Eptus 25 Tablet
COMPOSITION
Eplerenone IP ……25 mg
Eplerenone IP ……25 mg
What is Eptus?
DESCRIPTION :Eplerenone is a selective aldosterone receptor antagonist.
CLINICAL PHARMACOLOGY :
Pharmacodynamics :
Eplerenone binds to the mineralocorticoid receptor and blocks the binding of aldosterone. Aldosterone synthesis, which occurs primarily in the adrenal gland, is modulated by angiotensin II, adrenocorticotropic hormone (ACTH) and potassium. Aidosterone binds to mineralocorticoid receptors in both epithelial (e.g., kidney) and nonepithelial (e.g, heart
blood vessels, and brain) tissues and increases blood pressure through induction of sodium reabsorption and possibly other mechanisms. Eplerenone, being an aidosterone antagonist, has been showin to produce sustained increases in plasma renin and serum aldosterone, consistent with inhibition of the negative regulatory feedback of aldosterone on renin secretion. The resulting increased plasma renin activity and aldosterone circulating levels do not overcome the effect of Eplerenone on blood pressure. Eplerenone has relative selectivity in binding to recombinant human mineralocorticoid receptors compared to its binding to recombinant human glucocorticoid, progesterone and androgen receptors.
Eplerenone binds to the mineralocorticoid receptor and blocks the binding of aldosterone. Aldosterone synthesis, which occurs primarily in the adrenal gland, is modulated by angiotensin II, adrenocorticotropic hormone (ACTH) and potassium. Aidosterone binds to mineralocorticoid receptors in both epithelial (e.g., kidney) and nonepithelial (e.g, heart
blood vessels, and brain) tissues and increases blood pressure through induction of sodium reabsorption and possibly other mechanisms. Eplerenone, being an aidosterone antagonist, has been showin to produce sustained increases in plasma renin and serum aldosterone, consistent with inhibition of the negative regulatory feedback of aldosterone on renin secretion. The resulting increased plasma renin activity and aldosterone circulating levels do not overcome the effect of Eplerenone on blood pressure. Eplerenone has relative selectivity in binding to recombinant human mineralocorticoid receptors compared to its binding to recombinant human glucocorticoid, progesterone and androgen receptors.
Pharmacokinetics :
Absorption :
Oral Eplerenone appears to be well absorbed. The absolute bioavailability of Eplerenone is unknown. Absorption is not affected by food. Maximum concentrations (Cmax) are achieved within 1 to 2 hrs (Tmax) after oral administration of Eplerenone
Oral Eplerenone appears to be well absorbed. The absolute bioavailability of Eplerenone is unknown. Absorption is not affected by food. Maximum concentrations (Cmax) are achieved within 1 to 2 hrs (Tmax) after oral administration of Eplerenone
Distribution :
Eplerenone is 50% protein bound and is primarily bound to alpha-1-acid glycoprotein. Eplerenone does not preferentially bind to red blood celis. In healthy and hypertensive patients, the apparent volume of distribution at steady-state ranges from 43 to 90 L
Eplerenone is 50% protein bound and is primarily bound to alpha-1-acid glycoprotein. Eplerenone does not preferentially bind to red blood celis. In healthy and hypertensive patients, the apparent volume of distribution at steady-state ranges from 43 to 90 L
Metabolism :
Eplerenone is extensively metabolized in the liver, primarily by cytochrome P4503A4. No active metabolites have been identified. Eplerenone is not an inhibitor of
CYP1A2, CYP3A4, CYP2C19, CYP2C9, or CYP2D6. Eplerenone is not a substrate or
inhibitor of P-Glycoprotein at clinically relevant doses.
Eplerenone is extensively metabolized in the liver, primarily by cytochrome P4503A4. No active metabolites have been identified. Eplerenone is not an inhibitor of
CYP1A2, CYP3A4, CYP2C19, CYP2C9, or CYP2D6. Eplerenone is not a substrate or
inhibitor of P-Glycoprotein at clinically relevant doses.
