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. We comply with the HONcode standard for trustworthy health information. Cardiac Rhythm and Conduction Abnormalities. 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. Lamotrigine also displayed inhibitory properties in the kindling model in rats both during kindling development and in the fully kindled state. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as 1 week after starting treatment with AEDs and persisted for the duration of treatment assessed. A more specific analytical method should be used to confirm a positive result. It's also called a phantom pregnancy. Call your healthcare provider right away if you: 4. Adverse reactions consistent with elevated levels of Lamotrigine, such as dizziness, ataxia, and diplopia, could occur. The presence of phencyclidine (PCP) is the most common false positive in people taking Lamictal, according to the drug's manufacturer . 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). As soon as you become pregnant, your body begins producing hCG.. c The effect of other hormonal contraceptive preparations or hormone replacement therapy on the pharmacokinetics of Lamotrigine has not been systematically evaluated in clinical trials, although the effect may be similar to that seen with the ethinylestradiol/levonorgestrel combinations. Multiorgan hypersensitivity reactions, also known as drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred with Lamotrigine. Table 7. Both patients were taking the anti-seizure medication lamotrigine with nothing else in common. False-negative results can cause missed opportunities to detect misuse. Some clinicians have reported increased . have had aseptic meningitis after taking Lamotrigine tablets or Lamotrigine extended-release tablets. You may report side effects to FDA at 1800-FDA-1088. Controlled Adjunctive Clinical Trials in Adults with Epilepsy: Table 8 lists adverse reactions that occurred in adult patients with epilepsy treated with Lamotrigine tablets in placebo-controlled trials. A therapeutic plasma concentration range has not been established for Lamotrigine. In animal studies, administration of Lamotrigine during pregnancy resulted in developmental toxicity (increased mortality, decreased body weight, increased structural variation, neurobehavioral abnormalities) at doses lower than those administered clinically. Safety and efficacy of Lamotrigine tablets, used as adjunctive treatment for partial-onset seizures were not demonstrated in a small, randomized, double-blind, placebo-controlled withdrawal trial in very young pediatric patients (aged 1 to 24 months). 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. Lamotrigine tablets can cause other serious side effects. A home pregnancy test detects the presence of Human Chorionic Gonadotropin (HCG), a hormone produced during pregnancy. Evidence gathered from other sources suggests that self-induction by Lamotrigine may not occur when Lamotrigine is given as adjunctive therapy in patients receiving enzyme-inducing drugs such as 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)]. Dosage Adjustments to Lamotrigine Tablets in Adults with Bipolar Disorder Following Discontinuation of Psychotropic Medications. Dose adjustments limited to the pill-free week are not recommended. No differences in efficacy based on age, sex, or race were detected. The majority of Lamotrigine tablets pregnancy exposure data are from women with epilepsy. Although these trials were not designed to separately evaluate time to the occurrence of depression or mania, a combined analysis for the 2 trials revealed a statistically significant benefit for Lamotrigine over placebo in delaying the time to occurrence of both depression and mania, although the finding was more robust for depression. The adverse reactions that most commonly led to discontinuation of Lamotrigine tablets were rash (3%) and mania/hypomania/mixed mood adverse reactions (2%). Be sure to read the section below entitled What are the possible side effects of Lamotrigine tablets?. Clinical data suggest a higher incidence of rash, including serious rash, in patients receiving concomitant valproate than in patients not receiving valproate [see Warnings and Precautions (5.1)]. 