Oxcarbazepine (Oxcarbazepine)

Trade Name : Oxcarbazepine

West-Ward Pharmaceuticals Corp.

SUSPENSION

Strength 300 mg/5mL

OXCARBAZEPINE Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Oxcarbazepine (Oxcarbazepine) which is also known as Oxcarbazepine and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 300 mg/5mL per ml. Read more

Oxcarbazepine (Oxcarbazepine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 indicated for:
  • Arrayn- Array
  • Adults: initiate with a dose of 600 mg/day, given twice-a-day
  • 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.
  • Oxcarbazepine Oral Suspension USP
  • 300 mg/5 mL (60 mg/mL): off-white to slightly brown or red suspension.
  • u2022
  • 3
  • Oxcarbazepine is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate .
  • u2022
  • No data
  • The following serious adverse reactions are described below and elsewhere in the labeling:
  • The most common (u226510% more than placebo for adjunctive or low dose for monotherapy) adverse reactions in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and abnormal gait. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or .
  • No data
  • No data
  • u2022
  • 8.1
  • No data
  • No data
  • Oxcarbazepine Oral Suspension USP is an antiepileptic drug available as a 300 mg/5 mL (60 mg/mL) suspension for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5-dibenzo[b,u0192]azepine-5-carboxamide, and its structural formula is:
  • Oxcarbazepine USP is a white to off-white powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol and water. Its molecular weight is 252.27.
  • Oxcarbazepine Oral Suspension USP contains the following inactive ingredients: ascorbic acid, carboxymethylcellulose sodium, lemon lime flavor, methyl paraben, microcrystalline cellulose, propylene glycol, propylparaben, polysorbate, purified water, saccharin sodium, sorbic acid, and sucrose.
  • No data
  • Carcinogenesis
  • In 2-year carcinogenicity studies, oxcarbazepine was administered in the diet at doses of up to 100 mg/kg/day to mice and by gavage at doses of up to 250 mg/kg/day to rats, and the pharmacologically active 10-hydroxy metabolite (MHD) was administered orally at doses of up to 600 mg/kg/day to rats. In mice, a dose-related increase in the incidence of hepatocellular adenomas was observed at oxcarbazepine doses u226570 mg/kg/day, which is less than the maximum recommended human dose (MRHD) on a mg/m basis. In rats, the incidence of hepatocellular carcinomas was increased in females treated with oxcarbazepine at doses u226525 mg/kg/day (less than the MRHD on a mg/m basis), and incidences of hepatocellular adenomas and/or carcinomas were increased in males and females treated with MHD at doses of 600 mg/kg/day (2.4 times the MRHD on a mg/m basis) and u2265250 mg/kg/day (equivalent to the MRHD on a mg/m basis), respectively. There was an increase in the incidence of benign testicular interstitial cell tumors in rats at 250 mg oxcarbazepine/kg/day and at u2265250 mg MHD/kg/day, and an increase in the incidence of granular cell tumors in the cervix and vagina in rats at 600 mg MHD/kg/day.
  • Mutagenesis
  • Oxcarbazepine increased mutation frequencies in the Ames test in the absence of metabolic activation. Both oxcarbazepine and MHD produced increases in chromosomal aberrations and polyploidy in the Chinese hamster ovary assay in the absence of metabolic activation. MHD was negative in the Ames test, and no mutagenic or clastogenic activity was found with either oxcarbazepine or MHD in V79 Chinese hamster cells . Oxcarbazepine and MHD were both negative for clastogenic or aneugenic effects (micronucleus formation) in an rat bone marrow assay.
  • Impairment of Fertility
  • In a study in which male and female rats were administered oxcarbazepine (0, 25, 75 and 150 mg/kg/day) orally prior to and during mating and continuing in females during gestation, no adverse effects on fertility or reproductive performance were observed. The highest dose tested is less than the MRHD on a mg/m basis. In a fertility study in which rats were administered MHD (0, 50, 150, or 450 mg/kg/day) orally prior to and during mating and early gestation, estrous cyclicity was disrupted and numbers of corpora lutea, implantations, and live embryos were reduced in females receiving the highest dose (approximately 2 times the MRHD on a mg/m basis).
  • The effectiveness of oxcarbazepine as adjunctive and monotherapy for partial-onset seizures in adults, and as adjunctive therapy in children aged 2 to 16 years was established in seven multicenter randomized, controlled trials.
