Lamotrigine (Lamotrigine)

Trade Name : Lamotrigine

Amneal Pharmaceuticals of New York LLC

TABLET, ORALLY DISINTEGRATING

Strength 25 mg/1

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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 Amneal Pharmaceuticals of New York LLC. It is available in strength of 25 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
  • Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (2 to 17 years of age) and 0.08% to 0.3% in adults receiving lamotrigine. 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 as adjunctive therapy. 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) co-administration 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 n
  • WARNING: SERIOUS SKIN RASHES
  • See full prescribing information for complete boxed warning.
  • Warnings and Precautions,u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 8/2019
  • Hemophagocytic Lymphohistiocytosis ()
  • Lamotrigine is indicated for:
  • Epilepsyu2014adjunctive therapy in patients aged 2 years and older:
  • Epilepsyu2014monotherapy in patients aged 16 years and older:
  • 1.2
  • Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine orally disintegrating tablets in the acute treatment of mood episodes has not been established.
  • Epilepsy:
  • 2.4
  • 25 mg
  • IX526
  • 50 mg
  • IX527
  • 100 mg
  • IX528
  • 200 mg
  • IX529
  • u00a0Orally Disintegrating Tablets: 25 mg, 50 mg, 100 mg, and 200 mg. (, )
  • Lamotrigine orally disintegrating tablets are contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients .
  • Hypersensitivity to the drug or its ingredients. (, )
  • No data
  • The following serious adverse reactions are described in more detail in the section of the labeling:
  • Epilepsy:
  • Bipolar disorder:
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Significant drug interactions with lamotrigine are summarized in this section.
  • Uridine 5u00b4-diphospho-glucuronyl transferases (UGT) have been identified as the enzymes responsible for metabolism of lamotrigine. Drugs that induce or inhibit glucuronidation may, therefore, affect the apparent clearance of lamotrigine. 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.
  • Those drugs that have been demonstrated to have a clinically significant impact on lamotrigine metabolism are outlined in Table 13. Specific dosing guidance for these drugs is provided in the Dosage and Administration section .
  • Additional details of these drug interaction studies are provided in the Clinical Pharmacology section .
  • Table 13: Established and Other Potentially Significant Drug Interactions
  • u2193 = Decreased (induces lamotrigine glucuronidation).
  • u2191 = Increased (inhibits lamotrigine glucuronidation).
  • ? = Conflicting data.
  • Effect of Lamotrigine on Organic Cationic Transporter 2 Substrates
  • Lamotrigine is an inhibitor of renal tubular secretion via organic cationic transporter 2 (OCT2) proteins . This may result in increased plasma levels of certain drugs that are substantially excreted via this route. Co-administration of lamotrigine orally disintegrating tablets with OCT2 substrates with a narrow therapeutic index (e.g., dofetilide) is not recommended.
  • No data
  • 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 (0.17 mg/mL at 25u00b0C) and slightly soluble in 0.1 M hydrochlorideu00a0(4.1 mg/mL at 25u00b0C). The structural formula is:
  • Lamotrigine orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine and the following inactive ingredients: amino methacrylate copolymer, aspartame, black currant flavor, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, pregelatinized maize starch, sodium chloride, and stearic acid.
  • Lamotrigine orally disintegrating tablets are formulated using granulation technology in which the lamotrigine drug substance is granulated with stearic acid and eudragit EPO for taste masking. The formulation contains flavor and has a good mouth feel, no grittiness, no after taste, better palatability and gives a desired dissolution profile.
  • No data
  • No evidence of carcinogenicity was seen in mouse or rat following oral administration of lamotrigine for up to 2 years at doses up to 30 mg/kg/day and 10 to 15 mg/kg/day in mouse and rat, respectively. The highest doses tested are less than the human dose of 400 mg/day on a body surface area (mg/m) basis.
  • Lamotrigine was negative in gene mutation (Ames and mouse lymphoma ) assays and in clastogenicity ( human lymphocyte and rat bone marrow) assays.
  • No evidence of impaired fertility was detected in rats given oral doses of lamotrigine up to 20 mg/kg/day. The highest dose tested is less than the human dose of 400 mg/day on a mg/m basis.
  • No data
  • Lamotrigine Orally Disintegrating Tablets
  • 25 mg,
  • 50 mg,
  • 100 mg,
  • 200 mg,
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Blisterpacks
  • If the product is dispensed in a blisterpack, the patient should be advised to examine the blisterpack before use and not use if blisters are torn, broken, or missing.
