Natrixam Tablet
Indapamide + Amlodipine
1.5 mg + 5mg
ACI Limited
| Pack size | 30's pack |
|---|---|
| Unite Price | 15.00 BDT |
Indications
Natrixam Tablet is used for:
Treatment of essential hypertension
Adult Dose
Oral
Adult
Hypertension
Indicated as substitution therapy for treatment of essential hypertension in patients already controlled with indapamide and amlodipine given concurrently at the same dose level.
1 tab once daily preferably in the morning.
The fixed dose combination is not suitable for initiation therapy.
Patients with hepatic impairment: In severe hepatic impairment, treatment is contraindicated.
Child Dose
Renal Dose
Patients with renal impairment: In severe renal impairment (creatinine clearance below 30 mL/min), treatment is contraindicated.
In patients with mild to moderate renal impairment, no dose adjustment is needed.
Administration
May be taken with or without food: Preferably taken in the morning.
Contra Indications
Hypersensitivity to indapamide, amlodipine, other sulfonamides & dihydropyridine derivatives. Hypokalaemia; severe hypotension; cardiogenic shock; left ventricle outflow tract obstruction eg, high grade aortic stenosis; haemodynamically unstable heart failure after acute MI. Severe renal failure (CrCl <30 mL/min); hepatic encephalopathy or severe hepatic impairment.
Precautions
History of sulfonamide or penicillin allergy. Discontinue use if hepatic encephalopathy or photosensitivity reactions; choroidal effusion w/ visual field defect, transient myopia, acute angle-closure glaucoma occur.
Hypertensive crisis; severe heart failure (NYHA class III & IV), CHF. Hyperuricaemic patients; hypovolaemia. Monitor water & electrolyte (plasma Na, K, Ca) balance, blood glucose regularly.
Positive reaction in doping tests. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Mild to moderate hepatic impairment. Preexisting renal insufficiency. May affect ability to drive & use machines.
Not recommended during pregnancy & lactation. Childn & adolescents.
Pregnancy-Lactation
Given the effects of the individual components in this combination product on pregnancy and lactation: Indapamide + Amlodipine (Natrixam) is not recommended during pregnancy.
Indapamide + Amlodipine (Natrixam) is contraindicated during lactation.
Pregnancy:
Linked to indapamide: There are no or limited amount of data from the use of indapamide in pregnant women. Prolonged exposure to thiazide during the third trimester of pregnancy can reduce maternal plasma volume as well as uteroplacental blood flow, which may cause a feto-placental ischemia and growth retardation. Moreover, rare cases of hypoglycemia and thrombocytopenia in neonates have been reported following exposure near term.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Linked to amlodipine: The safety of amlodipine in human pregnancy has not been established.
In animal studies, reproductive toxicity was observed at high doses.
Breastfeeding:
Linked to indapamide: There is insufficient information on the excretion of indapamide/metabolites in human milk. Hypersensitivity to sulfonamide-derived medicines and hypokalemia might occur. A risk to newborns/infants cannot be excluded.
Indapamide is closely related to thiazide diuretics which have been associated, during breastfeeding, with a decrease or even suppression of milk lactation.
Linked to amlodipine: It is not known whether amlodipine is excreted in breast milk.
Fertility:
Linked to indapamide: Reproductive toxicity studies showed no effect on fertility in female and male rats. No effects on human fertility are anticipated.
Linked to amlodipine: Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Clinical data are insufficient regarding the potential effect of amlodipine on fertility. In one rat study, adverse reactions were found on male fertility.
Interactions
Indapamide:
Increased plasma lithium. Increased risk of ventricular arrhythmias w/ Torsade de pointes-inducing drugs eg, class IA & III antiarrhythmics, some antipsychotics eg, phenothiazines, benzamides, butyrophenones, pimozide; bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine IV, methadone, astemizole, terfenadine. Reduced antihypertensive effect w/ systemic NSAIDs eg, 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 w/ IV amphotericin B, systemic gluco- & mineralocorticoids, tetracosactide, stimulant laxatives. Hypokalaemia predisposed to digitalis toxicity w/ digitalis prep. Increased antihypertensive effect w/ baclofen. Increased incidence of hypersensitivity reactions to allopurinol. Hypo- or hyperkalaemia w/ K-sparing diuretics eg, amiloride, sprinolactone, 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. Decreased urinary Ca elimination. Increased plasma creatinine w/ ciclosporin, tacrolimus. Decreased antihypertensive effect w/ corticosteroids, systemic tetracosactide.
Amlodipine:
Risk of hyperkalaemia w/ dantrolene infusion. Increased bioavailability w/ grapefruit or grapefruit juice. Increased exposure w/ strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides (ie, erythromycin or clarithromycin), verapamil or diltiazem. Increased risk of hypotension w/ clarithromycin. Varied conc w/ strong CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Additive BP-lowering effects of antihypertensives. Increased tacrolimus blood levels. Increased exposure of mTOR inhibitors eg, sirolimus, temsirolimus, everolimus. Increased exposure w/ simvastatin.
Side Effects
Side effects of Indapamide + Amlodipine :
Indapamide: Hypokalaemia; maculopapular rash.
Amlodipine: Oedema. Somnolence, dizziness, headache; visual impairment, diplopia; palpitations; flushing; dyspnoea; abdominal pain, nausea, dyspepsia, changes of bowel habit, diarrhoea, constipation; swelling ankle, muscle spasms; fatigue, asthenia.
Mode of Action
Indapamide is a sulfonamide derivative with an indole ring, pharmacologically related to thiazide diuretics, which acts by inhibiting the reabsorption of sodium in the cortical dilution segment. It increases the urinary excretion of sodium and chlorides and, to a lesser extent, the excretion of potassium and magnesium, thereby increasing urine output and having an antihypertensive action.
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.
The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle.
Note
Natrixam 1.5 mg + 5mg Tablet generic name is Indapamide + Amlodipine. Natrixam 1.5 mg + 5mg Tablet is manufactured by ACI LimitedNatrixam is availble in all over Bangladesh.
Mes BD drug index information on Natrixam Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.