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. Patients could not be on more than 2 other anticonvulsants. Because there is inadequate experience in this population, Lamotrigine tablets should be used with caution in these patients. h Not administered, but an active metabolite of oxcarbazepine. When oral daily doses of Lamotrigine were given to pregnant rats during organogenesis, fetal, placental, and maternal folate concentrations were reduced. The primary endpoint was TIME (time to intervention for a mood episode or one that was emerging, time to discontinuation for either an adverse event that was judged to be related to bipolar disorder, or for lack of efficacy). Other Hormonal Contraceptives or Hormone Replacement Therapy. Experience in patients with hepatic impairment is limited. Infrequent: Yawn. Lamictal may cause false positives in urine drug tests. The authors conclude that both promethazine and chlorpromazine can cause false-positive amphetamines UDS and recommend confirmation of any presumptive positive results with a secondary method . The lowest effect dose for developmental neurotoxicity in rats is less than the human dose of 400 mg/day on a mg/m 2 basis. Low levels of hCG give false negative pregnancy test: If your body is not producing sufficient hCG, then the pregnancy test cannot . Isolated organ failure or isolated blood dyscrasias without evidence of multiorgan hypersensitivity may also occur. The overall mean values were calculated from individual study means that were weighted based on the number of volunteers/ subjects in each study. Infrequent: Akathisia, apathy, aphasia, central nervous system depression, depersonalization, dysarthria, dyskinesia, euphoria, hallucinations, hostility, hyperkinesia, hypertonia, libido decreased, memory decrease, mind racing, movement disorder, myoclonus, panic attack, paranoid reaction, personality disorder, psychosis, sleep disorder, stupor, suicidal ideation. Several meta-analyses have not reported an increased risk of major congenital malformations following Lamotrigine exposure in pregnancy compared with healthy and disease-matched controls. Dosing of Lamotrigine tablets should be based on therapeutic response [see Clinical Pharmacology (12.3)]. a Carbamazepine, phenytoin, phenobarbital, and primidone have been shown to increase the apparent clearance of Lamotrigine. Instruct patients to contact their healthcare providers immediately if they experience any signs or symptoms of these conditions [see Warnings and Precautions (5.3, 5.5) ]. Take Lamotrigine tablets exactly as prescribed. Data I'm very excited, but also cautious. The NAAED Pregnancy Registry observed an increased risk of isolated oral clefts: among 2,200 infants exposed to Lamotrigine early in pregnancy, the risk of oral clefts was 3.2 per 1,000 (95% CI: 1.4, 6.3), a 3-fold increased risk versus unexposed healthy controls. Starting Lamotrigine Tablets in Women Taking Estrogen-Containing Oral Contraceptives: (1) Taking Estrogen-Containing Oral Contraceptives: (2) Starting Estrogen-Containing Oral Contraceptives: (3) Stopping Estrogen-Containing Oral Contraceptives: Women and Other Hormonal Contraceptive Preparations or Hormone Replacement Therapy, In Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone, In Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidone, 100 to 200 mg/day with valproate alone 100 to 400 mg/day with valproate and other drugs that induce glucuronidation, In Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone, Give this daily dose, using the most appropriate combination of Lamotrigine 2- and 5-mg tablets, Therapy with Valproate to Monotherapy with Lamotrigine, In Patients NOT Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, Discontinuation of Psychotropic Drugs (excluding , Valproate, After Discontinuation of Carbamazepine, Phenytoin, Phenobarbital, or Primidone, Current Dose of Lamotrigine Tablets (mg/day), In vitro testing showed that Lamotrigine exhibits Class IB antiarrhythmic activity at therapeutically relevant concentrations, Placebo Patients with Events per 1,000 Patients, Drug Patients with Events per 1,000 Patients, Relative Risk: Incidence of Events in Drug Patients/ Incidence in Placebo Patients, Risk Difference: Additional Drug Patients with Events per 1,000 Patients. If the hormone is present, it triggers a chemical reaction and the test signals that you're pregnant. b Significantly greater than group receiving Lamotrigine tablets 300 mg ( P<0.05). Ofloxacin may also cause a false positive result for amphetamine or methamphetamine. Talk to your healthcare provider about the best way to feed your baby if you take Lamotrigine. Advise the patient to read the FDA-approved patient labeling (Medication Guide). In 10 male volunteers, rifampin (600 mg/day for 5 days) significantly increased the apparent clearance of a single 25-mg dose of Lamotrigine by approximately 2-fold (AUC decreased by approximately 40%). Positive: Yes, a faint test usually means a positive result! rash diarrhea All reported adverse reactions are included except those already listed in the previous tables or elsewhere in the labeling, those too general to be informative, and those not reasonably associated with the use of the drug. Rare: Deafness, lacrimation disorder, oscillopsia, parosmia, ptosis, strabismus, taste loss, uveitis, visual field defect. Approximately 11.5% of the 1,081 pediatric patients aged 2 to 16 years who received Lamotrigine tablets as adjunctive therapy in premarketing clinical trials discontinued treatment because of an adverse reaction. Patients were dosed on a fixed-dose regimen based on body weight and valproate