Rx Item-Oxcarbazepine 600MG 500 TAB-Cool Store- by Sun Pharma USA Gen Trileptal

TRILEPTAL- oxcarbazepine tablet, film coated
TRILEPTAL- oxcarbazepine suspension
Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE

Trileptal is 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 children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 2 years and above with partial seizures.

2 DOSAGE AND ADMINISTRATION



All dosing should be given in a twice-a-day regimen. Trileptal oral suspension and Trileptal film-coated tablets may be interchanged at equal doses.

Trileptal should be kept out of the reach and sight of children.

Before using Trileptal oral suspension, shake the bottle well and prepare the dose immediately afterwards. The prescribed amount of oral suspension should be withdrawn from the bottle using the oral dosing syringe supplied. Trileptal oral suspension can be mixed in a small glass of water just prior to administration or, alternatively, may be swallowed directly from the syringe. After each use, close the bottle and rinse the syringe with warm water and allow it to dry thoroughly.

Trileptal can be taken with or without food
DOSAGE FORMS AND STRENGTHS

Film-coated Tablets: 150 mg, 300 mg and 600 mg. Oral Suspension: 300 mg/5 mL (60 mg/mL)

4 CONTRAINDICATIONS

Trileptal should not be used in patients with a known hypersensitivity to oxcarbazepine or to any of its components.

5 WARNINGS AND PRECAUTIONS

5.1 Hyponatremia
Anaphylactic Reactions and Angioedema
Patients with a Past History of Hypersensitivity Reaction to Carbamazepine
Serious Dermatological Reactions
Association with HLA-B*1502
Suicidal Behavior and Ideation
Withdrawal of AEDs
Cognitive/Neuropsychiatric Adverse Events
ADVERSE REACTIONS

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.
OVERDOSAGE

Human Overdose Experience

Isolated cases of overdose with Trileptal have been reported. The maximum dose taken was approximately 24,000 mg. All patients recovered with symptomatic treatment.

Treatment and Management

There is no specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Removal of the drug by gastric lavage and/or inactivation by administering activated charcoal should be considered.

11 DESCRIPTION

Trileptal is an antiepileptic drug available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Trileptal is also available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H -dibenz[b,f ]azepine-5-carboxamide.
Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27.

Trileptal film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide.

Trileptal oral suspension contains the following inactive ingredients: ascorbic acid; dispersible cellulose; ethanol; macrogol stearate; methyl parahydroxybenzoate; propylene glycol; propyl parahydroxybenzoate; purified water; sodium saccharin; sorbic acid; sorbitol; yellow-plum-lemon aroma.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
The pharmacological activity of Trileptal is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine [see Clinical Pharmacology (12.3) ]. The precise mechanism by which oxcarbazepine and MHD exert their antiseizure 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.

Rx Item-Oxcarbazepine 600MG 500 TAB-Cool
Item No. RX769955, 769955, NDC No.: 62756-0185-13, 62756-185-13, 6275618513, 62756018513, 0185-13, 018513 UPC No. 3-62756-18513-5, 362756-185135, 362756185135

Rx Item-Oxcarbazepine 600MG 500 TAB-Cool
Item No. RX769955, 769955, NDC No.: 62756-0185-13, 62756-185-13, 6275618513, 62756018513, 0185-13, 018513 UPC No. 3-62756-18513-5, 362756-185135, 362756185135

Rx Item-Oxcarbazepine 600MG 500 TAB-Cool
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica

Oxcarbazepine 600MG 500 TAB-Co
Item No. RX769955, 769955, NDC No.: 62756-0185-13, 62756-185-13, 6275618513, 62756018513, 0185-13, 018513 UPC No. 3-62756-18513-5, 362756-185135, 362756185135

Oxcarbazepine 600MG 500 TAB-Co
Oxcarbazepine 600MG 500 TAB-Cool Store- by Sun Pharma USA Gen Trileptal Item No. RX769955, 769955, NDC No.: 62756-0185-13, 62756-185-13, 6275618513, 62756018513, 0185-13, 018513 UPC No. 3-62756-18513-