August 4, 2015
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Atacand HCT

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Atacand HCT




Side Effects
Interactions

SIDE EFFECTS

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%).

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.

Immunologic: Angioedema

Metabolic and Nutritional Disorders: Hyperkalemia, hyponatremia.

Respiratory System Disorders: Cough

Skin and Appendages Disorders: Pruritus, rash 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:

Gastrointestinal: 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

Musculoskeletal: muscle spasm

Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia

Special Senses: transient blurred vision, xanthopsia

Urogenital: impotence

Read the Atacand HCT (candesartan cilexetil-hydrochlorothiazide) Side Effects Center for a complete guide to possible side effects

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 Hydrochlorothiazde

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 with angiotensin II receptor antagonists or hydrochlorothiazide. Monitor serum lithium levels during concomitant use.

Interactions with Candesartan Cilexetil

Dual Blockade of the Renin-Angiotensin System (RAS)

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on ATACAND HCT and other agents that affect the RAS.

Do not co-administer aliskiren with ATACAND HCT in patients with diabetes. Avoid use of aliskiren with ATACAND HCT in patients with renal impairment (GFR < 60 ml/min) (see CONTRAINDICATIONS).

Interactions with Hydrochlorothiazide

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.

Ion 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%, respectively. Stagger the dosage of hydrochlorothiazide and ion exchange resins such that hydrochlorothiazide is administered at least 4 hours before or 4-6 hours after the administration of resins.

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) -Possible increased responsiveness to muscle relaxants such as curare derivatives.

Digitalis: Thiazide-induced hypokalemia or hypomagnesemia may predispose to digoxin toxicity.

Read the Atacand HCT Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 2/20/2015
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions

Atacand HCT - User Reviews

Atacand HCT User Reviews

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