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Lamotrigine (Lamotrigine)

Trade Name : Lamotrigine

Hikma Pharmaceuticals USA Inc.

TABLET

Strength 200 mg/1

LAMOTRIGINE Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Lamotrigine (Lamotrigine) which is also known as Lamotrigine and Manufactured by Hikma Pharmaceuticals USA Inc.. It is available in strength of 200 mg/1 per ml. Read more

Lamotrigine (Lamotrigine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions, Multiorgan Hypersensitivity July 2011Reactions and Organ Failure (5.2)Warnings and Precautions, Aseptic Meningitis (5.6) October 2010
  • Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (2 to 16 years of age) receiving lamotrigine as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In clinical trials of bipolar and other mood disorders, the rate of serious rash was 0.08% (0.8 per 1,000) in adult patients receiving lamotrigine as initial monotherapy and 0.13% (1.3 per 1,000) in adult patients receiving lamotrigine as adjunctive therapy. In a prospectively followed cohort of 1,983 pediatric patients (2 to 16 years of age) with epilepsy taking adjunctive lamotrigine, there was 1u00a0rash-related death. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate.
  • 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. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of lamotrigine, or (3) exceeding the recommended dose escalation for lamotrigine. However, cases have occurred in the absence of these factors.
  • Nearly all cases of life-threatening rashes caused by lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash.
  • Although benign rashes are also caused by lamotrigine, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring .
  • WARNING: SERIOUS SKIN RASHES
  • See full prescribing information for complete boxed warning.
  • Cases of life-threatening serious rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death, have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include (5.1):
  • coadministration with valproate
  • exceeding recommended initial dose of lamotrigine
  • exceeding recommended dose escalation of lamotrigine
  • Lamotrigine is an antiepileptic drug (AED) indicated for:
  • Epilepsyu2014adjunctive therapy in patients u22652u00a0years of age:
  • Epilepsyu2014monotherapy in patients u226516u00a0years of age:
  • Bipolar Disorder in patients u226518u00a0years of age:
  • partial seizures.n
  • primary generalized tonic-clonic seizures.n
  • generalized seizures of Lennox-Gastaut syndrome.
  • Epilepsy
  • Bipolar Disorder:
  • Tablets:
  • Lamotrigine is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients .
  • Hypersensitivity to the drug or its ingredients. (Boxed Warning, 4)
  • u2022 Life-threatening serious rash and/or rash-related death may result. (Boxed Warning, 5.1)u2022 Fatal or life-threatening hypersensitivity reaction: Multiorgan hypersensitivity reactions, also known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) may be fatal or life-threatening. Early signs may include rash, fever and lymphadenopathy.These reactions may be associated with other organ involvement, such as hepatitis, hepatic failure, blood dyscrasias, or acute multiorgan failure. Lamotrigine should be discontinued if alternate etiology for this reaction is not found. (5.2)n u2022 Blood dyscrasias (e.g., neutropenia, thrombocytopenia, pancytopenia: May occur, either with or without an associated hypersensitivity syndrome. (5.3)n u2022 Suicidal behavior and ideation. (5.4)
  • u2022 Clinical worsening, emergence of new symptoms, and suicidal ideation/behaviors may be associated with treatment of bipolar disorder. Patients should be closely monitored, particularly early in treatment or during dosage changes. (5.5)
  • u2022 Aseptic meningitis reported in pediatric and adult patients. (5.6)
  • u2022 Medication errors involving lamotrigine have occurred. In particular the name lamotrigine can be confused with names of other commonly used medications. (3.4, 5.7, 16, 17.10)
  • The following adverse reactions are described in more detail in the section of the label:
  • u2022 Most common adverse reactions (incidence u226510%) in adult epilepsy clinical studies were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, and rash. Additional adverse reactions (incidence u226510%) reported in children in epilepsy clinical studies included vomiting, infection, fever, accidental injury, pharyngitis, abdominal pain, and tremor. (6.1)
