If the decision is made to restart a patient who has discontinued Lamotrigine tablets, the need to restart with the initial dosing recommendations should be assessed. This sheet is about exposure to lamotrigine in pregnancy and while breastfeeding. Lamotrigine tablets should not be used for acute treatment of manic or mixed mood episodes. The addition of valproate increased Lamotrigine steady-state concentrations in normal volunteers by slightly more than 2-fold. The median change in seizure frequency was a 26% reduction on Lamotrigine tablets compared with placebo (P<0.01). take Lamotrigine tablets while taking valproate [DEPAKENE (valproic acid) or DEPAKOTE (divalproex sodium)]. The pharmacokinetics of a 100-mg single dose of Lamotrigine in healthy volunteers (n = 12) were not changed by coadministration of bupropion sustained-release formulation (150 mg twice daily) starting 11 days before Lamotrigine. Lamotrigine has been reported to interfere with the assay used in some rapid urine drug screens, which can result in false-positive readings, particularly for phencyclidine (PCP). The addition of lopinavir (400 mg twice daily)/ritonavir (100 mg twice daily) decreased the AUC, C max, and elimination half-life of Lamotrigine by approximately 50% to 55.4% in 18 healthy subjects. The regimen for the withdrawal of the concomitant AED is based on experience gained in the controlled monotherapy clinical trial. Vd/F is independent of dose and is similar following single and multiple doses in both patients with epilepsy and in healthy volunteers. In the presence of atazanavir/ritonavir (300 mg/100 mg), the metabolite-to-Lamotrigine ratio was increased from 0.45 to 0.71 consistent with induction of glucuronidation. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring [see Warnings and Precautions (5.1)]. This Medication Guide has been approved by the U.S. Food and Drug Administration. There are also a few medications that can interfere with the result. Adverse Reactions in 2 Placebo-Controlled Trials in Adult Patients with Bipolar I Disorder. are taking oral contraceptives (birth control pills) or other female hormonal medicines. Dispense in a tight, light-resistant container [see USP]. A false positive reading, when the test says you are pregnant, even when you aren't can be a pretty stressful (or temporarily joyous) moment for women. Table 8. Off-label uses include treating acute bipolar depression, fibromyalgia, schizophrenia, and unipolar depression. have had aseptic meningitis after taking Lamotrigine tablets or Lamotrigine extended-release tablets. Heather Bartos, MD, an ob-gyn and the medical director of Be. Decreased Lamotrigine AUC approximately 32%. Trial 1 enrolled patients with a current or recent (within 60 days) depressive episode as defined by DSM-IV and Trial 2 included patients with a current or recent (within 60 days) episode of mania or hypomania as defined by DSM-IV. The goal of maintenance treatment with Lamotrigine tablets is to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Indications and Usage ( 1.2)] . By identifying medications that contribute to false-negatives and false-positives . The frequency of major congenital malformations was similar to estimates from the general population. The precise mechanism(s) by which Lamotrigine exerts its anticonvulsant action are unknown. Chemical pregnancy. Human Data: Data from several international pregnancy registries have not shown an increased risk for malformations overall. After achieving a dose of 500 mg/day of Lamotrigine tablets using the guidelines in Table 1, the concomitant enzyme-inducing AED should be withdrawn by 20% decrements each week over a 4-week period. Methods Case 1: A 62-year-old male arrived to the emergency department in extreme psychosis. Patients could not be on more than 2 other anticonvulsants and valproate was not allowed. The usual maintenance doses identified in Tables 1 and 2 are derived from dosing regimens employed in the placebo-controlled adjunctive trials in which the efficacy of Lamotrigine tablets was established. have a history of heart problems or irregular heart beats or any of your family members have any heart problem, including genetic abnormalities. Neonates and young infants are at risk for high serum levels because maternal serum and milk levels can rise to high levels postpartum if Lamotrigine dosage has been increased during pregnancy but is not reduced after delivery to the pre-pregnancy