This information is not for clinical use. These highlights do not include all the information needed to use Atacand Hct safely and effectively. Before taking Atacand Hct please consult with your doctor. See full prescribing information for Atacand Hct.

Indications And Usage

ATACAND HCT is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).

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Contraindications

ATACAND HCT is contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

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 System: dizziness (2.9% vs 1.2%). The frequency of headache was greater than 2% (2.9%) in patients treated with ATACAND HCT but was less frequent than the rate in patients treated with placebo (5.2%). Other adverse events that have been reported, whether or not attributed to treatment, with an incidence of 0.5% or greater from the more than 2800 patients worldwide treated with ATACAND HCT included: Body as a Whole: inflicted injury, fatigue, pain, chest pain, peripheral edema, asthenia; Central and Peripheral Nervous System: vertigo, paresthesia, hypesthesia; Respiratory System Disorders: bronchitis, sinusitis, pharyngitis, coughing, rhinitis, dyspnea; Musculoskeletal System Disorders: arthralgia, myalgia, arthrosis, arthritis, leg cramps, sciatica; Gastrointestinal System Disorders: nausea, abdominal pain, diarrhea, dyspepsia, gastritis, gastroenteritis, vomiting; Metabolic and Nutritional Disorders: hyperuricemia, hyperglycemia, hypokalemia, increased BUN, creatine phosphokinase increased; Urinary System Disorders: urinary tract infection, hematuria, cystitis; Liver/Biliary System Disorders: hepatic function abnormal, increased transaminase levels; Heart Rate and Rhythm Disorders: tachycardia, palpitation, extrasystoles, bradycardia; Psychiatric Disorders: depression, insomnia, anxiety; Cardiovascular Disorders: ECG abnormal; Skin and Appendages Disorders: eczema, sweating increased, pruritus, dermatitis, rash; Platelet/Bleeding-Clotting Disorders: epistaxis; Resistance Mechanism Disorders: infection, viral infection; Vision Disorders: conjunctivitis; Hearing and Vestibular Disorders: tinnitus. Reported events seen less frequently than 0.5% included angina pectoris, myocardial infarction and angioedema. Candesartan Cilexetil Other adverse experiences that have been reported with candesartan cilexetil, without regard to causality, were: Body as a Whole: fever; Metabolic and Nutritional Disorders: hypertriglyceridemia; Psychiatric Disorders: somnolence; Urinary System Disorders: albuminuria. Post-Marketing Experience The following have been very rarely reported in post-marketing experience with candesartan cilexetil: Digestive: Abnormal hepatic function and hepatitis. Hematologic: Neutropenia, leukopenia, and agranulocytosis. Metabolic and Nutritional Disorders: hyperkalemia, hyponatremia. Renal: renal impairment, renal failure. Skin and Appendages Disorders: Pruritus and urticaria. Rare reports of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers. Hydrochlorothiazide Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, are listed below: Body As A Whole: weakness; Cardiovascular: hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs); Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, constipation, gastric irritation, anorexia; Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia; Hypersensitivity: anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, urticaria, purpura; Metabolic: electrolyte imbalance, glycosuria; Musculoskeletal: muscle spasm; Nervous System/Psychiatric: restlessness; Renal: renal failure, renal dysfunction, interstitial nephritis; Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia; Special Senses: transient blurred vision, xanthopsia; Urogenital: impotence. Laboratory Test Findings In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with the administration of ATACAND HCT. Creatinine, Blood Urea Nitrogen— Minor increases in blood urea nitrogen (BUN) and serum creatinine were observed infrequently. One patient was discontinued from ATACAND HCT due to increased BUN. No patient was discontinued due to an increase in serum creatinine. Hemoglobin and Hematocrit—Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.2 g/dL and 0.4 volume percent, respectively) were observed in patients treated with ATACAND HCT, but were rarely of clinical importance. Potassium— A small decrease (mean decrease of 0.1 mEq/L) was observed in patients treated with ATACAND HCT. In placebo-controlled trials, hypokalemia was reported in 0.4% of patients treated with ATACAND HCT as compared to 1.0% of patients treated with hydrochlorothiazide or 0.2% of patients treated with placebo. Liver Function Tests—Occasional elevations of liver enzymes and/or serum bilirubin have occurred.

Drug Interactions

Drug Interactions Candesartan Cilexetil No significant drug interactions have been reported in studies of candesartan cilexetil given with other drugs such as glyburide, nifedipine, digoxin, warfarin, hydrochlorothiazide, and oral contraceptives in healthy volunteers. 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. 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 − Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors, and with some angiotensin II receptor antagonists. An increase in serum lithium concentration has been reported during concomitant administration of lithium with candesartan cilexetil, so careful monitoring of serum lithium levels is recommended during concomitant use. Hydrochlorothiazide When administered concurrently the following drugs may interact with thiazide diuretics: Alcohol, barbiturates, or narcotics − Potentiation of orthostatic hypotension may occur. Antidiabetic drugs (oral agents and insulin) − Dosage adjustment of the antidiabetic drug may be required. Other antihypertensive drugs − Additive effect or potentiation. Cholestyramine and colestipol resins − Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Corticosteroids, ACTH − Intensified electrolyte depletion, particularly hypokalemia. Pressor amines (eg, norepinephrine) − Possible decreased response to pressor amines but not sufficient to preclude their use. Skeletal muscle relaxants, nondepolarizing (eg, tubocurarine) −Possible increased responsiveness to the muscle relaxant. Lithium −Generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with ATACAND HCT. Non-steroidal Anti-inflammatory Drugs − In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when ATACAND HCT and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.