Label 28 - Spread thinly on the affected skin only . Dosing of LAMICTAL should be based on therapeutic response [see Although estrogen-containing oral contraceptives have been shown to increase the clearance of lamotrigine [see The effect of other hormonal contraceptive preparations or hormone replacement therapy on the pharmacokinetics of lamotrigine has not been systematically evaluated. Dose escalation should follow the recommended guidelines for initiating adjunctive therapy with LAMICTAL based on concomitant AED or other concomitant medications (see Tables 1, 2, and 5). Inhalation powder; Liquid; Cream; Ointment; Spray; Inhalation powder All products. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.Acute overdosage with topical application of Lotriderm cream is unlikely and would not be expected to lead to a life-threatening situation; however topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.Toxic effects are unlikely to occur following accidental ingestion of Lotriderm cream. Ezetimibe inhibits the intestinal absorption of cholesterol. reactions seen in association with the use of LAMICTAL as monotherapy (100 to
Start typing to retrieve search suggestions. 6 Lake (100-mg tablet only), ferric oxide, yellow (150-mg tablet only), and FD&C Blue No. Patients were dosed based on body weight and valproate use. In addition, a number of reports of variably defined episodes of seizure exacerbation (e.g., seizure clusters, seizure flurries) were made.During the premarketing development of LAMICTAL, 20 sudden and unexplained deaths were recorded among a cohort of 4,700 patients with epilepsy (5,747 patient-years of exposure).Some of these could represent seizure-related deaths in which the seizure was not observed, e.g., at night. Although this rate exceeds that expected in a healthy population matched for age and sex, it is within the range of estimates for the incidence of sudden unexplained death in epilepsy (SUDEP) in patients not receiving LAMICTAL (ranging from 0.0005 for the general population of patients with epilepsy, to 0.004 for a recently studied clinical trial population similar to that in the clinical development program for LAMICTAL, to 0.005 for patients with Because valproate reduces the clearance of lamotrigine, the dosage of LAMICTAL in the presence of valproate is less than half of that required in its absence [see Accordingly, although there are no specific recommendations for periodic ophthalmological monitoring, prescribers should be aware of the possibility of long-term ophthalmologic effects.Lamotrigine has been reported to interfere with the assay used in some rapid urine drug screens, which can result in falsepositive readings, particularly for phencyclidine (The value of monitoring plasma concentrations of lamotrigine in patients treated with LAMICTAL has not been established. The lowest effect dose for preand post-natal developmental toxicity in rats is less than the human dose of 400 mg/day on a mg/mWhen administered to pregnant rats, lamotrigine decreased fetal folate concentrations at doses greater than or equal to 5 mg/kg/day, which is less than the human dose of 400 mg/day on a mg/mLamotrigine is present in milk from lactating women taking LAMICTAL (see The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LAMICTAL and any potential adverse effects on the breastfed infant from LAMICTAL or from the underlying maternal condition.Human milk-fed infants should be closely monitored for adverse events resulting from lamotrigine. The
To reduce the potential of medication errors, write and say LAMICTAL clearly. discontinued treatment because of an adverse reaction. Not all pack sizes may be marketed. The results given below are for all partial-onset seizures in the intent-to-treat population (all patients who received at least 1 dose of treatment) in each trial, unless otherwise indicated. clinical development program in adults with bipolar disorder, 2 patients
The seizure frequency reduction was statistically significant in the 500-mg/day group compared with the placebo group, but not in the 300-mg/day group.A second trial (n = 98) was a double-blind, placebo-controlled, randomized, crossover trial consisting of two 14-week treatment periods (the last 2 weeks of which consisted of dose tapering) separated by a 4-week washout period. The incidence of serious rash associated with hospitalization and discontinuation of LAMICTAL in a prospectively followed cohort of pediatric patients (aged 2 to 17 years) is approximately 0.3% to 0.8%. patients with epilepsy treated with LAMICTAL in placebo-controlled trials. There may therefore be a very small risk of such effects in human foetus. 4.5 Interaction with other medicinal products and other forms of interaction6.6 Special precautions for disposal and other handling9.