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 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 dihydropyridine derivatives. Hepatic encephalopathy or severe impairment of liver function. Hypokalemia. Severe hypotension. Shock (including cardiogenic shock). Obstruction of the outflow tract of the left ventricle eg, high grade aortic stenosis. Hemodynamically unstable heart failure after acute MI. Severe renal failure (CrCl <30 mL/min).

Discontinue use if hepatic encephalopathy or photosensitivity reactions occurs. Discontinue use as rapidly as possible if symptoms of choroidal effusion, acute myopia & secondary angle-closure glaucoma appear. Protect exposed areas to the sun or to artificial UVA. Hypertensive crisis. Hyponatremia; measure plasma Na prior to treatment then regularly 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 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 prior to investigation of parathyroid function. Monitor blood glucose particularly in presence of hypokalemia in diabetic patients. Patients w/ CHF. Hypovolemia. May increase tendency to gout attacks in hyperuricemic patients. May cause +ve reaction in doping tests. Not to be administered to patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Contains <1 mmol Na/tab. Minor or moderate influence on ability to drive & use machines. Renal impairment. Mild to moderate hepatic impairment. Not recommended during pregnancy & lactation. Elderly.

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 (eg, quinidine, hydroquinidine, disopyramide) & class III (eg, amiodarone, sotalol, ibutilide, dofetilide, ibutilide, bretylium) antiarrhythmics; phenothiazines (eg, chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (eg, amisulpride, sulpiride, sultopride, tiapride), butyrophenones (eg, 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 ASA (≥3 g daily). Risk of sudden hypotension &/or acute renal failure w/ ACE inhibitors. Increased risk of hypokalemia (additive effect) w/ other compd causing hypokalemia eg, amphotericin B (IV), gluco- & mineralocorticoids (systemic route), tetracosactide, stimulant laxatives. Hypokalemia &/or hypomagnesaemia predisposing to 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 eg, amiloride, spironolactone, triamterene. Increased risk of metformin-induced lactic acidosis. Increased risk of acute renal failure w/ large doses of iodinated contrast media. Antihypertensive effect & increased risk of orthostatic hypotension (additive effect) 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). Bioavailability may be increased w/ grapefruit or grapefruit juice. Exposure may be increased w/ strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil or diltiazem. Increased risk of hypotension w/ clarithromycin. Plasma conc may vary w/ strong CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Additive BP-lowering effects to other medicinal products w/ antihypertensive properties. Risk of increased tacrolimus blood levels. May increase exposure of mechanistic target of rapamycin inhibitors eg, sirolimus, temsirolimus & everolimus. Increased trough conc of ciclosporine in renal transplant patients. 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.

Rx