Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. =Decreased (induces Lamotrigine glucuronidation). Inhibition of this enzyme may interfere with the biosynthesis of nucleic acids and proteins. loss of consciousness. The in vitro electrophysiological effects of this metabolite have not been studied. For medical inquiries or to report side effects regarding Lamotrigine tablets please contact Advagen Pharma Limited, at 888-413-0949 or FDA at 1-800-FDA-1088. may cause aseptic meningitis, a serious inflammation of the protective membrane that covers the brain and spinal cord. Administration of Lamotrigine resulted in a 15% increase in topiramate concentrations. The following adverse reactions have been identified during postapproval use of Lamotrigine tablets. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. In cases of HLH reported with Lamotrigine, patients have presented with signs of systemic inflammation (fever, rash, hepatosplenomegaly, and organ system dysfunction) and blood dyscrasias. In the third trial, patients were not observed in a prospective baseline. Following an 8-week baseline phase, patients were randomized to 18 weeks of treatment with Lamotrigine tablets or placebo added to their current AED regimen of up to 2 drugs. Low levels of hCG give false negative pregnancy test: If your body is not producing sufficient hCG, then the pregnancy test cannot . 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. The first at-home pregnancy tests weren't developed until the late 1970s, and since then, the market has exploded and is now worth half a billion dollars. Myth #4: It is a good idea to stop lamotrigine when a patient relapses, because it is probably not working. Infrequent: Aspartate transaminase increased. Prior to initiation of treatment with Lamotrigine tablets, inform patients that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious medical event and instruct them to report any such occurrence to their healthcare providers immediately. Lamotrigine tablets should be discontinued if an alternative etiology for the signs or symptoms cannot be established. The highest dose tested is less than the human dose of 400 mg/day on a mg/m 2 basis. Patients in the control group were intentionally treated with a relatively low dose of valproate; as such, the sole objective of this trial was to demonstrate the effectiveness and safety of monotherapy with Lamotrigine tablets and cannot be interpreted to imply the superiority of Lamotrigine tablets to an adequate dose of valproate. Therefore, adjustments to the dosage of Lamotrigine tablets in the presence of progestogens alone will likely not be needed. If the false positive is blood related then this could be due to antibodies in your blood interfering with the test. Conversion from Adjunctive Therapy with Carbamazepine, Phenytoin, Phenobarbital, or Primidone to Monotherapy with Lamotrigine Tablets. 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)]. Nervous System These common side effects of lamotrigine may happen in more than 1 in 10 people. In 16 female volunteers, an oral contraceptive preparation containing 30 mcg ethinylestradiol and 150 mcg levonorgestrel increased the apparent clearance of Lamotrigine (300 mg/day) by approximately 2-fold with mean decreases in AUC of 52% and in C max of 39%. Strong or moderate inducers of the cytochrome P450 3A4 (CYP3A4) enzyme, which are also known to induce UGT, may also enhance the metabolism of Lamotrigine. Commonly reported side effects of lamotrigine include: ataxia, skin rash, headache, insomnia, and nausea. A recent delivery can give a false positive pregnancy test. As soon as you become pregnant, your body begins producing hCG.. 1. Clinical trials of Lamotrigine tablets for epilepsy and bipolar disorder did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients or exhibit a different safety profile than that of younger patients. You may report side effects to FDA at 1800-FDA-1088. b Drugs that induce Lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs,include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. For example if you eat a couple poppy seed cakes before testing, you can get a positive result for opiates. Serious rash associated with hospitalization and discontinuation of Lamotrigine occurred in 0.3% (11 of 3,348) of adult patients who received Lamotrigine tablets in premarketing clinical trials of epilepsy. Each time you fill your prescription, check the tablets you receive against the pictures of the tablets below. 