  • Advise the patient to read the FDA-approved patient labeling ().
  • Rash
  • Prior to initiation of treatment with lamotrigine orally disintegrating 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 tou00a0report any such occurrence to their healthcare providers immediately.
  • Hemophagocytic Lymphohistiocytosis
  • Prior to initiation of treatment with lamotrigine, inform patients that excessive immune activation may occur with lamotrigine and that they should report signs or symptoms such as fever, rash, or lymphadenopathy to a healthcare provider immediately.
  • Multiorgan Hypersensitivity Reactions, Blood Dyscrasias, and Organ Failure
  • Inform patients that multiorgan hypersensitivity reactions and acute multiorgan failure may occur with lamotrigine orally disintegrating tablets. Isolated organ failure or isolated blood dyscrasias without evidence of multiorgan hypersensitivity may also occur. Instruct patients to contact their healthcare providers immediately if they experience any signs or symptoms of these conditions .
  • Suicidal Thinking and Behavior
  • Inform patients, their caregivers, and families that AEDs, including lamotrigine orally disintegrating tablets, may increase the risk of suicidal thoughts and behavior. Instruct them to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts or behavior or thoughts about self-harm. Instruct them to immediately report behaviors of concern to their healthcare providers.
  • Worsening of Seizures
  • Instruct patients to notify their healthcare providers if worsening of seizure control occurs.
  • Central Nervous System Adverse Effects
  • Inform patients that lamotrigine orally disintegrating tablets may cause dizziness, somnolence, and other symptoms and signs of central nervous system depression. Accordingly, instruct them neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on lamotrigine orally disintegrating tablets to gauge whether or not they adversely affect their mental and/or motor performance.
  • Pregnancy and Nursing
  • Instruct patients to notify their healthcare providers if they become pregnant or intend to become pregnant during therapy and if they intend to breastfeed or are breastfeeding an infant.
  • Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 .
  • Inform patients who intend to breastfeed that lamotrigine is present in breast milk and advise them to monitor their child for potential adverse effects of this drug. Discuss the benefits and risks of continuing breastfeeding.
  • Oral Contraceptive Use
  • Instruct women to notify their healthcare providers if they plan to start or stop use of oral contraceptives or other female hormonal preparations. Starting estrogen-containing oral contraceptives may significantly decrease lamotrigine plasma levels and stopping estrogen-containing oral contraceptives (including the pill-free week) may significantly increase lamotrigine plasma levels . Also instruct women to promptly notify their healthcare providers if they experience adverse reactions or changes in menstrual pattern (e.g., break-through bleeding) while receiving lamotrigine orally disintegrating tablets in combination with these medications.
  • Discontinuing Lamotriginen- Orally Disintegrating Tablets
  • Instruct patients to notify their healthcare providers if they stop taking lamotrigine orally disintegrating tablets for any reason and not to resume lamotrigine orally disintegrating tablets without consulting their healthcare providers.
  • Aseptic Meningitis
  • Inform patients that lamotrigine orally disintegrating tablets may cause aseptic meningitis. Instruct them to notify their healthcare providers immediately if they develop signs and symptoms of meningitis such as headache, fever, nausea, vomiting, stiff neck, rash, abnormal sensitivity to light, myalgia, chills, confusion, or drowsiness while taking lamotrigine orally disintegrating tablets.
  • Potential Medication Errors
  • To avoid a medication error of using the wrong drug or formulation, strongly advise patients to visually inspect their tablets to verify that they are lamotrigine orally disintegrating tablets, as well as the correct formulation of lamotrigine orally disintegrating tablets, each time they fill their prescription . Refer the patient to the Medication Guide that provides depictions of the lamotrigine orally disintegrating tablets.
  • Manufactured by:n Whitby, Ontario, Canada L1N 5Z5n Manufactured for:n Bridgewater, NJ 08807n Rev. 10-2019-01
  • LAMOTRIGINE (la-moeu2019-tri-jeen) Orally Disintegrating Tablets
  • Phenylketonurics:
  • Contains Phenylalanine 2.80 mg Per 50 mg tablet
  • Contains Phenylalanine 5.60 mg Per 100 mg tablet
  • Contains Phenylalanine 11.20 mg Per 200 mg tablet
  • What is the most important information I should know about lamotrigine orally disintegrating tablets?
  • 1. Lamotrigine orally disintegrating tablets may cause a serious skin rash that may cause you to be hospitalized or even cause death.
