Candesartan cilexetil 8 mg/1
Candesartan cilexetil · TABLET · Zydus Lifesciences Limited
Candesartan cilexetil is a tablet containing candesartan cilexetil at 8 mg/1, taken oral. Manufactured by Zydus Lifesciences Limited.
Key Facts
- Brand Name
- Candesartan cilexetil
- Generic Name
- Candesartan cilexetil
- NDC Code (Product)
70771-1205- Manufacturer
- Zydus Lifesciences Limited
- Strength
- 8 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091390
- Marketing Start
- 02/22/2018
Recall History
Viatris
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Amerisource Health Services
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Apotex Corp.
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Apotex Inc.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Macleods Pharma Usa Inc
Failed Impurities/Degradation Specifications
Apotex Inc.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Apotex Inc.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Mylan Pharmaceuticals Inc.
Out-of-specification organic impurity results obtained during routine stability testing.
Sandoz Inc
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Sandoz, Inc
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing 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 cilexetil tablets 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 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 l…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Starting Dose Target Dose Adult Hypertension (2.1) 16 mg tablet once daily 8 to 32 mg tablet total daily dose Pediatric Hypertension (1 to ˂6 years) (2.2) 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) (2.2) <50 kg 4 to 8 mg tablet once daily >50 kg 8 to 16 mg tablet once daily <50 kg 4 to 16 mg tablet once daily or consider divided dose >50 kg 4 to 32 mg tablet once daily or consider divided dose Adult Heart Failure (2.3) 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 2.1 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 lit…
Contraindications
4 CONTRAINDICATIONS 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 (7.4)]. Known hypersensitivity to product components (4). Do not co-administer aliskiren with candesartan cilexetil tablets in patients with diabetes (4).
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). · 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. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including candesartan cilexetil. Monitor serum lithium levels. 7.3 Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal functi…
Adverse Reactions
6 ADVERSE REACTIONS · 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. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Candesartan cilexetil has been evaluated for safety in more than 3600 patients/subjects, including more than 3200 patients treated for hypertension. About 600 of these patients were studied for at least 6 months and about 200 for at least 1 year. In general, treatment with candesartan cilexetil was well tolerated. The overall incidence of adverse events reported with candesartan cilexetil was similar to placebo. The rate of withdrawals due to …
Frequently Asked Questions
What is Candesartan cilexetil used for?
Candesartan cilexetil contains Candesartan cilexetil. It is a tablet taken oral. Consult your doctor for specific uses.
Is Candesartan cilexetil a controlled substance?
Candesartan cilexetil is not classified as a controlled substance by the DEA.
What is the generic name for Candesartan cilexetil?
The generic name for Candesartan cilexetil is Candesartan cilexetil. There are 9 other brand versions of Candesartan cilexetil.
What is the NDC code for Candesartan cilexetil 8 mg/1?
The NDC (National Drug Code) for Candesartan cilexetil 8 mg/1 is 70771-1205, listed by Zydus Lifesciences Limited.
Other Candesartan cilexetil Dosages
Other Candesartan Brands
See all →- candesartan cilexetil and hydrochlorothiazide16 mg/143547-459
- ATACAND4 mg/162559-640
- ATACAND8 mg/162559-641
- candesartan cilexetil and hydrochlorothiazide16 mg/170771-1325
- candesartan cilexetil and hydrochlorothiazide32 mg/143547-460
- CANDESARTAN CILEXETIL16 mg/146708-343
- ATACAND HCT32 mg/162559-651
- Candesartan Cilexetil and Hydrochlorothiazide32 mg/162559-661
- ATACAND32 mg/162559-643
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)