OXCARBAZEPINE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

OXCARBAZEPINE

Composition:

OXCARBAZEPINE 300 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxcarbazepine oral suspension 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. Oxcarbazepine oral suspension 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 oxcarbazepine, during pregnancy. Encourage women who are taking oxcarbazepine 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 oxcarbazepine in pregnant women; however, oxcarbazepine 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 oxcarbazepine 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)]. D ata 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 1,000 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 oxcarbazepine 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 oxcarbazepine and any potential adverse effects on the breastfed infant from oxcarbazepine or from the underlying maternal condition. Contraception Use of oxcarbazepine 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 oxcarbazepine 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)] . Oxcarbazepine 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. Oxcarbazepine 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. Oxcarbazepine 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 [see 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 Oxcarbazepine in elderly volunteers (60 to 82 years of age), the maximum plasma concentrations and 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 (CLcr <30 mL/min) [see Dosage and Administration (2.7) and Clinical Pharmacology (12.3)] . The abuse potential of oxcarbazepine 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. Oxcarbazepine Oral Suspension (300 mg/5 mL) Each 5 mL contains 300 mg oxcarbazepine Read these instructions carefully to learn how to use the medicine dispensing system correctly. 1. A plastic adapter that you push into the neck of the bottle the first time that you open the bottle. The adapter must always stay in the bottle. 2. A bottle containing 250 mL of the medicine, with a child-resistant cap. Always replace the cap after use. 3. A 10 mL oral dosing syringe that fits into the plastic adapter to withdraw the prescribed dose of medicine from the bottle. 1. Shake the bottle of medicine for at least 10 seconds . 2. Remove the child-resistant cap by pushing it firmly down and turning it counter clockwise – to the left (as shown on the top of the cap). Note: Save the cap so you can close the bottle after each use. 3. Hold the open bottle upright on a table and push the plastic adapter firmly into the neck of the bottle as far as you can. 4. Replace the cap to be sure that the adapter has been fully forced into the neck of the bottle. Note: You may not be able to push the adapter fully down, but it will be forced into the bottle when you screw the cap back on. Now the bottle is ready to use with the syringe. The adapter must always stay in the bottle. The child-resistant cap should seal the bottle in between use. 1. Shake the bottle well. Prepare the dose right away. 2. Push and turn the child-resistant cap to open the bottle. Note: Always replace the cap after use. 3. Check that the plunger is all the way down inside the barrel of the syringe. 4. Keep the bottle upright and push the syringe firmly into the plastic adapter. 5. Hold the syringe in place and carefully turn the bottle upside down. 6. Slowly pull the plunger out so that the syringe fills with some medicine. Push the plunger back in just far enough to completely push out any large air bubbles that may be trapped in the syringe. 7. Slowly pull the plunger out until the top edge of the plunger is exactly level with the marker on the syringe barrel for the prescribed dose. Note: If the prescribed dose is more than 10 mL, you will need to refill the syringe to make up the full dose. 8. Carefully turn the bottle upright. Take out the syringe by gently twisting it out of the plastic adapter. The plastic adapter should stay in the bottle. 9. You can mix the dose of medicine in a small glass of water before it is swallowed, or you can drink it directly from the syringe. a. If you mix the medicine with water, add some water to a glass. Push in the plunger on the syringe all the way to empty all the medicine into the glass. Stir the medicine in the water and drink it all. b. If you use the syringe to take the medicine, the patient must sit upright. Push the plunger slowly to let the patient swallow the medicine. 10. Replace the child-resistant cap after use. Cleaning: After use, rinse the syringe with warm water and allow it to dry thoroughly. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2019-02

Product summary:

Oxcarbazepine Oral Suspension Oxcarbazepine Oral Suspension USP, 300 mg/5 mL (60 mg/mL), is supplied as off-white to slightly yellow colored suspension. Available in amber glass bottles containing 250 mL of oral suspension. Supplied with a 10 mL dosing syringe and press-in bottle adapter. 250 mL oral suspension in 1 Bottle:                                       NDC 65162-649-78 5 mL unit dose cup                                                                 NDC 65162-649-43 10 unit dose cups in a tray                                                     NDC 65162-649-48 Store oxcarbazepine oral suspension, USP in the original container. Shake well before using. Use within 7 weeks of first opening the bottle. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Amneal Pharmaceuticals LLC
----------
MEDICATION GUIDE
Oxcarbazepine (ox-kar-BAY-zeh-peen) Oral Suspension
What is the most important information I should know about
oxcarbazepine oral suspension?
Do not stop taking oxcarbazepine oral suspension without first talking
to your healthcare provider. Stopping
oxcarbazepine oral suspension suddenly can cause serious problems.
Oxcarbazepine oral suspension can cause serious side effects,
including:
1. Oxcarbazepine oral suspension 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 oxcarbazepine oral suspension.
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
oxcarbazepine oral suspension.
2. Oxcarbazepine oral suspension 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 bruising 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
oxcarbazepine oral suspension. Tell your
healthcare prov

Summary of Product characteristics

OXCARBAZEPINE- OXCARBAZEPINE SUSPENSION
AMNEAL PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXCARBAZEPINE ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR OXCARBAZEPINE
ORAL SUSPENSION.
OXCARBAZEPINE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Oxcarbazepine oral suspension 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
to 16 years
- Adjunctive therapy in the treatment of partial-onset seizures in
children 2 to 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 1,200 mg/day. (2.1)
Conversion to Monotherapy: withdrawal concomitant over 3 to 6 weeks;
reach maximum dose of
oxcarbazepine oral suspension in 2 to 4 weeks with increments of 600
mg/day at weekly intervals to a
recommended daily dose of 2,400 mg/day. (2.2)
Initiation of Monotherapy: Increments of 300 mg/day every third day to
a dose of 1,200 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 to 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 to exceed 60
mg/kg/day. (2.4)
Conversion to Monotherapy for Patients (Aged 4 to 16 Years): Maximum
increment of 10 mg/kg/day at
weekly intervals, concomitant antiepileptic drugs