Coveram 10/5 mg 15 tablets

Coveram 10/5 mg 15 tablets

Composition:
Each tablet contains:
- Perindopril arginine - 10 mg
- Amlodipine - 5 mg.
Excipients:
Lactose monohydrate, magnesium stearate, colloidal anhydrous silica, microcrystalline cellulose, crospovidone, sodium starch glycolate, povidone, calcium carbonate.
Description:
Coveram is a fixed-dose combination of an angiotensin-converting enzyme (ACE) inhibitor, perindopril arginine, and a calcium channel blocker, amlodipine.
It lowers blood pressure, reduces cardiac workload, dilates blood vessels, and improves coronary blood flow.
Amlodipine inhibits calcium influx into vascular smooth muscle, leading to vasodilation and reduced peripheral resistance.
Perindopril inhibits the conversion of angiotensin I to angiotensin II, thereby preventing vasoconstriction and blood pressure elevation.
Indications for Use:
- Arterial hypertension.
- Stable coronary artery disease (stable angina pectoris).
Indicated for patients requiring both perindopril and amlodipine therapy at fixed doses.
Dosage and Method of Administration:
Administer orally once daily, preferably at the same time each day, with or without food.
Initial dose: perindopril 3.5 mg/amlodipine 2.5 mg once daily, titrating every 7-14 days according to response.
Maximum daily dose: perindopril 14 mg/amlodipine 10 mg.
The dosage should be individualized and determined by the physician.
Contraindications:
- Hypersensitivity to perindopril, amlodipine, other ACE inhibitors, or dihydropyridine derivatives.
- Severe hypotension (systolic BP < 90 mmHg).
- Cardiogenic shock.
- Left ventricular outflow tract obstruction.
- Severe heart failure after myocardial infarction.
- Pregnancy and lactation.
- Age under 18 years.
- History of angioedema (including with ACE inhibitors).
- Concomitant use with aliskiren in patients with diabetes or renal impairment (eGFR < 60 mL/min/1.73 m²).
Precautions:
Use with caution in:
- Renal or hepatic impairment.
- Renal artery stenosis (including bilateral).
- Connective tissue diseases (SLE, scleroderma).
- Concomitant use with immunosuppressants, potassium-sparing diuretics, potassium supplements, lithium.
- Congestive heart failure, aortic/mitral stenosis, hypertrophic cardiomyopathy.
- Surgery or anesthesia, hypovolemia, dehydration.
- Patients of African descent (possible reduced efficacy).
Side Effects:
- Amlodipine-related:
Peripheral edema, flushing, palpitations, pruritus, rash, abdominal pain, nausea, dizziness, drowsiness, fatigue, muscle cramps, dyspepsia, constipation, gingival hyperplasia, pancreatitis, tremor, vision disturbances, tinnitus, depression, anxiety, insomnia, back pain, arthralgia, myalgia, thrombocytopenia, angioedema, hyperglycemia, weight gain or loss.
- Perindopril-related:
Headache, cough, edema, chest pain, ECG abnormality, palpitations, sleep disorder, paresthesia, nervousness, rash, diarrhea, abdominal pain, nausea, vomiting, proteinuria, renal impairment, myalgia, arthralgia, elevated ALT, AST, creatinine.
Pregnancy and Lactation:
- Contraindicated during pregnancy and breastfeeding.Drugs acting on the renin-angiotensin system may harm the fetus.
- Amlodipine is excreted in human milk; data on perindopril are limited.
- Breastfeeding should be discontinued during treatment.
Storage Conditions:
Store below 25 °C, in a dry place protected from light.
Packaging:
A carton box containing 15 tablets and a package insert.