Aju Pharm


Endure Medical
Full Prescribing Info
Candesartan cilexetil.
Each tablet contains: Candesartan (as cilexetil) 8 mg and Candesartan (as cilexetil) 16 mg.
Pharmacology: Pharmacokinetics: Candesartan cilexetil is an ester prodrug that is hydrolyzed during absorption from the gastrointestinal tract to the active form candesartan.
The absolute bioavailability for candesartan is about 40% when candesartan cilexetil is given as a solution and about 14% when given as tablets. Peak plasma concentrations of candesartan occur about 3 to 4 hours after oral doses. as tablets. Candesartan is more than 99% bound to plasma proteins. It is excreted in urine and bile mainly as unchanged drug and a small amount of inactive metabolites. The terminal elimination half-life is about 9 hours. Candesartan is not removed by haemodialysis.
For the management of hypertension and heart failure in patients with impaired left ventricular systolic function, either when angiotensin converting enzyme (ACE) inhibitors are not tolerated, or in addition to ACE inhibitors.
Dosage/Direction for Use
Candesartan cilexetil is given orally with or without food. Onset of antihypertensive action occurs about 2 hours after  dose and the maximum effect is achieved within about 4 weeks of starting therapy.
Management of hypertension: Initial dose is 8 mg once daily or 16 mg once daily. The dose should be adjusted according to response. The usual maintenance dose is 8 mg once daily, but doses up to 32 mg daily, as a single dose or in 2 divided doses, may be used. Lower initial doses should be considered in patients with intravascular volume depletion. Patients with renal or hepatic impairment may also require lower initial doses.
Heart failure: Initial dose of 4 mg once daily. Dose should be doubled at intervals of not less than two weeks up to 32 mg once daily if tolerated or as prescribed by the physician.
It is contraindicated to pregnant patients, patients with renal impairment and patients with hypersensitivity to the drug or any of its components.
Special Precautions
It should be used with caution in patients with renal artery stenosis. Reduced doses may be required in patients with renal impairment and should be considered in patients with hepatic impairment. Patients with volume depletion (for those who have received high-dose diuretic therapy) may experience hypotension; volume depletion should be corrected before starting therapy, or a low initial dose should be used.
Since hyperkalemia may occur, serum-potassium concentrations should be monitored, especially in the elderly and patients with renal impairment. Potassium-sparing diuretics should generally be avoided.
Adverse Reactions
Adverse effects include mild and transient dizziness, headache and dose-related orthostatic hypotension, impaired renal function, rarely rash, urticaria, pruritus, angioedema, and raised liver enzyme values, hyperkalemia, myalgia, arthralgia, respiratory disorders, back pain, gastrointestinal disturbances, fatigue and neutropenia. Rhabdomyolysis has been reported rarely.
Drug Interactions
Antihypertensive effects of Candesartan may be potentiated by drugs or other agents that lower blood pressure. An additive hyperkalemic effect is possible with potassium supplements, potassium-sparing diuretics, or other drugs that can cause hyperkalaemia. Candesartan and potassium-sparing diuretics should not generally be given together. Nonsteroidal anti-inflammatory drugs (NSAIDs) should be used with caution in patients taking Candesartan as the risk of renal impairment may be increased, particularly in those who are inadequately hydrated. Use of NSAIDs may also attenuate the hypotensive effect of candesartan. Candesartan and some other angiotensin II receptor antagonists are metabolized by cytochrome P450 isoenzymes and interactions may occur with drugs that affect these enzymes.
Store at temperatures not exceeding 30°C.
ATC Classification
C09CA06 - candesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Tab 8 mg x 10's, 100's. 16 mg x 10's, 100's.
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