Agencia Lei Va Hong
Concise Prescribing Info
Per 1.5 mg/5 mg MR tab Indapamide 1.5 mg, amlodipine besilate 5 mg. Per 1.5 mg/10 mg MR tab Indapamide 1.5 mg, amlodipine besilate 10 mg
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.
May be taken with or without food: Swallow whole w/ water, do not chew.
Hypersensitivity to indapamide/amlodipine or other sulphonamides & dihydropyridine derivatives. Severe renal failure (CrCl <30 mL/min); hepatic encephalopathy or severe liver impairment; hypokalaemia; severe hypotension; shock (including cardiogenic shock); obstruction of the outflow tract of the left ventricle (eg, high grade aortic stenosis); haemodynamically unstable heart failure after acute MI. Lactation.
Special Precautions
Discontinue treatment if hepatic encephalopathy, or photosensitivity reaction occurs. Hypertensive crisis. CHF. Measure plasma Na before starting treatment, then at regular intervals subsequently; frequent monitoring in elderly & cirrhotic patients. Frequently monitor plasma K in high risk populations eg, the elderly, malnourished &/or polymedicated, cirrhotic patients w/ oedema & ascites, CAD & cardiac failure patients. Possible decrease in urinary Ca excretion & slight & transitory rise in plasma Ca. Monitor blood glucose particularly in the presence of hypokalaemia in diabetic patients. Increased gout attacks in hyperuricaemic patients. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Mild to moderate hepatic impairment. Minor or moderate influence on the ability to drive & use machines. Pregnancy. Elderly.
Adverse Reactions
Somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema, fatigue.
Drug Interactions
Indapamide: Increased of plasma lithium. Increased risk of ventricular arrhythmias w/ Torsades de pointes-inducing drugs eg, class Ia (quinidine, hydroquinidine, disopyramide) & class III antiarrhythmics (amiodarone, sotalol, dofetilide, ibutilide), some antipsychotics eg, 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. Reduced 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 hypokalaemia w/ amphotericin B (IV), gluco- & mineralo-corticoids (systemic route), tetracosactide, stimulant laxatives. Increased antihypertensive effect w/ baclofen. Increased incidence of hypersensitivity reactions to allopurinol. Increased risk of metformin induced lactic acidosis. Increased risk of acute renal failure w/ iodinated contrast media. Increased antihypertensive effect & risk of orthostatic hypotension w/ imipramine-like antidepressants, neuroleptics. Risk of hypercalcaemia w/ Ca (salts). Risk of increased plasma creatinine w/ ciclosporin, tacrolimus. Decreased antihypertensive effect w/ corticosteroids, tetracosactide (systemic route). Digitalis prep. K-sparing diuretics (amiloride, spironolactone, triamterene). Amlodipine: Risk of hyperkalaemia w/ dantrolene (infusion). Increased bioavailability w/ grapefruit or grapefruit juice. Increased exposure w/ strong or moderate CYP3A4 inhibitors (PIs, azole antifungals, macrolides-like erythromycin or clarithromycin, verapamil or diltiazem). Decreased plasma conc w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Increased exposure of simvastatin. Additive effect w/ other antihypertensive drugs.
MIMS Class
Calcium Antagonists / Diuretics
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.
Natrixam MR tab 1.5/10 mg
Natrixam MR tab 1.5/5 mg
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