  • u2022 Most common adverse reactions (incidence >5%) in adult bipolar clinical studies were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia. (6.1)
  • To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Significant drug interactions with lamotrigine are summarized in Table 13. Additional details of these drug interaction studies are provided in the Clinical Pharmacology section .
  • u2193= Decreased (induces lamotrigine glucuronidation).
  • u2191= Increased (inhibits lamotrigine glucuronidation).
  • ? = Conflicting data.
  • Valproate increases lamotrigine concentrations more than 2-fold. (7, 12.3)
  • Carbamazepine, phenytoin, phenobarbital, and primidone decrease lamotrigine concentrations by approximately 40%. (7, 12.3)
  • Oral estrogen-containing contraceptives and rifampin also decrease lamotrigine concentrations by approximately 50%. (7, 12.3)
  • See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
  • Revised: 09/2011
  • Hepatic impairment: Dosage adjustments required. (2.1) n
  • Healthcare professionals can enroll patients in the Lamotrigine Pregnancy Registry (1-800-336-2176). Patients can enroll themselves in the North American Antiepileptic Drug Pregnancy Registry (1-888-233-2334). (8.1) n
  • Efficacy of lamotrigine, used as adjunctive treatment for partial seizures, was not demonstrated in a small randomized, double-blind, placebo-controlled study in very young pediatric patients (1 to 24 months). (8.4)
  • No data
  • Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)--triazine, its molecular formula is CHNCl, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pK of 5.7. Lamotrigine is very slightly soluble in water (0.17u00a0mg/mL at 25u00b0C) and slightly soluble in 0.1u00a0M HCl (4.1u00a0mg/mL at 25u00b0C). The structural formula is:
  • Lamotrigine Tablets, USPu00a0are supplied for oral administration as 25 mg (white), 100 mg (peach), 150 mg (cream), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose; magnesium stearate; microcrystalline cellulose; povidone; sodium starch glycolate; FD&C Yellow No. 6 Lake (100-mg tablet only); ferric oxide, yellow (150-mg tablet only); and FD&C Blue No. 2 Lake (200-mg tablet only).
  • No data
  • No evidence of carcinogenicity was seen in 1 mouse study or 2 rat studies following oral administration of lamotrigine for up to 2u00a0years at maximum tolerated doses (30u00a0mg/kg/day for mice and 10 to 15u00a0mg/kg/day for rats, doses that are equivalent to 90u00a0mg/m and 60 to 90u00a0mg/m, respectively). Steady-state plasma concentrations ranged from 1 to 4u00a0mcg/mL in the mouse study and 1 to 10u00a0mcg/mL in the rat study. Plasma concentrations associated with the recommended human doses of 300 to 500u00a0mg/day are generally in the range of 2 to 5u00a0mcg/mL, but concentrations as high as 19u00a0mcg/mL have been recorded.
  • Lamotrigine was not mutagenic in the presence or absence of metabolic activation when tested in 2u00a0gene mutation assays (the Ames test and the in vitro mammalian mouse lymphoma assay). In 2u00a0cytogenetic assays (the in vitro human lymphocyte assay and the in vivo rat bone marrow assay), lamotrigine did not increase the incidence of structural or numerical chromosomal abnormalities.
  • No evidence of impairment of fertility was detected in rats given oral doses of lamotrigine up to 2.4u00a0times the highest usual human maintenance dose of 8.33u00a0mg/kg/day or 0.4u00a0times the human dose on a mg/m basis. The effect of lamotrigine on human fertility is unknown.
  • No data
  • Lamotrigine Tablets, USP
  • 25u00a0mg, white, scored, round tablets debossed with W67 on one side, bottles of 100 and 1000.
  • 100u00a0mg, peach, scored, round tablets debossed with WW966 on one side, bottles of 100 and 1000.
  • 150u00a0mg, cream, scored, round tablets debossed with WW965 on one side, bottles of 60 and 1000.
  • 200u00a0mg, blue, scored, round tablets debossed with WW964 on one side, bottles of 60 and 1000.
  • Store at 20u00ba - 25u00b0C (68u00ba - 77u00b0F) [see USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • See Medication Guide that accompanies the product.
  • Lamotrigine Tablets
  • Read this Medication Guide before you start taking lamotrigine and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have questions about lamotrigine, ask your healthcare provider or pharmacist.
  • What is the most important information I should know about lamotrigine
  • 1. Lamotrigine may cause a serious skin rash that may cause you to be hospitalized or to stop lamotrigine; it may rarely cause death.