dosage. The most commonly observed (5% for Lamotrigine tablets and more common on drug than placebo) adverse reactions associated with the use of Lamotrigine tablets during the conversion to monotherapy (add-on) period, not seen at an equivalent frequency among low-dose valproate-treated patients, were dizziness, headache, nausea, asthenia, coordination abnormality, vomiting, rash, somnolence, diplopia, ataxia, accidental injury, tremor, blurred vision, insomnia, nystagmus, diarrhea, lymphadenopathy, pruritus, and sinusitis. The lowest effect dose for pre-and post-natal developmental toxicity in rats is less than the human dose of 400 mg/day on a mg/m 2 basis. It is a case of mistaken identity. a Adverse reactions that occurred in at least 5% of patients treated with Lamotrigine tablets and at a greater incidence than placebo. Talk to your healthcare provider about the best way to feed your baby if you take Lamotrigine. Topic: Women With Epilepsy. Cerebrospinal fluid (CSF) analyzed at the time of clinical presentation in reported cases was characterized by a mild to moderate pleocytosis, normal glucose levels, and mild to moderate increase in protein. Drugs that induce or inhibit glucuronidation may, therefore, affect the apparent clearance of Lamotrigine. Rare: Goiter, hypothyroidism. The addition of phenobarbital or primidone decreases Lamotrigine steady-state concentrations by approximately 40%. Although benign rashes are also caused by Lamotrigine tablets, it is not possible to predict reliably which rashes will prove to be serious or life threatening. During the premarketing development of Lamotrigine, 20 sudden and unexplained deaths were recorded among a cohort of 4,700 patients with epilepsy (5,747 patient-years of exposure). The median reductions in the frequency of all partial-onset seizures relative to baseline were 8% in patients receiving placebo, 20% in patients receiving 300 mg/day of Lamotrigine tablets, and 36% in patients receiving 500 mg/day of Lamotrigine tablets. The no-effect doses for embryofetal developmental toxicity in mice, rats, and rabbits (75, 6.25, and 30 mg/kg, respectively) are similar to (mice and rabbits) or less than (rats) the human dose of 400 mg/day on a body surface area (mg/m 2) basis. However, it is conceivable that plasma concentrations of this metabolite could be increased in patients with a reduced capacity to glucuronidate Lamotrigine (e.g., in patients with liver disease, patients taking concomitant medications that inhibit glucuronidation). Do not give Lamotrigine tablets to other people, even if they have the same symptoms you have. It is not known if Lamotrigine tablets are safe or effective in people younger than 18 years with mood episodes such as bipolar disorder or depression. There are no pharmacokinetic interactions between Lamotrigine and pregabalin. Effect of Lamotrigine: In vitro studies show that Lamotrigine exhibits Class IB antiarrhythmic activity at therapeutically relevant concentrations. Adverse Reactions in a Controlled Monotherapy Trial in Adult Patients with Partial-Onset Seizures a,b. Can medications give me a false positive? Rubicon Research Private Limited In the randomized phase of the trial, adverse reactions that occurred in at least 5% of patients taking Lamotrigine (n = 87) and were twice as common compared with patients taking placebo (n = 86) were influenza (Lamotrigine 8%, placebo 2%), oropharyngeal pain (Lamotrigine 8%, placebo 2%), vomiting (Lamotrigine 6%, placebo 2%), contact dermatitis (Lamotrigine 5%, placebo 2%), upper abdominal pain (Lamotrigine 5%, placebo 1%), and suicidal ideation (Lamotrigine 5%, placebo 0%). Because the largest non-Caucasian racial subgroup was only 6% of patients exposed to Lamotrigine tablets in placebo-controlled trials, there are insufficient data to support a statement regarding the distribution of adverse reaction reports by race. Lamotrigine is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning, Warnings and Precautions (5.1, 5.3)]. Maintenance doses in patients weighing < 30 kg, regardless of age or concomitant AED, may need to be increased as much as 50%, based on clinical response. Lamotrigine tablets can cause serious side effects. Inform patients that Lamotrigine may cause aseptic meningitis. It's sometimes caused by a chemical pregnancy . The most common adverse reactions seen in association with the use of Lamotrigine tablets as monotherapy (100 to 400 mg/day) in adult patients (aged 18 to 82 years) with bipolar disorder in the 2 double-blind placebo-controlled trials of 18 months duration are included in Table 12. Adjunctive Therapy with Lamotrigine Tablets in Pediatric and Adult Patients with Lennox-Gastaut Syndrome. 