Candetens

Candetens

candesartan

Manufacturer:

Berlico Mulia Farma
Concise Prescribing Info
Contents
Candesartan cilexetil
Indications/Uses
HTN. Heart failure & left ventricular systolic function disorder (LVEF ≤40%) when ACE inhibitor intolerance occur.
Dosage/Direction for Use
HTN Initially 4 mg daily, may be increased to max of 16 mg once daily based on patient response. Elderly >75 yr; moderate or severe kidney disorders; & mild to moderate liver disorders Initially 2 mg once daily, may be increased according to patient's response. Heart failure Initially 4 mg daily. May be increased up to 32 mg once daily or the highest tolerated dose, by doubling the dose at intervals of at least 2 wk.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Combination w/ aliskiren-containing drug in patients w/ diabetes or moderate to severe renal impairment (GFR ˂60 mL/min/1.73 m2). Severe liver damage &/or cholestasis. Pregnant & nursing women.
Special Precautions
Dual blockade of the Renin-Angiotensin-Aldosterone (RAA) system w/ drugs containing aliskiren. Combination therapy w/ aliskiren is not recommended due to increased risk of HTN, hyperkalemia, & altered renal function. Changes in renal function can be anticipated in certain patients. Periodic exam of serum K & creatinine levels is recommended in hypertensive patients w/ kidney failure. Patients w/ terminal renal failure (CrCl 15 mL/min); serum creatinine 265 mol/L (˃3 mg/dL); kidney transplant. Titration should be carried out w/ care by carefully checking BP in patients w/ kidney failure; hemodialysis patients. Check serum creatinine & K levels when increasing the dose. Increased risks of hypotension, hyperkalemia, & renal impairment (including acute renal failure) w/ ACE inhibitors. Monitor regularly & carefully patients in combination therapy w/ ACE inhibitors in heart failure. Renal function may deteriorate in patients w/ renal artery stenosis. Hypotension may occur during treatment in patients w/ heart failure; anesth & surgery in patients receiving AIIA. Hypovolemia must overcome prior to initiating treatment. Patients suffering from hemodynamic consequences associated w/ aortic & mitral valve stenosis, or obstructive hypertrophic cardiomyopathy. Not recommended in patients w/ primary hyperaldosteronism. Periodically check serum K, especially when used concomitantly w/ ACE inhibitors & K-sparing diuretics eg, spironolactone. Do not administer in patients w/ rare hereditary problems namely galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Patients should be adequately hydrated & monitoring renal function should be considered at initiation of combination therapy & periodically thereafter. Childn. Elderly & patients w/ dehydration in combination therapy w/ NSAIDs.
Adverse Reactions
Dizziness, headache. HTN: Vertigo; resp infections. Heart failure: Hypotension; hyperkalemia; kidney disorders; increased creatinine, urea, & K in lab exam; leukopenia, neutropenia, & agranulocytosis; hyponatremia; cough; nausea; elevated liver enzymes, abnormal liver function or hepatitis; angioedema, skin redness, urticaria, pruritus; back pain, arthralgia, myalgia; kidney impairment, including kidney failure in such patients.
Drug Interactions
Antihypertensive effect may be enhanced by other antihypertensive drugs. Concomitant administration w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other drugs that increase K levels (eg, heparin) may result in elevated levels of K, K in the blood. Adverse effects may occur w/ AIIA & monitoring of serum lithium levels is recommended during combination therapy. Decreased antihypertensive effect may occur w/ NSAIDs eg, indomethacin, selective COX-2 inhibitors, ASA, & nonselective NSAIDs. Combination therapy w/ NSAIDs can lead to an increased risk of worsening renal function, including possible acute renal failure, & increased serum K, especially in patients w/ preexisting poor kidney function.
MIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA06 - candesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Candetens tab 16 mg
Packing/Price
5 × 6's (Rp275,000/boks)
Form
Candetens tab 8 mg
Packing/Price
5 × 6's (Rp198,000/boks)
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