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Epilepsy: Adjunctive Use: Lamotrigine is indicated as adjunctive therapy for partial seizures and also the generalized seizures of Lennox-Gastaut syndrome in adults and pediatric patients (>/=2 years of age).Monotherapy Use: Lamotrigine is indicated for conversion to monotherapy in adults with partial seizures. Bipolar Disorder: Lamotrigine is indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes).


Lamotrigine is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

Adverse reactions:

Body as a Whole: Infrequent: Allergic reaction, chills, and malaise. Cardiovascular System: Infrequent: Flushing, hot flashes, hypertension, palpitations, postural hypotension, syncope, tachycardia, and vasodilation. Dermatological: Infrequent: Acne, alopecia, hirsutism, maculopapular rash, skin discoloration, and urticaria. Rare: Angioedema, erythema, exfoliative dermatitis, fungal dermatitis, herpes zoster, leukoderma, multiforme erythema, petechial rash, pustular rash, Stevens-Johnson syndrome, and vesiculobullous rash. Digestive System: Infrequent: Dysphagia, eructation, gastritis, gingivitis, increased appetite, increased salivation, liver function tests abnormal, and mouth ulceration. Rare: Gastrointestinal hemorrhage, glossitis, gum hemorrhage, gum hyperplasia, hematemesis, hemorrhagic colitis, hepatitis, melena, stomach ulcer, stomatitis, and tongue edema. Endocrine System: Rare: Goiter and hypothyroidism. Hematologic and Lymphatic System: Infrequent: Ecchymosis and leukopenia. Rare: Anemia, eosinophilia, fibrin decrease, fibrinogen decrease, iron deficiency anemia, leukocytosis, lymphocytosis, macrocytic anemia, petechia, and thrombocytopenia. Metabolic and Nutritional Disorders: Infrequent: Aspartate transaminase increased. Rare: Alcohol intolerance, alkaline phosphatase increase, alanine transaminase increase, bilirubinemia, general edema, gamma glutamyl transpeptidase increase, and hyperglycemia. Musculoskeletal System: Infrequent: Arthritis, leg cramps, myasthenia, and twitching. Rare: Bursitis, muscle atrophy, pathological fracture, and tendinous contracture. Nervous System: Frequent: Confusion and paresthesia. Infrequent: Akathisia, apathy, aphasia, CNS 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, and suicidal ideation. Rare: Choreoathetosis, delirium, delusions, dysphoria, dystonia, extrapyramidal syndrome, faintness, grand mal convulsions, hemiplegia, hyperalgesia, hyperesthesia, hypokinesia, hypotonia, manic depression reaction, muscle spasm, neuralgia, neurosis, paralysis, and peripheral neuritis. Respiratory System: Infrequent: Yawn. Rare: Hiccup and hyperventilation. Special Senses: Frequent: Amblyopia. Infrequent: Abnormality of accommodation, conjunctivitis, dry eyes, ear pain, photophobia, taste perversion, and tinnitus. Rare: Deafness, lacrimation disorder, oscillopsia, parosmia, ptosis, strabismus, taste loss, uveitis, and visual field defect. Urogenital System: Infrequent: Abnormal ejaculation, hematuria, impotence, menorrhagia, polyuria, and urinary incontinence. Rare: Acute kidney failure, anorgasmia, breast abscess, breast neoplasm, creatinine increase, cystitis, dysuria, epididymitis, female lactation, kidney failure, kidney pain, nocturia, urinary retention, and urinary urgency. Postmarketing Experience The following adverse events (not listed above in clinical trials or other sections of the prescribing information) have been identified during postapproval use of LAMICTAL. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic: Agranulocytosis, hemolytic anemia. Gastrointestinal: Esophagitis. Hepatobiliary Tract and Pancreas: Pancreatitis. Immunologic: Lupus-like reaction, vasculitis. Lower Respiratory: Apnea. Musculoskeletal: Rhabdomyolysis has been observed in patients experiencing hypersensitivity reactions. Neurology: Exacerbation of Parkinsonian symptoms in patients with pre-existing Parkinson's disease, tics. Non-site Specific: Progressive immunosuppression.


Estrogen-containing oral contraceptive Decreases lamotrigine levels approximately 50%, preparations containing 30 mcg ethinylestradiol and 150 mcg levonorgestrel Decrease in levonorgestrel component by 19%. Carbamazepine (CBZ) and CBZ epoxide Addition of carbamazepine decreases lamotrigine concentration approximately 40%. Phenobarbital/Primidone Decreased lamotrigine concentration approximately 40%. Phenytoin (PHT) Decreased lamotrigine concentration approximately 40%. Rifampin Decreased lamotrigine AUC approximately 40%. Valproate Increased lamotrigine concentrations slightly more than 2-fold.


Use with caution in Elderly people. Decreased liver function. Kidney failure. Parkinson's disease. History of allergic reactions or rash due to other antiepileptic medicines. Adverse skin reactions have been reported with lamotrigine. These reactions are usually mild and get better on their own, but can on rare occasions be more serious and potentially life-threatening. The risk is higher in children under 12 years of age and in people who are also taking the medicine valproate. When starting treatment with lamotrigine the dose is increased gradually to minimise the risk of developing a skin rash. For this reason it is very important to follow the instructions you are given with this medicine, and not to exceed the prescribed dose. If you or your child develop a rash, fever, facial swelling or swollen glands while taking this medicine you should consult your doctor immediately. This medicine may cause dizziness and double vision. As a result it could reduce your ability to drive or operate machinery safely. This medicine may rarely cause a decrease in the normal amounts of blood cells in the blood. For this reason you should consult your doctor immediately if you experience any of the following symptoms: unexplained bruising or bleeding, purple spots, sore throat, mouth ulcers, high temperature (fever), feeling tired or general illness. There may be a small increased risk of suicidal thoughts and behaviour in people taking antiepileptic medicines such as lamotrigine for any indication. For this reason, it is very important to seek medical advice if you, or someone else taking this medicine, experience any changes in mood, distressing thoughts, or feelings about suicide or self-harm at any point while taking this medicine.



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