>> endobj (2.1, 16) • Do not restart LAMICTAL in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks. (2.1, 5.1) • Adjustments to maintenance doses will be necessary in most patients starting or stopping estrogen-containing oral contraceptives. >> You will pay $20 or less if your insurance covers the Starter Kit. /F6 6 0 R OWP offers three Starter Kits (Orange, Blue, and Green), each based on FDA-approved 5-week titration schedules, for patients initiating lamotrigine therapy. Simplify Treatment from the Start with the Lamotrigine Starter Kit Ask your doctor to write or e-prescribe Lamotrigine Starter Kit (Orange, Blue, or Green) DAW-1 on your prescription so you’ll receive the Lamotrigine Starter Kit at the pharmacy. Fatalities associated with acute multiorgan failure and various degrees of hepatic failure have been reported. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection. Medication errors may also occur between the different formulations of lamotrigine.Some estrogen‐containing oral contraceptives have been shown to decrease serum concentrations of lamotrigine. Unless safety concerns require a more rapid withdrawal, the dose of lamotrigine should be tapered over a period of at least 2 weeks. [ ] [/Pattern /DeviceRGB] 1 2 . [0 /XYZ 36.1799999 /Producer (�� Q t 4 . >> For general questions or inquiries, or to order materials please contact us at:Determine which 5-week titration schedule is appropriate for your patient (Orange, Blue, or Green)Write or e-Prescribe Lamotrigine Starter Kit (Orange, Blue, or Green) DAW-1Provide savings card to patient or direct patient to access the savings card on a mobile device at lamotriginestarterkits.comTell patient to pick up Lamotrigine Starter Kit from pharmacy and to contact OWP Pharmaceuticals if there are questionsGeneric products are considered bioequivalent to the brand (reference drug) if the confidence interval (90%) for AUCThe FDA has determined that generic drugs that are classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the reference product.Cases of life‐threatening serious rashes, including Stevens‐Johnson syndrome, toxic epidermal necrolysis, and/or rash‐related death, have been caused by lamotrigine. : Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.Cases of life‐threatening serious rashes, including Stevens‐Johnson syndrome, toxic epidermal necrolysis, and/or rash‐related death, have been caused by lamotrigine. 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.
Because of the potential for serious outcomes of untreated meningitis due to other causes, patients should also be evaluated for other causes of meningitis and treated as appropriate.Medication errors involving lamotrigine have occurred. 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 lamotrigine, 20 sudden and unexplained deaths were recorded among a cohort of 4,700 patients with epilepsy (5,747 patient‐years of exposure).Because valproate reduces the clearance of lamotrigine, the dosage of lamotrigine in the presence of valproate is less than half of that required in its absence.Because lamotrigine binds to melanin, it could accumulate in melanin‐rich tissues over time. 10 0 obj endobj >> The most commonly observed adverse reactions (incidence ≥5%) reported in the use of lamotrigine as adjunctive treatment in children in epilepsy clinical studies included vomiting, infection, rash, fever, somnolence, accidental injury, dizziness, abdominal pain, diarrhea, nausea, ataxia, asthenia, bronchitis, flu syndrome, diplopia, and tremor.The most common adverse reactions (incidence >5%) in adult bipolar clinical studies were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia.To report SUSPECTED ADVERSE REACTIONS, contact OWP Pharmaceuticals Inc. at 1-800-273-6729 or FDA at 1-800-FDA-1088 or © 2020 OWP Pharmaceuticals, Inc. Naperville, IL 60563.