spironolactone (Rx)

Brand and Other Names:Aldactone, CaroSpir
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 25mg
  • 50mg
  • 100mg

PO suspension (CaroSpir)

  • 5mg/mL
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Primary Hyperaldosteronism

Tablet only

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

  • 100-400 mg PO qDay in preparation for surgery initially
  • Maintain lowest effective dose individualized for patient

Edematous Conditions

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

Tablet

  • 100 mg qDay or divided q12hr for 5 days initially; then adjust does based on patient response; if no clinical response, add second diuretic with more specific mechanism of action
  • Range: 25-200 mg PO qDay or divided q12hr

PO suspension

  • 75 mg PO qDay or divided doses initially; if sole therapy, administer for ≥5 days before increasing dose to obtain effect

Essential Hypertension

Adjunctive therapy for hypertension, to lower blood pressure

Tablet: 25-100mg PO qDay or divided q12hr initially; may adjust dosage to patient response q2weeks

PO suspension

  • 20-75 mg PO qDay or divided doses initially; may adjust dosage to patient response q2weeks
  • See Dosing Considerations

Congestive Heart Failure

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

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

Tablet

  • 12.5-25 mg PO qDay initially
  • Range: 25mg/day PO initially if serum potassium ≤5 mEq/L and serum creatinine ≤2.5 mg/dL; if tolerated, may increase to 50 mg/day as clinically indicated; if 25 mg/day not tolerated, reduce frequency to every other day

PO suspension

  • 20 mg PO qDay; if initial 20 mg dose is tolerated, dosage can be increased to 37.5 mg as clinically indicated

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

  • PO suspension for treatment of patients who develop hyperkalemia on 20 mg PO qDay may reduce dose to 20 mg qOD
  • PO suspension for treatment of CHF
    • CrCl 30-50 mL/min/1.73m²: 10 mg PO qDay initially owing to risk of hyperkalemia
  • tablet
    • 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

Dosing Considerations

Oral formulation

  • PO suspension formulation is not therapeutically equivalent to tablet
  • If PO suspension requires a dose titration >100 mg, use tablet
  • For hypertension: Doses >75 mg/day may not provide additional reductions in blood pressure

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 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)

25 mg PO qDay initially if serum potassium ≤5 mEq/L and serum creatinine ≤2.5 mg/dL

If initial dose is tolerated, may increase to 50 mg/day as clinically indicated; if not tolerated, reduce frequency to 25 mg qOD

ACC/AHA guidelines recommend aldosterone antagonist to be added to an ACE inhibitor 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

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            Adverse Effects

            Frequency Not Defined

            Gastric bleeding

            Ulceration

            Gastritis

            Decreased libido

            Inability to achieve or maintain erection

            Postmenopausal bleeding

            Breast and nipple pain

            Thrombocytopenia

            Fever

            Urticaria

            Maculopapular or erythematous cutaneous eruptions

            Anaphylactic reactions

            Vasculitis

            Hyperkalemia

            Electrolyte disturbances

            Hyponatremia

            Hypovolemia

            Lethargy

            Mental confusion

            Ataxia

            Dizziness

            Headache

            Drowsiness

            Renal dysfunction (including renal failure)

            Chloasma

            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

            All formulations

            • Hypersensitivity
            • Addison disease or other conditions associated with hyperkalemia
            • Coadministration with eplerenone

            Tablet only

            • Anuria
            • Severe renal impairment, acute renal insufficiency

            Cautions

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

            Discontinue use prior to adrenal vein catheterization

            Risk of orthostasis may occur with concurrent ethanol use

            Risk of gynecomastia and male sexual dysfunction

            Not recommended for pregnancy-induced hypertension

            Somnolence may occur; caution when operating heavy machinery

            Electrolyte imbalance

            • In cirrhosis, avoid electrolyte and acid/base imbalances that might lead to hepatic encephalopathy
            • PO suspension
              • Hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia may occur
              • Asymptomatic hyperuricemia can occur and rarely gout may occur; monitor serum electrolytes, uric acid, and blood glucose periodically

