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Eplerenone (Eplerenone)

Trade Name : Eplerenone

Eon Labs, Inc.

TABLET

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 (Eplerenone) which is also known as Eplerenone and Manufactured by Eon Labs, Inc.. It is available in strength of 25 mg/1 per ml. Read more

Eplerenone (Eplerenone) 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
  • Eplerenone tablets are an aldosterone antagonist indicated for:
  • HFrEF Post-MI:
  • (2.1)
  • Hypertension
  • (2.2)
  • For all patients
  • Measure serum potassium before starting eplerenone and periodically thereafter. n
  • Tablets: 25 mg, 50 mg n
  • Arrayn- For All Patients
  • Eplerenone is contraindicated in all patients with:
  • Arrayn- For Patients Treated for Hypertension
  • Eplerenone is contraindicated for the treatment of hypertension in patients with:
  • For all Patients:
  • For the Treatment of Hypertension:
  • No data
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • HFrEF Post-MI
  • (6.1)
  • Hypertension
  • (6.1)
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • u2022
  • 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.
  • Eplerenone tablets contain 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.
  • Eplerenone tablets for oral administration contain 25 mg or 50 mg of eplerenone and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, silicified microcrystalline cellulose, talc, titanium dioxide,. In addition, the 25 mg tablets also contain polysorbate and the 50 mg tablets also contain FD&C yellow No. 5 (tartrazine) and FD&C yellow No. 6, polydextrose and triacetin.
  • No data
  • Eplerenone was non-genotoxic in a battery of assays including bacterial mutagenesis (Ames test in spp. and ), mammalian cell mutagenesis (mouse lymphoma cells), in vitro chromosomal aberration (Chinese hamster ovary cells), rat bone marrow micronucleus formation, and 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
  • Eplerenone Tablets, for oral administration, are available as
  • Arrayn- 25 mg
  • White, round, film-coated tablets, debossed with u201cSZu201d on one side and u201c12u201d on the other side and supplied as:
  • NDC 0185-5368-30 bottles of 30
  • NDC 0185-5368-09 bottles of 90
  • Arrayn- 50 mg
  • Yellow, round, film-coated tablets, debossed with u201cSZu201d on one side and u201c16u201d on the other side and supplied as:
  • NDC 0185-5369-30 bottles of 30
  • NDC 0185-5369-09 bottles of 90
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.
  • Protect from light and moisture.
  • KEEP TIGHTLY CLOSED.
  • KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
  • Advise patients receiving eplerenone tablets:
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Manufactured by
  • Sandoz Inc.
  • Princeton, NJ 08540
  • 46192571
  • Rev. September 2018
  • MF5368REV09/18
  • NDC 0185-5368-30
  • Eplerenone Tablets
  • 25 mg
  • Rx only
  • 30 Tablets
  • Sandoz
  • NDC 0185-5369-30
  • Eplerenone Tablets
  • 50 mg
  • Contains FD&C Yellow No. 5 (tartrazine) as a color additive.
  • Rx only
  • 30 Tablets
  • Sandoz

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