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Trileptal

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Trileptal

Trileptal

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience

Most Common Adverse Reactions in All Clinical Studies

Adjunctive Therapy/Monotherapy in Adults Previously Treated with other AEDs

The most commonly observed ( ≥ 5%) adverse reactions seen in association with Trileptal and substantially more frequent than in placebo-treated patients were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, abnormal gait.

Approximately 23% of these 1,537 adult patients discontinued treatment because of an adverse experience. The adverse reactions most commonly associated with discontinuation were: dizziness (6.4%), diplopia (5.9%), ataxia (5.2%), vomiting (5.1%), nausea (4.9%), somnolence (3.8%), headache (2.9%), fatigue (2.1%), abnormal vision (2.1%), tremor (1.8%), abnormal gait (1.7%), rash (1.4%), hyponatremia (1.0%).

Monotherapy in Adults Not Previously Treated with other AEDs

The most commonly observed ( ≥ 5%) adverse reactions seen in association with Trileptal in these patients were similar to those in previously treated patients.

Approximately 9% of these 295 adult patients discontinued treatment because of an adverse experience. The adverse reactions most commonly associated with discontinuation were: dizziness (1.7%), nausea (1.7%), rash (1.7%), headache (1.4%).

Adjunctive Therapy/Monotherapy in Pediatric Patients 4 Years Old and Above Previously Treated with other AEDs

The most commonly observed ( ≥ 5%) adverse reactions seen in association with Trileptal in these patients were similar to those seen in adults.

Approximately 11% of these 456 pediatric patients discontinued treatment because of an adverse experience. The adverse reactions most commonly associated with discontinuation were: somnolence (2.4%), vomiting (2.0%), ataxia (1.8%), diplopia (1.3%), dizziness (1.3%), fatigue (1.1%), nystagmus (1.1%).

Monotherapy in Pediatric Patients 4 Years Old and Above Not Previously Treated with other AEDs

The most commonly observed ( ≥ 5%) adverse reactions seen in association with Trileptal in these patients were similar to those in adults.

Approximately 9.2% of 152 pediatric patients discontinued treatment because of an adverse experience. The adverse reactions most commonly associated ( ≥ 1%) with discontinuation were rash (5.3%) and maculopapular rash (1.3%).

Adjunctive Therapy/Monotherapy in Pediatric Patients 1 Month to < 4 Years Old Previously Treated or Not Previously Treated with other AEDs

The most commonly observed ( ≥ 5%) adverse reactions seen in association with Trileptal in these patients were similar to those seen in older children and adults except for infections and infestations which were more frequently seen in these younger children.

Approximately 11% of these 241 pediatric patients discontinued treatment because of an adverse experience. The adverse reaction most commonly associated with discontinuation were: convulsions (3.7%), status epilepticus (1.2%), and ataxia (1.2%).

Incidence in Controlled Clinical Studies:

The prescriber should be aware that the figures in Tables 3, 4, 5 and 6 cannot be used to predict the frequency of adverse reactions in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and nondrug factors to the adverse event incidences in the population studied.

Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Adults Previously Treated with other AEDs

Table 3 lists treatment-emergent signs and symptoms that occurred in at least 2% of adult patients with epilepsy treated with Trileptal or placebo as adjunctive treatment and were numerically more common in the patients treated with any dose of Trileptal. Table 4 lists treatment-emergent signs and symptoms in patients converted from other AEDs to either high dose Trileptal or low dose (300 mg) Trileptal. Note that in some of these monotherapy studies patients who dropped out during a preliminary tolerability phase are not included in the tables.

Table 3 : Treatment-Emergent Adverse Event Incidence in a Controlled Clinical Study of Adjunctive Therapy in Adults (Events in at Least 2% of Patients Treated with 2400 mg/day of Trileptal and Numerically More Frequent than in the Placebo Group)

