Renal Dose Adjustment (Based on CrCl)
- <30 mL/min: Start 150 mg bid; increase 300 mg/day q3 days or 600 mg qwk
Hepatic Dose Adjustment
- Mild to moderate impairment: No dose adjustments
- Severe impairment: Dose adjustment not defined
See Supplemental Patient Information
- Cognitive symptoms including psychomotor slowing, difficulty with concentration, and speech or language problems, somnolence or fatigue, and coordination abnormalities, including ataxia and gait disturbances have occurred in patients. It may be essential to discontinue therapy on occurrence of such events
- Rare occasions of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have occurred. Angioedema associated with laryngeal edema may be fatal. On development of any of these reactions after treatment with this drug discontinue therapy and initiate an alternative therapy. Avoid rechallenging such patients with this drug
- Clinically significant hyponatremia (sodium <125 mmol/L) may occur during therapy with this drug. Hyponatremia has occurred during the first three months of treatment; in some patients it has occurred > 1 yr after initiation of therapy. Asymptomatic patients are more susceptible. Symptomatic hyponatremia has been reported on post marketing surveillance. It may be essential to discontinue therapy in some patients. Measure serum sodium levels in patients undergoing maintenance therapy with this drug; it is particularly essential if the patient is having other medications known to decrease serum sodium levels or if symptoms possibly indicates presence of hyponatremia
- Inform patients who have had hypersensitivity reactions to carbamazepine that approximately 25%-30% of them will experience hypersensitivity reactions. Question patients about any prior experience with carbamazepine, and treat patients having a history of hypersensitivity reactions to carbamazepine only if the potential benefit justifies the potential risk. On development of signs or symptoms of hypersensitivity immediately discontinue therapy
- Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have occurred in patients undergoing therapy with this drug. Such serious skin reactions may be life threatening, and some patients may require hospitalization. Rarely such reactions may lead to fatal outcome. Recurrence of the serious skin reactions following rechallenge may occur. On development of a skin reaction while taking therapy with this drug consider discontinuing therapy and prescribe another antiepileptic medication
- Increased risk of suicidal thoughts or behavior is associated in patients taking this drug. Monitor treated patients for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Such effects may be observed as early as 1wk after initiation of therapy and persist for the duration of treatment. Balance the risk of suicidal thoughts or behavior with the risk of untreated illness before considering prescribing therapy with this drug. On emergence of suicidal thoughts and behavior during therapy consider whether the emergence of such symptoms in any given patient is related to the illness being treated
- Gradually withdraw therapy to minimize the potential of increased seizure frequency
- Multi-organ hypersensitivity reactions may occur; such reactions may be life threatening requiring hospitalization. Hematologic and lymphatic, hepatobiliary, renal , muscles and joints , nervous system, respiratory, hepatorenal syndrome, pruritus, and angioedema system may be affected. Discontinue therapy and initiate an alternative treatment on development of such reactions
- Rare reports of pancytopenia, agranulocytosis, and leukopenia have been reported on post-marketing surveillance. Consider discontinuation of the drug on developing of any evidence of these hematologic events
- Concomitant use with oral contraceptives may be render contraceptives less effective
- Plasma levels of the active metabolite of oxcarbazepine, the 10monohydroxy derivative (MHD), may gradually decrease throughout pregnancy due to physiological changes during pregnancy. Carefully monitor patients during pregnancy. Continue closer monitoring through the postpartum period as MHD levels may return after delivery
- Therapy is associated with decreasing T4, without changes in T3 or TSH
Cautions: Use cautiously in
- Renal impairment
- Depression
- History of depression
- Suicidal tendencies
- Patients with hyponatremia
- Hypersensitivity to carbamazepine, up to 30% cross sensitivity
- Pediatric population
- Geriatrics
Supplemental Patient Information
- Inform patients, their caregivers, and families that this drug increases the risk of suicidal thoughts and behavior in patients. Advise them of the necessity to remain 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. Instruct them to immediately report behaviors of concern to healthcare providers
Pregnancy Category:C
Breastfeeding: Limited information indicates that oxcarbazepine would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 25 March 2011). According to manufacturer's data a decision should be made for discontinuing nursing or to discontinue the drug in nursing women taking into account the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- OXcarbazepine 600 MG TABS [Bottle] (GLENMARK PHARMACEUTICALS)
60 mg = $259.98
180 mg = $742.97 - OXcarbazepine 300 MG TABS [Bottle] (GLENMARK PHARMACEUTICALS)
60 mg = $131
180 mg = $378.98 - OXcarbazepine 300 MG/5ML SUSP [Bottle] (SANDOZ)
250 5ml = $147.99
750 5ml = $425.96 - Trileptal 600 MG TABS [Bottle] (NOVARTIS)
60 mg = $450.01
180 mg = $1283.02 - Trileptal 300 MG TABS [Bottle] (NOVARTIS)
60 mg = $245.99
180 mg = $700 - Trileptal 150 MG TABS [Bottle] (NOVARTIS)
60 mg = $134.99
180 mg = $389.96 - OXcarbazepine 150 MG TABS [Bottle] (GLENMARK PHARMACEUTICALS)
30 mg = $39.99
90 mg = $109.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