Excretion :
Less than 5% of a dose is excreted unchanged in the urine and feces Followinga single oral dose, approximately 67% of the dose was excreted in the urine and 32% of the dose was excreted in the feces. It is human breast milk. Eplerenone and/or its metabolites are excreted into rat breast mik The plasma elimination halt- life is 3.5 to 6 hours known if Eplerenone is excreted into
Less than 5% of a dose is excreted unchanged in the urine and feces Followinga single oral dose, approximately 67% of the dose was excreted in the urine and 32% of the dose was excreted in the feces. It is human breast milk. Eplerenone and/or its metabolites are excreted into rat breast mik The plasma elimination halt- life is 3.5 to 6 hours known if Eplerenone is excreted into
Speclal populations :
Age :
No significant differences in Eplerenone pharmacokinetics were seen between paediatric (aged 2-16 years) and adult (aged 18-65 years) patients with mild-to-moderate hypertension.
No significant differences in Eplerenone pharmacokinetics were seen between paediatric (aged 2-16 years) and adult (aged 18-65 years) patients with mild-to-moderate hypertension.
Gender :
The phamacokinetics of Eplerenone 100 mg once daily did not differ significantly between males and females
The phamacokinetics of Eplerenone 100 mg once daily did not differ significantly between males and females
Renal Insufficlency :
Compared with healthy volunteers, steady-state Cmax and AUC values were increased by 24% and 38% in patients with severe renal impaiment (creatinine olearance [CLCR]1.8 Lh [30 ml/min) and decreased by 3% and 207% in
patients undergoing haemodialysis.
Compared with healthy volunteers, steady-state Cmax and AUC values were increased by 24% and 38% in patients with severe renal impaiment (creatinine olearance [CLCR]1.8 Lh [30 ml/min) and decreased by 3% and 207% in
patients undergoing haemodialysis.
Hepatic insufficlency :
At steady state, Eplerenone Cmax and AUC values increased by 3.6% and 42% In patients with moderate hepatic impairment (Child-Pugh Class B) versus healthy volunteers receiving Eplerenone 400mg once daily, and by 22% and d45% in patients aged > 65 years versus younger adults receiving Eplerenione 100mg once daily however, these increases were not considered clinically significant
At steady state, Eplerenone Cmax and AUC values increased by 3.6% and 42% In patients with moderate hepatic impairment (Child-Pugh Class B) versus healthy volunteers receiving Eplerenone 400mg once daily, and by 22% and d45% in patients aged > 65 years versus younger adults receiving Eplerenione 100mg once daily however, these increases were not considered clinically significant
What are eplerenone tablets for?
INDICATION AND USAGE :
Congestive Heart Failure Post-Myocardial Infarction –
Eplerenone is indicated to improve survival of stable patients withleft ventricular systolic dysfunction (ejection fraction /40%) and clinical evidence of cbngestive heart failurs after an acute myocardial infarction.
Congestive Heart Failure Post-Myocardial Infarction –
Eplerenone is indicated to improve survival of stable patients withleft ventricular systolic dysfunction (ejection fraction /40%) and clinical evidence of cbngestive heart failurs after an acute myocardial infarction.
Hypertension –
Eplerenone is indicated for the treatment of hypertension. Eplerenone may be used alone or in combination with other antihypertensive agents
Eplerenone is indicated for the treatment of hypertension. Eplerenone may be used alone or in combination with other antihypertensive agents
DOSAGE & ADMINISTRATION
In Congestive Heart Fallure Post-Myocardial Infarction –
The recommended dose of Eplerenone is 50 mg once daily, Treatment should be initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks as tolerated by the patient. Eplerenone may be administered with or without fo0d. Serum potassium should be measured before initiating Eplerenone therapy, within the flirst week and at one month ater the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereater. in EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Eicacy and
Survival Study) the majority of hyperkalemia was observed within the first three months after randomization, The dose should be adjusted based on the serum potassium level
and the dose adjustment table shown below.
The recommended dose of Eplerenone is 50 mg once daily, Treatment should be initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks as tolerated by the patient. Eplerenone may be administered with or without fo0d. Serum potassium should be measured before initiating Eplerenone therapy, within the flirst week and at one month ater the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereater. in EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Eicacy and
Survival Study) the majority of hyperkalemia was observed within the first three months after randomization, The dose should be adjusted based on the serum potassium level
and the dose adjustment table shown below.
