ATACAND HCT 32 mg/1
Candesartan Cilexetil and Hydrochlorothiazide · TABLET · ANI Pharmaceuticals, Inc.
ATACAND HCT is a tablet containing candesartan cilexetil and hydrochlorothiazide at 32 mg/1, taken oral. Manufactured by ANI Pharmaceuticals, Inc..
Key Facts
- Brand Name
- ATACAND HCT
- Generic Name
- Candesartan Cilexetil and Hydrochlorothiazide
- NDC Code (Product)
62559-651- Manufacturer
- ANI Pharmaceuticals, Inc.
- Strength
- 32 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA021093
- Drug Class
- Thiazide Diuretic [EPC]
- Marketing Start
- 10/01/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE ATACAND HCT is indicated for the treatment of hypertension, 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. There are no controlled trials demonstrating risk reduction with ATACAND HCT. 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 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in ra…
Dosage & Administration
DOSAGE AND ADMINISTRATION The usual recommended starting dose of candesartan cilexetil 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. Patients requiring further reduction in blood pressure should be titrated to 32 mg. Doses larger than 32 mg do not appear to have a greater blood pressure lowering effect. Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily. Use in Renal Impairment: Dosing recommendations for ATACAND HCT in patients with creatinine clearance < 30 mg/min cannot be provided (see SPECIAL POPULATIONS, Renal Insufficiency ). Use in moderate to severe Hepatic Impairment: ATACAND HCT is not recommended for initiation because the appropriate starting dose, 8 mg, cannot be given (see SPECIAL POPULATIONS, Hepatic Insufficiency ). Replacement Therapy: The combination may be substituted for the titrated components. Dose Titration by Clinical Effect: A patient whose blood pressure is not controlled on 25 mg of hydrochlorothiazide once daily can expect an incremental effect from ATACAND HCT 16-12.5 mg. A patient whose blo…
Warnings
WARNINGS Fetal Toxicity 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 ATACAND HCT as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations…
Contraindications
CONTRAINDICATIONS ATACAND HCT is contraindicated in patients who are hypersensitive to candesartan, to hydrochlorothiazide or to other sulfonamide-derived drugs. Do not co-administer aliskiren with ATACAND HCT in patients with diabetes (see PRECAUTIONS, Drug Interactions ). ATACAND HCT is contraindicated in patients with anuria.
Drug Interactions
Drug Interactions Because candesartan is not significantly metabolized by the cytochrome P450 system and at therapeutic concentrations has no effects on P450 enzymes, interactions with drugs that inhibit or are metabolized by those enzymes would not be expected. Interactions common to both Candesartan Cilexetil and Hydrochlorothiazide 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 deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving candesartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including candesartan may be attenuated by NSAIDs including selective COX-2 inhibitors. Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium …
Adverse Reactions
ADVERSE REACTIONS Candesartan Cilexetil-Hydrochlorothiazide ATACAND HCT has been evaluated for safety in more than 2800 patients treated for hypertension. More than 750 of these patients were studied for at least six months and more than 500 patients were treated for at least one year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse events reported with ATACAND HCT was comparable to placebo. The overall frequency of adverse experiences was not related to dose, age, gender, or race. In placebo-controlled trials that included 1089 patients treated with various combinations of candesartan cilexetil (doses of 2-32 mg) and hydrochlorothiazide (doses of 6.25-25 mg) and 592 patients treated with placebo, adverse events, whether or not attributed to treatment, occurring in greater than 2% of patients treated with ATACAND HCT and that were more frequent for ATACAND HCT than placebo were: Respiratory System Disorder: upper respiratory tract infection (3.6% vs 3.0%); Body as a Whole: back pain (3.3% vs 2.4%); influenza-like symptoms (2.5% vs 1.9%); Central/Peripheral Nervous S…
Frequently Asked Questions
What is ATACAND HCT used for?
ATACAND HCT contains Candesartan Cilexetil and Hydrochlorothiazide. It is a tablet taken oral. Consult your doctor for specific uses.
Is ATACAND HCT a controlled substance?
ATACAND HCT is not classified as a controlled substance by the DEA.
What is the generic name for ATACAND HCT?
The generic name for ATACAND HCT is Candesartan Cilexetil and Hydrochlorothiazide. There are 9 other brand versions of Candesartan Cilexetil and Hydrochlorothiazide.
What is the NDC code for ATACAND HCT 32 mg/1?
The NDC (National Drug Code) for ATACAND HCT 32 mg/1 is 62559-651, listed by ANI Pharmaceuticals, Inc..
Other ATACAND HCT Dosages
Other Candesartan Brands
See all →- candesartan cilexetil and hydrochlorothiazide16 mg/143547-459
- candesartan cilexetil and hydrochlorothiazide16 mg/170771-1325
- candesartan cilexetil and hydrochlorothiazide32 mg/143547-460
- Candesartan Cilexetil and Hydrochlorothiazide32 mg/162559-661
- Candesartan Cilexetil and Hydrochlorothiazide32 mg/133342-133
- Candesartan Cilexetil and Hydrochlorothiazide32 mg/162559-662
- Candesartan Cilexetil and Hydrochlorothiazide16 mg/162559-660
- candesartan cilexetil and hydrochlorothiazide32 mg/170771-1326
- candesartan cilexetil and hydrochlorothiazide32 mg/170771-1327
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)