Natrixam

Natrixam

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
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
Indications/Uses
Substitution therapy for the treatment of essential HTN in patients already controlled w/ indapamide & amlodipine given concurrently at the same dose level.
Dosage/Direction for Use
1 tab once daily preferably in the morning. The fixed dose combination is not suitable for initiation therapy. If a change of dosing is required, titration should be done w/ the individual components.
Administration
May be taken with or without food: Swallow whole w/ water, do not chew.
Contraindications
Hypersensitivity to indapamide/amlodipine or other sulfonamides or to dihydropyridine derivatives. Severe renal failure (CrCl <30 mL/min), 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), unstable heart failure after acute MI. Lactation.
Special Precautions
Discontinue immediately if hepatic encephalopathy or photosensitivity occur. Protect exposed areas to the sun or to artificial UVA. Hypertensive crisis. Measure plasma Na before start of treatment then at regular intervals subsequently. Risk of onset of hypokalemia on elderly, malnourished &/or polymedicated, cirrhotic patients w/ edema & ascites, CAD & cardiac failure patients; patients w/ long QT interval. Frank hypercalcemia may be due to previously unrecognized hyperparathyroidism. Monitor blood glucose in diabetics. Caution in patients w/ CHF; hyperuricemic patients; galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Mild to moderate hepatic impairment. May affect ability to drive or use machines. Not recommended during pregnancy. Childn & adolescents. Elderly (dose adjustment; treat according to renal function).
Adverse Reactions
Hypokalemia, somnolence, dizziness, headache, visual impairment, diplopia, palpitations, flushing, dyspnea, abdominal pain, nausea, dyspepsia, change of bowel habit, diarrhea, constipation, rash maculo-papular, ankle swelling, muscle spasms, edema, fatigue & asthenia.
Drug Interactions
Linked to indapamide: May decrease urinary lithium excretion. Increased risk of ventricular arrhythmias w/ torsades de pointes-inducing drugs eg, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, ibutilide; phenothiazine & benzamide antipsychotics; 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 when treatment w/ ACE inhibitors. Increased risk of hypokalemia w/ other compd causing hypokalemia eg, amphotericin B (IV), gluco- & mineralo-corticoids (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. May cause hypokalemia or hyperkalemia w/ K-sparing diuretics (amiloride, spironolactone, triamterene). May increase risk of metformin-induced lactic acidosis. Increased risk of acute renal failure w/ large doses of iodinated contrast media. Increased 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 corticosteroids, tetracosactide (systemic route). Linked to indapamide: Risk of hyperkalemia w/ dantrolene (infusion). Increased BP-lowering effects w/ grapefruit or grapefruit juice. Increased amlodipine exposure w/ strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides eg, erythromycin or clarithromycin, verapamil or diltiazem). Lowered plasma conc of amlodipine w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Added BP-lowering effects w/ other medicinal products. Risk of increase in tacrolimus blood levels. May increase exposure of simvastatin.
ATC Classification
C08GA02 - amlodipine and diuretics ; Belongs to the class of calcium-channel blockers in combination with diuretics. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Natrixam 1.5 mg/5 mg MR tab
Packing/Price
30's (P626.72/box)
Form
Natrixam 1.5 mg/10 mg MR tab
Packing/Price
30's (P709.8/box)
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