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ROWEEPRA

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Overview

What is ROWEEPRA?

ROWEEPRA is an antiepileptic drug available as 500 mg (yellow), 750 mg (orange), and 1,000 mg (white) tablets for oral administration.

The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-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, USP 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 (65.3g/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 tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, povidone, titanium dioxide, triacetin and additional agents listed below:

500 mg tablets: iron oxide yellow

750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red



What does ROWEEPRA look like?



What are the available doses of ROWEEPRA?

ROWEEPRA 500 mg tablets are yellow to light yellow, oval, film-coated tablets, bisect debossed with logo "OWP" and "500" on one side. The other side is blank.

ROWEEPRA 750 mg tablets are orange to light orange, oval, film-coated tablets, bisect debossed with logo "OWP" and "750" on one side. The other side is blank.

ROWEEPRA 1000 mg tablets are white, oval, film-coated tablets, bisect debossed with logo "OWP" and "1000" on one side. The other side is blank.

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

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?

ROWEEPRA is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.

ROWEEPRA is given orally with or without food. The ROWEEPRA dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

ROWEEPRA tablets should be swallowed whole. ROWEEPRA tablets should not be chewed or crushed.


What interacts with ROWEEPRA?

Sorry No Records found


What are the warnings of ROWEEPRA?

Sorry No Records found


What are the precautions of ROWEEPRA?

Sorry No Records found


What are the side effects of ROWEEPRA?

Sorry No records found


What should I look out for while using ROWEEPRA?

ROWEEPRA 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?


How should I store and handle ROWEEPRA?

