Natexam

Substitution therapy for treatment of 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. If change of posology is required, titration w/ individual components. Elderly Treat according to renal function. Mild to moderate hepatic impairment Start w/ the lowest dose.

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.

Not suitable for initiation therapy. Discontinue use if hepatic encephalopathy which can progress to hepatic coma; photosensitivity reactions; choroidal effusion w/ visual field defect, transient myopia, acute angle-closure glaucoma occur. Protect exposed areas to the sun or to artificial UVA. Hypertensive crisis. Hyponatraemia w/ hypovolaemia; measure plasma Na prior to treatment then regularly subsequently; frequent monitoring in elderly & cirrhotic patients. May lead to secondary compensatory metabolic alkalosis w/ concomitant loss of Cl ions. Hypokalaemia may cause muscle disorders. Frequently monitor plasma K in high-risk populations eg, elderly, malnourished &/or polymedicated, cirrhotic patients w/ oedema & ascites, CAD & cardiac failure patients; patients w/ long QT interval whether origin is congenital or iatrogenic. Increased urinary excretion of Mg resulting in hypomagnesaemia. May decrease urinary Ca excretion & slight & transitory rise in plasma Ca. Frank hypercalcaemia may be due to previously unrecognized hyperparathyroidism. W/draw treatment prior to investigation of parathyroid function. Monitor blood glucose particularly in presence of hypokalaemia in diabetic patients. Patients w/ CHF. Hypovolaemia. 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. Minor or moderate influence on ability to drive & use machines. Mild to moderate hepatic impairment. Preexisting renal insufficiency. Not recommended during pregnancy & lactation. 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; swelling ankle, muscle spasms; fatigue, asthenia.

Indapamide: Increased plasma lithium. Increased risk of ventricular arrythmias w/ Torsades de pointes-inducing medicines eg, class Ia (eg, quinidine, hydroquinidine, disopyramide) & class III (eg, amiodarone, sotalol, dofetilide, ibutilide, bretylium) antiarrhythmics; phenothiazines (eg, chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (eg, amisulpride, sulpiride, sultopride, tiapride), other antipsychotic (eg, pimozide); butyrophenones (eg, droperidol, haloperidol); bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine IV, methadone, astemizole, terfenadine. 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 hypokalaemia (additive effect) w/ other compd causing hypokalaemia eg, amphotericin B (IV), gluco- & mineralocorticoids (systemic route), tetracosactide, stimulant laxatives. Hypokalaemia &/or hypomagnesaemia predisposing to 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) 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 hypercalcaemia w/ Ca (salts). Risk of increased plasma creatinine w/ ciclosporin, tacrolimus. Decreased antihypertensive effect w/ corticosteroids, tetracosactide (systemic route). Amlodipine: Risk of hyperkalaemia 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 mTOR inhibitors eg, sirolimus, temsirolimus & everolimus. Increased trough conc of ciclosporin 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.

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