usual initial dose: 5/160 mg once daily in patients who are not volume-depleted.
- Dose may be increased after 1–2 weeks.
- Maximum dose: 10/320 mg once daily.
Add-on therapy:
- Patients not adequately controlled on amlodipine or valsartan alone may switch to Alkapress Plus.
- Patients with dose-limiting adverse reactions to either component may switch to a combination containing a lower dose of that component.
Replacement therapy:
- Patients receiving the two components separately may switch to the corresponding fixed combination.
Administration: May be taken with or without food.
Contraindications
- Hypersensitivity to amlodipine, valsartan, or any component of the product.
- Concomitant use of aliskiren in diabetic patients.
Precautions:
- Fetal toxicity: drugs acting on the renin-angiotensin system cause fetal injury and death; discontinue immediately when pregnancy is detected.
- Hypotension: particularly in volume- and/or salt-depleted patients; correct depletion before initiating therapy.
- Heart failure and post-MI: risk of symptomatic hypotension; initiate with caution.
- Renal impairment: possible acute renal failure; monitor renal function.
- Hyperkalemia: possible during RAS inhibition; monitor electrolytes.
- Risk of myocardial infarction or worsening angina: may occur when initiating amlodipine in severe coronary artery disease.
Side Effects
Most common (≥2%):
- Peripheral edema
- Nasopharyngitis
- Upper respiratory tract infection
- Dizziness
Less common (<1%):
- Orthostatic hypotension
- Postural dizziness.
Pregnancy and Breastfeeding:
Pregnancy:
Discontinue Alkapress Plus as soon as pregnancy is detected due to risk of severe fetal toxicity.
Lactation:
Limited data on presence in human milk.
Breastfeeding is not recommended during treatment with Alkapress Plus.
Storage Conditions:
Store below 30°C.
Keep in a dry place.
Keep out of reach of children.
Packaging:
Carton box containing 2 strips, each with 7 tablets.
Inner leaflet included.