Doxepin HCl capsules USP, equivalent to 10 mg of doxepin are hard gelatin capsules with buff opaque body and buff opaque cap, imprinted “Par 217” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-217-01).Doxepin HCl capsules USP, equivalent to 25 mg of doxepin are hard gelatin capsules with white opaque body and ivory opaque cap, imprinted “Par 218” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-218-01).Doxepin HCl capsules USP, equivalent to 50 mg of doxepin are hard gelatin capsules with ivory opaque body and ivory opaque cap, imprinted “Par 219” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-219-01).Doxepin HCl capsules USP, equivalent to 75 mg of doxepin are hard gelatin capsules with bright light green opaque body and bright light green opaque cap, imprinted “Par 220” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-220-01).Doxepin HCl capsules USP, equivalent to 100 mg of doxepin are hard gelatin capsules with white opaque body and bright light green opaque cap, imprinted “Par 221” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-221-01). Doxepin HCl capsules USP, equivalent to 150 mg of doxepin are buff opaque/buff opaque capsules, imprinted “Par 222” on both body and cap. They are supplied in bottles of 50 (NDC # 49884-222-03), 100 (NDC # 49884-222-01), and 500 (NDC # 49884-222-05).All sizes of 100’s or less are packaged with a child-resistant closure.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]Doxepin HCl capsules USP, equivalent to 10 mg of doxepin are hard gelatin capsules with buff opaque body and buff opaque cap, imprinted “Par 217” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-217-01).Doxepin HCl capsules USP, equivalent to 25 mg of doxepin are hard gelatin capsules with white opaque body and ivory opaque cap, imprinted “Par 218” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-218-01).Doxepin HCl capsules USP, equivalent to 50 mg of doxepin are hard gelatin capsules with ivory opaque body and ivory opaque cap, imprinted “Par 219” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-219-01).Doxepin HCl capsules USP, equivalent to 75 mg of doxepin are hard gelatin capsules with bright light green opaque body and bright light green opaque cap, imprinted “Par 220” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-220-01).Doxepin HCl capsules USP, equivalent to 100 mg of doxepin are hard gelatin capsules with white opaque body and bright light green opaque cap, imprinted “Par 221” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-221-01). Doxepin HCl capsules USP, equivalent to 150 mg of doxepin are buff opaque/buff opaque capsules, imprinted “Par 222” on both body and cap. They are supplied in bottles of 50 (NDC # 49884-222-03), 100 (NDC # 49884-222-01), and 500 (NDC # 49884-222-05).All sizes of 100’s or less are packaged with a child-resistant closure.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]Doxepin HCl capsules USP, equivalent to 10 mg of doxepin are hard gelatin capsules with buff opaque body and buff opaque cap, imprinted “Par 217” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-217-01).Doxepin HCl capsules USP, equivalent to 25 mg of doxepin are hard gelatin capsules with white opaque body and ivory opaque cap, imprinted “Par 218” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-218-01).Doxepin HCl capsules USP, equivalent to 50 mg of doxepin are hard gelatin capsules with ivory opaque body and ivory opaque cap, imprinted “Par 219” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-219-01).Doxepin HCl capsules USP, equivalent to 75 mg of doxepin are hard gelatin capsules with bright light green opaque body and bright light green opaque cap, imprinted “Par 220” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-220-01).Doxepin HCl capsules USP, equivalent to 100 mg of doxepin are hard gelatin capsules with white opaque body and bright light green opaque cap, imprinted “Par 221” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-221-01). Doxepin HCl capsules USP, equivalent to 150 mg of doxepin are buff opaque/buff opaque capsules, imprinted “Par 222” on both body and cap. They are supplied in bottles of 50 (NDC # 49884-222-03), 100 (NDC # 49884-222-01), and 500 (NDC # 49884-222-05).All sizes of 100’s or less are packaged with a child-resistant closure.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]Doxepin HCl capsules USP, equivalent to 10 mg of doxepin are hard gelatin capsules with buff opaque body and buff opaque cap, imprinted “Par 217” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-217-01).Doxepin HCl capsules USP, equivalent to 25 mg of doxepin are hard gelatin capsules with white opaque body and ivory opaque cap, imprinted “Par 218” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-218-01).Doxepin HCl capsules USP, equivalent to 50 mg of doxepin are hard gelatin capsules with ivory opaque body and ivory opaque cap, imprinted “Par 219” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-219-01).Doxepin HCl capsules USP, equivalent to 75 mg of doxepin are hard gelatin capsules with bright light green opaque body and bright light green opaque cap, imprinted “Par 220” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-220-01).Doxepin HCl capsules USP, equivalent to 100 mg of doxepin are hard gelatin capsules with white opaque body and bright light green opaque cap, imprinted “Par 221” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-221-01). Doxepin HCl capsules USP, equivalent to 150 mg of doxepin are buff opaque/buff opaque capsules, imprinted “Par 222” on both body and cap. They are supplied in bottles of 50 (NDC # 49884-222-03), 100 (NDC # 49884-222-01), and 500 (NDC # 49884-222-05).All sizes of 100’s or less are packaged with a child-resistant closure.