Posted by Sunnely on December 5, 2000, at 19:04:23
In reply to Trileptal TCA's , posted by KarenK on December 4, 2000, at 12:41:39
> My son's pdoc prescribed tegretol to take the place of depakote. Some of you have told me that trileptal is a better version of tegretol. On the Novartis website, they say not to take tegretol if you have a sensitivity to TCA's and then in the trileptal description they go on to say that many of the side effects of tegretol are the same in trileptal except of course the aplastic anemia and white blood count problem. So, to make a short story long, can you take trileptal if you have a sensitivity to TCA's? Am I reading that right?
>
> Love,
> Karen
+++++++++++++++++++++++++Hi Karen,
I have here in front of me the Package Insert or Prescribing Information (PI) of Trileptal (oxcarbazepine) tablets, Novartis Pharmaceuticals Corporation.
In the section of Hypersensitivity Reaction it says verbatim: "Patients who have had hypersensitivity reactions to carbamazepine (Tegretol) should be informed that approximately 25%-30% of them will experience hypersensitivity reactions with Trileptal. For this reason patients should be specifically questioned about any prior experience with carbamazepine, and patients with history of hypersensitivity reactions to carbamazepine should ordinarily be treated with Trileptal only if the potential benefit justifies the potential risk. If signs or symptoms of hypersensitivity develop, Trileptal should be discontinued immediately."
Nowhere in the PI did it mention that hypersensitivity to tricyclic antidepressant is a contraindication or to use caution with Trileptal. (Yes, I even used a magnifying lens to make sure I didn't miss it.)
Since Trileptal has some similarity in chemical structure to Tegretol, it is not surprising that both drugs have similarities in some of the side effects. Both drugs are associated with central nervous system adverse effects classified into 3 categories: 1) cognitive symptoms including psychomotor slowing, difficulty concentration, and speech or language problems, 2) somnolence or fatigue, 3) coodination abnormalities, including ataxia (unsteady gait). During clinical trials (epileptic patients), the most common adverse effects reported (5% or greater) were dizziness, somnolence, diplopia (double vision), fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, and abnormal gait. To avoid or minimize these side effects, Novartis includes a general recommendation as to dose titration (increase) for Trileptal (remember this is for patients with epilepsy): 150 mg twice a day for the first week, then increase to 300 mg twice a day on the second week, then increase to 600 mg twice a day on the third week. The maximum recommended daily dose of Trileptal as a single drug (monotherapy) is 2400 mg/day. In patients with kidney problem, Trileptal should be initiated at one half the usual dose and increased slowly; no dosage adjustments necessary for the elderly or for patients with mild-to-moderate liver impairment.
One possible side effect (similar to Tegretol) that should pose a bit of concern is the potential for hyponatremia (low blood sodium level). Clinically significant hyponatremia (sodium level below 125) can develop during Trileptal use. Critically low blood sodium level can cause nausea, malaise, headache, lethargy, confusion, agitation, obtundation and even seizures. Therefore, measurement of blood sodium level should be considered for patients during Trileptal treatment, particularly if the patient is receiving other medications known to decrease blood sodium levels (believe it or not, SSRIs are among them, especially in elderly women) or if symptoms of hyponatremia develop.
The following is the "Patient Information" regarding Trileptal:
1) Patients who have exhibited hypersensitivity reactions to carbamazepine should be informed that approximately 25%-30% of these patients may experience hypersensitivity reaction with Trileptal.
2) Female patients of childbearing age should be warned that the concurrent use of Trileptal with hormonal contraceptives may render this method of contraception less effective. Additional non-hormonal forms of contraception are recommended when using Trileptal.
3) Caution should be exercised if alcohol is taken in combination with Trileptal therapy, due to a possible additive sedative effect.
4) Patients should be advised that Trileptal may cause dizziness and somnolence. Accordingly, patients should be advised not to drive or operate machinery until they have gained sufficient experience on Trileptal to gauge whether it adversely affects their ability to drive or operate machinery.
Finally, Trileptal is approved by the US FDA as a treatment (alone or in combination with other anti-epileptic drugs) of epilepsy. It is not approved as treatment for bipolar disorder or any form of psychiatric disorder. Therefore, it is as an "off-label" indication if used for any psychiatric disorder or other disorders not approved by the FDA. There is absolutely nothing wrong with this type of prescribing practice.
poster:Sunnely
thread:49896
URL: http://www.dr-bob.org/babble/20001130/msgs/49994.html