use. Target doses were designed to approximate 5 mg/kg/day for patients taking valproate (maximum dose: 200 mg/day) and 15 mg/kg/day for patients not taking valproate (maximum dose: 400 mg/day). Maternal toxicity was observed at the higher dose tested. Lamotrigine can be used to treat the following partial seizures, primary generalized tonic-clonic seizures, bipolar I disorder maintenance and Lennox-Gastaut syndrome. if you are satisfied with my answer, please consider clicking on the accept button. Approximately 16% of 2,401 patients who received Lamotrigine tablets (50 to 500 mg/day) for bipolar disorder in premarketing trials discontinued therapy because of an adverse reaction, most commonly due to rash (5%) and mania/hypomania/mixed mood adverse reactions (2%). Adjunctive Therapy with Lamotrigine Tablets in Pediatric Patients with Partial-Onset Seizures. The structural formula is: Lamotrigine tablets, USP are supplied for oral administration as 25 mg, 100 mg, 150 mg and 200 mg tablets. Infrequent: Abnormal ejaculation, hematuria, impotence, menorrhagia, polyuria, urinary incontinence. Hemophagocytic lymphohistiocytosis (HLH) has occurred in pediatric and adult patients taking Lamotrigine for various indications. 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). This may cause serious side effects. If you miss a dose of Lamotrigine tablets take it as soon as you remember. Inform patients, their caregivers, and families that AEDs, including Lamotrigine tablets, may increase the risk of suicidal thoughts and behavior. 2. Common side effects of Lamotrigine tablets include: dizziness sleepiness are taking oral contraceptives (birth control pills) or other female hormonal medicines. The same meta-analyses evaluated the risk of additional maternal and infant outcomes including fetal death, stillbirth, preterm birth, small for gestational age, and neurodevelopmental delay. Its greatest benefit is in prevention. The dose should be increased every 1 to 2 weeks as follows: calculate 1.2 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose. Fertility treatments or improper testing are common causes of false positives. swelling of your face, eyes, lips, or tongue, unusual bruising or bleeding, looking pale, yellowing of your skin or the white part of your eyes, seizures for the first time or happening more often, pain and/or tenderness in the area towards the top of your stomach (enlarged liver and/or spleen). 11 /11. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. Because there is inadequate experience in this population, Lamotrigine tablets should be used with caution in these patients [see Dosage and Administration (2.1)] . Urine samples can be adulterated with other substances to mask positive results on urine drug testing. No data are available on the effects of the drug on milk production. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. Potential Source of False-Positive. Immunologic Hypogammaglobulinemia, lupus-like reaction, vasculitis. Rare: Hiccup, hyperventilation. abdominal pain stuffy nose Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. These data indicate that Lamotrigine does not influence the pharmacokinetics of levetiracetam and that levetiracetam does not influence the pharmacokinetics of Lamotrigine. 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%). HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic inflammation. Your healthcare provider may change your dose. Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash. The radioactivity in the urine consisted of unchanged Lamotrigine (10%), the 2-N-glucuronide (76%), a 5-N-glucuronide (10%), a 2-N-methyl metabolite (0.14%), and other unidentified minor metabolites (4%). Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Inhibition of this enzyme may interfere with the biosynthesis of nucleic acids and proteins. Stopping Lamotrigine tablets suddenly may cause serious problems. The International Lamotrigine Pregnancy Registry reported major congenital malformations in 2.2% (95% CI: 1.6%, 3.1%) of 1,558 infants exposed to Lamotrigine monotherapy in the first trimester of pregnancy. Last updated on Mar 1, 2023. Valproate + phenytoin and/or carbamazepine, Subjects taking carbamazepine, phenytoin, phenobarbital, or primidone, Subjects taking antiepileptic drugs with no known effect on the apparent clearance of Lamotrigine, Subjects taking carbamazepine, phenytoin, phenobarbital, or primidonea, manufacture(72888-025, 72888-026, 72888-027, 72888-028), analysis(72888-025, 72888-026, 72888-027, 72888-028), label(72888-025, 72888-026, 72888-027, 72888-028). The most commonly reported adverse reaction that led to discontinuation of Lamotrigine tablets was rash. By continuing to use this site you consent to the use of cookies on your device as described in our cookie policy unless you have disabled them. 