Body System/ Adverse Event Oxcarbazepine Dosage (mjg/day)
OXC 600
N=163 %
OXC 1200
N=171 %
OXC 2400
N=126 %
Placebo
N=166 %
Body as a Whole
  Fatigue 15 12 15 7
  Asthenia 6 3 6 5
  Edema Legs 2 1 2 1
  Weight Increase 1 2 2 1
  Feeling Abnormal 0 1 2 0
Cardiovascular System
  Hypotension 0 1 2 0
Digestive System
  Nausea 15 25 29 10
  Vomiting 13 25 36 5
  Pain Abdominal 10 13 11 5
  Diarrhea 5 6 7 6
  Dyspepsia 5 5 6 2
  Constipation 2 2 6 4
  Gastritis 2 1 2 1
Metabolic and Nutritional Disorders
  Hyponatremia 3 1 2 1
Musculoskeletal System
  Muscle Weakness 1 2 2 0
  Sprains and Strains 0 2 2 1
Nervous System
  Headache 32 28 26 23
  Dizziness 26 32 49 13
  Somnolence 20 28 36 12
  Ataxia 9 17 31 5
  Nystagmus 7 20 26 5
  Gait Abnormal 5 10 17 1
  Insomnia 4 2 3 1
  Tremor 3 8 16 5
  Nervousness 2 4 2 1
  Agitation 1 1 2 1
  Coordination Abnormal 1 3 2 1
  EEG Abnormal 0 0 2 0
  Speech Disorder 1 1 3 0
  Confusion 1 1 2 1
  Cranial Injury NOS 1 0 2 1
  Dysmetria 1 2 3 0
  Thinking Abnormal 0 2 4 0
Respiratory System
  Rhinitis 2 4 5 4
Skin and Appendages
  Acne 1 2 2 0
Special Senses
  Diplopia 14 30 40 5
  Vertigo 6 12 15 2
  Vision Abnormal 6 14 13 4
  Accommodation Abnormal 0 0 2 0

Table 4 : Treatment-Emergent Adverse Event Incidence in Controlled Clinical Studies of Monotherapy in Adults Previously Treated with Other AEDs (Events in at Least 2% of Patients Treated with 2400 mg/day of Trileptal and Numerically More Frequent than in the Low Dose Control Group)

Body System/ Adverse Event Oxcarbazepime Dosage (mg/day)
2400
N=86 %
300
N=86 %
Body as a Whole
  Fatigue 21 5
  Fever 3 0
  Allergy 2 0
  Edema Generalized 2 1
  Pain Chest 2 0
Digestive System
  Nausea 22 7
  Vomiting 15 5
  Diarrhea 7 5
  Dyspepsia 6 1
  Anorexia 5 3
  Pain Abdominal 5 3
  Mouth Dry 3 0
  Hemorrhage Rectum 2 0
  Toothache 2 1
Hemic and Lymphatic System
  Lymphadenopathy 2 0
Infections and Infestations
  Infection Viral 7 5
  Infection 2 0
Metabolic and Nutritional Disorders
  Hyponatremia 5 0
  Thirst 2 0
Nervous System
  Headache 31 15
  Dizziness 28 8
  Somnolence 19 5
  Anxiety 7 5
  Ataxia 7 1
  Confusion 7 0
  Nervousness 7 0
  Insomnia 6 3
  Tremor 6 3
  Amnesia 5 1
  Convulsions Aggravated 5 2
  Emotional Lability 3 2
  Hypoesthesia 3 1
  Coordination Abnormal 2 1
  Nystagmus 2 0
  Speech Disorder 2 0
Respiratory System
  Upper Respiratory Tract Infection 10 5
  Coughing 5 0
  Bronchitis 3 0
  Pharyngitis 3 0
Skin and Appendages
  Hot Flushes 2 1
  Purpura 2 0
Special Senses
  Vision Abnormal 14 2
  Diplopia 12 1
  Taste Perversion   5 0
  Vertigo 3 0
  Earache 2 1
  Ear Infection NOS 2 0
Urogenital and Reproductive System
  Urinary Tract Infection 5 1
  Micturition Frequency 2 1
  Vaginitis 2 0

Controlled Clinical Study of Monotherapy in Adults Not Previously Treated with other AEDs

Table 5 lists treatment-emergent signs and symptoms in a controlled clinical study of monotherapy in adults not previously treated with other AEDs that occurred in at least 2% of adult patients with epilepsy treated with Trileptal or placebo and were numerically more common in the patients treated with Trileptal.

Table 5 : Treatment-Emergent Adverse Event Incidence in a Controlled Clinical Study of Monotherapy in Adults Not Previously Treated with Other AEDs (Events in at Least 2% of Patients Treated with Trileptal and Numerically More Frequent than in the Placebo Group)

Body System/ Adverse Event Oxcarbazepine
N=55 %
Placebo
N=49 %
Body as a Whole
  Falling Down NOS 4 0
Digestive System
  Nausea 16 12
  Diarrhea 7 2
  Vomiting 7 6
  Constipation 5 0
  Dyspepsia 5 4
Musculoskeletal System
  Pain Back 4 2
Nervous System
  Dizziness 22 6
  Headache 13 10
  Ataxia 5 0
  Nervousness 5 2
  Amnesia 4 2
  Coordination Abnormal 4 2
  Tremor 4 0
Respiratory System
  Upper Respiratory Tract Infection 7 0
  Epistaxis 4 0
  Infection Chest 4 0
  Sinusitis 4 2
Skin and Appendages
  Rash 4 2
Special Senses
  Vision Abnormal 4 0

Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients Previously Treated with other AEDs

Table 6 lists treatment-emergent signs and symptoms that occurred in at least 2% of pediatric patients with epilepsy treated with Trileptal or placebo as adjunctive treatment and were numerically more common in the patients treated with Trileptal.

