Clinical Pharmacology Details


CANDESARTAN CILEXETIL


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Indications & Dose:


Adult and child > 16 yr


Hypertension:


PO initially 8 mg (hepatic imparment 2mg, renal impairment or intravascular voolume depletion 4mg) once daily, increased if necessary at interval of 4 weekes to max 32mg oncce daily Hypertension with intravascular volume depletion l



Adult: Initially 4 mg once daily, increased if necessary up to 32 mg daily, doses to be increased at intervals of 4 weeks; usual dose 8 mg once daily


Heart Failure


4mg once daily, increased at interval of at least 2 weekes to target dose 32mg once daily.


OVERDOSE:


No lethality was observed in acute toxicity studies in mice rats, and dogs given single oral doses of up to 2000 mg/kg of candesartan cilexetil. Candesartan cannot be removed by hemodialysis.


Treatment: The most likely manifestation of overdosage with Candesartan would be hypotension, dizziness and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension occur, supportive treatment should be instituted.

Contraindications:

Primary hyperaldosteronism; bilateral renal artery stenosis

Side Effects:

CNS: Anxiety, depression. dizziness (2.4%), drowsiness. fatigue (1.4%), headache (3.8%), lightheadedness, parethesia. vertigo
CV: Flushing, palpitations, tachycardia ia
EENT: Epistaxis
MS: Back pain. myalgia ( 1.9%)
RESP: Cough (1.8-6.5%), upper respiratory infection
SKIN: Facial edema, angioedema, diaphoresis
MISC: Angioedema

Cautions:

Precautions:

Hypovolemic patients (salt and/ or volume depleted; diuretic therapy) at greater risk of symptomatic hypotension: bilateral renal artery stenosis; aortic or mitral valve stenosis; hypertrophic cardiomyopathy; severe hepatic dysfunction/ cholestasis

Interaction:

Drugs


Cimetidine: Increased levels of candesartan


Fluconazole: Decreased conversion to active metabolite (CYP2C9 inhibition), loss of antihypertensive effects


Lithium: Increased renal lithium reabsorption at the proximal tubular site due to the natriuresis associated with the inhibition of aldosterone secretion; increased risk of lithium toxicity


Potassium-sparing diuretics, salt substitutes, potassium supplements: Increased risk of hyperkalemia


Phenobarbital: Decreased levels of candesartan


Rifampin: Induced metabolism resulting in a decrease in the area under the concentration-time curse (AUC) and half-life and reduced efficacy of candesartan

Warnings:

Adverse Effects:

Lactations:

Pregnancy category C ( 1 1st trimester) and 1) (2nd and 3rd trimester); use caution in nursing mothers

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: