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spironolactone (Rx)Brand and Other Names:Aldactone

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 25mg
  • 50mg
  • 100mg
more...

Primary Hyperaldosteronism

As a diagnostic agent

  • Long test: 400 mg PO qDay for 3-4 weeks
  • Short test: 400 mg PO qDay for 4 days

Short-term perioperative treatment for adrenalectomy

  • Initial: 100-400 mg PO qDay in preparation for surgery
  • Maintenance: Lowest effective dose individualized for patient

Edematous Conditions

Cirrhosis of the liver with edema and/or ascites; nephrotic syndrome

Initial: 100 mg qDay or divided q12hr for 5 days; if no clinical response, add second diuretic with more specific mechanism of action

Range: 25-200 mg PO qDay or divided q12hr

Essential Hypertension

Initial: 25-100 mg PO qDay or divided q12hr for >2 weeks; adjust to patient response

Congestive Heart Failure

Indicated for NYHA class II/IV heart failure (provided CrCl >30 mL/min and serum K <5 mEq/dL)

Initial: 25 mg PO qDay

Range: 12.5-25 mg/day PO; may increase to 50 mg/day if needed; if 25 mg/day not tolerated, reduce to 25 mg every other day

ACC/AHA guidelines recommend aldosterone antagonist to be added to an ACEI or ARB, plus a beta blocker; patient conditions may also require additional medications (eg, loop diuretics, hydralazine, nitrates, digoxin)

Hypokalemia

Range: 25-100 mg PO qDay

Hirsutism (Off-label)

Women with hirsutism

50-200 mg PO qDay or divided q12hr

Acne (Off-label)

Females with hormonal acne

50-200 mg PO qDay or divided q12hr

Dosing Modifications

Renal impairment

  • CrCl ≥50 mL/min/1.73 m²: 12.5-25 mg qDay; use maintenance dose of 25 mg qDay or q12hr after 4 weeks of treatment with potassium ≤5 mEq/L
  • CrCl 30-49 mL/min/1.73 m²: 12.5 mg qDay or every other day; use maintenance dose of 12.5-25 mg qDay after 4 weeks of treatment with potassium ≤5 mEq/L
  • CrCl <30 mL/min/1.73 m²: Avoid use

Overdose Management

May use normal saline for volume replacement

May use dopamine or norepinephrine to treat hypotension

Treat hyperkalemia with IV glucose (dextrose 25% in water), concurrently with rapid-acting insulin and IV sodium bicarbonate; oral/rectal solutions of Kayexalate in sorbitol can be used if needed

If dysrhythmia due to decreased K+ or Mg+ suspected, replace aggressively

Discontinue treatment if no symptoms after 6 hr

Dosage Forms & Strengths

tablet

  • 25mg
  • 50mg
  • 100mg
more...

Edema (Off-label)

CHF, cirrhosis, ascites, and nephrotic syndrome

1-3.3 mg/kg/day PO or divided q12hr; not to exceed 3.3 mg/kg/day or up to 100 mg/day 

Hypertension (Off-label)

Among therapeutic options recommended by the National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents

1-3.3 mg/kg/day PO or divided q12hr; not to exceed 3.3 mg/kg/day or up to 100 mg/day 

Hyperaldosteronism (Orphan)

Orphan designation for primary hyperaldosteronism

Sponsor

  • CMP Pharma, Inc; PO Box 147, 8026 US Highway 264A; Farmville, NC 27828

Diuresis

12.5 mg PO qDay in 1-2 divided doses; increase by 25-50 mg q5Days PRN; adjust for renal impairment

Hyperaldosteronism

Initial: 400 mg/day PO, THEN

100-300 mg/day

Congestive heart failure

Indicated for NYHA class II/IV heart failure (provided CrCl >30 mL/min and serum K <5 mEq/dL)

Initial: 25 mg PO qDay

Range: 12.5-25 mg/day PO; may increase to 50 mg/day if needed; if 25 mg/day not tolerated, reduce to 25 mg every other day

ACC/AHA guidelines recommend aldosterone antagonist to be added to an ACEI or ARB, plus a beta blocker; patient conditions may also require additional medications (eg, loop diuretics, hydralazine, nitrates, digoxin)

Dosing considerations

Caution with heart failure and avoid with CrCl <30 mL/min (Beers criteria)

In heart failure, the risk of hyperkalemia is higher in older adults, especially if taking >25 mg/day or with concomitant NSAID, ACE inhibitor, ARB, or potassium supplement

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Interactions

Interaction Checker

spironolactone and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Drowsiness

            Lethargy

            Headache

            Mental confusion

            Rash

            Urticaria

            Stevens-Johnson syndrome, toxic epidermal necrolysis

            Drug rash with eosinophilia and systemic symptoms (DRESS)

            Gynecomastia

            Impotence

            Menstrual disorders

            Abdominal cramping

            Diarrhea

            Gastritis

            Nausea

            Vomiting

            Breast pain

            Leukopenia

            Electrolyte disturbances

            Leg cramps

            Dizziness

            Alopecia

            Pruritus

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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

            Contraindications

            Hypersensitivity

            Anuria

            Severe renal impairment, acute renal insufficiency

            Addison’s disease or other conditions associated with hyperkalemia

            Coadministration with eplerenone

            Cautions

            Use caution in diabetes mellitus, diabetic nephropathy, fluid and electrolyte imbalance, hepatic disease, metabolic acidosis

            Concomitant use with K+-sparing diuretics or ACE inhibitors

            If used for edema alone, maintain initial dose for at least 5 days before adjustments

            Avoid potassium-rich diet or supplements

            Monitor serum potassium; severe hyperkalemia may occur with concomitant use with other potassium-sparing diuretics, or ACE inhibitors, angiotensin II antagonists, NSAIDs, heparin, LMWH, potassium supplements, salt substitutes, or other drugs known to cause hyperkalemia

            Risk of potentially fatal hyperkalemia in severe heart failure patients

            Discontinue if hyperkalemia develops

            Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine

            Risk of gynecomastia and male sexual dysfunction

            Not recommended for pregnancy-induced hypertension

            In cirrhosis, avoid electrolyte and acid/base imbalances that might lead to hepatic encephalopathy

            Somnolence may occur; caution when operating heavy machinery

            Excess amounts of electrolyte loss can result in profound diuresis; adjust to avoid dehydration; correct electrolyte disturbances resulting from therapy

            Discontinue use prior to adrenal vein catherization

            Risk of hyperkalemia increases with declining renal function

            Risk of orthostasis may occur with oncurrent ethanol use

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Metabolite excreted into breast milk; discontinue breastfeeding or do not use drug

            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

            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+

            Increases testosterone clearance and estradiol production; blocks conversion of potent androgens to weaker ones in peripheral tissues

            Absorption

            Increased with food

            Bioavailability: 73%

            Onset: 2-4 hr

            Duration: 2-3 days

            Peak serum time: 3-4 hr

            Distribution

            Protein bound: 90%

            Metabolism

            Metabolized by the liver and kidneys

            Metabolites: Canrenone, 7-alpha-thiomethylspirolactone, 6-beta-hydroxy-7-alpha-thiomethylspirolactone (active)

            Elimination

            Half-life: Parent drug (1.3-1.4 hr); metabolite [canrenone] (9-23 hr)

            Excretion: Urine (47-57%); feces (35-41%)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            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.
            OR Other Restrictions
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