Table 6 : Treatment-Emergent Adverse Event Incidence in Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients Previously Treated with Other AEDs (Events in at Least 2% of Patients Treated with Trileptal and Numerically More Frequent than in the Placebo Group)

Body System/ Adverse Event Oxcarbazepine
N=171 %
Placebo
N=139 %
Body as a Whole
  Fatigue 13 9
  Allergy 2 0
  Asthenia 2 1
Digestive System
  Vomiting 33 14
  Nausea 19 5
  Constipation 4 1
  Dyspepsia 2 0
Nervous System
  Headache 31 19
  Somnolence 31 13
  Dizziness 28 8
  Ataxia 13 4
  Nystagmus 9 1
  Emotional Lability 8 4
  Gait Abnormal 8 3
  Tremor 6 4
  Speech Disorder 3 1
  Concentration Impaired 2 1
  Convulsions 2 1
  Muscle Contractions Involuntary 2 1
Respiratory System
  Rhinitis 10 9
  Pneumonia 2 1
Skin and Appendages
  Bruising 4 2
  Sweating Increased 3 0
Special Senses
  Diplopia 17 1
  Vision Abnormal 13 1
  Vertigo 2 0

Other Events Observed in Association with the Administration of Trileptal

In the paragraphs that follow, the adverse events, other than those in the preceding tables or text, that occurred in a total of 565 children and 1,574 adults exposed to Trileptal and that are reasonably likely to be related to drug use are presented. Events common in the population, events reflecting chronic illness and events likely to reflect concomitant illness are omitted particularly if minor. They are listed in order of decreasing frequency. Because the reports cite events observed in open label and uncontrolled trials, the role of Trileptal in their causation cannot be reliably determined.

Body as a Whole: fever, malaise, pain chest precordial, rigors, weight decrease.

Cardiovascular System: bradycardia, cardiac failure, cerebral hemorrhage, hypertension, hypotension postural, palpitation, syncope, tachycardia.

Digestive System: appetite increased, blood in stool, cholelithiasis, colitis, duodenal ulcer, dysphagia, enteritis, eructation, esophagitis, flatulence, gastric ulcer, gingival bleeding, gum hyperplasia, hematemesis, hemorrhage rectum, hemorrhoids, hiccup, mouth dry, pain biliary, pain right hypochondrium, retching, sialoadenitis, stomatitis, stomatitis ulcerative.

Hematologic and Lymphatic System: thrombocytopenia.

Laboratory Abnormality: gamma-GT increased, hyperglycemia, hypocalcemia, hypoglycemia, hypokalemia, liver enzymes elevated, serum transaminase increased.

Musculoskeletal System: hypertonia muscle.

Nervous System: aggressive reaction, amnesia, anguish, anxiety, apathy, aphasia, aura, convulsions aggravated, delirium, delusion, depressed level of consciousness, dysphonia, dystonia, emotional lability, euphoria, extrapyramidal disorder, feeling drunk, hemiplegia, hyperkinesia, hyperreflexia, hypoesthesia, hypokinesia, hyporeflexia, hypotonia, hysteria, libido decreased, libido increased, manic reaction, migraine, muscle contractions involuntary, nervousness, neuralgia, oculogyric crisis, panic disorder, paralysis, paroniria, personality disorder, psychosis, ptosis, stupor, tetany.

Respiratory System: asthma, dyspnea, epistaxis, laryngismus, pleurisy.

Skin and Appendages: acne, alopecia, angioedema, bruising, dermatitis contact, eczema, facial rash, flushing, folliculitis, heat rash, hot flushes, photosensitivity reaction, pruritus genital, psoriasis, purpura, rash erythematous, rash maculopapular, vitiligo, urticaria.

Special Senses: accommodation abnormal, cataract, conjunctival hemorrhage, edema eye, hemianopia, mydriasis, otitis externa, photophobia, scotoma, taste perversion, tinnitus, xerophthalmia.

Surgical and Medical Procedures: procedure dental oral, procedure female reproductive, procedure musculoskeletal, procedure skin.

Urogenital and Reproductive System: dysuria, hematuria, intermenstrual bleeding, leukorrhea, menorrhagia, micturition frequency, pain renal, pain urinary tract, polyuria, priapism, renal calculus.

Other: Systemic lupus erythematosus.