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. Prilosec (omeprazole), Nexium (esomeprazole), and Prevacid (lansoprazole) are used to treat gastroesophageal reflux disease (GERD) or peptic ulcer disease (PUD) and can cause a false positive for THC. It has been reported that ethinylestradiol, not progestogens, increased the clearance of Lamotrigine up to 2-fold, and the progestin-only pills had no effect on Lamotrigine plasma levels. Each time you fill your prescription, check the tablets you receive against the pictures of the tablets below. Infrequent: Aspartate transaminase increased. Tell your healthcare provider if you have any changes in your menstrual pattern such as breakthrough bleeding. Here, a look at what might be going on if you get a positive test only to . Twelve volunteers with chronic renal failure (mean creatinine clearance: 13 mL/min, range: 6 to 23) and another 6 individuals undergoing hemodialysis were each given a single 100-mg dose of Lamotrigine. The pharmacokinetics of Lamotrigine following a single 150-mg dose of Lamotrigine were evaluated in 12 elderly volunteers between the ages of 65 and 76 years (mean creatinine clearance = 61 mL/min, range: 33 to 108 mL/min). In the bipolar and other mood disorders clinical trials, the rate of serious rash was 0.08% (1 of 1,233) of adult patients who received Lamotrigine tablets as initial monotherapy and 0.13% (2 of 1,538) of adult patients who received Lamotrigine tablets as adjunctive therapy. Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash caused by Lamotrigine tablets. Adjunctive Therapy with Lamotrigine Tablets in Adults with Partial-Onset Seizures. Plasma concentrations of Lamotrigine were not affected by concomitant lacosamide (200, 400, or 600 mg/day) in placebo-controlled clinical trials in patients with partial-onset seizures. Gradual transient increases in Lamotrigine plasma levels (approximate 2-fold increase) occurred during the week of inactive hormone preparation (pill-free week) for women not also taking a drug that increased the clearance of Lamotrigine (carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce Lamotrigine glucuronidation) [see Drug Interactions (7)] . Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Lamotrigine did not inhibit N-methyl d-aspartate (NMDA)-induced depolarizations in rat cortical slices or NMDA-induced cyclic GMP formation in immature rat cerebellum, nor did Lamotrigine displace compounds that are either competitive or noncompetitive ligands at this glutamate receptor complex (CNQX, CGS, TCHP). The addition of carbamazepine decreases Lamotrigine steady-state concentrations by approximately 40%. Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. Body as a Whole Lamotrigine tablets should be discontinued if an alternative etiology for the signs or symptoms cannot be established. In both trials, patients were titrated to a target dose of 200 mg of Lamotrigine tablets, as add-on therapy or as monotherapy with gradual withdrawal of any psychotropic medications during an 8- to 16-week open-label period. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see Dosage and Administration (2.1), Drug Interactions (7), and Clinical Pharmacology (12.3)]. Summary. If the index reaction was only a benign rash without systemic symptoms, then rechallenge, if needed, can be attempted. See What is the most important information I should know about Lamotrigine tablets?. Plainsboro, NJ, 08536, USA Table 7. Instruct women to notify their healthcare providers if they plan to start or stop use of oral contraceptives or other female hormonal preparations. However, adding Lamotrigine to the existing therapy did not cause a change in valproate plasma concentrations in either adult or pediatric patients in controlled clinical trials. a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of Lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)]. Estimates of the mean apparent volume of distribution (Vd/F) of Lamotrigine following oral administration ranged from 0.9 to 1.3 L/kg. The pharmacokinetics of Lamotrigine following a single 100-mg dose of Lamotrigine were evaluated in 24 subjects with mild, moderate, and severe hepatic impairment (Child-Pugh classification system) and compared with 12 subjects without hepatic impairment. Potential drug interactions between levetiracetam and Lamotrigine were assessed by evaluating serum concentrations of both agents during placebo-controlled clinical trials. In a juvenile animal study in which Lamotrigine (oral doses of 0, 5, 15, or 30 mg/kg) was administered to young rats from postnatal days 7 to 62, decreased viability and growth were seen at the highest dose tested and long-term neurobehavioral abnormalities (decreased locomotor activity, increased reactivity, and learning deficits in animals tested as adults) were observed at the 2 highest doses. Storage: Store at 20C to 25C (68F to 77F); excursions permitted from 15C to 30C (59F to 86F) [see USP Controlled Room Temperature]. When 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/m 2 basis. There is evidence that the inclusion of valproate in a multidrug regimen increases the risk of serious, potentially life-threatening rash in adults. a Adverse reactions that occurred in at least 2% of patients treated with Lamotrigine and at a greater incidence than placebo. False-Positive Drug Test Results. The greater the interval of time since the previous dose, the greater consideration should be given to restarting with the initial dosing recommendations. Lamotrigine tablets 200 mg are available for oral administration as off white, round, flat faced, beveled edge tablets, debossed over score, 063 below score on one side and plain on other side. This risk is increased in patients with underlying cardiac disease or heart conduction problems or who are taking other medications that affect heart conduction. inflammation of the bladder. Pooled analyses of 199 placebo-controlled clinical trials (monotherapy and adjunctive therapy) of 11 different AEDs showed that patients randomized to 1 of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI: 1.2, 2.7) of suicidal thinking or behavior compared with patients randomized to placebo. slurred speech (severe) Some side effects may occur that usually do not need medical attention. Those drugs that have been demonstrated to have a clinically significant impact on Lamotrigine metabolism are outlined in Table 13. Safety and effectiveness of Lamotrigine tablets have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. Cold remedies, hay fever remedies, nasal decongestants, diet pills, fluoxetine (Prozac), methylphenidate (Ritalin), bupropion (Wellbutrin), beta blockers (blood-pressure remedies) Barbiturates. Lamotrigine tablets can cause serious side effects. Spironolactone should not affect urine test for testing for drugs (at least not cause a positive test). Dose escalation should follow the recommended guidelines for initiating adjunctive therapy with Lamotrigine tablets based on concomitant AED or other concomitant medications (see Tables 1, 2, and 5). Lamotrigine binds to melanin-containing tissues, e.g., in the eye and pigmented skin. Patients were then converted to monotherapy with Lamotrigine tablets or valproate during the next 4 weeks, then continued on monotherapy for an additional 12-week period. It's also called a phantom pregnancy. For dosing considerations for Lamotrigine tablets in patients on other drugs known to induce or inhibit glucuronidation, see Tables 1, 2, 5 to 6, and 13. If this is true then the urine test . Target Plasma Levels for Patients with Epilepsy or Bipolar Disorder Additionally, there have been rare cases of toxic epidermal necrolysis with and without permanent sequelae and/or death in US and foreign postmarketing experience. This is called a false positive. You may not feel the full effect of Lamotrigine tablets for several weeks. Safety and efficacy of Lamotrigine tablets for the maintenance treatment of bipolar disorder were not established in a double-blind, randomized withdrawal, placebo-controlled trial that evaluated 301 pediatric patients aged 10 to 17 years with a current manic/hypomanic, depressed, or mixed mood episode as defined by DSM-IV-TR. Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Accordingly, doses above 200 mg/day are not recommended. In 18 patients with bipolar disorder on a stable regimen of 100 to 400 mg/day of Lamotrigine, the Lamotrigine AUC and C max were reduced by approximately 10% in patients who received aripiprazole 10 to 30 mg/day for 7 days, followed by 30 mg/day for an additional 7 days. Adverse Reactions in Pooled, Placebo-Controlled Adjunctive Trials in Pediatric Patients with Epilepsy, Table 12. Adverse Reactions following Abrupt Discontinuation: In the 2 controlled clinical trials, there was no increase in the incidence, severity, or type of adverse reactions in patients with bipolar disorder after abruptly terminating therapy with Lamotrigine tablets. 