            Hyperkalemia

            • Concomitant use with K+-sparing diuretics or ACE inhibitors
            • Risk of hyperkalemia increases with declining renal function
            • If used for edema alone, maintain initial dose for at least 5 days before adjustments
            • Avoid potassium-rich diet or supplements
            • Discontinue if hyperkalemia develops; monitor serum potassium; severe hyperkalemia may occur with concomitant use with other potassium-sparing diuretics or ACE inhibitors, angiotensin II antagonists, NSAIDs, heparin, low molecular weight heparin, potassium supplements, salt substitutes, or other drugs known to cause hyperkalemia
            • Risk of potentially fatal hyperkalemia in severe heart failure patients
            • Discontinue or interrupt therapy if serum potassium >5m mEq/L or serum creatinine >4 mg/L
            • Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine
            • For PO suspension: Monitor serum potassium ≥1 week of initiation, titration, and regularly thereafter; closer monitoring may be required with coadministration of drugs that cause hyperkalemia or in renally impaired patients

            Excessive diuresis

            • Excess amounts of electrolyte loss can result in profound diuresis; adjust to avoid dehydration; correct electrolyte disturbances resulting from therapy
            • Excessive diuresis may cause symptomatic dehydration, hypotension, and worsening renal function, particularly in salt-depleted patients or those taking ACE inhibitors and ARBs
            • Risk of worsening of renal function can also occur with concomitant use of nephrotoxic drugs (eg, aminoglycosides, cisplatin, NSAIDs); monitor volume status and renal function periodically

            Drug interactions with PO suspension

            • Coadministration of PO suspension and lithium reduces the renal clearance of lithium, inducing a high risk of lithium toxicity
            • Reported that of coadministration of PO suspension and an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of loop, potassium-sparing, and thiazide diuretics
            • Acetylsalicylic acid: Reported that single dose of 600 mg of acetylsalicylic acid inhibited the natriuretic effect of spironolactone, which was hypothesized be due to inhibition of tubular secretion of canrenone, causing decreased effectiveness of spironolactone
            • Drugs/supplements increasing serum potassium: Concomitant administration of PO formulation with potassium supplementation, salt substitutes containing potassium, a diet rich in potassium, or drugs that can increase potassium, including ACE inhibitors, ARBs, NSAIDs, heparin and low molecular weight heparin, may lead to severe hyperkalemia
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            Pregnancy & Lactation

            Pregnancy

            Limited available data did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone; risks may occur to the mother and fetus associated with heart failure, cirrhosis, and poorly controlled hypertension during pregnancy

            Potential risk to the male fetus due to antiandrogenic properties of spironolactone; avoid spironolactone in pregnant women or advise a pregnant woman of the potential risk to a male fetus

            Disease-associated maternal and embryo/fetal risks

            • Pregnant women with CHF are at increased risk for preterm birth; stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester; closely monitor pregnant patients with CHF
            • Pregnant women with symptomatic cirrhosis generally have poor outcomes (eg, hepatic failure, variceal hemorrhage, preterm delivery, fetal growth restriction, and maternal death); pregnant women with cirrhosis of the liver should be monitored and managed accordingly
            • Hypertension in pregnancy increases the maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean delivery, postpartum hemorrhage); hypertension increases the fetal risk for intrauterine growth restriction and death

            Lactation

            Unknown if distributed in human breast milk

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

            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 water 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% (tablet)

            Onset: 2-4 hr (tablet)

            Duration: 2-3 days (tablet)

            Peak serum time: 3-4 hr (tablet); 0.5-1.5 hr (PO suspension); 2.5-5 hr (PO suspension, active metabolite)

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

            Half-life (PO suspension): Parent drug (1-2 hr); metabolite [canrenone] (10-35 hr)

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

            Excretion (PO suspension): Urine

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            Administration

            Storage

            Tablet: Store below 77°F (25°C)

            PO suspension: Store at 68-77°F (20-25°C); excursions permitted to 59-86°F (15-30°C); shake well before use, dispense in a tight container as defined in the USP

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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.
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            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.
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            Code Definition
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            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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