Post-Marketing And Other Experience

The following adverse events not seen in controlled clinical trials have been observed in named patient programs or post-marketing experience:

Body as a Whole: multi-organ hypersensitivity disorders characterized by features such as rash, fever, lymphadenopathy, abnormal liver function tests, eosinophilia and arthralgia [see WARNINGS AND PRECAUTIONS]

Anaphylaxis: [see WARNINGS AND PRECAUTIONS]

Digestive System: pancreatitis and/or lipase and/or amylase increase

Hematologic and Lymphatic Systems: aplastic anemia [see WARNINGS AND PRECAUTIONS]

Metabolism: hypothyroidism

Skin and Appendages: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis [see WARNINGS AND PRECAUTIONS]

Read the Trileptal (oxcarbazepine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Oxcarbazepine can inhibit CYP2C19 and induce CYP3A4/5 with potentially important effects on plasma concentrations of other drugs. The inhibition of CYP2C19 by oxcarbazepine and MHD can cause increased plasma concentrations of drugs that are substrates of CYP2C19. Oxcarbazepine and MHD induce a subgroup of the cytochrome P450 3A family (CYP3A4 and CYP3A5) responsible for the metabolism of dihydropyridine calcium antagonists, oral contraceptives and cyclosporine resulting in a lower plasma concentration of these drugs. [see CLINICAL PHARMACOLOGY]

In addition, several AEDs that are cytochrome P450 inducers can decrease plasma concentrations of oxcarbazepine and MHD. No autoinduction has been observed with Trileptal.

Antiepileptic Drugs

Potential interactions between Trileptal and other AEDs were assessed in clinical studies. The effect of these interactions on mean AUCs and Cmin are summarized in Table 7.

Table 7 : Summary of AED Interactions with Trileptal

AED Coadministered Dose of AED (mg/day) Trileptal Dose (mg/day) Influence of Trileptal on AED Concentration (Mean Change, 90% Confidence Interval) Influence of AED on MHD Concentration (Mean Change, 90% Confidence Interval)
Carbamazepine 400-2000 900 nc1 40% decrease [CI: 17% decrease, 57% decrease]
Phenobarbital 100-150 600-1800 14% increase [CI: 2% increase, 24% increase] 25% decrease [CI: 12% decrease, 51% decrease]
Phenytoin 250-500 600-1800 > 1200-2400 nc1,2 up to 40% increase3 [CI: 12% increase, 60% increase] 30% decrease [CI: 3% decrease, 48% decrease]
Valproic acid 400-2800 600-1800 nc1 18% decrease [CI: 13% decrease, 40% decrease]
1nc denotes a mean change of less than 10%
2Pediatrics
3Mean increase in adults at high Trileptal doses

In vivo, the plasma levels of phenytoin increased by up to 40% when Trileptal was given at doses above 1200 mg/day. Therefore, when using doses of Trileptal greater than 1200 mg/day during adjunctive therapy, a decrease in the dose of phenytoin may be required. The increase of phenobarbital level, however, is small (15%) when given with Trileptal.

Strong inducers of cytochrome P450 enzymes (i.e., carbamazepine, phenytoin and phenobarbital) have been shown to decrease the plasma levels of MHD (29%-40%).

No autoinduction has been observed with Trileptal.

Hormonal Contraceptives

Coadministration of Trileptal with an oral contraceptive has been shown to influence the plasma concentrations of the two hormonal components, ethinylestradiol (EE) and levonorgestrel (LNG). The mean AUC values of EE were decreased by 48% [90% CI: 22-65] in one study and 52% [90% CI: 38-52] in another study. The mean AUC values of LNG were decreased by 32% [90% CI: 20-45] in one study and 52% [90% CI: 42-52] in another study. Therefore, concurrent use of Trileptal with hormonal contraceptives may render these contraceptives less effective. Studies with other oral or implant contraceptives have not been conducted.

Calcium Antagonists

After repeated coadministration of Trileptal, the AUC of felodipine was lowered by 28% [90% CI: 20-33]. Verapamil produced a decrease of 20% [90% CI: 18-27] of the plasma levels of MHD.

Other Drug Interactions

Cimetidine, erythromycin and dextropropoxyphene had no effect on the pharmacokinetics of MHD. Results with warfarin show no evidence of interaction with either single or repeated doses of Trileptal.

Drug/Laboratory Test Interactions

There are no known interactions of Trileptal with commonly used laboratory tests.

Drug Abuse And Dependence

Abuse

The abuse potential of Trileptal has not been evaluated in human studies.

Dependence

Intragastric injections of oxcarbazepine to four cynomolgus monkeys demonstrated no signs of physical dependence as measured by the desire to self-administer oxcarbazepine by lever pressing activity.

Read the Trileptal Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 6/20/2014
This monograph has been modified to include the generic and brand name in many instances.

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