Canderin

Canderin

candesartan

Manufacturer:

Dexa Medica
Full Prescribing Info
Contents
Candesartan cilexetil.
Action
Pharmacology: Candesartan is a nonpeptide angiotensin II antagonist that selectively blocks the binding of angiotensin II to the AT1 receptors in tissues eg, vascular smooth muscle and the adrenal gland. In the renin-angiotensin system, angiotensin I is converted by angiotensin-converting enzyme (ACE) to form angiotensin II. Angiotensin II stimulates the adrenal cortex to synthesize and secrete aldosterone, which decreases the excretion of sodium and increases the excretion of potassium. Angiotensin II also acts as vasoconstrictor in vascular smooth muscle. By blocking the binding of angiotensin II to the AT1 receptors, candesartan causes vasodilation and decreases the effects of aldosterone. The negative feedback regulation of angiotensin II on renin secretion is also inhibited, resulting in a rise in plasma concentrations and consequent rise in angiotensin II plasma concentrations; however, these effects do not counteract the blood pressure-lowering effect that occurs.
Pharmacokinetics: The onset of antihypertensive effect occurs about 2 hrs after administration and the maximum effect is achieve within 4 weeks after initiating the therapy.
Indications/Uses
Treatment of hypertension, heart failure and impaired left ventricle systolic function (left ventricular ejection fraction (≤40%) when ACE-inhibitors are not tolerated.
Dosage/Direction for Use
Hypertension: Initially 4 mg once daily. The dose should be adjusted according to response and with a maximum dose of 16 mg daily. The maximum effect is achieved within 4 weeks after initiating therapy.
Elderly: No initial dosage adjustment is necessary.
Impaired Renal Function: No initial dosage adjustment is necessary in mild renal impairment. A lower initial dose of 2 mg once daily is suggested for patients with moderate and severe renal impairment. The dose may be adjusted according to response.
Impaired Hepatic Function: An initial dose of 2 mg once daily is recommended in patients with mild to moderate hepatic impairment. The dose may be adjusted according to response. There is no experience in patients with severe hepatic impairment.
Heart Failure: The usual recommended initial dose is 4 mg once daily. Up-titration to the target dose of 32 mg once daily or the highest tolerated dose is done by doubling the dose at intervals of at least 2 weeks.
Special Patient Populations: No initial dose adjustment is necessary for elderly patients or in patients with intravascular volume depletion, renal impairment or mild to moderate hepatic impairment.
Administration: Candesartan should be taken once daily with or without food, and can be administered with other antihypertensive drugs.
Overdosage
Symptoms: Based on pharmacological considerations, the main manifestation of an overdose is likely to be symptomatic hypotension and dizziness.
Treatment: If symptomatic hypotension should occur, symptomatic treatment should be instituted and vital signs be monitored. The patient should be placed supine with the legs elevated. If this is not sufficient, plasma volume should be increased by infusion of, eg, isotonic saline solution. Sympathomimetic medicinal products may be administered if the previously mentioned measures are not sufficient.
Candesartan is not removed by hemodialysis.
Contraindications
Patients with known hypersensitivity to candesartan or any ingredient of Canderin. Patient with severe hepatic impairment and/or cholestasis.
Use in pregnancy & lactation: Canderin tablet is not recommended in pregnant and lactating women.
Special Precautions
General: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system [RAAS (eg, patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis)], treatment with other medicinal products that affect this system has been associated with acute hypotension, azotemia, oliguria, or rarely, acute renal failure. The possibility of similar effects cannot be excluded with angiotensin II receptor antagonists. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.
Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take Canderin tablet.
Renal Impairment: As with other agents inhibiting the RAAS, changes in renal function may be anticipated in susceptible patients treated with candesartan. When candesartan is used in hypertensive patients with renal impairment, periodic monitoring of serum potassium and creatinine levels is recommended. There is limited experience in patients with very severe or end-stage renal impairment (CrCl <15 mL/min). In these patients, candesartan should be carefully titrated with thorough monitoring of blood pressure.
Evaluation of patients with heart failure should include periodic assessments of renal function especially in elderly patients ≥75 years, and patients with impaired renal function. During dose titration of candesartan, monitoring of serum creatinine and potassium is recommended.
Concomitant Therapy with an ACE Inhibitor in Heart Failure: The risk of adverse events, especially in renal function impairment and hyperkalemia, may increase when candesartan is used in combination with an ACE inhibitor. Patients with such treatment should be monitored regularly and carefully.
