Natrixam

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

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

1 tab once daily preferably in the morning.

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

Hypersensitivity to indapamide, amlodipine, other sulfonamides, or to dihydropyridine derivatives. Hepatic encephalopathy or severe impairment of liver function; hypokalemia, severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of left ventricle (eg, high grade aortic stenosis), hemodynamically unstable heart failure after acute MI. Severe renal failure (CrCl <30 mL/min). Lactation.

Fixed dose combination is not suitable for initiation therapy. Discontinue immediately if hepatic encephalopathy or photosensitivity occurs. Protect exposed areas to the sun or to artificial UVA. Hypertensive crisis. Hyponatremia; measure plasma Na before starting treatment, then at regular intervals subsequently. Hypokalemia may cause muscle disorders. Increased urinary excretion of Mg resulting in hypomagnesemia. May lead to secondary compensatory metabolic alkalosis w/ concomitant loss of Cl ions. Risk of onset of hypokalemia in high-risk populations eg, elderly, malnourished &/or polymedicated, cirrhotic patients w/ edema & ascites, CAD & cardiac failure patients; patients w/ long QT interval whether the origin is congenital or iatrogenic. May decrease urinary Ca excretion & slight & transitory rise in plasma Ca. Frank hypercalcemia may be due to previously unrecognized hyperparathyroidism. W/draw treatment before the investigation of parathyroid function. Monitor blood glucose particularly in the presence of hypokalemia in diabetic patients. CHF. Hypovolemia. Increased gout attacks in hyperuricemic patients. Choroidal effusion, acute myopia & secondary angle-closure glaucoma. Athletes. Contains <1 mmol Na/tab. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Minor or moderate influence on the ability to drive & use machines. Mild to moderate hepatic impairment. Not recommended during pregnancy. Childn & adolescents. Elderly (treat according to renal function).

Indapamide: Hypokalemia; maculopapular rash. Amlodipine: Edema. Somnolence, dizziness, headache; visual impairment, diplopia; palpitations; flushing; dyspnea; abdominal pain, nausea, dyspepsia, change of bowel habit, diarrhea, constipation; ankle swelling, muscle spasms; fatigue, asthenia.

Indapamide: Increased plasma lithium. Increased risk of ventricular arrhythmias w/ torsades de pointes-inducing drugs eg, class Ia (quinidine, hydroquinidine, disopyramide) & class III (amiodarone, sotalol, ibutilide, dofetilide, ibutilide) antiarrhythmics; phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, sultopride, tiapride), butyrophenones (droperidol, haloperidol); bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine IV. Possible reduction of antihypertensive effect w/ NSAIDs (systemic route) including COX-2 selective inhibitors, high dose salicylic acid (≥3 g/day). Risk of sudden hypotension &/or acute renal failure w/ ACE inhibitors. Increased risk of hypokalemia w/ other compd causing hypokalemia eg, amphotericin B (IV), gluco- & mineralocorticoids (systemic route), tetracosactide, stimulant laxatives. Hypokalemia predisposing to the toxic effects of digitalis. Increased antihypertensive effect w/ baclofen. May increase incidence of hypersensitivity reactions to allopurinol. Hypokalemia or hyperkalemia (particularly in patients w/ renal failure or diabetes) w/ K-sparing diuretics (amiloride, spironolactone, triamterene). Increased risk of metformin-induced lactic acidosis. Increased risk of acute renal failure w/ large doses of iodinated contrast media. Increased antihypertensive effect & risk of orthostatic hypotension w/ imipramine-like antidepressants, neuroleptics. Risk of hypercalcemia w/ Ca (salts). Risk of increased plasma creatinine w/ ciclosporine, tacrolimus. Decreased antihypertensive effect w/ corticosteroids, tetracosactide (systemic route). Amlodipine: Risk of hyperkalemia w/ dantrolene (infusion). Increased bioavailability w/ grapefruit or grapefruit juice. Increased exposure w/ strong or moderate CYP3A4 inhibitors [PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil or diltiazem]. Increased risk of hypotension w/ clarithromycin. Lowered plasma conc w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Added BP-lowering effects w/ other medicinal products w/ antihypertensive properties. Risk of increased tacrolimus blood levels. Increased exposure to 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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