  • There is no way to tell if a mild rash will become more serious. A serious skin rash can happen at any time during your treatment with lamotrigine orally disintegrating tablets, but is more likely to happen within the first 2 to 8 weeks of treatment. Children and teenagers aged between 2 and 17 years have a higher chance of getting this serious skin rash while taking lamotrigine orally disintegrating tablets.
  • 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. A healthcare provider should examine you to decide if you should continue taking lamotrigine orally disintegrating tablets.
  • 2. Other serious reactions, including serious blood problems or liver problems.
  • 3. Like other antiepileptic drugs, lamotrigine orally disintegrating tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
  • 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 orally disintegrating tablets without first talking to a healthcare provider.
  • How can I watch for early symptoms of suicidal thoughts and actions in myself or a family member?
  • 4. Lamotrigine orally disintegrating tablets may 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 orally disintegrating tablets, which your doctor would check for if you developed meningitis while taking lamotrigine orally disintegrating tablets.
  • Lamotrigine orally disintegrating tablets can cause other serious side effects.n- u201cWhat are the possible side effects of lamotrigine orally disintegrating tablets?u201d
  • 5. People prescribed lamotrigine orally disintegrating tablets have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine, so always check that you receive lamotrigine orally disintegrating tablets.
  • Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for lamotrigine orally disintegrating tablets:
  • These pictures show the distinct wording, colors, and shapes of the tablets that help to identify the right strength of lamotrigine orally disintegrating tablets. Immediately call your pharmacist if you receive a lamotrigine tablet that does not look like one of the tablets shown below, as you may have received the wrong medication.
  • Lamotrigine Orally Disintegrating Tablets
  • What are lamotrigine orally disintegrating tablets?
  • Do not take lamotrigine orally disintegrating tablets.
  • Before taking lamotrigine orally disintegrating tablets, tell your healthcare provider about all of your health conditions, including if you:
  • Tell your healthcare provider about all the medicines you take
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.n
  • How should I take lamotrigine orally disintegrating tablets?
  • What should I avoid while taking lamotrigine orally disintegrating tablets?
  • Do not drive, operate machinery,u00a0 or do other dangerous activities until you know how lamotrigine orally disintegrating tablets affect you.
  • What are the possible side effects of lamotrigine orally disintegrating tablets?
  • Lamotrigine orally disintegrating tablets can cause serious side effects.
  • See u201cWhat is the most important information I should know about lamotrigine orally disintegrating tablets?u201d
  • Common side effects of lamotrigine orally disintegrating tablets include:
  • These are not all the possible side effects of lamotrigine orally disintegrating tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1u2011800-FDA-1088.
  • How should I store lamotrigine orally disintegrating tablets?
  • General information about the safe and effective use of lamotrigine orally disintegrating tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lamotrigine orally disintegrating tablets for a condition for which it was not prescribed. Do not give lamotrigine orally disintegrating tablets to other people, even if they have the same symptoms that you have. It may harm them.
  • If you take a urine drug screening test, lamotrigine may make the test result positive for another drug. If you require a urine drug screening test, tell the healthcare professional administering the test that you are taking lamotrigine.
  • This Medication Guide summarizes the most important information about lamotrigine orally disintegrating tablets. You can ask your healthcare provider or pharmacist for information about lamotrigine orally disintegrating tablets that is written for health professionals.
  • For more information, call Amneal Pharmaceuticals at 1-877-835-5472.
  • What are the ingredients in lamotrigine orally disintegrating tablets?
  • Active ingredient: lamotrigine.
  • Inactive ingredients: amino methacrylate copolymer, aspartame, black currant flavor, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, pregelatinized maize starch, sodium chloride, and stearic acid.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • DEPAKENE and DEPAKOTE are registered trademarks of Abbott Laboratories.
  • Manufactured by:
  • Patheon Inc.
  • Whitby, Ontario, Canada L1N 5Z5u00a0
  • Manufactured for:
  • Amneal Pharmaceuticals LLC
  • Bridgewater, NJ 08807
  • Rev. 10-2019-01
  • No data
  • No data
  • No data
  • No data

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