Ethinyl Estradiol and Norethindrone Tablets (Balziva)- FDA

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Other: Systemic lupus erythematosus. Experience from clinical trials indicates that serum sodium levels return toward normal when the TRILEPTAL dosage is reduced or discontinued, or when the patient was treated conservatively (e. Laboratory data from clinical trials suggest that TRILEPTAL use was associated with decreases in T4, without changes in T3 or TSH.

The following adverse reactions have been identified during postapproval use of TRILEPTAL. Therefore, it is recommended that Ethinyl Estradiol and Norethindrone Tablets (Balziva)- FDA plasma levels of phenytoin be monitored during the period of TRILEPTAL titration and dosage modification.

A decrease in the dose of phenytoin may be required. If TRILEPTAL and strong CYP3A4 inducers or UGT inducers are administered concurrently, it is recommended that the plasma levels of MHD be monitored during the period of TRILEPTAL titration.

Dose adjustment of TRILEPTAL may be required after initiation, dosage modification, or discontinuation of such inducers. Studies with other oral or implant contraceptives have not been conducted. Intragastric injections of oxcarbazepine to 4 cynomolgus monkeys demonstrated no signs of physical dependence as measured by the desire to self-administer oxcarbazepine by lever pressing activity. In the 14 controlled epilepsy studies 2.

Most patients who developed hyponatremia were asymptomatic but patients in the clinical trials were frequently monitored and some had uk indications for TRILEPTAL dose reduced, discontinued, or had their fluid intake restricted for hyponatremia.

Whether or not these maneuvers prevented the occurrence of more severe events is unknown. Cases of symptomatic hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH) have been reported during postmarketing use. In clinical trials, patients whose treatment with TRILEPTAL was discontinued due to hyponatremia generally experienced normalization of serum sodium within Optipranolol (Metipranolol Ophthalmic Solution)- FDA few days without additional treatment.

Measurement of serum sodium levels should be considered for patients during maintenance treatment with TRILEPTAL, particularly if the patient is receiving other medications known to decrease serum sodium levels (e. Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of TRILEPTAL.

Angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions after treatment with TRILEPTAL, the drug should be Ethinyl Estradiol and Norethindrone Tablets (Balziva)- FDA and an alternative treatment started.

For this reason patients should be specifically questioned about any prior experience with carbamazepine, and patients with a history of hypersensitivity reactions to carbamazepine should ordinarily be treated with TRILEPTAL only if the potential benefit justifies the potential risk. Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with TRILEPTAL use.

Such serious skin reactions may be life threatening, and some Ethinyl Estradiol and Norethindrone Tablets (Balziva)- FDA have required hospitalization with very rare reports of fatal outcome. The median time of onset for reported cases was 19 days after treatment initiation. Recurrence of the serious skin reactions following rechallenge with TRILEPTAL has dexday been reported.

The reporting rate of TEN and SJS associated with TRILEPTAL use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate estimates by a factor Ethinyl Estradiol and Norethindrone Tablets (Balziva)- FDA 3- to 10-fold. Estimates of the background incidence rate for these serious skin reactions in the general population range between 0.

Therefore, if a patient develops a skin reaction while taking TRILEPTAL, consideration should be given to discontinuing TRILEPTAL use and prescribing another antiepileptic medication. The chemical structure of Trileptal is similar to that of carbamazepine.

Antiepileptic drugs (AEDs), including TRILEPTAL, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. There were 4 suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.



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