candesartan/hydrochlorothiazide (Rx)

Brand and Other Names:Atacand HCT
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

candesartan/hydrochlorothiazide

tablet

  • 16mg/12.5mg
  • 32mg/12.5mg
  • 32mg/25mg
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Hypertension

16-32 mg candesartan/12.5-25 mg HCTZ PO qDay; optimum therapeutic effect expected within 4 weeks

Safety & efficacy not established

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Interactions

Interaction Checker

and candesartan/hydrochlorothiazide

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     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Adverse reactions with combination products and individual agents

            1-10%

            Headache (3%)

            Dizziness (3%)

            Upper respiratory tract infection (4%)

            Back pain (3%)

            Flu-like syndrome (2%)

            Frequency Not Defined

            Candesartan

            • Peripheral edema
            • Dizziness
            • Fatigue
            • Abdominal pain
            • Diarrhea
            • Nausea
            • Arthralgia
            • Back pain
            • Chest pain
            • Albuminuria
            • Bronchitis
            • Coughing
            • Pharyngitis
            • Rhinitis
            • URI

            Hydrochlorothiazide

            • Anorexia
            • Epigastric distress
            • Hypotension
            • Orthostatic hypotension
            • Photosensitivity
            • Anaphylaxis
            • Anemia
            • Confusion
            • Erythema multiforme
            • Stevens-Johnson syndrome
            • Exfoliative dermatitis including toxic epidermal necrolysis
            • Dizziness
            • Headache
            • Hyperuricemia
            • Hypokalemia and/or hypomagnesemia
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            Warnings

            Black Box Warnings

            Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death

            Contraindications

            Hypersensitivity to candesartan, hydrochlorothiazide, or sulfonamides

            Pregnancy (2nd and 3rd trimesters): Significant risk of fetal/neonatal morbidity and mortality

            Gout

            Refractory hypercalcemia

            Refractory hypokalemia

            Severe hepatic impairment and/or cholestasis

            Do not coadminister with aliskiren in patients with diabetes mellitus

            As initial therapy

            Cautions

            Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without history of allergy or bronchial asthma, but are more likely in patients with such a history

            Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)

            Photosensitivity may occur

            Monitor serum electrolytes periodically; drugs that inhibit the renin-angiotensin system can cause hyperkalemia; hydrochlorothiazide can cause hypokalemia and hyponatremia; hypomagnesema can result in hypokalemia which appears difficult to treat despite potassium repletion

            Thiazides decrease urinary calcium excretion and may cause mild elevation of serum calcium; avoid therapy in patients with hypercalcemia

            Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for renal function changes (including acute renal failure) compared to monotherapy

            Caution in aortic mitral stenosis, hepatic impairment, hypercholesterolemia, hypercalcemia, parathyroid disease, pre-existing renal insufficiency, systemic lupus erythematosus, bilateral renal artery stenosis or anuria

            Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides

            Thiazides may decrease urinary calcium excretion

            Symptomatic hypotension most likely to occur in patients who have been volume and/or salt depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting’ may require temporarily reducing dose or volume repletion; volume and/or salt depletion should be corrected before initiating therapy

            In patients with heart failure, therapy may cause excessive hypotension, which may lead to oliguria, azotemia, and (rarely) with acute renal failure and death; in such patients therapy should be started under close medical supervision; monitor closely for first 2 weeks of treatment and whenever dose of candesartan or diuretic is increased

            Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function

            Hydrochlorothiazide may raise serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients

            Thiazide diuretics reported to cause exacerbation or activation of systemic lupus erythematosus

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            Pregnancy & Lactation

            Pregnancy Category: C (1st trimester); D (2nd and 3rd trimesters)

            Lactation: enters breast milk/contraindicated

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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