Monitor therapy, Digoxin: Spironolactone may increase the serum concentration of Digoxin. Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Birmingham, AL 35211, NDC 69584-852-10 Cirrhosis of the liver when edema is not responsive to fluid and sodium restriction. Patients with renal impairment are at increased risk of hyperkalemia. By competing with aldosterone for receptor sites, Spironolactone provides effective therapy for the edema and ascites in those conditions. Diuretics are used to treat volume overload, but as noted above, care must be taken to avoid volume depletion. Monitor therapy, Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. For surgical candidates, the last dose should be administered the day of surgery; discontinue spironolactone on postoperative day 1 (ES [Funder 2016]; Young 2019). Figure 2. Identification Name Spironolactone Accession Number DB00421 Description. Tablet: Administer with or without food; however, administer consistently with respect to food. Tablets: 50 mg oval, white to off-white, scored, convex, coated, debossed with 853 left of the bisect on one side and debossed with “O” on the other side. Monitor therapy, Ciprofloxacin (Systemic): Spironolactone may enhance the arrhythmogenic effect of Ciprofloxacin (Systemic). OXFORD PHARMACEUTICALS Background and Methods Aldosterone is important in the pathophysiology of heart failure. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy, Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. The mean half-life values of its metabolites including canrenone, 7-α-(thiomethyl) spirolactone (TMS), and 6-ß-hydroxy-7-α-(thiomethyl) spirolactone (HTMS) are 16.5, 13.8, and 15 hours, respectively. No teratogenic or other embryotoxic effects were observed in mice, but the 20 mg/kg dose caused an increased rate of resorption and a lower number of live fetuses in rabbits. Use of a mineralocorticoid receptor antagonist can be considered again in the second and third trimesters if necessary; high doses have been associated with intrauterine growth restriction (monitor) (Riester 2015). 73% were male and median age was 67. Data from a randomized, double-blind, placebo-controlled trial of patients with heart failure with preserved ejection fraction (HFpEF) suggest that spironolactone may be effective at reducing hospitalizations for heart failure, which was one component of the composite primary end point. Monitor therapy, Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Its effects on the RAAS … Data from more than 25,000 US patients with treatment-resistant hypertension, all of whom qualified for assessment for primary aldosteronism, show just 1.6% were tested. Nuclear receptors such as the MR comprise discrete domains for specific functions including ligand binding, activation, and DNA recognition. Lithium: Spironolactone reduces the renal clearance of lithium, inducing a high risk of lithium toxicity [see Warnings and Precautions (5.1) and Drug Interactions (7.2)]. Safety and effectiveness in pediatric patients have not been established. Another option is a mineralocorticoid receptor antagonist like eplerenone and spironolactone that not only removes extra salt and fluid but also holds onto potassium. Based on the American College of Cardiology Foundation (ACCF)/AHA guideline for the management of heart failure, spironolactone (along with other guideline-directed medical therapies) is effective and recommended to reduce morbidity and mortality in patients with heart failure (New York Heart Association class II to IV) with a left ventricular ejection fraction (LVEF) ≤35%. Heart failure with preserved ejection fraction (off-label use): Note: May be considered for use in patients with symptomatic heart failure with preserved ejection fraction (≥45%) who have an elevated serum natriuretic peptide level or have been hospitalized for heart failure in the last 12 months (ACC/AHA/HFSA [Yancy 2017]; Pitt 2014). • Elderly: Avoid use of tablets >25 mg/day in elderly patients with heart failure or with reduced renal function (eg, CrCl <30 mL/minute or eGFR ≤30 mL/minute/1.73 m2 [ACC/AHA (Yancy 2013)]). Edema (diuresis): Limited data available: Infants, Children, and Adolescents: Oral: Initial: 1 to 3 mg/kg/day divided every 6 to 24 hours; titrate as needed; reported maximum daily dose range: 4 to 6 mg/kg/day in divided doses every 6 to 12 hours or 400 mg/day, whichever is less (Giefer 2011; Kliegman 2016; Sabri 2003; van der Vorst 2006), Hypertension: Limited data available: Infants, Children, and Adolescents: Oral: Initial: 1 mg/kg/day divided every 12 to 24 hours; titrate as needed up to a maximum daily dose: 3.3 mg/kg/day or 100 mg/day, whichever is less (NHBPEP 2004; Park 2014), Primary aldosteronism (caused by adrenal hyperplasia), treatment: Limited data available: Infants, Children, and Adolescents: Oral: 1 to 3 mg/kg/day; maximum daily dose: 100 mg/day (Kliegman 2016), 5 mg/mL Oral Suspension (ASHP Standard Concentration) (ASHP 2017). Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery or for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism) Management: Consider avoiding this combination by temporarily suspending treatment with diuretics, or seeking alternatives to oral sodium phosphate bowel preparation. Based upon the available evidence, we suggest treatment with a mineralocorticoid receptor antagonist in selected patients with HFpEF who can be appropriately monitored. Add small portions of distilled water and mix to a uniform paste; mix while adding cherry syrup to almost 120 mL; transfer to a calibrated glass bottle, rinse mortar with cherry syrup, and add quantity of cherry syrup sufficient to make 120 mL. Dose reduction or interruption of therapy may be necessary with development of hyperkalemia. Management: Patients receiving spironolactone should omit their pre-test dose on the day selected for cosyntropin testing. These effects were associated with retarded ovarian follicle development and a reduction in circulating estrogen levels, which would be expected to impair mating, fertility, and fecundity. Monitor therapy, Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Nervous system/psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness. The recommended initial daily dose is 25 to 100 mg of Spironolactone administered in either single or divided doses is recommended. (9) “Spironolactone Dose-Response Relationships in Healthy Subjects”, McInness G, Br. Monitor therapy, Cholestyramine Resin: May enhance the adverse/toxic effect of Spironolactone. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Spironolactone is indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. Monitor therapy, Diacerein: May enhance the therapeutic effect of Diuretics. Monitor therapy, Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. EACH TABLET CONTAINS: Teratology studies with Spironolactone have been carried out in mice and rabbits at doses of up to 20 mg/kg/day. These subgroup analyses must be interpreted cautiously. Addition of angiotensin receptor blockade or mineralocorticoid antagonism to maximal angiotensin-converting enzyme inhibition in diabetic nephropathy. Administer with or without food; however, administer consistently with respect to food. Monitor therapy, Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Figure 1. All drugs may cause side effects. Manufactured By: May be considered as initial therapy for females who cannot conceive or who are using reliable contraception (Barbieri 2019; ES [Martin 2018]). Last updated on Nov 1, 2020. Drug class: aldosterone receptor antagonists, Mineralocorticoid (Aldosterone) Receptor Antagonists. In patients taking concomitant digoxin, use an assay that does not interact with Spironolactone. Pharmacodynamics. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. • It is used to treat heart failure (weak heart). Monitor therapy, Eplerenone: May enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Stable for 3 months at room temperature or refrigerated (Nahata 1993). Absorption Closely monitor pregnant patients for destabilization of their heart failure. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In patients with serum potassium ≤5.0 mEq/L and eGFR >50 mL/min/1.73 m², initiate treatment at 25 mg once daily. Patients with Hepatic Impairment: The terminal half-life of Spironolactone has been reported to be increased in patients with cirrhotic ascites [see Use in Specific Populations (8.7)]. Isosorbide Dinitrate & Hydralazine: Isosorbide (Isordil®) plus Hydralazine (Apresoline®) or J Am Soc Nephrol . PHARMACEUTICALS, LLC, NDC 69584-853-10 Consider therapy modification, Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. 8000087 Rev. Actual risks may be related to duration and severity of maternal hypertension. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. ALDACTONE causes increased amounts of sodium and water to be excreted, while potassium is retained. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. This particular effect may be unique to Spironolactone. OXFORD PHARMACEUTICALS, LLC Spironolactone is indicated in the following settings: Spironolactone can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology (12.3)]. A subgroup of patients who were enrolled on the basis of natriuretic peptide criteria displayed a reduction in the composite primary end point (cardiovascular death, aborted cardiac arrest, or hospitalization for heart failure) [Pitt 2014]. Edematous states in which secondary aldosteronism is usually involved include congestive heart failure, hepatic cirrhosis, and nephrotic syndrome. Patients who develop hyperkalemia on 25 mg once daily may have their dosage reduced to 25 mg every other day [see Warnings and Precautions (5.1)]. Consider therapy modification, Tacrolimus (Systemic): Potassium-Sparing Diuretics may enhance the hyperkalemic effect of Tacrolimus (Systemic). Elimination EACH TABLET CONTAINS: Primary Hyperaldosteronism. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. STORE at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Spironolactone has known endocrine effects in animals including progestational and antiandrogenic effects. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Select one or more newsletters to continue. Data from a systematic review and network meta-analysis of published randomized trials of adult females with hirsutism (including idiopathic hirsutism and hirsutism in women with polycystic ovary syndrome or nonclassic congenital adrenal hyperplasia) support the use of spironolactone in the treatment of hirsutism [Barrionuevo 2018]. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. Excretion: The metabolites are excreted primarily in the urine and secondarily in bile. Assess response at 6-month intervals before adjusting dose, adding additional agents, or switching to alternative therapy (Barbieri 2019; ES [Martin 2018]). In patients requiring >100 mg/dose, use tablets (>100 mg/dose of suspension may result in spironolactone concentration higher than expected). Doses greater than 100 mg/day generally do not provide additional reductions in blood pressure [see Dosage and Administration (2.3)]. Spironolactone USP ..... 100 mg Worsening of renal function can also occur with concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and NSAIDs). Comparison between nonsteroidal mineralocorticoid receptor antagonist (finerenone) and steroidal mineralocorticoid receptor antagonists Mode of mineralocorticoid receptor antagonism. 09/2020 R00 Note: When initiating therapy, verify the following: serum creatinine ≤2.5 mg/dL in men and ≤2 mg/dL in women or eGFR >30 mL/minute/1.73 m2 and serum potassium <5 mEq/L. There was a history of myocardial infarction in 28%, of hypertension in 24%, and of diabetes in 22%. Spironolactone is substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: • Fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, dizziness, passing out, fast heartbeat, increased thirst, seizures, loss of strength and energy, lack of appetite, unable to pass urine or change in amount of urine passed, dry mouth, dry eyes, nausea, or vomiting. Heart failure with reduced ejection fraction: Note: Should be considered for use in patients with symptomatic (New York Heart Association class II to IV) heart failure with reduced ejection fraction (≤35%) who are already taking optimal doses of other heart failure therapies (ACC/AHA/HFSA [Yancy 2017]; ACCF/AHA [Yancy 2013]). Use is contraindicated in patients with hyperkalemia; use caution in conditions known to cause hyperkalemia. DISPENSE in a tight, light-resistant, child-resistant closure container. To be eligible to participate patients had to have an ejection fraction of ≤ 35%, NYHA class III-IV symptoms, and a history of NYHA class IV symptoms within the last 6 months before enrollment. Avoid triple therapy with the combined use of an ACE inhibitor, ARB, and spironolactone. Monitor therapy, Bromperidol: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. A 25 mg/mL oral suspension may be made with tablets and either a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Ora-Sweet SF and Ora-Plus. Label "shake well." Heart failure with reduced ejection fraction: To increase survival, manage edema, and reduce need for hospitalization in patients with heart failure with reduced ejection fraction and New York Heart Association class III to IV symptoms; usually administered in conjunction with other heart failure therapies.
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