Natexam

Natexam

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Concise Prescribing Info
Contents
Per 1.5/5 mg tab Indapamide 1.5 mg, amlodipine 5 mg. Per 1.5/10 mg tab Indapamide 1.5 mg, amlodipine 10 mg
Indications/Uses
Substitution therapy for treatment of essential HTN in patients already controlled w/ indapamide & amlodipine given concurrently at the same dose level.
Dosage/Direction for Use
1 tab daily as single dose, preferably in the morning. If a change of the posology is required, titration should be done w/ the individual components. Elderly Treat according to renal function. Mild to moderate hepatic impairment Start w/ the lowest dose. Mild to moderate renal impairment No dose adjustment needed.
Administration
May be taken with or without food: Swallow whole w/ water, do not chew.
Contraindications
Hypersensitivity to indapamide, amlodipine, to other sulfonamides, to 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.
Special Precautions
Not suitable for initiation therapy. Stop treatment in case of hepatic encephalopathy, photosensitivity. Efficacy is not established in hypertensive crisis. Measure Na & K levels before & during treatment. Monitor Na more frequently in elderly & cirrhotic patients. High risk of hypokalemia in elderly, malnourished &/or polymedicated, cirrhotic patients w/ oedema & ascites. Hypokalaemia may cause muscle disorders, rhabdomyolysis. Patients w/ CAD, cardiac failure & long QT interval. First measurement of plasma K 1 wk after start of treatment & more frequent monitoring required. May favor the onset of Torsades de pointes, which may be fatal. Stop treatment before investigating parathyroid function. Monitor blood glucose in diabetic patients especially in case of hypokalaemia. Cardiac failure. Preexisting renal insufficiency may worsen at start of treatment due to reduction in glomerular filtration. Amlodipine not dialysable. Increased tendency of gout attacks. Not to be taken in galactose intolerance/total lactase deficiency/glucose-galactose malabsorption. Start at the lowest dose in mild to moderate hepatic impairment. Choroidal effusion, acute myopia & secondary angle-closure glaucoma. May cause +ve reaction in doping test in athletes. Not recommended for breastfeeding woman. Safety & efficacy in childn & adolescents have not been established. Elderly to be treated according to renal function.
Adverse Reactions
Oedema. Hypokalaemia, somnolence, dizziness, headache, palpitations, flushing, visual impairment, diplopia, dyspnoea, abdominal pain, nausea, dyspepsia, change of bowel habit, diarrhoea, constipation, rash maculo-papular, ankle swelling, muscle spasms, fatigue, asthenia. Insomnia, altered mood (including anxiety), depression, tremor, dysgeusia, syncope, hypoaesthesia, paraesthesia, tinnitus, hypotension, arrhythmia (including bradycardia, ventricular tachycardia & atrial fibrillation), cough, rhinitis, vomiting, dry mouth, purpura, alopecia, skin discolouration, hyperhidrosis, pruritus, rash, exanthema, urticaria, arthralgia, myalgia, back pain, micturition disorder, nocturia, pollakiuria, erectile dysfunction, gynaecomastia, chest pain, pain, malaise, increased or decreased wt. Confusional state, vertigo. Leukopenia, thrombocytopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia, hypersensitivity, hyperglycaemia, hypercalcaemia, hypertonia, peripheral neuropathy, MI, vasculitis, pancreatitis, gastritis, gingival hyperplasia, hepatitis, jaundice, increased hepatic enzymes, abnormal hepatic function, angioedema, TEN, SJS, erythema multiforme, exfoliative dermatitis, Quincke’s oedema, photosensitivity, renal failure. Hyponatraemia w/ hypovolaemia, Torsades de pointes (potentially fatal), possibility of onset of hepatic encephalopathy in case of hepatic insufficiency, possible worsening of pre-existing SLE, ECG QT prolonged, increased blood glucose & uric acid, extrapyramidal disorder (extrapyramidal syndrome), myopia, blurred vision, acute angle-closure glaucoma, choroidal effusion, muscular weakness, rhabdomyolysis.
Drug Interactions
Not recommended: Lithium, dantrolene, grapefruit or grapefruit juice. Precautions for use: Torsades de pointes-inducing medicines, NSAIDs (systemic route) including COX-2 selective inhibitors, high dose acetylsalicylic acid (≥3 g daily), ACE inhibitors, other compd causing hypokalaemia, digitalis prep, baclofen, allopurinol, CYP3A4 inhibitors, CYP3A4 inducers, simvastatin. To be taken into consideration: K-sparing diuretics, metformin, iodinated contrast media, imipramine-like antidepressants, neuroleptics, Ca (salts), ciclosporine, tacrolimus, corticosteroids, tetracoside (systemic route), mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus), other medicinal products w/ antihypertensive properties.
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.
Presentation/Packing
Form
Natexam 1.5/10 mg tab
Packing/Price
30's (Rp265,900/pak)
Form
Natexam 1.5/5 mg tab
Packing/Price
30's
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