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ROWEEPRA XR
Overview
What is ROWEEPRA XR?
ROWEEPRA XR is an antiepileptic drug available as 500 mg and 750 mg (white) 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 C
H
N
O
and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:
Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 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. (Solubility limits are expressed as g/100 mL solvent.)
ROWEEPRA XR tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, ethylcellulose, glyceryl behenate, hypromellose2910, lactose monohydrate, povidone K90, magnesium stearate, titanium dioxide and triacetin.
The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.
USP dissolution test is pending
What does ROWEEPRA XR look like?
What are the available doses of ROWEEPRA XR?
ROWEEPRA XR 500 mg tablets are white oval oblong tablets, debossed with "LP332" on one side and blank on the other side.
ROWEEPRA XR 750 mg tablets are white oval oblong tablets, debossed with "LP79" on one side and blank on the other side.
What should I talk to my health care provider before I take ROWEEPRA XR?
Pregnancy: Plasma levels of levetiracetam may be decreased and therefore need to be monitored closely during pregnancy. Based on animal data, may cause fetal harm (
,
)
How should I use ROWEEPRA XR?
ROWEEPRA XR is indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.
ROWEEPRA XR is administered once daily.
Initiate treatment 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 daily dose of 3,000 mg/day.
What interacts with ROWEEPRA XR?
Sorry No Records found
What are the warnings of ROWEEPRA XR?
Sorry No Records found
What are the precautions of ROWEEPRA XR?
Sorry No Records found
What are the side effects of ROWEEPRA XR?
Sorry No records found
What should I look out for while using ROWEEPRA XR?
ROWEEPRA XR is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see
].
ROWEEPRA XR is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see
].
What might happen if I take too much ROWEEPRA XR?
How should I store and handle ROWEEPRA XR?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [seeUSP Controlled Room Temperature]. Product: 50090-1382NDC: 50090-1382-0 3 mL in a VIAL Product: 50090-1382NDC: 50090-1382-0 3 mL in a VIAL
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. The antiepileptic activity of levetiracetam was assessed in a number of animal models of epileptic seizures. Levetiracetam did not inhibit single seizures induced by maximal stimulation with electrical current or different chemoconvulsants and showed only minimal activity in submaximal stimulation and in threshold tests. Protection was observed, however, against secondarily generalized activity from focal seizures induced by pilocarpine and kainic acid, two chemoconvulsants that induce seizures that mimic some features of human complex partial seizures with secondary generalization. Levetiracetam also displayed inhibitory properties in the kindling model in rats, another model of human complex partial seizures, both during kindling development and in the fully kindled state. The predictive value of these animal models for specific types of human epilepsy is uncertain.
In vitro
in vivo
Levetiracetam at concentrations of up to 10 µM did not demonstrate binding affinity for a variety of known receptors, such as those associated with benzodiazepines, GABA (gamma-aminobutyric acid), glycine, NMDA (N-methyl-D-aspartate), re-uptake sites, and second messenger systems. Furthermore,
studies have failed to find an effect of levetiracetam on neuronal voltage-gated sodium or T-type calcium currents and levetiracetam does not appear to directly facilitate GABAergic neurotransmission. However,
studies have demonstrated that levetiracetam opposes the activity of negative modulators of GABA- and glycine-gated currents and partially inhibits N-type calcium currents in neuronal cells.
A saturable and stereoselective neuronal binding site in rat brain tissue has been described for levetiracetam. Experimental data indicate that this binding site is the synaptic vesicle protein SV2A, thought to be involved in the regulation of vesicle exocytosis. Although the molecular significance of levetiracetam binding to synaptic vesicle protein SV2A is not understood, levetiracetam and related analogs showed a rank order of affinity for SV2A which correlated with the potency of their antiseizure activity in audiogenic seizure-prone mice. These findings suggest that the interaction of levetiracetam with the SV2A protein may contribute to the antiepileptic mechanism of action of the drug.
Non-Clinical Toxicology
ROWEEPRA XR is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see ]. ROWEEPRA XR is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see ].ROWEEPRA XR may cause behavioral abnormalities and psychotic symptoms. Patients treated with ROWEEPRA XR should be monitored for psychiatric signs and symptoms.
Behavioral abnormalities
Levetiracetam Extended-release Tablets
A total of 7% of Levetiracetam Extended-release Tablets-treated patients experienced non-psychotic behavioral disorders (reported as irritability and aggression) compared to 0% of placebo-treated patients. Irritability was reported in 7% of Levetiracetam Extended-release Tablets-treated patients. Aggression was reported in 1% of Levetiracetam Extended-release Tablets-treated patients.
No patient discontinued treatment or had a dose reduction as a result of these adverse reactions.
The number of patients exposed to Levetiracetam Extended-release Tablets was considerably smaller than the number of patients exposed to immediate-release Levetiracetam tablets in controlled trials. Therefore, certain adverse reactions observed in the immediate-release Levetiracetam controlled trials will likely occur in patients receiving Levetiracetam Extended-release Tablets.
Immediate-Release Levetiracetam Tablets
A total of 13% of adult patients and 38% of pediatric patients (4 to 16 years of age) treated with immediate-release Levetiracetam 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% and 19% 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 discontinued treatment due to behavioral adverse reactions, compared to 0.2% of placebo-treated patients. The treatment dose was reduced in 0.8% of adult patients treated with immediate-release Levetiracetam, compared to 0.5% of placebo-treated patients. Overall, 11% of pediatric patients treated with immediate-release Levetiracetam experienced behavioral symptoms associated with discontinuation or dose reduction, compared to 6.2% of placebo-treated pediatric patients.
One percent of adult patients and 2% of pediatric patients (4 to 16 years of age) treated with immediate-release Levetiracetam experienced psychotic symptoms, compared to 0.2% and 2%, respectively, in adult and placebo-treated pediatric patients. In the controlled study that assessed the neurocognitive and behavioral effects of immediate-release Levetiracetam in pediatric patients 4 to 16 years of age, 1.6% Levetiracetam-treated patients experienced paranoia, compared to no placebo-treated patients. There were 3.1% patients treated with immediate-release Levetiracetam who experienced confusional state, compared to no placebo-treated patients [ ].
Psychotic symptoms
Immediate-Release Levetiracetam tablets
One percent of Levetiracetam-treated adult patients experienced psychotic symptoms compared to 0.2% of placebo-treated patients.
Two (0.3%) Levetiracetam-treated adult patients were hospitalized and their treatment was discontinued due to psychosis. Both events, reported as psychosis, 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.
The following adverse reactions are discussed in more details in other sections of labeling:
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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