Natrilam

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

1 tab daily as single dose, 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. 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. Severe renal failure (CrCl <30 mL/min); hepatic encephalopathy or severe impairment of liver function. Lactation.

Not suitable for initiation therapy. Discontinue in cases of hepatic encephalopathy; photosensitivity. May increase tendency to gout attacks in hyperuricaemic patients. Patients w/ heart failure. Monitor plasma Na, K, Ca & blood glucose. Not to be administered to patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May influence ability to drive & use machines. Hepatic & renal dysfunction; preexisting renal insufficiency. Not recommended during pregnancy. 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; ankle swelling, muscle spasms; fatigue, asthenia.

Indapamide: Increased risk of ventricular arrhythmias w/ torsades de pointes-inducing medicines eg, class Ia (quinidine, hydroquinidine, disopyramide) & III (amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, 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. Possible reduction in antihypertensive effect w/ NSAIDs (systemic) eg, COX-2 selective inhibitors, high-dose acetylsalicylic acid (≥3 g daily). Risk of sudden hypotension &/or acute renal failure w/ ACE inhibitors. Increased risk of hypokalaemia (additive effect) w/ other compd causing hypokalaemia eg, amphotericin B (IV), gluco- & mineralocorticoids (systemic), tetracosactide, stimulant laxatives. Hypokalaemia predisposing to the toxic effects of digitalis. Increased antihypertensive effect w/ baclofen. May increase incidence of hypersensitivity reactions to allopurinol. Hypokalaemia or hyperkalaemia (particularly in patients w/ renal failure or diabetes) may occur w/ K-sparing diuretics (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. Risk of hypercalcaemia w/ Ca salts. Risk of increased plasma creatinine w/ ciclosporine, tacrolimus. Decreased antihypertensive effect w/ corticosteroids, tetracosactide (systemic). Not recommended: Increased plasma lithium. Amlodipine: Risk of hyperkalaemia w/ dantrolene (infusion). Bioavailability may be increased w/ grapefruit or grapefruit juice. May increase exposure 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 effect w/ other antihypertensive medicinal products. Risk of increased tacrolimus blood levels. May increase 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.

POM