TRILEPTAL- oxcarbazepine tablet, film coated TRILEPTAL- oxcarbazepine suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXCARBAZEPINE (UNII: VZI5B1W380) (OXCARBAZEPINE - UNII:VZI5B1W380)

Available from:

Novartis Pharmaceuticals Corporation

INN (International Name):

OXCARBAZEPINE

Composition:

OXCARBAZEPINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. TRILEPTAL is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [see Warnings and Precautions (5.2, 5.3) ]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as TRILEPTAL, during pregnancy. Encourage women who are taking TRILEPTAL during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of TRILEPTAL in pregnant women; however, TRILEPTAL is closely related structurally to carbamazepine, which is considered to be teratogenic in humans. Data on a limited number of pregnancies from pregnancy registries suggest that TRILEPTAL monotherapy use is associated with congenital malformations (e.g., craniofacial defects, such as oral clefts, and cardiac malformations, such as ventricular septal defects). Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation) were observed in the offspring of animals treated with either oxcarbazepine or its active 10-hydroxy metabolite (MHD) during pregnancy at doses similar to the maximum recommended human dose (MRHD). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations An increase in seizure frequency may occur during pregnancy because of altered levels of the active metabolite of oxcarbazepine. Monitor patients carefully during pregnancy and through the postpartum period [see Warnings and Precautions (5.10)] . Data Human Data Data from published registries have reported craniofacial defects, such as oral clefts and cardiac malformations, such as ventricular septal defects in children with prenatal oxcarbazepine exposure. Animal Data When pregnant rats were given oxcarbazepine (0, 30, 300, or 1000 mg/kg/day) orally throughout the period of organogenesis, increased incidences of fetal malformations (craniofacial, cardiovascular, and skeletal) and variations were observed at the intermediate and high doses (approximately 1.2 and 4 times, respectively, the MRHD on a mg/m2 basis). Increased embryofetal death and decreased fetal body weights were seen at the high dose. Doses ≥300 mg/kg/day were also maternally toxic (decreased body weight gain, clinical signs), but there is no evidence to suggest that teratogenicity was secondary to the maternal effects. In a study in which pregnant rabbits were orally administered MHD (0, 20, 100, or 200 mg/kg/day) during organogenesis, embryofetal mortality was increased at the highest dose (1.5 times the MRHD on a mg/m2 basis). This dose produced only minimal maternal toxicity. In a study in which female rats were dosed orally with oxcarbazepine (0, 25, 50, or 150 mg/kg/day) during the latter part of gestation and throughout the lactation period, a persistent reduction in body weights and altered behavior (decreased activity) were observed in offspring exposed to the highest dose (less than the MRHD on a mg/m2 basis). Oral administration of MHD (0, 25, 75, or 250 mg/kg/day) to rats during gestation and lactation resulted in a persistent reduction in offspring weights at the highest dose (equivalent to the MRHD on a mg/m2 basis). Risk Summary Oxcarbazepine and its active metabolite (MHD) are present in human milk after TRILEPTAL administration. The effects of oxcarbazepine and its active metabolite (MHD) on the breastfed infant or on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TRILEPTAL and any potential adverse effects on the breastfed infant from TRILEPTAL or from the underlying maternal condition. Contraception Use of TRILEPTAL with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with decreased plasma concentrations of these hormones and may result in a failure of the therapeutic effect of the oral contraceptive drug. Advise women of reproductive potential taking TRILEPTAL who are using a contraceptive containing ethinylestradiol or levonorgestrel to use additional or alternative non-hormonal birth control [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)] . TRILEPTAL is indicated for use as adjunctive therapy for partial-onset seizures in patients aged 2 to 16 years. The safety and effectiveness for use as adjunctive therapy for partial-onset seizures in pediatric patients below the age of 2 have not been established. TRILEPTAL is also indicated as monotherapy for partial-onset seizures in patients aged 4 to 16 years. The safety and effectiveness for use as monotherapy for partial-onset seizures in pediatric patients below the age of 4 have not been established. TRILEPTAL has been given to 898 patients between the ages of 1 month to 17 years in controlled clinical trials (332 treated as monotherapy) and about 677 patients between the ages of 1 month to 17 years in other trials [s ee Warnings and Precautions (5.11), Adverse Reactions (6.1) , Clinical Pharmacology (12.3), and Clinical Studies (14 ) ]. There were 52 patients over age 65 in controlled clinical trials and 565 patients over the age of 65 in other trials. Following administration of single (300 mg) and multiple (600 mg/day) doses of TRILEPTAL in elderly volunteers (60 to 82 years of age), the maximum plasma concentrations and area under the curve (AUC) values of MHD were 30% to 60% higher than in younger volunteers (18 to 32 years of age). Comparisons of creatinine clearance in young and elderly volunteers indicate that the difference was due to age-related reductions in creatinine clearance. Close monitoring of sodium levels is required in elderly patients at risk for hyponatremia [see Warnings and Precautions (5.1) ]. Dose adjustment is recommended for renally impaired patients (creatinine clearance < 30 mL/min) [see Dosage and Administration (2. 7 ) and Clinical Pharmacology (12.3) ]. The abuse potential of TRILEPTAL has not been evaluated in human studies. 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. Trileptal® (oxcarbazepine) Oral Suspension           300 mg/5 mL Each 5 mL contains 300 mg oxcarbazepine Instructions for Use Read these instructions carefully to learn how to use the medicine dispensing system correctly. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 March 2018 T2018-33 © Novartis

