spironolactone/hydrochlorothiazide (Rx)

Brand and Other Names:Aldactazide
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

spironolactone/hydrochlorothiazide

tablet

  • 25mg/25mg
  • 50mg/50mg
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Edema, Ascites, Congestive Heart Failure

1-8 tablets/day PO (spironolactone 25 mg/hydrochlorothiazide 25 mg)

1-4 tablets/day PO (spironolactone 50 mg/hydrochlorothiazide 50 mg)

Hypertension, Hypokalemia (Diuretic Induced)

2-4 tablets/day PO (spironolactone 25 mg/hydrochlorothiazide 25 mg)

1-2 tablets/day PO (spironolactone 50 mg/hydrochlorothiazide 50 mg)

Geriatric dosing

Avoid spironolactone doses >25 mg/day in heart failure, or patients with CrCl< 30 mL/min; heart failure and risk of hyperkalemia is higher in older adults taking doses > 25 mg/day, or taking concomitant angiotensin-converting enzyme inhibitor, angiotensin-receptor blocker, NSAID, or potassium supplement

Renal Impairment

CrCL <30 mL/min: Hydrochlorothiazide efficacy decreased

Not for administration in hyperkalemia, anuria, acute renal insufficiency, or significant impairment of renal excretory function

Hepatic Impairment

Acute or severe hepatic failure: Contraindicated

Safety and efficacy not established

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Interactions

Interaction Checker

and spironolactone/hydrochlorothiazide

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            Adverse Effects

            Frequency Not Defined

            Spironolactone

            • Drowsiness
            • Lethargy
            • Headache
            • Stevens-Johnson Syndrome
            • Rash
            • Urticaria
            • Gynecomastia
            • Impotence
            • Menstrual disorders
            • Abdominal cramping
            • Diarrhea
            • Gastritis
            • Nausea/vomiting
            • Drug rash with eosinophilia and systemic symptoms (DRESS)
            • Toxic epidermal necrolysis

            Hydrochlorothiazide

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

            Black Box Warnings

            Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats; use only for specified indications

            Fixed-dose combination

            • Fixed-dose combination drugs are not indicated for initial therapy of edema or hypertension; edema or hypertension requires therapy titrated to the individual patient
            • If the fixed combination represents the dosage so determined, its use may be more convenient in patient management
            • Treatment of hypertension and edema is not static, but must be reevaluated as conditions in each patient warrant

            Contraindications

            Hypersensitivity to spironolactone, hydrochlorothiazide, or sulfonamides

            Acute renal failure

            Acute/severe hepatic failure

            Anuria

            Hyperkalemia

            Addison’s disease or other conditions associated with hyperkalemia

            Coadministration with eplerenone

            Cautions

            Somnolence and dizziness reported

            Caution with hepatic impairment

            Spironolactone

            • May cause hyperkalemia; risk may be increased in patients with renal insufficiency, diabetes mellitus, or if coadministered with other drugs/diet that raise serum potassium levels
            • Gynecomastia reported

            Hydrochlorothiazide

            • May cause hypokalemia and hyponatremia; risk of hypokalemia may be increased in patients with cirrhosis, brisk diuresis, or if coadministered with other drugs that lower serum potassium
            • May cause hypomagnesemia, which can then result in hypokalemia which appears difficult to treat despite potassium repletion
            • May alter glucose tolerance and increase risk for hyperglycemia
            • May increase serum levels of calcium and uric acid by decreasing urinary excretion; may also increase cholesterol and triglycerides
            • Thiazides diuretics may add to or potentiate the action of other antihypertensive drugs
            • Sensitivity reactions to thiazides may occur in patients with or without a history of allergy or bronchial asthma
            • Sulfonamide derivatives, including thiazides, have been reported to exacerbate or activate systemic lupus erythematosus
            • Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: discontinue drug or do not nurse

            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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            Pharmacology

            Mechanism of Action

            Spironolactone: Aldosterone antagonist with diuretic and antihypertensive effects; competitive binding of receptors at aldosterone-dependent Na-K exchange site in distal tubules results in increased excretion of Na+, Cl-, and H2O and retention of K+ and H+

            Hydrochlorothiazide: Thiazide diuretic; inhibits sodium reabsorption in distal renal tubules, resulting in increased excretion of water and of sodium, potassium, and hydrogen ions

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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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