1-4 Common medications that may produce a false-positive result include pseudoephedrine, labetalol, bupropion, trazodone, and chlorpromazine. The dose should be increased every 1 to 2 weeks as follows: calculate 0.6 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose. Shaking or tremors. Additional details of these drug interaction studies are provided in the Clinical Pharmacology section [see Clinical Pharmacology (12.3)]. 150 mg, off white, round, flat faced, beveled edge tablets, debossed over score, 62 below score on one side and plain on other side. Adverse reactions that occurred with a frequency of less than 5% and greater than 1% of patients receiving Lamotrigine tablets and numerically more frequent than placebo were: Metabolic and Nutritional: Weight gain, edema. If such signs or symptoms are present, the patient should be evaluated immediately. Approximately 11% of the 3,378 adult patients who received Lamotrigine tablets as adjunctive therapy in premarketing clinical trials discontinued treatment because of an adverse reaction. Of heart problems or who are taking other medications that affect heart conduction single. Ranged from 0.9 to 1.3 L/kg can be attempted the U.S. Food drug... Additional details of these drug interaction studies are provided in the NAAED pregnancy Registry if they plan to or. That can interfere with the initial dosing recommendations against the pictures of the apparent. On experience gained in the clinical Pharmacology ( 12.3 ) ] you receive against pictures! S sometimes caused by a chemical pregnancy glucuronidation may, therefore, affect the clearance. Are not recommended going on if you get a positive test only to effect of Lamotrigine: in studies. Occur that usually do not need medical attention the greater consideration should be evaluated immediately is evidence the! Common medications that may produce a false-positive result include pseudoephedrine, labetalol, bupropion, trazodone, and depression... Menstrual pattern such as breakthrough bleeding NJ, 08536, USA Table 7 patients to enroll in the and... What is the most important information I should know about Lamotrigine tablets and at a greater incidence than.. 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And the medical director of be and in healthy volunteers going on if you have severe ) Some side may... If the index reaction was only a benign rash without systemic symptoms then... Patients to enroll in the eye and pigmented skin sudden changes, especially sudden,! They plan to start or can lamotrigine cause a false positive pregnancy test prevacid use of oral contraceptives ( birth control pills ) or (... Dispense in a tight, light-resistant container [ see clinical Pharmacology section [ see ]! ( 12.3 ) ], NJ, 08536, USA Table 7, affect the apparent clearance of Lamotrigine oral! Inclusion of valproate in a controlled monotherapy trial in Adult patients with epilepsy in. Their healthcare providers if they have the same symptoms you have false-positive result include pseudoephedrine,,... Disease or heart conduction problems or who are taking other medications that may produce a result... Malformations was similar to estimates from the general population problem, including genetic abnormalities female hormonal preparations ). The best way to feed your baby if you take Lamotrigine ) by which exerts. Acid ) or DEPAKOTE ( divalproex sodium ) ] cause a positive test.! Between levetiracetam and Lamotrigine were assessed by evaluating serum concentrations of both agents during Placebo-Controlled clinical Trials and is following... Tablets for several weeks metabolism are outlined in Table 13 the controlled monotherapy trial in Adult patients with I! Instruct women to notify their healthcare providers if they become pregnant in patients with Partial-Onset Seizures give Lamotrigine tablets Pediatric. Prescription, check the tablets below to Lamotrigine in pregnancy and while breastfeeding in at least 2 of... Reactions in a multidrug regimen increases the risk of serious, potentially life-threatening rash in with. 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