Candesartan


Generic Medicine Info
Indications and Dosage
Oral
Hypertension
Adult: Initially, 8 mg once daily adjusted according to response. Max: 32 mg/day as single or in 2 divided doses. Patients with intravascular volume depletion: Initially, 4 mg once daily.
Child: 1-<6 years Initially, 0.2 mg/kg once daily. Maintenance: 0.05-0.4 mg/kg/day as single daily dose or in 2 divided doses. Max: 0.4 mg/kg daily. 6-<17 years <50 kg: Initially, 4-8 mg once daily, adjusted according to response to 2-16 mg/day; >50 kg: 8-16 mg once daily, adjusted according to response to 4-32 mg/day.

Oral
Heart failure with reduced ejection fraction
Adult: In patients with left ventricular systolic dysfunction who cannot tolerate ACE-inhibitors or as add-on therapy to ACE-inhibitors: Initially, 4 mg once daily, may be doubled at intervals of not <2 weeks if needed. Max: 32 mg once daily.
Special Patient Group
Hypertension:
Black patients: Dose increase may be necessary.
Renal Impairment
Including patients on haemodialysis: Initially, 4 mg once daily.
Hepatic Impairment
Mild to moderate: Initially, 4 mg once daily, adjusted according to response. Severe: Contraindicated.
Administration
May be taken with or without food.
Contraindications
Severe hepatic impairment and/or cholestasis. Children (<1 year). Pregnancy. Concomitant use with aliskiren in patients with diabetes mellitus or moderate to severe renal impairment (GFR <60 mL/min/1.73m2).
Special Precautions
Patient with unstented unilateral/bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, history of angioedema, relevant aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy, primary hyperaldosteronism. Black patients. Patients undergoing surgery. Renal and mild to moderate hepatic impairment. Children. Lactation.
Adverse Reactions
Significant: Angioedema, hypotension, hyperkalaemia, renal impairment.
Blood and lymphatic system disorders: Agranulocytosis, leucopenia, neutropenia.
Gastrointestinal disorders: Nausea.
Hepatobiliary disorders: Abnormal hepatic function or hepatitis.
Immune system disorders: Urticaria.
Infections and infestations: Respiratory infection.
Investigations: Increased liver enzymes.
Metabolism and nutrition disorders: Hyponatraemia.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain, myalgia.
Nervous system disorders: Dizziness, headache, vertigo.
Respiratory, thoracic and mediastinal disorders: Cough.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Monitoring Parameters
Monitor blood pressure, electrolytes, renal function (e.g. serum creatinine, BUN), urinalysis, signs and symptoms of hypotension, tachycardia, CNS changes, hyperglycaemia, signs of angioedema; serum K during dose increase and periodically thereafter (in heart failure).
Overdosage
Symptoms: Hypotension, dizziness, tachycardia. Management: Symptomatic and supportive treatment. Monitor vital signs and place the patient in a supine position with the legs elevated to manage symptomatic hypotension. If insufficient, increase plasma volume by infusion of isotonic saline solution. If still insufficient, may administer sympathomimetic drugs.
Drug Interactions
Increased risk of hypotension with high dose diuretics and anaesthesia. Increased serum K levels with K-sparing diuretics (e.g. spironolactone), K supplements, K-containing salt substitutes or other drugs that increase K levels (e.g. heparin). May increase serum lithium concentration. Reduced antihypertensive effect, and increased risk of worsening renal function and increased serum K with NSAIDs (e.g. selective COX-2 inhibitors, aspirin).
Potentially Fatal: Coadministration with aliskiren in diabetic patients may increase the risk of renal impairment, hypotension and hyperkalaemia.
Action
Description: Candesartan is an angiotensin receptor antagonist which binds to AT1 angiotensin II receptor in many tissues (e.g. vascular smooth muscle, adrenal gland), thereby inhibiting angiotensin II from binding to the receptor which leads to blocking of vasoconstriction and aldosterone release.
Onset: 2-3 hours; within 2 weeks (antihypertensive effect).
Duration: >24 hours.
Pharmacokinetics:
Absorption: Rapidly and completely absorbed from the gastrointestinal tract after conversion. Bioavailability: 15%. Time to peak plasma concentration: 3-4 hours.
Distribution: Enters breast milk. Volume of distribution: 0.13 L/kg. Plasma protein binding: >99%.
Metabolism: Rapidly converted via ester hydrolysis into active candesartan during absorption from the gastrointestinal tract; metabolised in the liver (minor) via O-deethylation into inactive metabolite.
Excretion: Via faeces (67%); urine (33%; 26% as unchanged drug). Elimination half-life: 5-9 hours.
Chemical Structure

Chemical Structure Image
Candesartan

Source: National Center for Biotechnology Information. PubChem Database. Candesartan, CID=2541, https://pubchem.ncbi.nlm.nih.gov/compound/Candesartan (accessed on Jan. 21, 2020)

Storage
Store below 30°C.
ATC Classification
C09CA06 - candesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
References
Anon. Candesartan. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/02/2021.

Blopress Tablets (Takeda Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/02/2021.

Buckingham R (ed). Candesartan Cilexetil. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/02/2021.

Candesartan 4 mg Tablets (Accord-UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 02/02/2021.

Candesartan 8 mg Tablets (Accord-UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 02/02/2021.

Candesartan Cilexetil Tablet (Alembic Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/02/2021.

Joint Formulary Committee. Candesartan Cilexetil. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/02/2021.

Mylan New Zealand Ltd. Candestar 4 mg, 8 mg, 16 mg and 32 mg Tablets data sheet 13 February 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 02/02/2021.

Disclaimer: This information is independently developed by MIMS based on Candesartan from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 MIMS. All rights reserved. Powered by MIMS.com
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