Drugplain

ATACAND 4 mg/1

Candesartan Cilexetil · TABLET · ANI Pharmaceuticals, Inc.

No Recall History
Plain English

ATACAND is a tablet containing candesartan cilexetil at 4 mg/1, taken oral. Manufactured by ANI Pharmaceuticals, Inc..

Key Facts

Brand Name
ATACAND
Generic Name
Candesartan Cilexetil
NDC Code (Product)
62559-640
Manufacturer
ANI Pharmaceuticals, Inc.
Strength
4 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
NDA020838
Marketing Start
10/01/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea1,788 reports
fatigue1,769 reports
drug ineffective1,760 reports
nausea1,703 reports
headache1,630 reports
dizziness1,606 reports
diarrhoea1,383 reports
malaise1,379 reports
fall1,332 reports
blood pressure increased1,311 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ATACAND is 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); ATACAND reduces cardiovascular death and heart failure hospitalization (1.2) . 1.1 Hypertension ATACAND is 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. Many patients will require more than one d…

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 < 6 years) (2.2) 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) (2.2) < 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 (2.3) 4 mg tablet once daily 32 mg tablet once daily 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 ATACAND is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. ATACAND 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 …

Contraindications

4 CONTRAINDICATIONS ATACAND is contraindicated in patients who are hypersensitive to candesartan. Do not co-administer aliskiren with ATACAND in patients with diabetes [see Drug Interactions (7.4) ]. Known hypersensitivity to product components (4) . Do not co-administer aliskiren with ATACAND 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) . • 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 ATACAND 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 ATACAND. 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 function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including candesartan, may result in …

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 ANI Pharmaceuticals, Inc. at 1-855-204-1431 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 ATACAND 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 ATACAND was well tolerated. The overall incidence of adverse events reported with ATACAND was similar to placebo. The rate of withdrawals due to adverse events in all trials in patients (75…

Frequently Asked Questions

What is ATACAND used for?

ATACAND contains Candesartan Cilexetil. It is a tablet taken oral. Consult your doctor for specific uses.

Is ATACAND a controlled substance?

ATACAND is not classified as a controlled substance by the DEA.

What is the generic name for ATACAND?

The generic name for ATACAND is Candesartan Cilexetil. There are 9 other brand versions of Candesartan Cilexetil.

What is the NDC code for ATACAND 4 mg/1?

The NDC (National Drug Code) for ATACAND 4 mg/1 is 62559-640, listed by ANI Pharmaceuticals, Inc..

Product NDC

62559-640

Package NDC

62559-640-30

Other Candesartan Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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