OXTELLAR XR 300 mg/1

OXCARBAZEPINE · TABLET · Supernus Pharmaceuticals, Inc.

No Recall History

Plain English

OXTELLAR XR is a tablet containing oxcarbazepine at 300 mg/1, taken oral. Manufactured by Supernus Pharmaceuticals, Inc..

Key Facts

Brand Name: OXTELLAR XR
Generic Name: OXCARBAZEPINE
NDC Code (Product): 17772-122
Manufacturer: Supernus Pharmaceuticals, Inc.
Strength: 300 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA202810
Drug Class: Anti-epileptic Agent [EPC]
Marketing Start: 01/17/2013

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,906 reports

seizure1,400 reports

off label use1,078 reports

fatigue837 reports

somnolence757 reports

hyponatraemia704 reports

dizziness702 reports

headache692 reports

drug interaction684 reports

fall602 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Oxtellar XR is indicated for the treatment of partial-onset seizures in patients 6 years of age and older. Oxtellar XR® is indicated for the treatment of partial-onset seizures in patients 6 years of age and older. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Adult Patients: The recommended initial dosage is 600 mg once per day. Increase the dosage in weekly increments of 600 mg once per day, based on clinical response and tolerability, to a recommended maintenance dosage of 1200 mg to 2400 mg once per day. ( 2.2 ) In adult patients with a creatinine clearance <30 mL/min, initiate at one-half the usual starting dosage and increase slowly. ( 2.3 ) Pediatric Patients: The recommended dosage is based on body weight and is administered orally once per day. Increase the dosage in weekly intervals based on clinical response and tolerability, to the recommended dosage. ( 2.2 ) Geriatric Patients: Start at lower dosage (300 mg or 450 mg/day) and increase slowly. ( 2.4 ) In conversion of oxcarbazepine immediate-release to Oxtellar XR ® , higher dosages of Oxtellar XR may be necessary. ( 2.7 , 12.3 ) 2.1 Important Administration Instructions Administer Oxtellar XR as a single daily dose taken on an empty stomach (at least 1 hour before or at least 2 hours after meals) [see Clinical Pharmacology (12.3) ] . If Oxtellar XR is taken with food, adverse reactions are more likely to occur because of increased peak levels [see…

Contraindications

4 CONTRAINDICATIONS Oxtellar XR is contraindicated in patients with a known hypersensitivity to oxcarbazepine, to any of the components of Oxtellar XR, or to eslicarbazepine acetate. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.2 , 5.3) ]. Known hypersensitivity to oxcarbazepine, any of the components of Oxtellar XR, or to eslicarbazepine acetate. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Phenytoin, Carbamazepine, and Phenobarbital: Coadministration decreased blood levels of an active metabolite of Oxtellar XR: Greater dosage of Oxtellar XR may be required. ( 2.5 , 7.2 ) Oral Contraceptives : Advise patients that Oxtellar XR may decrease the effectiveness of hormonal contraceptives. Additional non-hormonal forms of contraception are recommended. ( 7.3 ) 7.1 Effect of Oxtellar XR on Other Drugs It is recommended that the plasma levels of phenytoin be monitored during the period of Oxtellar XR titration and dosage modification [see Clinical Pharmacology (12.3) ]. A decrease in the dosage of phenytoin may be required. 7.2 Effect of Other Drugs on Oxtellar XR If Oxtellar XR and strong CYP3A4 inducers or UGT inducers (e.g., rifampin, carbamazepine, phenytoin and phenobarbital) are administered concurrently, it is recommended that the plasma levels of MHD be monitored during the period of Oxtellar XR titration [see Clinical Pharmacology (12.3) ]. Dosage adjustment of Oxtellar XR may be required after initiation, dosage modification, or discontinuation of such inducers [see Dosage and Administration (2.5) ]. 7.3 Hormonal Contraceptives Concurrent use of…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described in other sections of the labeling: Hyponatremia [see Warnings and Precautions (5.1) ] Anaphylactic Reactions and Angioedema [see Warnings and Precautions (5.2) ] Cross Hypersensitivity Reaction to Carbamazepine [see Warnings and Precautions (5.3) ] Serious Dermatological Reactions [see Warnings and Precautions (5.4) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ] Withdrawal of AEDs [see Warnings and Precautions (5.6) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see Warnings and Precautions (5.7) ] Hematologic Reactions [see Warnings and Precautions (5.8) ] Risk of Seizures in the Pregnant Patient [see Warnings and Precautions (5.9) ] Most commonly observed (≥5% and more frequent than placebo) adverse reactions in adults were dizziness, somnolence, headache, balance disorder, tremor, vomiting, diplopia, asthenia, and fatigue. ( 6.1 ) Adverse reactions in pediatric patients are similar to those seen in adult patients. To report SUSPECTED ADVERSE REACTIONS, contact Supernus, Inc. at (1-866-398-0833) or contact FDA at 1-800-FDA-1088 or www.fd…

Frequently Asked Questions

What is OXTELLAR XR used for?

OXTELLAR XR contains OXCARBAZEPINE. It is a tablet taken oral. Consult your doctor for specific uses.

Is OXTELLAR XR a controlled substance?

OXTELLAR XR is not classified as a controlled substance by the DEA.

What is the generic name for OXTELLAR XR?

The generic name for OXTELLAR XR is OXCARBAZEPINE. There are 12 other brand versions of OXCARBAZEPINE.

What is the NDC code for OXTELLAR XR 300 mg/1?

The NDC (National Drug Code) for OXTELLAR XR 300 mg/1 is 17772-122, listed by Supernus Pharmaceuticals, Inc..

Product NDC

17772-122

Package NDC

17772-122-01

Other Oxcarbazepine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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