In Hypertension –
In patients with hypertension the recommended starting dose of Eplerenone is 50 mg administered once daily, The full therapeutic effect of Eplerenone is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of Eplerenone should be increased to 50 mg twice daily. Eplerenone may be used alone or in combination with other antihypertensive agents. For patients recelving weak CYP3A4 inhibitors, such as erythromycin, saquinavir, verapamil. and fuconazole the starting dose should be reduced to 25 mg once daily.
In patients with hypertension the recommended starting dose of Eplerenone is 50 mg administered once daily, The full therapeutic effect of Eplerenone is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of Eplerenone should be increased to 50 mg twice daily. Eplerenone may be used alone or in combination with other antihypertensive agents. For patients recelving weak CYP3A4 inhibitors, such as erythromycin, saquinavir, verapamil. and fuconazole the starting dose should be reduced to 25 mg once daily.
CONTRAINDICATIONS
Eplerenone is contraindicated in all patients with the following –
• Known or suspected hypersensitivity to Eplerenone
• Serum potassium >5.5 mEq/Lat initiation
• Creatinine clearance =30 m/min
• Concomitant use with the following potent CYP3A4 inhibitors: kotoconazole and Itraconazole.
Eplerenone is contraindicated in all patients with the following –
• Known or suspected hypersensitivity to Eplerenone
• Serum potassium >5.5 mEq/Lat initiation
• Creatinine clearance =30 m/min
• Concomitant use with the following potent CYP3A4 inhibitors: kotoconazole and Itraconazole.
Eplerenone is also contraindicated for the treatment ot hypertension in patients with the
following –
• Serum creatinine >2.0mg/dL in males or > 1.8mg/dL in females
• Creatinine clearance <50 mL/min
• Type 2 diabetes with microalbuminuria
• Concomitant use of potassium supplements or potassium-sparing (amiloride, spironolatone, or triamterene) diuretics
following –
• Serum creatinine >2.0mg/dL in males or > 1.8mg/dL in females
• Creatinine clearance <50 mL/min
• Type 2 diabetes with microalbuminuria
• Concomitant use of potassium supplements or potassium-sparing (amiloride, spironolatone, or triamterene) diuretics
ADVERSE REACTIONS :
Eplerenone is generaly well tolerated. The overall incidence of adverse events reported
Eplerenone is generaly well tolerated. The overall incidence of adverse events reported
with Eplerenone is similar o that reported with placebo. Adverse events seen are mild and aransient. Most commony reported adverse events are headache, dizziness, fatigue,
abdominal pain, coughing, influenza-like symptoms, albuminuria and lipid profile changes like hyperchonterolemia and hypertriglyceridemia. Gynecomastia and abnomal vaginal bleennave occurred inrequently (less than f9) in patienits receiving
Fplerenone. Elevated iveenzymes [Serum alanine aminotransferase (ALT) and gamma amvl transpeptidase (GGTD), reduction in serum sodium levels and increases in serumn Creatinine, blood urea nitrooen (BUN) and uric acid have been reported. Dose-related hyoerkalemia has been reported during Eplerenone therapy. Angina pectoris and
myocardialinfarction have occurred in patients treated with Eplerenone.
abdominal pain, coughing, influenza-like symptoms, albuminuria and lipid profile changes like hyperchonterolemia and hypertriglyceridemia. Gynecomastia and abnomal vaginal bleennave occurred inrequently (less than f9) in patienits receiving
Fplerenone. Elevated iveenzymes [Serum alanine aminotransferase (ALT) and gamma amvl transpeptidase (GGTD), reduction in serum sodium levels and increases in serumn Creatinine, blood urea nitrooen (BUN) and uric acid have been reported. Dose-related hyoerkalemia has been reported during Eplerenone therapy. Angina pectoris and
myocardialinfarction have occurred in patients treated with Eplerenone.
