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Spritam
Overview
What is Spritam?
SPRITAM (levetiracetam) is an antiepileptic drug available as 250 mg, 500 mg, 750 mg, and 1000 mg round, white to off-white, spearmint-flavored tablets for oral suspension.
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 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).
SPRITAM tablets for oral suspension contain 250 mg, 500 mg, 750 mg, or 1000 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor.
SPRITAM tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression.
SPRITAM tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed.
What does Spritam look like?
What are the available doses of Spritam?
Tablet(s) for oral suspension:
What should I talk to my health care provider before I take Spritam?
How should I use Spritam?
SPRITAM is indicated as adjunctive therapy in the treatment of partial onset seizures in patients with epilepsy 4 years of age and older weighing more than 20 kg.
SPRITAM is intended to disintegrate in the mouth when taken with a sip of liquid. As a primary method of administration, place tablet on the tongue with a dry hand, follow with a sip of liquid and swallow only after the tablet disintegrates. Do not swallow tablet(s) intact. Partial tablet(s) should not be administered. SPRITAM disintegrates in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth when taken with a sip of liquid.
Alternately, add whole SPRITAM tablet(s) to a small volume of liquid in a cup (one tablespoon or enough to cover the medicine). Allow the tablet(s) to disperse prior to consuming the entire contents immediately. After administration of the suspension, re-suspend any residue by adding an additional small volume of liquid and swallow the full amount. No attempt should be made to administer partial quantities of the dispersed tablet(s).
Administer SPRITAM orally, with or without food. The SPRITAM dosing regimen depends on the indication, age group, and renal function.
Patients should be instructed not to push the tablet through the foil. The foil should be peeled from the blister by bending up and lifting the peel tab around the blister seal.
What interacts with Spritam?
Sorry No Records found
What are the warnings of Spritam?
Sorry No Records found
What are the precautions of Spritam?
Sorry No Records found
What are the side effects of Spritam?
Sorry No records found
What should I look out for while using Spritam?
SPRITAM is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [].
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What might happen if I take too much Spritam?
How should I store and handle Spritam?
Store at 20° to 25°C (68° to 77°F)Protect from moisture.Store at 20° to 25°C (68° to 77°F)Protect from moisture.Carbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade OfficeCarbatrol(carbamazepine) extended-release capsules is supplied in three dosage strengths.100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with the Shire logo in white ink.Supplied in bottles of 120........................... NDC 54092-171-12200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-172-12300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with the Shire logo in white ink.Supplied in bottles of 120 ............................NDC 54092-173-12Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.Manufactured for: 300 Shire Way, Lexington, MA 02421To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch© 2018 Shire US Inc.Rev 02/2018Carbatrol is registered in the US Patent and Trade Office
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 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
SPRITAM is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [].Clinically meaningful drug interactions have occurred with concomitant medications and include, but are not limited to the following:
Agents Highly Bound to Plasma Protein:
Carbamazepine is not highly bound to plasma proteins; therefore, administration of Carbatrol to a patient taking another drug that is highly protein bound should not cause increased free concentrations of the other drug.
Agents that Inhibit Cytochrome P450 Isoenzymes and/or Epoxide Hydrolase:
Carbamazepine is metabolized mainly by cytochrome P450 (CYP) 3A4 to the active carbamazepine 10,11-epoxide, which is further metabolized to the trans-diol by epoxide hydrolase. Therefore, the potential exists for interaction between carbamazepine and any agent that inhibits CYP3A4 and/or epoxide hydrolase. Agents that are CYP3A4 inhibitors that have been found, or are expected, to increase plasma levels of Carbatrol are the following:
Acetazolamide, azole antifungals, cimetidine, clarithromycin(), dalfopristin, danazol, delavirdine, diltiazem, erythromycin(), fluoxetine, fluvoxamine, grapefruit juice, isoniazid, itraconazole, ketoconazole, loratadine, nefazodone, niacinamide, nicotinamide, protease inhibitors, propoxyphene, quinine, quinupristin, troleandomycin, valproate(), verapamil, zileuton.
Array
Thus, if a patient has been titrated to a stable dosage of Carbatrol, and then begins a course of treatment with one of these CYP3A4 or epoxide hydrolase inhibitors, it is reasonable to expect that a dose reduction for Carbatrol may be necessary.
Agents that Induce Cytochrome P450 Isoenzymes:
Carbamazepine is metabolized by CYP3A4. Therefore, the potential exists for interaction between carbamazepine and any agent that induces CYP3A4. Agents that are CYP inducers that have been found, or are expected, to decrease plasma levels of Carbatrol are the following:
Cisplatin, doxorubicin HCL, felbamate, rifampin, phenobarbital, phenytoin(), primidone, methsuximide, and theophylline
Array
Thus, if a patient has been titrated to a stable dosage on Carbatrol, and then begins a course of treatment with one of these CYP3A4 inducers, it is reasonable to expect that a dose increase for Carbatrol may be necessary.
Agents with Decreased Levels in the Presence of Carbamazepine due to Induction of Cytochrome P450 Enzymes:
Carbamazepine is known to induce CYP1A2 and CYP3A4. Therefore, the potential exists for interaction between carbamazepine and any agent metabolized by one (or more) of these enzymes. Agents that have been found, or are expected to have decreased plasma levels in the presence of Carbatrol due to induction of CYP enzymes are the following:
Acetaminophen, alprazolam, amitriptyline, bupropion, buspirone, citalopram, clobazam, clonazepam, clozapine, cyclosporin, delavirdine, desipramine, diazepam, dicumarol, doxycycline, ethosuximide, felbamate, felodipine, glucocorticoids, haloperidol, itraconazole, lamotrigine, levothyroxine, lorazepam, methadone, midazolam, mirtazapine, nortriptyline, olanzapine, oral and other hormonal contraceptives(), oxcarbazepine, phenytoin(), praziquantel, protease inhibitors, quetiapine, risperidone, theophylline, topiramate, tiagabine, tramadol, triazolam, trazodone(), valproate, warfarin(), ziprasidone, and zonisamide.
Array
Array
Array
Array
Thus, if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of treatment with Carbatrol, it is reasonable to expect that a dose increase for the concomitant agent may be necessary.
Agents with Increased Levels in the Presence of Carbamazepine:
Carbatrol increases the plasma levels of the following agents:
Clomipramine HCl, phenytoin(), and primidone
Array
Thus, if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of the treatment with Carbatrol, it is reasonable to expect that a dose decrease for the concomitant agent may be necessary.
Pharmacological/Pharmacodynamic Interactions with Carbamazepine:
Coadministration of Carbatrolwith delavirdine may lead to loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors (see ).
Concomitant administration of carbamazepine and lithium may increase the risk of neurotoxic side effects.
Given the anticonvulsant properties of carbamazepine, Carbatrol may reduce the thyroid function as has been reported with other anticonvulsants. Additionally, anti-malarial drugs, such as chloroquine and mefloquine, may antagonize the activity of carbamazepine.
Thus if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of treatment with Carbatrol, it is reasonable to expect that a dose adjustment may be necessary.
Because of its primary CNS effect, caution should be used when Carbatrol is taken with other centrally acting drugs and alcohol.
SPRITAM may cause behavioral abnormalities and psychotic symptoms. Patients treated with SPRITAM 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, respectively, 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 the 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 [see ].
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 serious adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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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. 315.72Tips
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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).