May 23, 2017
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Trileptal

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Trileptal




Side Effects
Interactions

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

Clinical Trials Experience

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.

Most Common Adverse Reactions In All Clinical Studies

Adjunctive Therapy/Monotherapy in Adults Previously Treated with Other AEDs

The most common ( ≥ 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions with TRILEPTAL: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus tremor, and abnormal gait.

Approximately 23% of these 1,537 adult patients discontinued treatment because of an adverse reaction. 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 common ( ≥ 5%) adverse reactions 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 reaction. 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 common ( ≥ 5%) adverse reactions 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 reaction. 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 common ( ≥ 5%) adverse reactions with TRILEPTAL in these patients were similar to those in adults.

Approximately 9.2% of 152 pediatric patients discontinued treatment because of an adverse reaction. 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 common ( ≥ 5%) adverse reactions 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 reaction. The adverse reactions most commonly associated with discontinuation were: convulsions (3.7%), status epilepticus (1.2%), and ataxia (1.2%).

Controlled Clinical Studies Of Adjunctive Therapy/Monotherapy In Adults Previously Treated With Other AEDs

Table 3 lists adverse reactions 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 adverse reactions in patients converted from other AEDs to either high-dose TRILEPTAL (2400 mg/day) or low-dose (300 mg/day) 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 : Adverse Reactions in a Controlled Clinical Study of Adjunctive Therapy with TRILEPTAL in Adults

Body System/ Adverse Reaction TRILEPTALDosage (mg/day)
TRILEPTAL 600
N=163 %
TRILEPTAL 1200
N=171 %
TRILEPTAL 2400
N=126 %
Placebo
N=166 %
Body as a Whole
  Fatigue 15 12 15 7
  Asthenia 6 3 6 5
  Leg Edema 2 1 2 1
  Increased Weight 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
  Abdominal Pain 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
  Abnormal Gait 5 10 17 1
  Insomnia 4 2 3 1
  Tremor 3 8 16 5
  Nervousness 2 4 2 1
  Agitation 1 1 2 1
Abnormal
  Coordination 1 3 2 1
  Abnormal EEG 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
  Abnormal Thinking Respiratory System 0 2 4 0
  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
  Abnormal Vision  6 14 13 4
Abnormal
 Accommodation 0 0 2 0

Table 4 : Adverse Reactions in Controlled Clinical Studies of Monotherapy with TRILEPTAL in Adults Previously Treated with Other AEDs

Body System/
Adverse Reaction
TRILEPTAL 2400 mg/day
N=86 %
TRILEPTAL 300 mg/day
N=86 %
Body as a Whole
  Fatigue 21 5
  Fever 3 0
  Allergy 2 0
  Generalized Edema 2 1
  Chest Pain 2 0
Digestive System
  Nausea 22 7
  Vomiting 15 5
  Diarrhea 7 5
  Dyspepsia 6 1
  Anorexia 5 3
  Abdominal Pain 5 3
  Dry Mouth 3 0
  Hemorrhage Rectum 2 0
  Toothache 2 1
Hemic and Lymphatic System
  Lymphadenopathy 2 0
Infections and Infestations
  Viral Infection 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
  Aggravated Convulsions 5 2
  Emotional Lability 3 2
  Hypoesthesia 3 1
  Abnormal Coordination 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
  Abnormal Vision 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 adverse reactions 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 : Adverse Reactions in a Controlled Clinical Study of Monotherapy with TRILEPTAL in Adults Not Previously Treated with Other AEDs

Body System/
Adverse Reaction
TRILEPTAL
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
  Back Pain 4 2
Nervous System
  Dizziness  22 6
  Headache 13 10
  Ataxia 5 0
  Nervousness 5 2
  Amnesia 4 2
  Abnormal Coordination 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 adverse reactions 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 : Adverse Reactions in Controlled Clinical Studies of Adjunctive Therapy/Monotherapy with TRILEPTAL in Pediatric Patients Previously Treated with Other AEDs

Body System/
Adverse Reaction
TRILEPTAL
N=55%
Placebo
N=49%
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
  Abnormal Gait 8 3
  Tremor 6 4
  Speech Disorder 3 1
  Impaired Concentration 2 1
  Convulsions 2 1
  Involuntary Muscle Contractions 2 1
Respiratory System
  Rhinitis 10 9
  Pneumonia 2 1
Skin and Appendages
  Bruising 4 2
  Increased Sweating 3 0
Special Senses
  Diplopia 17 1
  Abnormal Vision  13 1
  Vertigo 2 0

Other Events Observed In Association With The Administration Of TRILEPTAL

In the paragraphs that follow, the adverse reactions, 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, urinary tract pain, polyuria, priapism, renal calculus.

Other: Systemic lupus erythematosus.

Laboratory Tests

Serum sodium levels below 125 mmol/L have been observed in patients treated with TRILEPTAL [see WARNINGS AND PRECAUTIONS]. Experience from clinical trials indicates that serum sodium levels return toward normal when the TRILEPTAL dosage is reduced or discontinued, or when the patient was treated conservatively (e.g., fluid restriction).

Laboratory data from clinical trials suggest that TRILEPTAL use was associated with decreases in T4, without changes in T3 or TSH.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of TRILEPTAL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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]

Cardiovascular System: atrioventricular block

Immune System Disorders: 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 and Nutrition Disorders: hypothyroidism and syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Skin and Subcutaneous Tissue Disorders: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis [see WARNINGS AND PRECAUTIONS], Acute Generalized Exanthematous Pustulosis (AGEP)

Musculoskeletal, connective tissue and bone disorders: There have been reports of decreased bone mineral density, osteoporosis and fractures in patients on long-term therapy with TRILEPTAL.

Injury, Poisoning, and Procedural Complications: fall Nervous System Disorders: dysarthria

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

DRUG INTERACTIONS

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]
Lamotrigine 200 1200 nc1 nc1
1 nc denotes a mean change of less than 10%
2 Pediatrics
3 Mean increase in adults at high TRILEPTAL doses

When using doses of TRILEPTAL greater than 1200 mg/day during adjunctive therapy, a decrease in the dose of phenytoin may be required.

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

Hormonal Contraceptives

Concurrent use of TRILEPTAL with hormonal contraceptives may render these contraceptives less effective [see CLINICAL PHARMACOLOGY]. Studies with other oral or implant contraceptives have not been conducted.

Drug Abuse And Dependence

Abuse

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

Dependence

Intragastric injections of oxcarbazepine to 4 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

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/11/2017

Side Effects
Interactions

Trileptal - User Reviews

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