WABNINGS AND PRECAUTIONS :
Keep out of reach of children
General :
Eplerenone should be administered cautiously in patients with
• Concomitant administration of weak inhibitors of CYP3A4 (eg. erythromiycin, saquinavir, verapamil, fuconazole)
• Metabolic or respiratory acidosis (potentiation of hyperkalemic effects)
Eplerenone should be administered cautiously in patients with
• Concomitant administration of weak inhibitors of CYP3A4 (eg. erythromiycin, saquinavir, verapamil, fuconazole)
• Metabolic or respiratory acidosis (potentiation of hyperkalemic effects)
Hyperkalemia :
Eplerenone can cause hyperkalemia which can lead to serious, sometimes tatal arhythmias. This risk can be minimized by patient selection, avoidance of certalin
concomitant treatments, and monitoring. Periodic monitoring is recommended in patients at risk for the development of hyperkalemia (including patients receiving concomitant ACE inhibitors or angiotensin receptor antagonists) until the effect of Eplerenone is established. Diabetic patients with CHF post-MI, including those with proteinuria, should also be treated with caiution (increased risk of hyperkalemia),
Eplerenone can cause hyperkalemia which can lead to serious, sometimes tatal arhythmias. This risk can be minimized by patient selection, avoidance of certalin
concomitant treatments, and monitoring. Periodic monitoring is recommended in patients at risk for the development of hyperkalemia (including patients receiving concomitant ACE inhibitors or angiotensin receptor antagonists) until the effect of Eplerenone is established. Diabetic patients with CHF post-MI, including those with proteinuria, should also be treated with caiution (increased risk of hyperkalemia),
Patients with hepatic insufficlency :
At steady state, Eplerenone Cmax and AUC values increased by 3.6% and 42 in patients with moderate hepatic impairment (Child-Pugh Class B) versUs healn volunteers receiving Eplerenone 400mg once daily, and by 22% and 45% in patients aged 65 years versus younger adults recelving Eplerenone 100mg once daily, however, these creases were not considered clinicaly significant. The use of Eplerenone in patients with severe hepatic impairment has not been evaluated
At steady state, Eplerenone Cmax and AUC values increased by 3.6% and 42 in patients with moderate hepatic impairment (Child-Pugh Class B) versUs healn volunteers receiving Eplerenone 400mg once daily, and by 22% and 45% in patients aged 65 years versus younger adults recelving Eplerenone 100mg once daily, however, these creases were not considered clinicaly significant. The use of Eplerenone in patients with severe hepatic impairment has not been evaluated
Patients with renal insufficiency :
Patients with CHF post MI who have serum creatinine levels >2.0 mg/dL (males) or >1.8B
mg/dl (females) or creatinine clearance 50 mL/min should not be treated with Eplerenone (increased risk of hyperkalemia wth declining renal function).
Patients with CHF post MI who have serum creatinine levels >2.0 mg/dL (males) or >1.8B
mg/dl (females) or creatinine clearance 50 mL/min should not be treated with Eplerenone (increased risk of hyperkalemia wth declining renal function).
CARCINOGENESIS MUTAGENESIS IMPAIRMENT OE FERTILITY :
There was increased risk of carcinogenesis in heterozygous P53 deficient mice when fested for 6 months at dosages up to 1000 mg/kg/day (systemic AlUC 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 ater 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/kgiday (systernic AUC exposures up to 2-12 times the exposure in humans receiving the 100-mg/day therapeutic dose) Repeat dose administration of Eplerenone to rats incteases the hepatic conjugation and clearance of thyroxin. which results in increased levels of TSH by a compenisatory mechanism. Drugs that have
produced thyroid tumors by this rodent-specific mechanism have not shown a similar effect in humans.
times the exposure in humans receiving the 100-mg/day therapeutic dose). Statistically significant increases in benign thyroid tumors were observed ater 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/kgiday (systernic AUC exposures up to 2-12 times the exposure in humans receiving the 100-mg/day therapeutic dose) Repeat dose administration of Eplerenone to rats incteases the hepatic conjugation and clearance of thyroxin. which results in increased levels of TSH by a compenisatory mechanism. Drugs that have
produced thyroid tumors by this rodent-specific mechanism have not shown a similar effect in humans.
Eplerenone was not shown to have any mutagenic potential in in vitro tests such as bacterial mutagenesis, mammalian cell mutagenesis, chromosomal aberration; in vivo rat bone marrow micronucleus formation and in vivolex vivo unscheduled DNA synthesis in rat liver.
