Natrixam

Per 1.5 mg/5 mg MR-FC tab Indapamide 1.5 mg, amlodipine 5 mg. Per 1.5 mg/10 mg MR-FC tab Indapamide 1.5 mg, amlodipine 10 mg

Substitution therapy for essential HTN in patients already controlled w/ indapamide & amlodipine given concurrently at same dose level.

1 tab once daily.

May be taken with or without food: Preferably taken in the morning. Swallow whole w/ water, do not chew.

Hypersensitivity to indapamide, amlodipine, other sulfonamides & dihydropyridine derivatives. Hypokalaemia; severe hypotension; cardiogenic shock; left ventricle outflow tract obstruction eg, high grade aortic stenosis; haemodynamically unstable heart failure after acute MI. Severe renal failure (CrCl <30 mL/min); hepatic encephalopathy or severe hepatic impairment.

History of sulfonamide or penicillin allergy. Discontinue use if hepatic encephalopathy which can progress to hepatic coma; photosensitivity reactions; choroidal effusion w/ visual field defect, transient myopia, acute angle-closure glaucoma occur. Hypertensive crisis; severe heart failure (NYHA class III & IV), CHF. Hyperuricaemic patients; hypovolaemia. Avoid exposure to sun or artificial UVA. Monitor water & electrolyte (plasma Na, K, Mg, Ca) balance, blood glucose regularly. +ve reaction in doping tests. Not to be administered in patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Mild to moderate hepatic impairment. Preexisting renal insufficiency. Not recommended during pregnancy & lactation. Childn & adolescents.

Indapamide: Hypokalaemia; maculopapular rash. Amlodipine: Oedema. Somnolence, dizziness, headache; visual impairment, diplopia; palpitations; flushing; dyspnoea; abdominal pain, nausea, dyspepsia, change of bowel habit, diarrhoea, constipation; swelling ankle, muscle spasms; fatigue, asthenia.

Indapamide: Increased plasma lithium. Increased risk of ventricular arrhythmias w/ Torsade de pointes-inducing drugs eg, class IA & III antiarrhythmics, some antipsychotics (eg, phenothiazines, benzamides, butyrophenones, pimozide), bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine IV, methadone, astemizole, terfenadine. Reduced antihypertensive effect w/ systemic NSAIDs eg, COX-2 selective inhibitors, high-dose ASA (≥3 g daily). Risk of sudden hypotension &/or acute renal failure w/ ACE inhibitors. Increased risk of hypokalaemia w/ IV amphotericin B, systemic gluco- & mineralocorticoids, tetracosactide, stimulant laxatives. Hypokalaemia &/or hypomagnesaemia predisposed to digitalis toxicity w/ digitalis prep. Increased antihypertensive effect w/ baclofen. Increased incidence of hypersensitivity reactions to allopurinol. Hypo- or hyperkalaemia w/ K-sparing diuretics eg, amiloride, spironolactone, triamterene. Increased risk of metformin-induced lactic acidosis. Increased risk of acute renal failure w/ iodinated contrast media (large doses). Increased antihypertensive effect & risk of orthostatic hypotension w/ imipramine-like antidepressants, neuroleptics. Decreased urinary Ca elimination. Increased plasma creatinine w/ ciclosporin, tacrolimus. Decreased antihypertensive effect w/ corticosteroids, systemic tetracosactide. Amlodipine: Risk of hyperkalaemia w/ dantrolene infusion. Increased bioavailability w/ grapefruit or grapefruit juice. Increased exposure w/ strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides (ie, erythromycin or clarithromycin), verapamil or diltiazem. Increased risk of hypotension w/ clarithromycin. Varied conc w/ strong CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Additive BP-lowering effects to other antihypertensives. Increased tacrolimus blood levels. Increased exposure of mTOR inhibitors eg, sirolimus, temsirolimus, everolimus. Increased exposure w/ simvastatin.

Calcium Antagonists / Diuretics

C08GA02 - amlodipine and diuretics ; Belongs to the class of calcium-channel blockers in combination with diuretics. Used in the treatment of cardiovascular diseases.

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