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Elepsia XR

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Overview

What is Elepsia XR?

ELEPSIA XR contains levetiracetam, an antiepileptic drug, as extended-release tablets for oral administration.

The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is CHNO and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:

Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane.

Each extended-release tablet contains 1,000 mg or 1,500 mg of levetiracetam. Inactive ingredients: povidone, hypromellose, amino methacrylate copolymer, colloidal silicon dioxide, magnesium stearate, talc, silicified microcrystalline cellulose, crospovidone, sodium lauryl sulfate, FD&C Blue #1 aluminum lake, ethylcellulose, dibutyl sebacate, triethyl citrate, polysorbate 20, polyvinyl alcohol, polyethylene glycol, and polysorbate 80. The imprinting ink contains shellac glaze, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide.



What does Elepsia XR look like?



What are the available doses of Elepsia XR?

Sorry No records found.

What should I talk to my health care provider before I take Elepsia XR?

Sorry No records found

How should I use Elepsia XR?

ELEPSIA XR is administered once daily.

Treatment should be initiated with a dose of 1,000 mg once daily. The once daily dosage may be adjusted in increments of 1,000 mg every 2 weeks to a maximum recommended once daily dose of 3,000 mg.

ELEPSIA XR should be taken whole; do not split or cut tablets.


What interacts with Elepsia XR?

Sorry No Records found


What are the warnings of Elepsia XR?

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What are the precautions of Elepsia XR?

Sorry No Records found


What are the side effects of Elepsia XR?

Sorry No records found


What should I look out for while using Elepsia XR?


What might happen if I take too much Elepsia XR?


How should I store and handle Elepsia XR?

Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.Naproxen Tablets USP, 250 mg are White, Round, Unscored Tablet; Debossed "West-ward 346" and are available in:Naproxen Tablets USP, 375 mg are White, Oblong, Unscored Tablet; Debossed "West-ward 347" and are available in:Naproxen Tablets USP, 500 mg are White, Oblong, Unscored Tablet; Debossed "West-ward 348" and are available in:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured By: Eatontown, NJ 07724 Revised October 2009 Naproxen Tablets USP, 250 mg are White, Round, Unscored Tablet; Debossed "West-ward 346" and are available in:Naproxen Tablets USP, 375 mg are White, Oblong, Unscored Tablet; Debossed "West-ward 347" and are available in:Naproxen Tablets USP, 500 mg are White, Oblong, Unscored Tablet; Debossed "West-ward 348" and are available in:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured By: Eatontown, NJ 07724 Revised October 2009 Naproxen Tablets USP, 250 mg are White, Round, Unscored Tablet; Debossed "West-ward 346" and are available in:Naproxen Tablets USP, 375 mg are White, Oblong, Unscored Tablet; Debossed "West-ward 347" and are available in:Naproxen Tablets USP, 500 mg are White, Oblong, Unscored Tablet; Debossed "West-ward 348" and are available in:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured By: Eatontown, NJ 07724 Revised October 2009 Naproxen Tablets USP, 250 mg are White, Round, Unscored Tablet; Debossed "West-ward 346" and are available in:Naproxen Tablets USP, 375 mg are White, Oblong, Unscored Tablet; Debossed "West-ward 347" and are available in:Naproxen Tablets USP, 500 mg are White, Oblong, Unscored Tablet; Debossed "West-ward 348" and are available in:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured By: Eatontown, NJ 07724 Revised October 2009 Naproxen Tablets USP, 250 mg are White, Round, Unscored Tablet; Debossed "West-ward 346" and are available in:Naproxen Tablets USP, 375 mg are White, Oblong, Unscored Tablet; Debossed "West-ward 347" and are available in:Naproxen Tablets USP, 500 mg are White, Oblong, Unscored Tablet; Debossed "West-ward 348" and are available in:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured By: Eatontown, NJ 07724 Revised October 2009


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology
Patients taking ELEPSIA XR should be monitored for behavioral abnormalities.

Levetiracetam Extended-Release Tablets

A total of 6.5% of patients treated with levetiracetam extended-release tablets experienced non-psychotic behavioral disorders (reported as irritability and aggression), compared to no patient on placebo. Irritability was reported in 6.5% of patients treated with levetiracetam extended-release tablets. Aggression was reported in 1.3% of patients treated with levetiracetam extended-release tablets.

No patient discontinued treatment or had a dose reduction as a result of these adverse reactions.

There is considerably less controlled clinical trial experience with levetiracetam extended-release tablets than with immediate-release levetiracetam tablets, and some adverse reactions observed with immediate-release levetiracetam tablets may not have been detected in levetiracetam extended-release tablets clinical trials because of limited number of patients. These adverse reactions may however occur in patients receiving ELEPSIA XR.

Immediate-Release Levetiracetam Tablets

A total of 13.3% of adult patients and 37.6% of pediatric patients (4 to 16 years of age) treated with immediate-release levetiracetam tablets experienced non-psychotic behavioral symptoms (reported as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesias, irritability, nervousness, neurosis, and personality disorder), compared to 6.2% and 18.6% of adult and pediatric patients on placebo. A randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of immediate-release levetiracetam tablets as adjunctive therapy in pediatric patients (4 to 16 years of age). An exploratory analysis suggested a worsening in aggressive behavior in patients treated with immediate-release levetiracetam tablets in that study .

A total of 1.7% of adult patients treated with immediate-release levetiracetam tablets discontinued treatment due to behavioral adverse events, compared to 0.2% of patients on placebo. The treatment dose was reduced in 0.8% of adult patients treated with immediate-release levetiracetam tablets, compared to 0.5% of patients on placebo. Overall, 10.9% of pediatric patients treated with immediate-release levetiracetam tablets experienced behavioral symptoms associated with discontinuation or dose reduction, compared to 6.2% of pediatric patients on placebo.

One percent of adult patients and 2% of pediatric patients (4 to 16 years of age) treated with immediate-release levetiracetam tablets experienced psychotic symptoms, compared to 0.2% and 2%, respectively, in adult and pediatric patients on placebo. In the controlled study that assessed the neurocognitive and behavioral effects of immediate-release levetiracetam tablets in pediatric patients 4 to 16 years of age, 1 (1.6%) patient treated with levetiracetam experienced paranoia, compared to no patients on placebo. There were 2 (3.1%) patients treated with immediate-release levetiracetam tablets who experienced confusional state, compared to no patients on placebo .

Two (0.3%) adult patients treated with immediate-release levetiracetam tablets were hospitalized, and their treatment was discontinued due to psychosis. In both patients, the psychosis event developed within the first week of treatment, and resolved within 1 to 2 weeks following treatment discontinuation. There was no difference between drug and placebo-treated patients in the incidence of pediatric patients who discontinued treatment due to psychotic and non-psychotic adverse reactions.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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