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. No differences in efficacy based on age, sex, or race, as measured by change in seizure frequency, were detected. For dosing considerations for Lamotrigine tablets in patients on estrogen-containing contraceptives and atazanavir/ritonavir, see below and Table 13. Case 2's presentation combined with a comprehensive history at the facility ruled out PCP use. Usual Adjunctive Maintenance Dose for Epilepsy. Table 11. This may result in increased plasma levels of certain drugs that are substantially excreted via this route. 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. a painful, red or swollen tongue. Animal Data: When Lamotrigine was administered to pregnant mice, rats, or rabbits during the period of organogenesis (oral doses of up to 125, 25, and 30 mg/kg, respectively), reduced fetal body weight and increased incidences of fetal skeletal variations were seen in mice and rats at doses that were also maternally toxic. The target dose of Lamotrigine tablets is 200 mg/day (100 mg/day in patients taking valproate, which decreases the apparent clearance of Lamotrigine, and 400 mg/day in patients not taking valproate and taking either carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitor lopinavir/ritonavir that increase the apparent clearance of Lamotrigine). Effect of Lamotrigine: In vitro studies show that Lamotrigine exhibits Class IB antiarrhythmic activity at therapeutically relevant concentrations. The AUC and C max of olanzapine were similar following the addition of olanzapine (15 mg once daily) to Lamotrigine (200 mg once daily) in healthy male volunteers (n = 16) compared with the AUC and C max in healthy male volunteers receiving olanzapine alone (n = 16). Postmarketing cases of aseptic meningitis have been reported in pediatric and adult patients taking Lamotrigine for various indications. Lamotrigine is present in milk from lactating women taking Lamotrigine tablets (see Data). Generally, females receiving either Lamotrigine tablets as adjunctive therapy or placebo were more likely to report adverse reactions than males. Discontinuation Strategy Simultaneously decrease to 250 mg/day and maintain for 1 week. The NAAED Pregnancy Registry reported major congenital malformations among 2.0% of 1,562 infants exposed to Lamotrigine monotherapy in the first trimester. Steady-state trough plasma concentrations of Lamotrigine were not affected by concomitant pregabalin (200 mg 3 times daily) administration. The risk of getting a serious skin rash is higher if you: Call your healthcare provider right away if you have any of the following: These symptoms may be the first signs of a serious skin reaction. There was little difference between females and males in the rates of discontinuation of Lamotrigine tablets for individual adverse reactions. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking Lamotrigine tablets as adjunctive therapy. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 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. Nervous System The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Lamotrigine tablets were associated with an increased risk for infectious adverse reactions (Lamotrigine tablets 37%, placebo 5%), and respiratory adverse reactions (Lamotrigine tablets 26%, placebo 5%). generalized seizures of Lennox-Gastaut syndrome. This risk is increased in patients with underlying cardiac disease or heart conduction problems or who are taking other medications that affect heart conduction. Storage: Store at 20C to 25C (68F to 77F); excursions permitted from 15C to 30C (59F to 86F) [see USP Controlled Room Temperature]. Significantly reduced concentrations of folate are associated with teratogenesis [see Use in Specific Populations (8.1)] . 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). In a study of 19 patients with intellectually disabilities and concurrent . When used correctly, home pregnancy tests are 99% accurate. It is a test result that is returned when a substance tests positive for another compound. Instruct patients to notify their healthcare providers if they stop taking Lamotrigine tablets for any reason and not to resume Lamotrigine tablets without consulting their healthcare providers. Within each of these age-groups, specific dosing recommendations are provided depending upon concomitant AEDs or other concomitant medications (see Table 1 for patients older than 12 years and Table 2 for patients aged 2 to 12 years). Renal and Urinary Disorders Tubulointerstitial nephritis (has been reported alone and in association with uveitis). The risk of nonserious rash may be increased when the recommended initial dose and/or the rate of dose escalation for Lamotrigine tablets is exceeded and in patients with a history of allergy or rash to other AEDs. Few patients with severe renal impairment have been evaluated during chronic treatment with Lamotrigine tablets. Reduced concentrations were partially returned to normal when supplemented with folinic acid. 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