Haemodialysis: During dialysis, the blood pressure may be particularly sensitive to AT1 receptor blockade as a result of reduced plasma volume and activation of the RAAS. Therefore, candesartan should be carefully titrated with thorough monitoring of blood pressure in patients on haemodialysis.
Renal Artery Stenosis: Other medicinal products that affect the RAAS, ie, angiotensin converting enzyme (ACE) inhibitors, may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. A similar effect may be anticipated with angiotensin II receptor antagonists.
Hypotension: Symptomatic hypotension may occur. Patients at particular risk include those with volume- or salt-depletion secondary to salt restriction, prolonged diuretic therapy, heart failure or dialysis. In patients with heart failure, a temporary reduction in the dosage of candesartan and/or of a diuretic may be needed; blood pressure should be monitored during dosage escalation and periodically thereafter.
Surgery/Anesthesia: Hypotension may occur in patients undergoing major surgery and anesthesia who are receiving angiotensin II receptor antagonists, including candesartan, presumably secondry to blockade of the RAAS. Rarely, hypotension may be severe enough to require volume expansion and/or vasopressors.
Aortic and Mitral Valve Stenosis (Obstructive Hypertrophic Cardiomyopathy): As with other vasodilators, special caution is indicated in patients suffering from haemodynamically relevant aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy.
Primary Hyperaldosteronism: Patients with primary hyperaldosteronism will not generally respond to antihypertensive medicinal products acting through inhibition of the RAAS. Therefore, the use of candesartan is not recommended.
Hyperkalemia: Hyperkalemia may occur in patients with congestive heart failure receiving candesartan especially in those receiving concomitant therapy with an ACE inhibitor and/or a potassium-sparing diuretic eg, spironolactone. Serum potassium should be monitored during dosage escalation and periodically thereafter.
Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes-containing potassium, or other medicinal products that may increase potassium levels (eg, heparin), may lead to increases of serum potassium in patients with hypertension.
Sensitivity Reactions: Sensitivity reactions including various anaphylactoid reaction and/or angioedema have been reported with use of angiotensin II receptor antagonists including candesartan. Candesartan is not recommended in patients with a history of angioedema associated with or unrelated to ACE or angiotensin II receptor therapy.
Effects on the Ability to Drive or Operate Machinery: Caution when driving or doing other things requiring alertness because of possible dizziness during treatment.
Carcinogenicity: There was no evidence of carcinogenicity.
Use in pregnancy: When used in pregnancy during the 2nd and 3rd trimesters, medicinal products that act directly on the renin-angiotensin system can cause fetal and neonatal injury (hypotension, renal dysfunction, oliguria and/or anuria, oligohydramnios, skull hypoplasia, intrauterine growth retardation) and death. Cases of lung hypoplasia, facial abnormalities and limb contractures have also been described.
Candesartan should not be used in pregnancy. If pregnancy is detected during treatment, candesartan should be discontinued as soon as possible.
Use in lactation: It is not known whether candesartan is distributed in breast milk. Discontinue nursing or the use of Canderin because of the potential risk in nursing infants.
Use in children: The safety and efficacy of candesartan have not been established in children and adolescents <18 years.
Adverse Reactions
Adverse effects occurring in ≥1% of patients receiving candesartan include back pain, dizziness, upper respiratory tract infection, pharyngitis and rhinitis. The incidence of adverse effects was not affected by age, gender or race.
Drug Interactions
Candesartan is eliminated only to a minor extent by hepatic metabolism (CYP2C9). Available interaction studies indicate no effect on CYP2C9 and CYP3A4 but the effect on other cytochrome P-450 isoenzymes is presently unknown.
The antihypertensive effect of candesartan may be enhanced by other medicinal products with blood pressure-lowering properties.
Pharmacokinetic interaction (increased serum lithium concentrations) when candesartan is used concomitantly with lithium. Careful monitoring of serum lithium concentrations is recommended during concomitant use.
When angiotensin II receptor antagonists are administered simultaneously with nonsteroidal anti-inflammatory drugs (ie, indometacin), attenuation of the antihypertensive effect may occur. The bioavailability of candesartan is not affected by food.
Storage
Store at temperatures below 30°C. Protect from light.
ATC Classification
C09CA06 - candesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Tab 8 mg x 3 x 10's. 16 mg x 3 x 10's.
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