Decreased weights of seminal vesicles and apididymides and slightly decreased fertiity
was noticed in male rats treated with Eplerenone at 1000 mg/kg/day for 10weeks (AUC 17 times that at the 100 mg/day human therapeutic dose). Dose-related prostate atrophy was seen in dogs when Eplerenone was administered at dosages of 15 mg/kg/day and higher (AUC 5 times that at the 100-mg/day human therapeutic dose). Dogs with prostate atrophy did not show any decline in libido, sexual performance, or semen quality.
was noticed in male rats treated with Eplerenone at 1000 mg/kg/day for 10weeks (AUC 17 times that at the 100 mg/day human therapeutic dose). Dose-related prostate atrophy was seen in dogs when Eplerenone was administered at dosages of 15 mg/kg/day and higher (AUC 5 times that at the 100-mg/day human therapeutic dose). Dogs with prostate atrophy did not show any decline in libido, sexual performance, or semen quality.
USE IN SPECIAL POPULATION :
Pregnancy :
Teratogenic Effects –
USFDA Pregnancy Category B –
There are no adequate and well-controlled studies of Eplerenone in pregnant women. No
teratogenic effects were seen in rats or rabbits, although decreased body weight in matemal rabbits and increased rabbit fetal resorptions and post-implantation loss were observed at the highest administered dosage. Because animal reproduction studies are not always predictive of human response, Eplerenone should be used during pregnancy only if the potential benefitjustifies the risk to the fetus.
Teratogenic Effects –
USFDA Pregnancy Category B –
There are no adequate and well-controlled studies of Eplerenone in pregnant women. No
teratogenic effects were seen in rats or rabbits, although decreased body weight in matemal rabbits and increased rabbit fetal resorptions and post-implantation loss were observed at the highest administered dosage. Because animal reproduction studies are not always predictive of human response, Eplerenone should be used during pregnancy only if the potential benefitjustifies the risk to the fetus.
Nursing Mothers :
Eplerenone andor its metabolites are oxcreted into rat breast milk. It is not known whether
Eperenone is excreted into human breast milk; therefore, Eplerenone should not bo uiie
mursing mothers unless the potential benefit justifies the potential risk 1o the intant.
Eplerenone andor its metabolites are oxcreted into rat breast milk. It is not known whether
Eperenone is excreted into human breast milk; therefore, Eplerenone should not bo uiie
mursing mothers unless the potential benefit justifies the potential risk 1o the intant.
Pediatric Use :
The safety and efficacy of Eplerenone has not been establishedin pediatric patients.
The safety and efficacy of Eplerenone has not been establishedin pediatric patients.
Geriatric use :
No overall differences in safety or effectiveness have been observed between elderly and younger hypertensive patients. No ditferences in overall incidence of adverse events were observed between elderly and younger patients with CHF post MI. However, due to age related decreases in creatinine clearance. the incidence of laboratory-documented hyperkalemia was increased in patients 65 years and older
No overall differences in safety or effectiveness have been observed between elderly and younger hypertensive patients. No ditferences in overall incidence of adverse events were observed between elderly and younger patients with CHF post MI. However, due to age related decreases in creatinine clearance. the incidence of laboratory-documented hyperkalemia was increased in patients 65 years and older
DRUGINTEBACTIONS :
Inhibitors of CYP450 3A4: A 1.7-fold increase in Cmax of Eplerenone and a 5.4-fold increase in AUC of Eplerenone was seen when a single dose of Eplerenone 100 mg was
administered with ketoconazole 200 mg BID, a potent inhibitor of the CYP3A4 pathway. Eplerenone should not be used with strong inhibitors of CYP450 3A4 (e.g. ketoconazole, itraconazole). Administration of Eplerenone with other CYP3A4 inhibitors (e.g erythromycin, verapamil, saquinavir and fluconazole) resulted in increases in Cmax of
Eplerenone ranging from 1.4-to 1.6-fold and AUC from 2.0 to 29-fold.
administered with ketoconazole 200 mg BID, a potent inhibitor of the CYP3A4 pathway. Eplerenone should not be used with strong inhibitors of CYP450 3A4 (e.g. ketoconazole, itraconazole). Administration of Eplerenone with other CYP3A4 inhibitors (e.g erythromycin, verapamil, saquinavir and fluconazole) resulted in increases in Cmax of
Eplerenone ranging from 1.4-to 1.6-fold and AUC from 2.0 to 29-fold.
