سعر ناتريكسام ام ار 1.5/10مجم 28 قرص 2025

Natrixam M.R. 1.5/10 mg, 28 modified-release film-coated tablets (indapamide 1.5 mg + amlodipine 10 mg), Servier: substitution therapy for essential hypertension.

• Substitution therapy for essential hypertension in patients already controlled with indapamide and amlodipine given concurrently at the same dose level.Population: Adults already controlled on the free combinationEthiopian Food and Drug Authority (EFDA)

• Most commonly reported with the components given separately: hypokalaemia, somnolence, dizziness, headache, visual impairment, diplopia, palpitations, flushing, dyspnoea, abdominal pain, nausea, dyspepsia, change of bowel habit, diarrhoea, constipation, maculopapular rash, ankle swelling, muscle spasms, oedema, fatigue and asthenia.International label, same product · Ethiopian Food and Drug Authority (EFDA)

• Hypersensitivity to the active substances, other sulfonamides, dihydropyridines or excipients; severe renal failure; hepatic encephalopathy or severe liver impairment; hypokalaemia; severe hypotension; shock (including cardiogenic); left ventricular outflow obstruction (e.g. high-grade aortic stenosis); haemodynamically unstable heart failure after acute myocardial infarction.International label, same product · Ethiopian Food and Drug Authority (EFDA)

• Indapamide component: risk of hepatic encephalopathy in liver impairment, photosensitivity, hyponatraemia and hypokalaemia (with arrhythmia/torsades de pointes risk), slight rise in plasma calcium, and need for glucose monitoring in diabetics. Amlodipine component: safety in hypertensive crisis not established; caution in heart failure.International label, same product · Ethiopian Food and Drug Authority (EFDA)

• LithiumIncreased plasma lithium with signs of overdose (decreased urinary lithium excretion); if a diuretic is necessary, careful monitoring of plasma lithium and dose adjustment are required.Ethiopian Food and Drug Authority (EFDA)
• Strong or moderate CYP3A4 inhibitors; CYP3A4 inducers; grapefruitCYP3A4 inhibitors may increase amlodipine exposure; inducers (e.g. rifampicin, St John's wort) may lower it; grapefruit or grapefruit juice is not recommended.Ethiopian Food and Drug Authority (EFDA)
• SimvastatinAmlodipine 10 mg increased simvastatin 80 mg exposure by 77%; limit simvastatin to 20 mg daily in patients on amlodipine.Ethiopian Food and Drug Authority (EFDA)

• Not recommended during pregnancy. Indapamide: limited data; prolonged third-trimester thiazide exposure can reduce maternal plasma volume and uteroplacental blood flow; rare neonatal hypoglycaemia and thrombocytopenia after exposure near term. Amlodipine: safety in human pregnancy not established; reproductive toxicity at high doses in animals.International label, same product · Ethiopian Food and Drug Authority (EFDA)
• Not recommended during lactation (EFDA-published SmPC, revision 04.2022): insufficient data on excretion of indapamide in milk (possible sulfonamide hypersensitivity/hypokalaemia in the infant; thiazide-like diuretics may suppress lactation); unknown whether amlodipine is excreted in milk.International label, same product · Ethiopian Food and Drug Authority (EFDA)

• Indapamide: Inhibits sodium reabsorption in the cortical diluting segment, increasing urinary sodium and chloride excretion (and to a lesser extent potassium and magnesium); antihypertensive action linked to improved arterial compliance and reduced peripheral resistance.
• Amlodipine: Inhibits transmembrane calcium influx into vascular smooth muscle and cardiac muscle; peripheral arterial vasodilator.