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]Doxepin HCl capsules USP, equivalent to 10 mg of doxepin are hard gelatin capsules with buff opaque body and buff opaque cap, imprinted “Par 217” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-217-01).Doxepin HCl capsules USP, equivalent to 25 mg of doxepin are hard gelatin capsules with white opaque body and ivory opaque cap, imprinted “Par 218” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-218-01).Doxepin HCl capsules USP, equivalent to 50 mg of doxepin are hard gelatin capsules with ivory opaque body and ivory opaque cap, imprinted “Par 219” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-219-01).Doxepin HCl capsules USP, equivalent to 75 mg of doxepin are hard gelatin capsules with bright light green opaque body and bright light green opaque cap, imprinted “Par 220” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-220-01).Doxepin HCl capsules USP, equivalent to 100 mg of doxepin are hard gelatin capsules with white opaque body and bright light green opaque cap, imprinted “Par 221” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-221-01). Doxepin HCl capsules USP, equivalent to 150 mg of doxepin are buff opaque/buff opaque capsules, imprinted “Par 222” on both body and cap. They are supplied in bottles of 50 (NDC # 49884-222-03), 100 (NDC # 49884-222-01), and 500 (NDC # 49884-222-05).All sizes of 100’s or less are packaged with a child-resistant closure.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]Doxepin HCl capsules USP, equivalent to 10 mg of doxepin are hard gelatin capsules with buff opaque body and buff opaque cap, imprinted “Par 217” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-217-01).Doxepin HCl capsules USP, equivalent to 25 mg of doxepin are hard gelatin capsules with white opaque body and ivory opaque cap, imprinted “Par 218” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-218-01).Doxepin HCl capsules USP, equivalent to 50 mg of doxepin are hard gelatin capsules with ivory opaque body and ivory opaque cap, imprinted “Par 219” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-219-01).Doxepin HCl capsules USP, equivalent to 75 mg of doxepin are hard gelatin capsules with bright light green opaque body and bright light green opaque cap, imprinted “Par 220” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-220-01).Doxepin HCl capsules USP, equivalent to 100 mg of doxepin are hard gelatin capsules with white opaque body and bright light green opaque cap, imprinted “Par 221” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-221-01). Doxepin HCl capsules USP, equivalent to 150 mg of doxepin are buff opaque/buff opaque capsules, imprinted “Par 222” on both body and cap. They are supplied in bottles of 50 (NDC # 49884-222-03), 100 (NDC # 49884-222-01), and 500 (NDC # 49884-222-05).All sizes of 100’s or less are packaged with a child-resistant closure.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]Doxepin HCl capsules USP, equivalent to 10 mg of doxepin are hard gelatin capsules with buff opaque body and buff opaque cap, imprinted “Par 217” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-217-01).Doxepin HCl capsules USP, equivalent to 25 mg of doxepin are hard gelatin capsules with white opaque body and ivory opaque cap, imprinted “Par 218” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-218-01).Doxepin HCl capsules USP, equivalent to 50 mg of doxepin are hard gelatin capsules with ivory opaque body and ivory opaque cap, imprinted “Par 219” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-219-01).Doxepin HCl capsules USP, equivalent to 75 mg of doxepin are hard gelatin capsules with bright light green opaque body and bright light green opaque cap, imprinted “Par 220” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-220-01).Doxepin HCl capsules USP, equivalent to 100 mg of doxepin are hard gelatin capsules with white opaque body and bright light green opaque cap, imprinted “Par 221” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-221-01). Doxepin HCl capsules USP, equivalent to 150 mg of doxepin are buff opaque/buff opaque capsules, imprinted “Par 222” on both body and cap. They are supplied in bottles of 50 (NDC # 49884-222-03), 100 (NDC # 49884-222-01), and 500 (NDC # 49884-222-05).All sizes of 100’s or less are packaged with a child-resistant closure.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]Doxepin HCl capsules USP, equivalent to 10 mg of doxepin are hard gelatin capsules with buff opaque body and buff opaque cap, imprinted “Par 217” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-217-01).Doxepin HCl capsules USP, equivalent to 25 mg of doxepin are hard gelatin capsules with white opaque body and ivory opaque cap, imprinted “Par 218” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-218-01).Doxepin HCl capsules USP, equivalent to 50 mg of doxepin are hard gelatin capsules with ivory opaque body and ivory opaque cap, imprinted “Par 219” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-219-01).Doxepin HCl capsules USP, equivalent to 75 mg of doxepin are hard gelatin capsules with bright light green opaque body and bright light green opaque cap, imprinted “Par 220” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-220-01).Doxepin HCl capsules USP, equivalent to 100 mg of doxepin are hard gelatin capsules with white opaque body and bright light green opaque cap, imprinted “Par 221” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-221-01). Doxepin HCl capsules USP, equivalent to 150 mg of doxepin are buff opaque/buff opaque capsules, imprinted “Par 222” on both body and cap. They are supplied in bottles of 50 (NDC # 49884-222-03), 100 (NDC # 49884-222-01), and 500 (NDC # 49884-222-05).All sizes of 100’s or less are packaged with a child-resistant closure.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]