  • The effectiveness of oxcarbazepine as monotherapy for partial-onset seizures in children aged 4 to 16 years was determined from data obtained in the studies described, as well as by pharmacokinetic/pharmacodynamic considerations.
  • Oxcarbazepine Oral Suspension USP
  • 300 mg/5 mL (60 mg/mL) oral suspension is supplied as an off-white to slightly brown or red suspension.
  • NDC 0054-0199-59: Bottle of 250 mL with a 10 mL dosing syringe and press-in bottle adapter
  • Storage
  • Store oxcarbazepine oral suspension in the original container. Shake well before using. Use within 7 weeks of first opening the bottle.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Advise the patient to read the FDA-approved patient labeling ().
  • Administration Information
  • Counsel patients that oxcarbazepine may be taken with or without food. For oxcarbazepine oral suspension, advise patients to shake the bottle well and prepare the dose immediately afterwards using the oral dosing syringe supplied. Inform patients that oxcarbazepine oral suspension can be mixed in a small glass of water just prior to administration or, alternatively, may be swallowed directly from the syringe. Instruct patients to discard any unused oxcarbazepine oral suspension after 7 weeks of first opening the bottle.
  • Hyponatremia
  • Advise patients that oxcarbazepine may reduce the serum sodium concentrations especially if they are taking other medications that can lower sodium. Instruct patients to report symptoms of low sodium like nausea, tiredness, lack of energy, confusion, and more frequent or more severe seizures .
  • Anaphylactic Reactions and Angioedema
  • Anaphylactic reactions and angioedema may occur during treatment with oxcarbazepine. Advise patients to report immediately signs and symptoms suggesting angioedema (swelling of the face, eyes, lips, tongue or difficulty in swallowing or breathing) and to stop taking the drug until they have consulted with their physician .
  • Cross Hypersensitivity Reaction to Carbamazepine
  • Inform patients who have exhibited hypersensitivity reactions to carbamazepine that approximately 25% to 30% of these patients may experience hypersensitivity reactions with oxcarbazepine. Patients should be advised that if they experience a hypersensitivity reaction while taking oxcarbazepine they should consult with their physician immediately .
  • Serious Dermatological Reactions
  • Advise patients that serious skin reactions have been reported in association with oxcarbazepine. In the event a skin reaction should occur while taking oxcarbazepine, patients should consult with their physician immediately .
  • Suicidal Behavior and Ideation
  • Patients, their caregivers, and families should be counseled that AEDs, including oxcarbazepine, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers .
  • Driving and Operating Machinery
  • Advise patients that oxcarbazepine may cause adverse reactions such as dizziness, somnolence, ataxia, visual disturbances, and depressed level of consciousness. Accordingly, advise patients not to drive or operate machinery until they have gained sufficient experience on oxcarbazepine to gauge whether it adversely affects their ability to drive or operate machinery .
  • Multi-Organ Hypersensitivity
  • Instruct patients that a fever associated with other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately .
  • Hematologic Events
  • Advise patients that there have been rare reports of blood disorders reported in patients treated with oxcarbazepine. Instruct patients to immediately consult with their physician if they experience symptoms suggestive of blood disorders .
  • Drug Interactions
  • Caution female patients of reproductive potential that the concurrent use of oxcarbazepine with hormonal contraceptives may render this method of contraception less effective . Additional non-hormonal forms of contraception are recommended when using oxcarbazepine.
  • Caution should be exercised if alcohol is taken in combination with oxcarbazepine, due to a possible additive sedative effect.
  • Pregnancy Registry
  • Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eastontown, NJ 07724
  • 10004212/06
  • Revised February 2019
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10004212/06
  • Revised February 2019
  • Read these instructions carefully to learn how to use the medicine dispensing system correctly.
  • Arrayn- The Medicine Dispensing System
  • There are 3 parts to the dispensing system:
  • Note:
  • 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.
  • Arrayn- Taking the Medicine
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10004212/06
  • Revised February 2019
  • NDC: 0054-0199-59

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