Blokatens 5/160 mg 28 tablets

Blokatens 5/160 mg 28 tablets

Composition:
Each film-coated tablet contains:
Active ingredients:
- Amlodipine besylate 6.9 mg equivalent to 5 mg amlodipine base
- Valsartan 160 mg.
Inactive ingredients:
Microcrystalline cellulose, mannitol, povidone, crospovidone, colloidal silicon dioxide, magnesium stearate, polysorbate 80, hypromellose, polyethylene glycol, titanium dioxide, talc.
Description:
Blokatens is a fixed-dose combination antihypertensive medication containing a calcium channel blocker (amlodipine) and an angiotensin II receptor blocker (valsartan).
It is indicated for patients whose blood pressure is not adequately controlled by monotherapy with either component.
The combination provides additive blood pressure reduction through complementary mechanisms of action.
Indications for use:
- Treatment of essential hypertension in adults whose blood pressure is not adequately controlled on amlodipine or valsartan alone.
Dosage and method of administration:
Individual titration of the components is recommended before switching to the fixed-dose combination.
- Blokatens 5/80 mg: for patients inadequately controlled with amlodipine 5 mg or valsartan 80 mg monotherapy.
- Blokatens 5/160 mg: for patients inadequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
- Blokatens 10/160 mg: for patients not controlled on Blokatens 5/160 mg.
Administer orally with water, with or without food.
Special populations:
- Renal impairment: No adjustment needed for mild to moderate impairment; limited data in severe cases.
- Hepatic impairment: Contraindicated in severe hepatic dysfunction, biliary cirrhosis, or cholestasis. In mild to moderate impairment without cholestasis, maximum valsartan dose is 80 mg daily.
- Elderly: Caution when increasing dosage.
- Pediatric use: Safety and efficacy not established.
Contraindications:
- Hypersensitivity to amlodipine, valsartan, dihydropyridine derivatives, or any excipient.
- Severe hepatic impairment, biliary cirrhosis, or cholestasis.
- Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m²).
- Severe hypotension, cardiogenic shock, obstruction of the left ventricular outflow tract (e.g., aortic stenosis).
- Hemodynamically unstable heart failure after myocardial infarction.
- Pregnancy and lactation.
Precautions:
- Pregnancy: Discontinue immediately if pregnancy is detected; may cause fetal injury or death.
- Hypotension: Possible in volume- or salt-depleted patients.
- Hyperkalemia: Risk increases with potassium supplements or potassium-sparing diuretics.
- Renal artery stenosis: Use with caution; possible increases in urea and creatinine.
- Heart failure or post-MI: Monitor renal function.
- Angioedema: Has been reported with valsartan.
- Dual blockade of RAAS: Avoid concomitant use with ACE inhibitors or aliskiren.
Side effects:
- Common: Headache, dizziness, flushing, peripheral edema, fatigue, nausea.
- Uncommon: Orthostatic hypotension, somnolence, hyperkalemia, tachycardia, rash.
- Rare: Angioedema, leukopenia, thrombocytopenia, elevated liver enzymes.
Pregnancy and breastfeeding:
Contraindicated during pregnancy and lactation.
Drugs acting on the renin-angiotensin system can cause fetal injury or death.
If pregnancy occurs, discontinue immediately.
Storage conditions:
Store below 30°C in a dry place.
Keep in the original package to protect from moisture.
Keep out of reach of children.
Packaging:
Carton box containing 2 blisters 14 film-coated tablets each package leaflet.