Erastapex Co 40/10 mg 30 tablets
Apex Pharma
Apex Pharma
Composition
Each tablet contains
Olmesartan medoxomil 40 mg.
Amlodipine 10 mg.
Excipients: pregelatinized starch, silicified microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Product Description
Erastapex Co is a combined antihypertensive agent containing an angiotensin II receptor antagonist (olmesartan medoxomil) and a calcium channel blocker (amlodipine).
The combination provides synergistic antihypertensive action, resulting in greater blood pressure reduction compared to monotherapy.
Indications for Use
Essential hypertension in patients not adequately controlled by monotherapy with olmesartan medoxomil or amlodipine.
Method of Administration and Dosage
Oral, once daily, at the same time, regardless of meals, swallowed with water.
Recommended dose: 1 tablet containing 5 mg amlodipine + 20 mg olmesartan medoxomil.
If blood pressure reduction is insufficient, 1 tablet containing 10 mg amlodipine + 40 mg olmesartan medoxomil may be used once daily.
Maximum daily dose: olmesartan 40 mg, amlodipine 10 mg.
Contraindications
Severe hepatic impairment (> 9 Child‑Pugh score).
Biliary obstruction, cholestasis.
Severe renal impairment (CrCl < 20 ml/min).
Post‑renal transplant (no clinical experience).
Severe left ventricular outflow obstruction (e.g., severe aortic stenosis).
Severe arterial hypotension (SBP < 90 mmHg).
Shock (including cardiogenic).
Hemodynamically unstable heart failure after myocardial infarction.
Concomitant use with aliskiren in patients with diabetes or renal impairment (eGFR < 60 ml/min/1.73 m²).
Pregnancy, lactation.
Age under 18 years.
Hypersensitivity to olmesartan, amlodipine, dihydropyridine derivatives, or excipients.
Precautions
Use with caution in
Aortic/mitral valve stenosis.
Hypertrophic obstructive cardiomyopathy.
Concomitant lithium therapy.
Hyperkalemia, hyponatremia, hypovolemia.
Mild to moderate renal impairment (CrCl 20–60 ml/min).
Primary aldosteronism.
Renovascular hypertension (bilateral renal artery stenosis or stenosis of a solitary kidney).
Conditions with RAAS activation.
Chronic heart failure (NYHA III–IV).
Ischemic heart disease (acute or chronic).
Sick sinus syndrome, hypotension, cerebrovascular disease.
Mild to moderate hepatic impairment (< 9 Child‑Pugh score).
Elderly patients, patients of African descent.
Adverse Effects
Immune system: rare — hypersensitivity, urticaria.
Nervous system: common — dizziness, headache; uncommon — hypoesthesia, paresthesia, somnolence; rare — syncope.
Psychiatric: uncommon — decreased libido.
Cardiovascular: uncommon — palpitations, tachycardia, marked hypotension, orthostatic hypotension; rare — flushing.
Respiratory: uncommon — cough, dyspnea.
Ear/vestibular: uncommon — vertigo.
Gastrointestinal: uncommon — dry mouth, abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting.
Urinary system: uncommon — pollakiuria.
Reproductive system: uncommon — erectile dysfunction/impotence.
Skin: uncommon — rash.
Musculoskeletal: uncommon — back pain, muscle cramps, limb pain.
Other: common — fatigue, peripheral edema; uncommon — asthenia; rare — facial edema.
Laboratory: uncommon — changes in potassium, uric acid, creatinine, increased GGT activity.
Pregnancy and Lactation
Contraindicated.
Storage Conditions
Store at temperatures not exceeding 30 °C, in a dry place.
Packaging
Carton box containing 3 blisters of 10 tablets and paper insert.