Oxca tablets

Oxca

  • Active Ingredient: Oxcarbazepine
  • 600 mg, 300 mg, 150 mg
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What is Oxca?

The active ingredient of Oxca brand is oxcarbazepine. Oxcarbazepine is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and pain. 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. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, povidone, polyethylene glycol, croscarmellose sodium, microcrystalline cellulose, crospovidone, sodium stearyl fumarate, hypromellose, polysorbate 80, titanium dioxide and yellow iron oxide.

Used for

Oxca is used to treat diseases such as: Anxiety, Bipolar Disorder, Borderline Personality Disorder, Cyclothymic Disorder, Epilepsy, Neuropathic Pain, Seizures, Trigeminal Neuralgia.

Side Effect

Possible side effects of Oxca include: pain or burning while urinating; restlessness; constipation; tightness in the chest; feeling of constant movement of self or surroundings; rectal bleeding; awkwardness.

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Oxca

Oxca is a keto-analog of carbamazepine that has been available in Scandinavia for many years and only recently become licensed in the rest of Europe. It undergoes less oxidative metabolism than carbamazepine and is a less potent enzyme inducer . There have been no convincing literature reports of symptomatic hepatic injury with Oxca. However, there is cross-reactivity between carbamazepine and Oxca , with an estimated frequency of 25% . The immunological basis of this cross-reactivity has been demonstrated recently in an in vitro study that showed that the T cell response to carbamazepine is polyclonal and that some subsets of T cells recognize both carbamazepine and Oxca . Therefore, it is possible that an individual who has suffered hepatic injury with carbamazepine will develop a similar injury with Oxca; in such patients, Oxca should either be used with caution (i.e., with close monitoring) or, preferably, not at all. Cross-reactivity with HLA-B*1502 has also been suggested , but whether HLA-A*3101 also predisposes to Oxca hypersensitivity is unknown at present.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to Oxca.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking Oxca.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Background

Oxca (ox" kar baz' e peen) is a keto analog of carbamazepine and functions as a prodrug being rapidly converted to 10-hydroxycarbazepine. Oxca and carbamazepine are iminostilbenes related chemically to the tricyclic antidepresants and unrelated in structure to most other anticonvulsants. They appear to act by suppression of spread of seizure activity by reduction in the posttetanic potentiation of synaptic transmission. Oxca was approved for use in epilepsy in the United States in 2000 and remains in common use. Oxca is indicated for prevention and management of partial, complex, mixed and generalized seizures and is commonly used alone or in combination with other anticonvulsants. It is used off-label to treat bipolar disorder. Oxca is available as tablets of 150, 300 and 600 mg generically and under the commercial name of Trileptal and as an extended release form under the name Oxtellar XR. Oral formulations for use in children are also available. The recommended starting dose in adults is 300 mg twice daily followed by increases at weekly intervals based upon clinical response, the usual final dose being 600 mg twice daily. Frequent side effects include drowsiness, sedation, ataxia, blurred vision, nausea, vomiting, and skin rash.

What should I discuss with my healthcare prov >

You should not take this medicine if you are allergic to Oxca or eslicarbazepine.

To make sure Oxca is safe for you, tell your doctor if you have ever had:

  • liver disease;
  • kidney disease;
  • mood problems or suicidal thoughts; or
  • if you are allergic to carbamazepine (Carbatrol, Tegretol).

Some people have thoughts about suicide while taking Oxca. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking Oxca during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant while taking Oxca for seizures.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Oxca on the baby.

Oxca can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking Oxca.

Oxca can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking Oxca.

Do not give this medicine to a child without medical advice. There are specific age restrictions for the use of Oxca in children, depending on the dose form and whether it is used alone or with other medicines.

Introduction

Oxca is a keto analogue of carbamazepine and, like the parent drug, is a potent anticonvulsant used alone or in combination with other agents in the therapy of poartial seizures. Oxca has been linked to rare instances of clinically apparent acute drug induced liver injury which resembles carbamazepine hepatotoxicity.

Before taking this medicine

You should not take Oxca if you are allergic to Oxca or eslicarbazepine.

Tell your doctor if you have ever had:

mood problems or suicidal thoughts; or

Some people have thoughts about suicide while taking Oxca. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking Oxca during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant while taking Oxca for seizures.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Oxca on the baby.

Oxca can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

You should not breast-feed while you are taking Oxca.

Do not give this medicine to a child without medical advice. There are specific age restrictions for the use of Oxca in children, depending on the dose form and whether it is used alone or with other medicines.

Oxca increased mutation frequencies in the in vitro Ames test in the absence of metabolic activation. Both Oxca and MHD produced increases in chromosomal aberrations and polyploidy in the Chinese hamster ovary assay in vitro in the absence of metabolic activation. MHD was negative in the Ames test, and no mutagenic or clastogenic activity was found with either Oxca or MHD in V79 Chinese hamster cells in vitro. Oxca and MHD were both negative for clastogenic or aneugenic effects (micronucleus formation) in an in vivo rat bone marrow assay.

What should I avo >

Do not drink alcohol. Drinking alcohol can increase certain side effects of Oxca. Alcohol may also increase the risk of seizures.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Oxca may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients Previously Treated with Other AEDs

Table 6 lists adverse reactions that occurred in at least 2% of pediatric patients with epilepsy treated with Oxca or placebo as adjunctive treatment and were numerically more common in the patients treated with Oxca.

Co-administration with CYP-inducing AEDs (e.g., carbamazepine, phenobarbital, phenytoin): Increased Oxca dose may be required because of decreased exposure to 10-monohydroxy derivative (MHD )

Conversion from immediate release to Oxtellar XR: Higher doses of Oxtellar XR may be required

  • CrCl less than 30 mL/min: Decrease initial dose by 50%; titrate up slowly

  • Mild to moderate, adult and pediatric: No dose adjustment required
  • Severe, adult: Unknown if dosage adjustment necessary
  • Severe, pediatric: Unknown if dosage adjustment necessary for immediate release dosage form; extended release, not recommended

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing Oxca or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and 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.

Dependence

Intragastric injections of Oxca to 4 cynomolgus monkeys demonstrated no signs of physical dependence as measured by the desire to self-administer Oxca by lever pressing activity.

The apparent volume of distribution of MHD is 49 L.

Approximately 40% of MHD is bound to serum proteins, predominantly to albumin. Binding is independent of the serum concentration within the therapeutically relevant range. Oxca and MHD do not bind to alpha-1-acid glycoprotein.

Long-Term Effects

  • See "What Are Side Effects Associated with Using Oxca?"

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