Candesartan is the generic equivalent of the brand-name drug Candesartan. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Candesartan through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE 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 <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of…
Adverse Reactions
6 ADVERSE REACTIONS • 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 . 6.1 Clinical Studies Experience Because clin…
Drug Interactions
7 DRUG INTERACTIONS • 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…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Starting Dose Target Dose Adult Hypertension ( 2.1 ) 16 mg tablet once daily 8 - 32 mg tablet total daily dose Pediatric Hypertension (1 to 50 kg 8 – 16 mg tablet once daily 50 kg 4 – 32 mg tablet once daily or consider divided dose Adult Heart Failure ( 2.3 ) 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. 2.1 Adult Hypertension D…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION 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 name…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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