Candesartan 8 mg Tablets

Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: · Treatment of hypertension in adults and children 1 to

• Starting Dose Target Dose Adult Hypertension 16 mg tablet once daily 8 to 32 mg tablet total daily dose Pediatric Hypertension (1 to ˂6 years) 0.2 mg/kg oral suspension once daily 0.05 to 0.4 mg/kg oral suspension once daily or consider divided dose Pediatric Hypertension (6 to ˂17 years) 50 kg 8 to 16 mg tablet once daily 50 kg 4 to 32 mg tablet once daily or consider divided dose Adult Heart Failure 4 mg tablet once daily 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 tablet is 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
• Dosing recommendations cannot be provided for patients with severe hepatic insufficiency [see Clinical Pharmacology ] . …

32 mg are light pink, round, biconvex, uncoated mottled tablets debossed with ‘L171’on one side and scoring on other side. Tablets 32 mg (3).

The antihypertensive effects of candesartan cilexetil were evaluated in hypertensive children 1 to

• 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 tablets 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: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc
• Bedminster, NJ 07921, USA Revised: 07/2021

• 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 tablets 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). · Dual inhibition of the renin- angiotension system: Increased risk of renal impairment, hypotension, and hyperkalemia (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. …

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. When pregnancy is detected, discontinue candesartan cilexetil tablets as soon as possible [see Use in Specific Populations (8.1)]. 5.2 Morbidity in Infants Children

· Most common adverse reactions which caused adult patients to discontinue therapy for: o Hypertension were headache (0.6%) and dizziness (0.3%) (6.1). o 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 Alembic Pharmaceuticals Limited at 1-866-210-9797 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. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.