RASILEZ HCl
ALISKIREN AND HYDROCHLOROTHIAZIDE · by NOVARTIS
Composition
Tab 300/12.5 mg: Aliskiren 300 mg. hydrochloro-thiazide 12.5 mg Tab 300/25 mg: Aliskiren 300 mg, hydrochlorothiazide 25 mg. Tab 150/12.5 mg: Aliskiren 150 mg, hydrochlorothiazide 12.5 mg. Tab
Indications & Dosage
Essential hypertension: Adults: 1 tab once daily. Children: Not recommended,
Contraindications
Acute porphyrias, anuria, renal decompensation, concomitant treatment with an ACE inhibitor or an angiotensin-II receptor antagonist in patients with an eGFR less than 60 ml/minute/1.73m2,concomitant treatment with an ACE inhibitor or anangiotensin-II receptor antagonist in patients with diabetes mellitus, hereditary angioedema, idiopathic angioedema
Precautions
First dose may cause hypotension in patients taking concomitant diuretics, on a low sodium diet, or who are dehydrate - initiate with care, renal artery stenosis, renal impairment, monitor plasma-potassium concentration and renal function in renal impairment, diabetes mellitus and heart failure, gout, patients with moderate to high cholesterol concentrations.Monitor plasma-potassium concentration in renal impairment. Monitor patients with a history of angioedema closely during treatment
Interactions
Angiotensin-II receptor antagonists, anticoagulants, antifungals, potassium salts, beta-blockers, ACE in-hibitors, neuromuscular blocking agents, oral hypoglycaemien, NSAIDs.
Pregnancy
Contraindicated in pregnancy.
Lactation
Not recommended.
Side Effects
Arthralgia, dizziness, hyperkalaemia, diarrhoea, liver disorders, nausea, vertigo, vomiting. Rare: Acute renal failure (reversible on discontinuation of treatment), hypotension, palpitation, peripheral oedema, cough, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, anaemia, angioedema, erythema.