Candesartan

Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: · Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ). · Treatment of heart failure (NYHA class II-IV); candesartan reduces cardiovascular death and heart failure hospitalization ( 1.2 ). 1.1 Hypertension Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to

• Starting Dose Target Dose Adult Hypertension 16 mg tablet once daily 8 - 32 mg tablet total daily dose Pediatric Hypertension (1 to < 6 years) 0.20 mg/kg oral suspension once daily 0.05 - 0.4 mg/kg oral suspension once daily or consider divided dose Pediatric Hypertension (6 to < 17 years) < 50 kg 4 – 8 mg tablet once daily > 50 kg 8 – 16 mg tablet once daily < 50 kg 4 – 16 mg tablet once daily or consider divided dose > 50 kg 4 – 32 mg tablet once daily or consider divided dose Adult Heart Failure 4 mg tablet once daily 32 mg tablet once daily 1 1 The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by patient
• Adult Hypertension Dosage must be individualized
• Blood pressure response is dose related over the range of 2 to 32 mg
• The usual recommended starting dose of candesartan cilexetil tablets are 16 mg once daily when it is used as monotherapy in patients who are not volume depleted
• Candesartan cilexetil tablets can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg
• Larger doses do not appear to have a greater effect, and there is relatively little experience with such doses
• Most of the antihypertensive effect is present within 2 weeks, and maximal blood pressure reduction is generally obtained within 4 to 6 weeks of treatment with candesartan cilexetil tablets
• Use in Hepatic Impairment: Initiate with 8 mg candesartan cilexetil tablets in patients with moderate hepatic insufficiency. …

4 mg are white to off-white, circular, biconvex, uncoated tablets, debossed with “ML 52” on one side and breakline on other side. 8 mg are light pink, circular, biconvex, uncoated tablets, debossed with “ML 53” on one side and breakline on other side. 16 mg are pink, circular, biconvex, uncoated tablets, debossed with “ML 54” on one side and breakline on other side. …

• The antihypertensive effects of candesartan cilexetil were evaluated in hypertensive
• Children 1 to < 17 years of age in randomized, double-blind clinical studies [see Clinical Studies ]
• The pharmacokinetics of candesartan cilexetil have been evaluated
• In pediatric patients 1 to < 17 years of age [see Clinical Pharmacology ]
• Children < 1 year of age must not receive candesartan cilexetil for hypertension [see see Warnings and Precautions ]

• Advise patient to read FDA-approved patient labeling (Patient Information)
• Pregnancy Advise female patients of childbearing age about the consequences of exposure to candesartan cilexetil during pregnancy
• Discuss treatment options with women planning to become pregnant
• Tell patients to report pregnancies to their physicians as soon as possible
• Manufactured by: Macleods Pharmaceuticals Limited, INDIA Manufactured for: Macleods Pharma USA, Inc
• Princeton, NJ 08540 All brand names listed are the registered trademarks of their respective owners
• All brand names listed are the registered trademarks of their respective owners
• Revised: 12/2022

• Candesartan cilexetil tablets are contraindicated in patients who are hypersensitive to candesartan
• Do not co-administer aliskiren with candesartan cilexetil tablets in patients with diabetes [see Drug Interactions ]
• Known hypersensitivity to product components
• Do not co-administer aliskiren with candesartan cilexetil in patients with diabetes

• Lithium: Increases in serum lithium concentrations and toxicity ( 7 ). • NSAIDs use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7 ) • Combined inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7 ) 7.1 Agents Increasing Serum Potassium Co-administration of candesartan cilexetil with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. …

• Observe for signs and symptoms of hypotension ( 5.3 ). • Monitor renal function ( 5.4 ) and potassium levels ( 5.5 ). 5.1 Fetal Toxicity Candesartan cilexetil tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure and death. …

• Most common adverse reactions which caused adult patients to discontinue therapy for: ○ Hypertension were headache (0.6%) and dizziness (0.3%) ( 6.1 ). ○ Heart Failure were hypotension (4.1%) ( 5.3 ), abnormal renal function (6.3%) ( 5.4 ), and hyperkalemia (2.4%) ( 5.5 ). To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

8.1 Pregnancy Risk Summary Candesartan cilexetil can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. …

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. In mice given single oral doses of the primary metabolite, candesartan, the minimum lethal dose was greater than 1000 mg/kg but less than 2000 mg/kg. The most likely manifestation of overdosage with candesartan cilexetil would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. …

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