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|Candesartan Cilexetil/Hydrochlorothiazide

Candesartan Cilexetil / Hydrochlorothiazide

Trade Names:
Atacand HCT
- Tablets 16 mg candesartan, 12.5 mg hydrochlorothiazide
- Tablets 32 mg candesartan, 12.5 mg hydrochlorothiazide

Mechanism of Action

Pharmacology

Antagonizes the effect of angiotensin II (vasoconstriction and aldosterone secretion) by blocking the angiotensin II receptor (AT ₁ receptor) in vascular smooth muscle and the adrenal gland, producing decreased BP.

Increases chloride, sodium, and water excretion by interfering with transport of sodium ions across renal tubular epithelium.

Indications and Usage

Treatment of hypertension.

Contraindications

Any component of product; patients with anuria or hypersensitivity to sulfonamide-derived drugs.

Dosage and Administration

PO Atacand HCT may be substituted for previously titrated individual components. The daily dose range for Atacand HCT tablets is candesartan 16 mg combined with hydrochlorothiazide 12.5 mg to candesartan 32 mg combined with hydrochlorothiazide 25 mg.

General Advice

Give every day in the morning, with or without food. Administer with food if GI upset occurs.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F). Keep container tightly closed.

Drug Interactions

Increased risk of orthostatic hypotension.

Dosage adjustment of antidiabetic agent may be necessary.

Increased electrolyte depletion, increasing risk of hypokalemia.

The diuretic, natriuretic, and hypertensive effects of loop, potassium-sparing, and thiazide diuretics may be reduced.

Decreased responsiveness of the pressor amine.

Increased responsiveness of the muscle relaxant.

May reduce hydrochlorothiazide absorption; give hydrochlorothiazide at least 2 h before sequestrant.

May cause hyperglycemia.

Diuretic-induced hypokalemia and hypomagnesemia may lead to digitalis-induced arrhythmias.

Because renal excretion of lithium may be reduced, avoid use if possible.

Synergistic effects may occur, resulting in profound diuresis and serious electrolyte abnormalities.

Hypoglycemic effect of sulfonylurea may be decreased, necessitating an increase in sulfonylurea dosage.

Laboratory Test Interactions

Hydrochlorothiazide may decrease serum protein-bound iodine levels without signs of thyroid disturbances; may cause diagnostic interference of serum electrolyte levels, blood and urine glucose levels, serum bilirubin levels, and serum uric acid levels.

Adverse Reactions

Cardiovascular

Tachycardia; palpitation; extrasystoles; bradycardia; abnormal ECG.

Hypotension (including orthostatic hypotension).

CNS

Dizziness; vertigo; paresthesia; hypesthesia; depression; insomnia; anxiety; somnolence.

Restlessness; headache.

Dermatologic

Eczema; increased sweating; pruritus; dermatitis; rash; urticaria.

Erythema multiforme (including Stevens-Johnson syndrome); exfoliative dermatitis (including toxic epidermal necrolysis); alopecia.

EENT

Sinusitis; pharyngitis; rhinitis; conjunctivitis; tinnitus.

Transient blurred vision; xanthopsia.

GI

Nausea; abdominal pain; diarrhea; dyspepsia; gastritis; gastroenteritis; vomiting.

Pancreatitis; sialadenitis; cramping; constipation; gastric irritation; anorexia.

Genitourinary

UTI; hematuria; cystitis; albuminuria.

Renal failure; renal dysfunction; interstitial nephritis; impotence.

Hematologic

Epistaxis; neutropenia; leukopenia; agranulocytosis.

Aplastic anemia; hemolytic anemia; thrombocytopenia.

Hepatic

Abnormal hepatic function; increased transaminase levels.

Metabolic

Hyperuricemia; hyperglycemia; hypokalemia; increased BUN; increased creatine phosphokinase; hypertriglyceridemia.

Electrolyte imbalance; glycosuria.

Respiratory

Upper respiratory tract infection; influenza-like symptoms; bronchitis; cough; dyspnea.

Respiratory distress (including pneumonitis and pulmonary edema).

Miscellaneous

Back pain; fatigue; pain; chest pain; peripheral edema; asthenia; arthralgia; myalgia; arthrosis; arthritis; leg cramps; sciatica; infection; viral infection.

Fever; weakness; anaphylactic reactions; necrotizing angiitis; photosensitivity; muscle spasm; purpura.

Precautions

Pregnancy

Category D (second and third trimester); Category C (first trimester). Can cause injury and death to fetus if used during second or third trimester.

Lactation

Candesartan: Undetermined; HCTZ: excreted in breast milk.

Children

Safety and efficacy in children less than 18 yr not established.

Renal Function

Use with caution.

Hepatic Function

Use with caution.

Diabetics

May require adjustments of insulin or oral hypoglycemic agents; hyperglycemia may occur.

Hyperuricemia

May occur, or acute gout may be precipitated.

Hypotension/Volume-depleted patients

Symptomatic hypotension may occur after initiation of therapy in patients who are intravascularly volume depleted. Correct these conditions prior to administration.

Systemic lupus erythematosus

May be activated or exacerbated.

Overdosage

Symptoms

Hypotension, dizziness, tachycardia, bradycardia

Electrolyte depletion (eg, hypokalemia, hypochloremia, hyponatremia), dehydration

Patient Information

• Explain name, dose, action, and potential side effects of drug.
• Advise patient to take every day as prescribed, without regard to meals.
• Advise patient to try to take each dose at about the same time every day.
• Inform patient that drug controls, but does not cure, hypertension and to continue taking drug as prescribed even when BP is not elevated.
• Caution patient not to change the dose or stop taking unless advised by health care provider.
• Instruct patient to continue taking other BP medications as prescribed by health care provider.
• Instruct patient in BP and pulse measurement skills.
• Advise patient to monitor and record BP and pulse at home and to inform health care provider if abnormal measurements are noted. Also advise patient to take record of BP and pulse to each follow-up visit.
• Caution patient to avoid sudden position changes to prevent orthostatic hypotension.
• Instruct patient to lie or sit down if experiencing dizziness or lightheadedness when standing.
• Caution patient that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to excessive fall in BP resulting in lightheadedness or fainting.
• Instruct diabetic patient to monitor blood glucose more frequently when drug is started or dose is changed and to inform health care provider of significant changes in readings.
• Caution patient to avoid unnecessary exposure to UV light (sunlight, tanning booths), use sunscreen, and wear protective clothing when exposed to UV light to avoid photosensitivity reaction.
• Emphasize to hypertensive patient importance of other modalities on BP: weight control, regular exercise, smoking cessation, and moderate intake of alcohol and salt.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
• Instruct patient to stop taking drug and immediately report any of the following symptoms to health care provider: fainting, swelling of the face, lips, eyelids, or tongue.
• Caution patient to not take any prescription or OTC medications, potassium salt substitutes, or potassium dietary supplements unless advised by health care provider.
• Advise patient that follow-up visits and lab tests may be required to monitor therapy and to keep appointments.