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Eplerenone (Inspra)

Trade Name : Inspra

G.D. Searle LLC Division of Pfizer Inc

TABLET, FILM COATED

Strength 25 mg/1

EPLERENONE 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 Eplerenone (Inspra) which is also known as Inspra and Manufactured by G.D. Searle LLC Division of Pfizer Inc. It is available in strength of 25 mg/1 per ml. Read more

Eplerenone (Inspra) 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
  • INSPRA is an aldosterone antagonist indicated for:
  • Improving survival of stable patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. ()
  • 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. ()
  • HFrEF Post-MI
  • Hypertension
  • For all patients:
  • Measure serum potassium before starting INSPRA and periodically thereafter. ()
  • Tablets: 25 mg, 50 mg ()
  • For all patients:
  • For the treatment of hypertension:
  • The risk of hyperkalemia is higher in patients with impaired renal function, proteinuria, diabetes and those concomitantly treated with ACEs, ARBs, NSAIDs and moderate CYP3A inhibitors. Minimize the risk of hyperkalemia with proper patient selection and monitoring . Monitor patients for the development of hyperkalemia until the effect of INSPRA is established. Patients who develop hyperkalemia (5.5u20135.9 mEq/L) may continue INSPRA therapy with proper dose adjustment. Dose reduction decreases potassium levels. Patients on moderate CYP3A inhibitors that cannot be avoided should have their dose of eplerenone reduced n
  • Hyperkalemia: Patients with decreased renal function, diabetes, proteinuria or patients who are taking ACEs and ARBs, NSAIDs or moderate CYP3A inhibitors are at increased risk. Monitor serum potassium levels and adjust dose as needed. ()
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • HFrEF Post-MI
  • Hypertension
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or n
  • No data
  • CYP3A Inhibitors: In post-MI HFrEF patients do not exceed 25 mg once daily when used with moderate CYP3A inhibitors (e.g., verapamil, erythromycin, saquinavir, fluconazole). In patients with hypertension initiate at 25 mg once daily. For inadequate blood pressure response, dosing may be increased to a maximum of 25 mg twice daily. (, , )
  • No data
  • No cases of human overdosage with eplerenone have been reported. Lethality was not observed in mice, rats, or dogs after single oral doses that provided C exposures at least 25 times higher than in humans receiving eplerenone 100 mg/day. Dogs showed emesis, salivation, and tremors at a C 41 times the human therapeutic C, progressing to sedation and convulsions at higher exposures.
  • The most likely manifestation of human overdosage would be anticipated to be hypotension or hyperkalemia. Eplerenone cannot be removed by hemodialysis. Eplerenone has been shown to bind extensively to charcoal. If symptomatic hypotension should occur, supportive treatment should be instituted. If hyperkalemia develops, standard treatment should be initiated.
  • INSPRA contains eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor.
  • Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, u03b3-lactone, methyl ester, (7u03b1,11u03b1,17u03b1)-. Its empirical formula is CHO and it has a molecular weight of 414.50. The structural formula of eplerenone is represented below:
  • Eplerenone is an odorless, white to off-white crystalline powder. It is very slightly soluble in water, with its solubility essentially pH-independent. The octanol/water partition coefficient of eplerenone is approximately 7.1 at pH 7.0.
  • INSPRA tablets for oral administration contain 25 mg or 50 mg of eplerenone and the following inactive ingredients: lactose, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, talc, magnesium stearate, titanium dioxide, polyethylene glycol, polysorbate 80, and iron oxide yellow and iron oxide red.
  • No data
  • Eplerenone was non-genotoxic in a battery of assays including in vitro bacterial mutagenesis (Ames test in spp. and ), in vitro mammalian cell mutagenesis (mouse lymphoma cells), in vitro chromosomal aberration (Chinese hamster ovary cells), in vivo rat bone marrow micronucleus formation, and in vivo/ex vivo unscheduled DNA synthesis in rat liver.
  • There was no drug-related tumor response in heterozygous P53 deficient mice when tested for 6 months at dosages up to 1000 mg/kg/day (systemic AUC exposures up to 9 times the exposure in humans receiving the 100 mg/day therapeutic dose). Statistically significant increases in benign thyroid tumors were observed after 2 years in both male and female rats when administered eplerenone 250 mg/kg/day (highest dose tested) and in male rats only at 75 mg/kg/day. These dosages provided systemic AUC exposures approximately 2 to 12 times higher than the average human therapeutic exposure at 100 mg/day. Repeat dose administration of eplerenone to rats increases the hepatic conjugation and clearance of thyroxin, which results in increased levels of TSH by a compensatory mechanism. Drugs that have produced thyroid tumors by this rodent-specific mechanism have not shown a similar effect in humans.
  • Male rats treated with eplerenone at 1000 mg/kg/day for 10 weeks (AUC 17 times that at the 100 mg/day human therapeutic dose) had decreased weights of seminal vesicles and epididymides and slightly decreased fertility. Dogs administered eplerenone at dosages of 15 mg/kg/day and higher (AUC 5 times that at the 100 mg/day human therapeutic dose) had dose-related prostate atrophy. The prostate atrophy was reversible after daily treatment for 1 year at 100 mg/kg/day. Dogs with prostate atrophy showed no decline in libido, sexual performance, or semen quality. Testicular weight and histology were not affected by eplerenone in any test animal species at any dosage.
  • No data
  • INSPRA Tablets are yellow, diamond biconvex, and film-coated. They are debossed with on one side. They are supplied as follows:
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u201330u00b0C (59u201386u00b0F) [See USP Controlled Room Temperature].
  • Advise patients receiving INSPRA:
  • LAB-0079-18.0
  • NDC 0025-1710-01
  • Pfizer
  • INSPRA
  • 25 mg
  • 30 Tabletsn n
  • INSPRA
  • 25 mg
  • G.D. Searle LLCDivision of Pfizer Inc,NY, NY 10017
  • EXP & LOT AREA
  • UNIT DOSE
  • NDC 0025-1710-03
  • Pfizer
  • INSPRA
  • 25 mg
  • For in-institution use only
  • 100 Tabletsn n
  • NDC 0025-1720-03
  • Pfizer
  • INSPRA
  • 50 mg
  • 30 Tabletsn n

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