03/2023. The occurrence of false-positives is mostly affected by the type of immunoassay used and the particular agent being tested. The addition of carbamazepine decreases Lamotrigine steady-state concentrations by approximately 40%. 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. Adjunctive Therapy with Lamotrigine Tablets in Pediatric and Adult Patients with Lennox-Gastaut Syndrome. What is the most important information I should know about Lamotrigine tablets? Epilepsy: For patients receiving Lamotrigine tablets in combination with other AEDs, a re-evaluation of all AEDs in the regimen should be considered if a change in seizure control or an appearance or worsening of adverse reactions is observed. Discontinuing similar medications during pregnancy has been associated with a significant increase in symptom relapse. How can I watch for early symptoms of suicidal thoughts and actions in myself or a family member? To provide a meaningful estimate of the proportion of individuals having adverse reactions, similar types of adverse reactions were grouped into a smaller number of standardized categories using modified COSTART dictionary terminology. The net effects of drug interactions with Lamotrigine are summarized in Tables 13 and 15, followed by details of the drug interaction studies below. Symptoms have been reported to occur within 8 to 24 days following the initiation of treatment. Over-the-counter analgesics such as ibuprofen, naproxen and ketoprofen have been known to cause innocent drug-test . Lamotrigine may cause aseptic meningitis, a serious inflammation of the protective membrane that covers the brain and spinal cord. Therefore, dose escalation should follow the recommended guidelines for initiating adjunctive therapy with Lamotrigine tablets based on the concomitant AED or other concomitant medications (see Tables 1, 5, and 7). Aciphex (rabeprazole sodium) - PPIs may test positive for THC. There have been reports of omeprazole causing false positives on urine drug tests, but it appears uncommon. Lamotrigine pharmacokinetic parameters for pediatric patients are summarized in Table 16. False-positive results for amphetamine and methamphetamine were the most commonly reported. If you have had a fast heartbeat, heart failure, or other heart problems, you should not take lamotrigine. As with other AEDs, physiological changes during pregnancy may affect Lamotrigine concentrations and/or therapeutic effect. Some of the patients treated with Lamotrigine who developed aseptic meningitis had underlying diagnoses of systemic lupus erythematosus or other autoimmune diseases. 11 /11. Here, a look at what might be going on if you get a positive test only to . 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. 100 mg, off white, round, flat faced, beveled edge tablets, debossed over score, 61 below score on one side and plain on other side. 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. Difficulty sleeping. Rash, photophobia, myalgia, chills, altered consciousness, and somnolence were also noted in some cases. Nervous System Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real . It's also called a phantom 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)] . The goal of the transition regimen is to attempt to maintain seizure control while mitigating the risk of serious rash associated with the rapid titration of Lamotrigine tablets. A woman who had sex soon after birth might take a pregnancy test to get a false positive pregnancy test. 9. Amphetamine. Inform patients that multiorgan hypersensitivity reactions and acute multiorgan failure may occur with Lamotrigine. Like other antiepileptic drugs, Lamotrigine tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. PRINCIPAL DISPLAY PANEL - 25 mg - 100 Counts Bottle Label - NDC 72888-025-01, PRINCIPAL DISPLAY PANEL - 25 mg - 500 Counts Bottle Label - NDC 72888-025-05, PRINCIPAL DISPLAY PANEL - 25 mg - 1000 Counts Bottle Label - NDC 72888-025-00, PRINCIPAL DISPLAY PANEL - 100 mg - 100 Counts Bottle Label - NDC 72888-026-01, PRINCIPAL DISPLAY PANEL - 100 mg - 500 Counts Bottle Label - NDC 72888-026-05, PRINCIPAL DISPLAY PANEL - 100 mg - 1000 Counts Bottle Label - NDC 72888-026-00, PRINCIPAL DISPLAY PANEL - 150 mg - 60 Counts Bottle Label - NDC 72888-027-60, PRINCIPAL DISPLAY PANEL - 150 mg - 500 Counts Bottle Label - NDC 72888-027-05, PRINCIPAL DISPLAY PANEL - 200 mg - 60 Counts Bottle Label - NDC 72888-028-60, PRINCIPAL DISPLAY PANEL - 200 mg - 500 Counts Bottle Label - NDC 72888-028-05. b Drugs that induce Lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. 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