  • u00a0There is no way to tell if a mild rash will develop into a more serious reaction. These serious skin reactions are more likely to happen when you begin taking lamotrigine, within the first 2 to 8 weeks of treatment. But it can happen in people who have taken lamotrigine for any period of time. Children between 2 to 16 years of age have a higher chance of getting this serious skin reaction while taking lamotrigine.
  • The risk of getting a rash is higher if you:
  • Lamotrigine can also cause other types of allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.
  • Call your healthcare provider right away if you have any of the following:
  • These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking lamotrigine.
  • 2. Like other antiepileptic drugs,u00a0lamotrigine may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
  • Arrayn- Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
  • Do not stop lamotrigine without first talking to a healthcare provider.
  • How can I watch for early symptoms of suicidal thoughts and actions?
  • 3. Lamotrigine may rarely cause aseptic meningitis, a serious inflammation of the protective membrane that covers the brain and spinal cord.
  • Call your healthcare provider right away if you have any of the following symptoms:
  • Meningitis has many causes other than lamotrigine, which your doctor would check for if you developed meningitis while taking lamotrigine.u00a0
  • Lamotrigine can have other serious side effects.
  • 4. Patients prescribed lamotrigine have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine, so always check that you receive lamotrigine.
  • Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for lamotrigine:
  • Lamotrigine Tablets
  • u00a0u00a0
  • What is lamotrigine?
  • Lamotrigine is a prescription medicine used:
  • It is not known if lamotrigine is safe or effective in children or teenagers under the age of 18 with mood disorders such as bipolar disorder or depression.
  • It is not known if lamotrigine is safe or effective when used alone as the first treatment of seizures in adults.
  • Who should not take lamotrigine?
  • You should not take lamotrigine if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in lamotrigine. See the end of this leaflet for a complete list of ingredients in lamotrigine.
  • What should I tell my healthcare provider before taking lamotrigine?
  • Before taking lamotrigine, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take or if you are planning to take a new medicine, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using lamotrigine with certain other medicines can affect each other, causing side effects.
  • How should I take lamotrigine?
  • What should I avoid while taking lamotrigine?
  • What are possible side effects of lamotrigine?
  • Common side effects of lamotrigine include:
  • Tell your healthcare provider about any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of lamotrigine. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. To resport SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001 or theu00a0FDA at 1-800-FDA-1088.
  • How should I store lamotrigine?
  • General information about lamotrigine
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lamotrigine for a condition for which it was not prescribed. Do not give lamotrigine to other people, even if they have the same symptoms you have. It may harm them.
  • This Medication Guide summarizes the most important information about lamotrigine. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about lamotrigine that is written for healthcare professionals.
  • What are the ingredients in lamotrigine?
  • Lamotrigine Tablets
  • Active ingredient: lamotrigine.
  • Inactive ingredients: lactose; magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, FD&C Yellow No. 6 Lake (100-mg tablet only), ferric oxide, yellow (150-mg tablet only), and FD&C Blue No. 2 Lake (200-mg tablet only).
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • *DEPAKENE and DEPAKOTE are registered trademarks of Abbott Laboratories.
  • Distributed by:n Eatontown, NJ 07724 USA
  • Manufactured by:n P.O.Box 182400 Amman 11118-Jordan
  • Lamotrigine Tablets, USP25 mgNDC 0143-9967
  • Lamotrigine Tablets, USP100 mgNDC 0143-9966
  • Lamotrigine Tablets, USP150 mgNDC 0143-9965
  • u00a0Lamotrigine Tablets, USP200 mgNDC 0143-9964

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