ACE inhibitors and angiotensin lI receptor blockers :
The addition of Eplerenone 50 100 mg to angiotensin converting enzyme (ACE) inhibitors and angiontensin lI receptor blockers (ARBs) increased mean serum potassium slightly (about 0.09-0.13 mea/L), Inastudy in diabetics with microalbuminuria, Eplerenone 200 mg combined with the ACE inhibitor enalapril 10 mg increased the frequency of hyperkalemia (serum potassium>55 meq/L from 17% on enalaprl alone to 38% Butin another study in patients with CHF post MI, rates of patients with maximum potassium levels >5.5 mEgl were similar regardless of the concomitant use of ACE inhibitor/ARB with Eplerenone Because the concomitant Use of another mineralocorticoid receptor blocker and ACE inhibitors or ARBs has led to clinically relevant hyperkalemia, caution should be used in administering Eplerenone with these drugs.
The addition of Eplerenone 50 100 mg to angiotensin converting enzyme (ACE) inhibitors and angiontensin lI receptor blockers (ARBs) increased mean serum potassium slightly (about 0.09-0.13 mea/L), Inastudy in diabetics with microalbuminuria, Eplerenone 200 mg combined with the ACE inhibitor enalapril 10 mg increased the frequency of hyperkalemia (serum potassium>55 meq/L from 17% on enalaprl alone to 38% Butin another study in patients with CHF post MI, rates of patients with maximum potassium levels >5.5 mEgl were similar regardless of the concomitant use of ACE inhibitor/ARB with Eplerenone Because the concomitant Use of another mineralocorticoid receptor blocker and ACE inhibitors or ARBs has led to clinically relevant hyperkalemia, caution should be used in administering Eplerenone with these drugs.
Lithium :
Lithium toxicity has been reponed in patients receiving lithium concomitantly
with diuretics and ACE inhibitors. Serum lithium levels should be monitored frequently f
Eplerenone is administered concomitantly with lithium.
Lithium toxicity has been reponed in patients receiving lithium concomitantly
with diuretics and ACE inhibitors. Serum lithium levels should be monitored frequently f
Eplerenone is administered concomitantly with lithium.
Nonsteroldal ant-inflammatory drugs (NSAIDB) :
A drug interaction study of Eplerenone with an NSAID has not been conducted. The administration of other potassium-sparing antihypertensives with NSAIDs has been shown to reduce the antihypertensive effect in some patients and result in severe hyperkalemia in patients with
impaired renal function. Therefore, when Eplerenone and NSAIDs are used concomitantly, patients should be observed to detemine whether the desired efect on blood pressure is obtained.
A drug interaction study of Eplerenone with an NSAID has not been conducted. The administration of other potassium-sparing antihypertensives with NSAIDs has been shown to reduce the antihypertensive effect in some patients and result in severe hyperkalemia in patients with
impaired renal function. Therefore, when Eplerenone and NSAIDs are used concomitantly, patients should be observed to detemine whether the desired efect on blood pressure is obtained.
OVERDOSAGE :
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 Cmax exposures at
least 25 times higher than in humans receiving Eplerenone 100 mg/day. Dogs showed emesis, salivation, and tremors at a Cmax 41 times the human therapeutic Cmax, 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. ll symiptomatic hypotension should occur, supportive treatment should be instituted. If hyperkalemia develops, standard treatment should be initiated.
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 Cmax exposures at
least 25 times higher than in humans receiving Eplerenone 100 mg/day. Dogs showed emesis, salivation, and tremors at a Cmax 41 times the human therapeutic Cmax, 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. ll symiptomatic hypotension should occur, supportive treatment should be instituted. If hyperkalemia develops, standard treatment should be initiated.
Is eplerenone a steroid?
Answer -No
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Presentation : Eptus 25mg Tablet Strip of 15 Tablets
Manufactured By : Glenmark Pharmaceuticals