MedCallyLooking up the FDA label…
Looking up the FDA label…
Also sold as Candesartan Cilexetil, candesartan cilexetil and hydrochlorothiazide
FDA boxed warning
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue candesartan cilexetil tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. · When pregnancy is detected, discontinue candesartan cilexetil tablets as soon as possible. · Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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. · Treatment of heart failure (NYHA class II-IV); candesartan reduces cardiovascular death and heart failure hospitalization. 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 fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. …
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
6 ADVERSE REACTIONS • Most common adverse reactions which caused adult patients to discontinue therapy for: ○ Hypertension were headache (0.6%) and dizziness (0.3%). ○ Heart Failure were hypotension (4.1%), abnormal renal function (6.3%), and hyperkalemia (2.4%). 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 clinical studies are conducted under widely varying condi…
Having one of these?
A doctor will tell you whether it matters and what to do about it. Written answer, a week of free follow-ups.
Ask a doctor — $19.99Candesartan cilexetil tablets are contraindicated in patients who are hypersensitive to candesartan. Do not co-administer aliskiren with candesartan cilexetil tablets in patients with diabetes. Known hypersensitivity to product components. Do not co-administer aliskiren with candesartan cilexetil in patients with diabetes.
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…
7 DRUG INTERACTIONS • Lithium: Increases in serum lithium concentrations and toxicity. • NSAIDs use may lead to increased risk of renal impairment and loss of antihypertensive effect • Combined inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia 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 potassiu…
Taking something else alongside it?
Interaction warnings are written per drug, not for your particular combination. A doctor can check yours.
Ask about my combinationSame medicine, sold as
Works in a similar way — angiotensin ii receptor blockers (arbs)
These are different medicines in the same family, not swaps for each other. Which one suits you is a prescribing decision.