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Spironolactone (Spironolactone)

Trade Name : Spironolactone

PD-Rx Pharmaceuticals, Inc.

TABLET, FILM COATED

Strength 25 mg/1

SPIRONOLACTONE Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Spironolactone (Spironolactone) which is also known as Spironolactone and Manufactured by PD-Rx Pharmaceuticals, Inc.. It is available in strength of 25 mg/1 per ml. Read more

Spironolactone (Spironolactone) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Spironolactone is an aldosterone antagonist indicated for:
  • The treatment of NYHA Class IIIu2013IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (n n n n n n n n n )n n n n n n n n n
  • Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (n n n n n n n n n )n n n n n n n n n
  • The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (n n n n n n n n n ).n n n n n n n n n
  • Treatment of primary hyperaldosternism for: (n n n n n n n n n ) tttttttttn n n n n n n n n n
  • No data
  • Heart Failure: Initiate treatment at 25 mg once daily (n n n n n n n n n ). n n n n n n n n n
  • Hypertension: Initiate treatment at 25 to 100 mg daily in either single or divided doses (n n n n n n n n n ).n n n n n n n n n
  • Edema: Initiate therapy in a hospital setting and titrate slowly. The recommended initial daily dose is 100 mg in single or divided doses (n n n n n n n n n ).n n n n n n n n n
  • Primary hyperaldosteronism: Initiate treatment at 100 to 400 mg in preparation for surgery. In patients unsuitable for surgery use the lowest effective dosage determined for the individual patient (n n n n n n n n n ).n n n n n n n n n
  • ntttttSpironolactone tablets USP 25 mg are light yellow to yellow colored, round, biconvex, film coated tablets with inscription u201cADu201d on one side and plain on the other side having faint odour of peppermint.ntttt
  • ntttttSpironolactone tablets USP 50 mg are light orange to orange colored, oval, biconvex, film coated tablets with inscription u201cAEu201d on one side and breakline on the other side having faint odour of peppermint.ntttt
  • ntttttSpironolactone tablets USP 100 mg are light peach to peach colored, round, biconvex, film coated tablets with inscription u201cAFu201d on one side and breakline on the other side having faint odour of peppermint.ntttt
  • Tablets: 25 mg, 50 mg, and 100 mg (n n n n n n n n n )n nn n nn n nn
  • Spironolactone tablets are contraindicated in the patients with:
  • Spironolactone tablets are contraindicated in patients with (n n n n n n n n n ):n nn n nn n nn
  • Hyperkalemia
  • Addison's disease
  • Concomitant use of eplerenone
  • No data
  • Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter (n n n n n n n n n ).n n n n n n n n n
  • Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically (n n n n n n n n n ).n n n n n n n n n
  • Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically (n n n n n n n n n ).n n n n n n n n n
  • Gynecomastia: Spironolactone can cause gynecomastia (n n n n n n n n n ).n n n n n n n n n
  • The following clinically significant adverse reactions are described elsewhere in the labeling:
  • The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.
  • Digestive:
  • Reproductive:
  • Hematologic:
  • Hypersensitivity:
  • Metabolism:n- [see n n n n n n n n n , n n n n n n n n n ]n n n n n n n n n
  • Musculoskeletal
  • Nervous system/psychiatric:
  • Liver/biliary:
  • Renal:
  • Skin:
  • The most common adverse reaction with spironolactone treatment is gynecomastia (n n n n n n n n n , n n n n n n n n n ).n nn n nn n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare, Inc. at 1866-941-7875 or www.accordhealthcare.us or FDA at 1-800-FDA-1088 or n n n n n n n n n .n n n n n n n n n
  • No data
  • Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia (n n n n n n n n n , n n n n n n n n n ).n n n n n n n n n
  • Lithium: Increased risk of lithium toxicity (n n n n n n n n n ).n n n n n n n n n
  • NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of spironolactone (n n n n n n n n n ).n n n n n n n n n
  • Digoxin: spironolactone can interfere with radioimmunologic assays of digoxin exposure (n n n n n n n n n ).n n n n n n n n n
  • Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use (n n n n n n n n n ).n n n n n n n n n
  • Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of spironolactone (n n n n n n n n n ).n n n n n n n n n
  • No data
  • Pregnancy: Based on animal data, spironolactone may affect sex differentiation of the male during embryogenesis (n n n n n n n n n )n n n n n n n n n
  • The oral LDn n n n n n n n n of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits.n nn n nn n nn
  • Acute overdosage of spironolactone may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Hyperkalemia may occur, especially in patients with impaired renal function.
  • Treatment:
  • Spironolactone oral tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7u03b1-mercapto-3-oxo-17u03b1-pregn-4-ene-21-carboxylic acid u03b3-lactone acetate, which has the following structural formula:
  • Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.
  • Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths.
  • No data
  • No data
  • No data
  • Spironolactone tablets USP 25 mg tablets are Light yellow to yellow colored, round, biconvex, film coated tablets with inscription u201cADu201d on one side and plain on the other side having faint odour of peppermint, supplied as:
  • NDC 43063-862-30 Bottles of 30
  • NDC 43063-862-60 Bottles of 60
  • NDC 43063-862-90 Bottles of 90
  • NDC 43063-862-01 Bottles of 100
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature] Protect from light. Dispense in tight, Light-resistant containers.nttttt
  • Patients who receive spironolactone tablets should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes.
  • n Manufactured For:
  • nttttManufactured By:
  • 51 2946 1 721675
  • Issued August 2019
  • No data

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

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Name Patient Supply

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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