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Epleron 50
Incepta Pharmaceuticals Ltd.
Generic: Eplerenone
Safety Advices
বাংলা
English
UNSAFE
Epleron 50 may cause excessive drowsiness with alcohol.
SAFE IF PRESCRIBED
Epleron 50 is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.
CONSULT YOUR DOCTOR
Information regarding the use of Epleron 50 during breastfeeding is not available. Please consult your doctor.
UNSAFE
Epleron 50 may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.
CAUTION
Epleron 50 should be used with caution in patients with kidney disease. Dose adjustment of Epleron 50 may be needed. Please consult your doctor.
Use of Epleron 50 is not recommended in patients with severe kidney disease.
CAUTION
Epleron 50 should be used with caution in patients with liver disease. Dose adjustment of Epleron 50 may be needed. Please consult your doctor.
Use of Epleron 50 is not recommended in patients with severe liver disease as the data available is limited.
Medicine Overview of Epleron 50mg Tablet
Introduction
Epleron 50 is a medicine known as a diuretic (water pill). It is mainly used in the treatment of heart failure and high blood pressure. It is also used to reduce swelling (oedema) caused by some other conditions. Epleron 50 can be taken with or without food, but you should take it in the same way each time to get the most benefit. Taking it with food can reduce some side effects and taking it early in the day can prevent you from having to get up at night to go to the toilet. You should keep using this medicine...
... Show moreUses of Epleron 50
- Hypertension (high blood pressure)
- Edema
Side effects of Epleron 50
Common
- Dizziness
- Diarrhea
- Nausea
- Cough
- Flu-like symptoms
- Fatigue
- Increased potassium level in blood
- Increased creatinine level in blood
How to use Epleron 50
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Epleron 50 may be taken with or without food, but it is better to take it at a fixed time.
How Epleron 50 works
Epleron 50 is a potassium-sparing diuretic. It lowers blood pressure and swelling by removing the extra water and electrolytes from the body without loss of potassium.
What if you forget to take Epleron 50?
If you miss a dose of Epleron 50, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
- Epleron 50 helps remove fluid from your body when used with other drugs.
- It can make you feel dizzy for the first few days. Do not drive or do anything requiring concentration until you know how Epleron 50 affects you.
- It may increase the level of potassium in your blood. Avoid taking potassium supplements and potassium-rich foods such as banana and broccoli.
- Your doctor will regularly check your kidney function and the amount of potassium in your blood while you are on this medicine.
- Notify your doctor if you experience dizziness, diarrhea, vomiting, fast or irregular heartbeat, swelling in feet, or difficulty breathing.
- Inform your doctor if you are pregnant, planning pregnancy or breastfeeding.
Brief Description
Indication
Hypertension, Heart failure, Congestive heart failure, Left ventricular dysfunction, Acute myocardial infarction
Administration
May be taken with or without food.
Adult Dose
Hypertension (HTN)
Initial 50 mg PO qDay; may increase to 50 mg PO q12hr; may take up to four weeks for full therapeutic response; hyperkelemia may occur with doses >100 mg/day
Heart Failure Post MI
Initial 25 mg PO qDay; may titrate to maximum of 50 mg once daily within 4 weeks as tolerated
Dose adjustments may be required based on potassium levels
Hepatic Impairment
Dose adjustment not necessary
Renal Dose
Renal Impairment
Contraindicated if CrCl 2 mg/dL in males or >1.8 mg/dL in females
Contraindication
For all patients: Serum potassium >5.5 mEq/L at initiation; CrCl ?30 mL/min; concomitant use of strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir). For patients treated for hypertension: Patients with type 2 DM with microalbuminuria; serum creatinine >2 mg/dL (male), or >1.8 mg/dL (female); CrCl <50 mL/min; concomitant use of potassium supplements or potassium-sparing diuretics (e.g. amiloride, spironolactone, or triamterene).
Mode of Action
Aldosterone binds to mineralocorticoid receptors in both epithelial (e.g. kidney, GI tract) and nonepithelial (e.g. heart, blood vessels, brain) tissues; causing increases in blood pressure by inducing sodium reabsorption, vascular remodeling, water retention and possibly other mechanisms. Eplerenone is a relatively selective mineralocorticoid receptor antagonist, blocking binding of aldosterone and reducing blood pressure. Eplerenone also appears to have cardioprotective effect in patients with congestive heart failure (CHF) after myocardial infarction (MI).
Precaution
Measure serum potassium levels before starting therapy, within the first wk, and periodically thereafter. Increased risk of hyperkalaemia in patients with impaired renal functions; diabetic patients with CHF post-MI (especially those with proteinuria); or concurrent use of agents affecting the rennin-angiotensin-aldosterone system. Safety and efficacy not established in patients with severe hepatic impairment; or paediatric patients <18 yr. Elderly. Pregnancy and lactation.
Lactation: unknown if excreted into breast milk, discontinue drug or nursing
Side Effect
1-10%
Hyperkalemia (2-10%),Increased risk of hyperkalemia with presence of renal dysfunction
1-3%
Dizziness,Fatigue/malaise,Abdominal pain,Diarrhea,Albuminuria,Hypercholesterolemia,Hypertriglyceridemia,Cough
<1%
Abnormal vaginal bleeding,Gynecomastia,Mastodynia
Pregnancy Category Note
Pregnancy Available data from published case reports on eplerenone use during pregnancy are insufficient to establish a drug-associated risk of major birth defects, miscarriage, adverse maternal or fetal outcomes; in animal studies, no adverse developmental effects were observed when eplerenone was administered to pregnant rats and rabbits during organogenesis at exposures 32 and 31 times, respectively the human exposure at the 100 mg/day therapeutic dose Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant...
... Show moreInteraction
Concomitant use with CYP3A4 Inhibitors (e.g. ketoconazole, voriconazole, itraconazole, fluconazole, clarithromycin, diltiazem saquinavir, verpamil, ritonavir) may increase serum concentrations of Eplerenone. CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital) may decrease Eplerenone efficacy. Eplerenone may enhance hyperkalaemic effect of ACE inhibitors, angiotensin II receptor blockers, potassium-sparing diuretics or potassium salts.
Concomitant use with diazoxide, MAOIs, pentoxifylline, prostacyclin analogues may enhance hypotensive effect of antihypertensives.
NSAIDs may possibly reduce the antihypertensive and/or diuretic effects of potassium-sparing diuretics and may increase risk of hyperkalaemia. Lithium toxicity has been reported when used with ACE inhibitors or diuretics; monitor lithium levels when used with Eplerenone.
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