Aliskiren + hydrochlorothiazide


Concise Prescribing Info
Indications/Uses
Hypertension.
Dosage/Direction for Use
Adult: PO Each tab contains Aliskiren (mg)/Hydrochlorothiazide (mg): 150/12.5, 150/25, 300/12.5, 300/25: 1 tab once daily. Dosage is individualised and may be increased after at least 2-4 weeks, according to response. Max: Aliskiren 300 mg and hydrochlorothiazide 25 mg/day.
Administration
May be taken with or without food. Take consistently w/ or w/o meals. Avoid taking w/ high fat meals.
Contraindications
Hypersensitivity to aliskiren and other sulfonamide-derived drugs. Anuria, volume depletion, history of angioedema, hereditary or idiopathic angioedema. Severe hepatic and renal impairment (GFR <30 mL/min/1.73m2). Concomitant use with ACE inhibitors or angiotensin II receptor antagonists in patient with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73m2). Concomitant use with potent P-glycoprotein (P-gp) inhibitors (e.g. ciclosporin, itraconazole and quinidine). Pregnancy.
Special Precautions
Patient with prediabetes or diabetes, history or risk for gout, history of allergy or bronchial asthma; volume or salt depletion, renal artery stenosis, CV disease, post MI, hypercalcaemia, moderate or high cholesterol levels, parathyroid disease, SLE. Mild to moderate renal and hepatic impairment. Lactation. Patient Counselling This drug may cause dizziness or drowsiness, if affected, do not drive or operate machinery. Monitoring Parameters Correct hypovolaemia or salt depletion prior to initiation of therapy. Monitor blood pressure, serum electrolytes, BUN, serum creatinine, fluid status; parathyroid and renal function.
Adverse Reactions
Significant: Electrolyte disturbances (e.g, hyper or hypokalaemia, hypochloraemic alkalosis, hypomagnesaemia, hypophosphataemia, hypercalcaemia, hyponatraemia), hypersensitivity reactions (e.g. urticaria), gout, hypotension, syncope, acute transient myopia, acute angle-closure glaucoma, photosensitivity, acute renal failure, metabolic disturbances (e.g. hypercholesterolaemia, hypertriglyceridaemia, altered glucose tolerance, hyperuricaemia), SLE exacerbation or activation. Cardiac disorders: Palpitations. Gastrointestinal disorders: Diarrhoea, decreased appetite, nausea, vomiting, oral mucosal reactions. Investigations: Increased liver enzymes. Metabolism and nutrition disorders: Peripheral oedema. Musculoskeletal and connective tissue disorders: Arthralgia. Nervous system disorders: Dizziness. Reproductive system and breast disorders Impotence. Respiratory, thoracic and mediastinal disorders: Cough. Skin and subcutaneous tissue disorders: Urticaria, rash, Stevens Johnson syndrome, toxic epidermal necrolysis, pruritus.
Potentially Fatal: Anaphylactic reactions, angioedema.
Drug Interactions
Aliskiren: Increased risk of hypotension with other antihypertensives. Increased risk of acute renal failure with ACE inhibitors, angiotensin II receptor antagonists or NSAIDs. Antihypertensive effect may be reduced with NSAIDs. Increased serum levels with atorvastatin, ketoconazole, verapamil. Decreases furosemide concentrations. Increased risk of hyperkalaemia with potassium-sparing diuretics, potassium supplements or any substances that may increase serum potassium levels. Hydrochlorothiazide: Increases toxicity of lithium. May potentiate orthostatic hypotension with barbiturates and narcotics. Increased hypokalaemic effect with corticosteroids or ACTH. Potentiation of orthostatic hypotension with barbiturates or opioids. Reduced antihypertensive effect by drugs that cause fluid retention (e.g. corticosteroids, NSAIDs, carbenoxolone). Enhanced nephrotoxicity of NSAIDs. May reduce the therapeutic effect of antidiabetics.
ATC Classification
C09XA02 - aliskiren ; Belongs to the class of renin-inhibitors. Used in the treatment of cardiovascular disease.
C03AA03 - hydrochlorothiazide ; Belongs to the class of low-ceiling thiazide diuretics.
Disclaimer: This information is independently developed by CIMS based on aliskiren + hydrochlorothiazide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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