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Oxcarbazepine

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Overview

What is Oxcarbazepine?

Oxcarbazepine Tablets USP are an antiepileptic drug available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo- -dibenz[b,f]azepine-5-carboxamide, and its structural formula is:

Oxcarbazepine, USP is a light orange to creamish white or off-white powder.  It is soluble in acetic acid, sparingly soluble in chloroform, practically insoluble in water. Its molecular weight is 252.27.

Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide (yellow), hypromellose, magnesium stearate, meglumine, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.



What does Oxcarbazepine look like?



What are the available doses of Oxcarbazepine?

Film-coated Tablets:

What should I talk to my health care provider before I take Oxcarbazepine?

How should I use Oxcarbazepine?

Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in pediatric patients aged 4 years and above with epilepsy, and as adjunctive therapy in pediatric patients aged 2 years and above with partial seizures.

Initiate oxcarbazepine tablets with a dose of 600 mg/day, given twice-a-day. If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the maximum recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day show somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects. Initiate oxcarbazepine tablets with a dose of 600 mg/day, given twice-a-day. If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the maximum recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day show somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects.

Dosage adjustment is recommended with concomitant use of strong CYP3A4 enzyme inducers or UGT inducers, which include certain antiepileptic drugs (AEDs) [ ].


What interacts with Oxcarbazepine?

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What are the warnings of Oxcarbazepine?

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What are the precautions of Oxcarbazepine?

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What are the side effects of Oxcarbazepine?

Sorry No records found


What should I look out for while using Oxcarbazepine?

Oxcarbazepine tablets are contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [ ].


What might happen if I take too much Oxcarbazepine?


How should I store and handle Oxcarbazepine?

Unopened vials of gemcitabine for injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] [].Tablets150 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-137-01Bottle of 500.........NDC 68462-137-05300 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-138-01Bottle of 500.........NDC 68462-138-05600 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-139-01Bottle of 500.........NDC 68462-139-05Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Tablets150 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-137-01Bottle of 500.........NDC 68462-137-05300 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-138-01Bottle of 500.........NDC 68462-138-05600 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-139-01Bottle of 500.........NDC 68462-139-05Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Tablets150 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-137-01Bottle of 500.........NDC 68462-137-05300 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-138-01Bottle of 500.........NDC 68462-138-05600 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-139-01Bottle of 500.........NDC 68462-139-05Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Tablets150 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-137-01Bottle of 500.........NDC 68462-137-05300 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-138-01Bottle of 500.........NDC 68462-138-05600 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-139-01Bottle of 500.........NDC 68462-139-05Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Tablets150 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-137-01Bottle of 500.........NDC 68462-137-05300 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-138-01Bottle of 500.........NDC 68462-138-05600 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-139-01Bottle of 500.........NDC 68462-139-05Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Tablets150 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-137-01Bottle of 500.........NDC 68462-137-05300 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-138-01Bottle of 500.........NDC 68462-138-05600 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-139-01Bottle of 500.........NDC 68462-139-05Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Tablets150 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-137-01Bottle of 500.........NDC 68462-137-05300 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-138-01Bottle of 500.........NDC 68462-138-05600 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-139-01Bottle of 500.........NDC 68462-139-05Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Tablets150 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-137-01Bottle of 500.........NDC 68462-137-05300 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-138-01Bottle of 500.........NDC 68462-138-05600 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-139-01Bottle of 500.........NDC 68462-139-05Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Tablets150 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-137-01Bottle of 500.........NDC 68462-137-05300 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-138-01Bottle of 500.........NDC 68462-138-05600 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-139-01Bottle of 500.........NDC 68462-139-05Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Tablets150 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-137-01Bottle of 500.........NDC 68462-137-05300 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-138-01Bottle of 500.........NDC 68462-138-05600 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-139-01Bottle of 500.........NDC 68462-139-05Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Tablets150 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-137-01Bottle of 500.........NDC 68462-137-05300 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-138-01Bottle of 500.........NDC 68462-138-05600 mg Film-Coated Tablets:Bottle of 100.........NDC 68462-139-01Bottle of 500.........NDC 68462-139-05Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The pharmacological activity of oxcarbazepine is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine [see ]. The precise mechanism by which oxcarbazepine and MHD exert their anti-seizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. These actions are thought to be important in the prevention of seizure spread in the intact brain. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the anticonvulsant effects of the drug. No significant interactions of oxcarbazepine or MHD with brain neurotransmitter or modulator receptor sites have been demonstrated.

Non-Clinical Toxicology
Oxcarbazepine tablets are contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [ ].

See CLINICAL PHARMACOLOGY: Pharmacokinetics.

Clinically significant hyponatremia (sodium <125 mmol/L) can develop during oxcarbazepine use. In the 14 controlled epilepsy studies 2.5% of oxcarbazepine-treated patients (38/1,524) had a sodium of less than 125 mmol/L at some point during treatment, compared to no such patients assigned placebo or active control (carbamazepine and phenobarbital for adjunctive and monotherapy substitution studies, and phenytoin and valproate for the monotherapy initiation studies). Clinically significant hyponatremia generally occurred during the first 3 months of treatment with oxcarbazepine, although there were patients who first developed a serum sodium <125 mmol/L more than 1 year after initiation of therapy. Most patients who developed hyponatremia were asymptomatic but patients in the clinical trials were frequently monitored and some had their oxcarbazepine dose reduced, discontinued, or had their fluid intake restricted for hyponatremia. Whether or not these maneuvers prevented the occurrence of more severe events is unknown. Cases of symptomatic hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH) have been reported during postmarketing use. In clinical trials, patients whose treatment with oxcarbazepine was discontinued due to hyponatremia generally experienced normalization of serum sodium within a few days without additional treatment.

Measurement of serum sodium levels should be considered for patients during maintenance treatment with oxcarbazepine, particularly if the patient is receiving other medications known to decrease serum sodium levels (e.g., drugs associated with inappropriate ADH secretion) or if symptoms possibly indicating hyponatremia develop (e.g., nausea, malaise, headache, lethargy, confusion, obtundation, or increase in seizure frequency or severity).Measurement of serum sodium levels should be considered for patients during maintenance treatment with oxcarbazepine, particularly if the patient is receiving other medications known to decrease serum sodium levels (e.g., drugs associated with inappropriate ADH secretion) or if symptoms possibly indicating hyponatremia develop (e.g., nausea, malaise, headache, lethargy, confusion, obtundation, or increase in seizure frequency or severity).

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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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