Product summary:

Tablets 150 mg Film-Coated Tablets: pale grey-green, ovaloid, slightly biconvex, scored on both sides. Imprinted with “T/D” on one side and “C/G” on the other side. Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35 300 mg Film-Coated Tablets: yellow, ovaloid, slightly biconvex, scored on both sides. Imprinted with “TE/TE” on one side and “CG/CG” on the other side. Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05 Unit Dose (blister pack) Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06 600 mg Film-Coated Tablets: light pink, ovaloid, slightly biconvex, scored on both sides. Imprinted with “TF/TF” on one side and “CG/CG” on the other side. Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05 Unit Dose (blister pack) Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Suspension 300 mg/5 mL (60 mg/mL) Oral Suspension:  off-white to slightly brown or slightly red suspension. Available in amber glass bottles containing 250 mL of oral suspension. Supplied with a 10 mL dosing syringe and press-in bottle adapter. Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52 Store TRILEPTAL oral suspension in the original container. Shake well before using. Use within 7 weeks of first opening the bottle. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

TRILEPTAL- OXCARBAZEPINE SUSPENSION
Novartis Pharmaceuticals Corporation
----------
This Medication Guide has been approved by the
U.S. Food and Drug Administration
Revised: May 2020
MEDICATION GUIDE
TRILEPTAL (try-LĔP-tăl)
(oxcarbazepine)
film-coated tablets, for oral use
and
oral suspension
What is the most important information I should know about TRILEPTAL?
Do not stop taking TRILEPTAL without first talking to your healthcare
provider. Stopping TRILEPTAL
suddenly can cause serious problems.
TRILEPTAL can cause serious side effects, including:
1. TRILEPTAL may cause the level of sodium in your blood to be low.
Symptoms of low blood sodium
include:
• nausea
• confusion
• tiredness (lack of energy)
• more frequent or more severe seizures
• headache
Similar symptoms that are not related to low sodium may occur from
taking TRILEPTAL. You should
tell your healthcare provider if you have any of these side effects
and if they bother you or they do not go
away.
Some other medicines can also cause low sodium in your blood. Be sure
to tell your healthcare provider
about all the other medicines that you are taking.
Your healthcare provider may do blood tests to check your sodium
levels during your treatment with
TRILEPTAL.
2. TRILEPTAL may also cause allergic reactions or serious problems
which may affect organs and other
parts of your body like the liver or blood cells. You may or may not
have a rash with these types of
reactions.
Call your healthcare provider right away if you have any of the
following:
• swelling of your face, eyes, lips, or tongue
• painful sores in the mouth or around your eyes
• trouble swallowing or breathing
• yellowing of your skin or eyes
• a skin rash
• unusual brusing or bleeding
• hives
• severe fatigue or weakness
• fever, swollen glands, or sore throat that do not go
away or come and go
• severe muscle pain
• frequent infections or infections that do not go
away
Many people who are allergic to carbamazepine are also allergic to
TRILEPTAL. Tell your healthc

Summary of Product characteristics

TRILEPTAL- OXCARBAZEPINE TABLET, FILM COATED
TRILEPTAL- OXCARBAZEPINE SUSPENSION
NOVARTIS PHARMACEUTICALS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRILEPTAL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRILEPTAL.
TRILEPTAL (OXCARBAZEPINE) FILM-COATED TABLETS, FOR ORAL USE
TRILEPTAL (OXCARBAZEPINE) ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
TRILEPTAL is indicated for:
Adults: Monotherapy or adjunctive therapy in the treatment of
partial-onset seizures
Pediatrics:
- Monotherapy in the treatment of partial-onset seizures in children
4-16 years
- Adjunctive therapy in the treatment of partial-onset seizures in
children 2-16 years (1)
DOSAGE AND ADMINISTRATION
Adults: initiate with a dose of 600 mg/day, given twice a day
Adjunctive Therapy: Maximum increment of 600 mg/day at approximately
weekly intervals. The
recommended daily dose is 1200 mg/day (2.1)
Conversion to Monotherapy: Withdrawal concomitant over 3 to 6 weeks;
reach maximum dose of
TRILEPTAL in 2 to 4 weeks with increments of 600 mg/day at weekly
intervals to a recommended daily
dose of 2400 mg/day (2.2)
Initiation of Monotherapy: Increments of 300 mg/day every third day to
a dose of 1200 mg/day (2.3)
Initiate at one-half the usual starting dose and increase slowly in
patients with a creatinine clearance <
30 mL/min (2.7)
Pediatrics: initiation with 8 to 10 mg/kg/day, given twice a day. For
patients aged 2 to < 4 years and under
20 kg, a starting dose of 16 to 20 mg/kg/day may be considered.
Recommended daily dose is dependent
upon patient weight.
Adjunctive Patients (Aged 2-16 Years): For patients aged 4 to 16
years, target maintenance dose
should be achieved over 2 weeks (2.4). For patients aged 2 to < 4
years, maximum maintenance dose
should be achieved over 2 to 4 weeks and should not exceed 60
mg/kg/day (2.4)
Conversion to Monotherapy for Patients (Aged 4-16 Years): Maximum
increment of 10 mg/kg/day at
weekly intervals, concomita