Candesartan

FDA label

Read the full label on DailyMed ↗

Titration Heart failure: double the dose at approximately 2-week intervals as tolerated.

Renal No adult dose adjustment stated. Pediatric patients with GFR <30 mL/min/1.73m² must not receive candesartan (not studied). Monitor renal function; consider withholding or discontinuing on a clinically significant decline.

Hepatic Moderate impairment: initiate at 8 mg. Severe impairment: no dosing recommendation can be provided.

Instructions

• May be taken with or without food.
• Total daily dose may be given once daily or split into two equal doses.
• Correct volume and/or salt depletion before initiating.
• For children who cannot swallow tablets, compound an oral suspension 0.1–2.0 mg/mL (1 mg/mL typical): grind tablets to a paste in Ora-Plus + Ora-Sweet SF (1:1) or Ora-Blend SF, make to volume, dispense in amber PET; store below 30°C, do not freeze, shake well, 100-day expiry, use within 30 days of opening.

Available strengths

• tab 4, 8, 16, 32 mg

Contraindications

• Do not co-administer with aliskiren in patients with diabetes

Cautions

• Fetal toxicity — discontinue as soon as pregnancy is detected (oligohydramnios, fetal renal failure, lung hypoplasia, skull hypoplasia, death).
• Children <1 y must not receive candesartan for hypertension — RAS blockade affects immature kidney development.
• Symptomatic hypotension, most likely in volume/salt-depleted patients (diuretics, salt restriction, dialysis, diarrhea, vomiting); monitor BP during dose escalation and periodically.
• Hypotension during major surgery/anesthesia — rarely severe enough to need IV fluids and/or vasopressors.
• Impaired renal function including acute renal failure, particularly with renal artery stenosis, CKD, severe heart failure or volume depletion — monitor renal function periodically.
• Hyperkalemia — risk increased with other potassium-raising drugs; monitor serum potassium periodically.

Adverse reactions

• Hypertension trials: upper respiratory tract infection 6%, dizziness 4%, back pain 3%, pharyngitis 2%, rhinitis 2%.
• Most common reasons for discontinuation in hypertension: headache 0.6%, dizziness 0.3%.
• Heart failure (vs placebo): hypotension 18.8% (4.1% led to discontinuation), abnormal renal function 12.5% (6.3% led to discontinuation), hyperkalemia 6.3% (2.4% led to discontinuation).
• Pediatric: worsening renal disease in 1/93 children 1 to <6 y and 3/240 aged 6 to <17 y.
• Postmarketing (very rare): angioedema, hyperkalemia, hyponatremia, cough, pruritus/rash/urticaria, abnormal hepatic function and hepatitis, neutropenia/leukopenia/agranulocytosis; rare rhabdomyolysis.

Pregnancy Can cause fetal harm — discontinue as soon as pregnancy is detected; second/third-trimester exposure reduces fetal renal function and increases fetal/neonatal morbidity and death.

Lactation Unknown whether excreted in human milk (present in rat milk); breastfeeding is not recommended during treatment.