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Clinical Information

Chemical Structure

No Image found
Clinical 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, in vitro 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 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 is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see

].

Drugs Metabolized by P450 2D6

In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., citalopram, escitalopram, fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.

Doxepin is primarily metabolized by CYP2D6 (with CYP1A2 & CYP3A4 as minor pathways). Inihibitors or substrates of CYP2D6 (i.e., quinidine, selective serotonin reuptake inhibitors [SSRIs]) may increase the plasma concentration of doxepin when administered concomitantly. The extent of interaction depends on the variability of effect on CYP2D6. The clinical significance of this interaction with doxepin has not been systematically evaluated.

MAO Inhibitors

Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors. Therefore, MAO inhibitors should be discontinued at least two weeks prior to the cautious initiation of therapy with doxepin HCl. The exact length of time may vary and is dependent upon the particular MAO inhibitor being used, the length of time it has been administered, and the dosage involved.

Cimetidine

Cimetidine has been reported to produce clinically significant fluctuations in steady-state serum concentrations of various tricyclic antidepressants. Serious anticholinergic symptoms (i.e., severe dry mouth, urinary retention and blurred vision) have been associated with elevations in the serum levels of tricyclic antidepressants when cimetidine therapy is initiated. Additionally, higher than expected tricyclic antidepressant levels have been observed when they are begun in patients already taking cimetidine. In patients who have been reported to be well controlled on tricyclic antidepressants receiving concurrent cimetidine therapy, discontinuation of cimetidine has been reported to decrease established steady-state serum tricyclic antidepressant levels and compromise their therapeutic effects.

Alcohol

It should be borne in mind that alcohol ingestion may increase the danger inherent in any intentional or unintentional doxepin HCl overdosage. This is especially important in patients who may use alcohol excessively.

Tolazamide

A case of severe hypoglycemia has been reported in a type II diabetic patient maintained on tolazamide (1 gm/day) 11 days after the addition of doxepin (75 mg/day).

Drowsiness

Since drowsiness may occur with the use of this drug, patients should be warned of the possibility and cautioned against driving a car or operating dangerous machinery while taking the drug. Patients should also be cautioned that their response to alcohol may be potentiated.

Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of doxepin HCl and observed closely (see ).

Suicide

Since suicide is an inherent risk in any depressed patient and may remain so until significant improvement has occurred, patients should be closely supervised during the early course of therapy. Prescriptions should be written for the smallest feasible amount.

Psychosis

Should increased symptoms of psychosis or shift to manic symptomatology occur, it may be necessary to reduce dosage or add a major tranquilizer dosage regimen.







ROWEEPRA may cause behavioral abnormalities and psychotic symptoms. Patients treated with ROWEEPRA should be monitored for psychiatric signs and symptoms.

Behavioral abnormalities

In clinical studies, 13% of adult levetiracetam-treated patients and 38% of pediatric levetiracetam-treated patients (4 to 16 years of age) compared to 6% and 19% of adult and pediatric placebo-treated patients, experienced non-psychotic behavioral symptoms (reported as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesias, irritability, nervousness, neurosis, and personality disorder).

A randomized double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of levetiracetam as adjunctive therapy in pediatric patients (4 to 16 years of age). The results from an exploratory analysis indicated a worsening in levetiracetam-treated patients on aggressive behavior (one of eight behavior dimensions) as measured in a standardized and systematic way using a validated instrument, the Achenbach Child Behavior Checklist (CBCL/6-18).

In clinical studies in pediatric patients 1 month to < 4 years of age, irritability was reported in 12% of the levetiracetam-treated patients compared to 0% of placebo-treated patients.

In clinical studies, 1.7% of adult levetiracetam-treated patients 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 levetiracetam-treated patients and in 0.5% of placebo-treated patients. Overall, 11% of levetiracetam-treated pediatric patients experienced behavioral symptoms associated with discontinuation or dose reduction, compared to 6% of placebo-treated patients.

Psychotic symptoms

In clinical studies, 1% of levetiracetam-treated adult patients, 2% of levetiracetam-treated pediatric patients 4 to 16 years of age, and 17% of levetiracetam-treated pediatric patients 1 month to <4 years of age experienced psychotic symptoms, compared to 0.2%, 2%, and 5%, in the corresponding age groups treated with placebo. In a controlled study that assessed the neurocognitive and behavioral effects of levetiracetam in pediatric patients 4 to 16 years of age, 1.6% of levetiracetam-treated patients experienced paranoia, compared to 0% of placebo-treated patients. In the same study, 3.1% of levetiracetam-treated patients experienced confusional state, compared to 0% of placebo-treated patients [ ].

In clinical studies, 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 the 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:

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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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).