1. Lamotrigine TabletsLamotrigine Tablets (Lametec) is used asadjunctive therapy in the treatment of epilepsy, forpartial seizures and generalised seizures,including tonic-clonic seizures and the seizuresassociated with Lennox-Gastaut syndrome inadults as well as children above 2 years of age.Lamotrigine is also used for the prevention ofmood episodes in patients with bipolardisorder. The Swiss Pharmacy, Geneva Switzerland

2. Lamotrigine TabletsChemical Structure The Swiss Pharmacy, Geneva Switzerland 3. Lamotrigine TabletsActive IngredientThe active pharmaceutical ingredientpresent in Lametec tablets isLamotrigine.Each Lametec 25 mg tablet contains25 mg of the active ingredientLamotrigine. The Swiss Pharmacy, Geneva Switzerland 4. Lamotrigine TabletsRecommended Adult DosageDosage in Epilepsy add-on therapy for Adults(over 12 years of age):In patients taking valproate with/without any otheranti-epileptic medicine (AEM), the initial lamotriginedose is 25 mg every alternate day for two weeks,followed by 25 mg once a day for two weeks.Thereafter, the dose should be increased by amaximum of 25 to 50 mg every 1 to 2 weeks untilthe optimal response is achieved. The usualmaintenance dose to achieve optimal response is100 to 200 mg/day given once a day or in twodivided doses.The recommended adult (over 12years) dosage for lametec (mg/day) is given below: The Swiss Pharmacy, Geneva Switzerland 5. Lamotrigine TabletsRecommended Adult DosageUsual Maintenance Dose With enzyme-inducingantiepileptic drugs(EIAEDs) & No Valproic acid(VPA):Weeks 1 & 2: 50mg/day (Once a day)Weeks 3 & 4: 100mg/day (Two divided doses)Usual Maintenance Dose: 300mg to 500mg/day(Two divided doses). To achieve maintenence dosesmay be incresed by 100mg/day every 1-2 weeks. The Swiss Pharmacy, Geneva Switzerland 6. Lamotrigine TabletsRecommended Adult DosageEIAEDs & Valproic acid (VPA):Weeks 1 & 2: 25 mg every other dayWeeks 3 & 4: 25mg (Once a day)Usual Maintenance Dose: 100mg to 400mg/day(Two divided doses). To achieve maintenence dosesmay be incresed by 25 mg - 50mg/day every 1-2weeks. As there exists a risk of rash the initial doseand subsequent dose escalation should not beexceeded. The Swiss Pharmacy, Geneva Switzerland 7. Lamotrigine TabletsRecommended Dose Children (2 to 12 years of age):In patients taking valproate with/without any other AEM,the initial lamotrigine dose for treatment of in Epilepsy is0.15 mg/kg bodyweight/day given once a day for twoweeks, followed by 0.3 mg/kg/day once a day for twoweeks.Thereafter, the dose should be increased by amaximum of 0.3 mg/kg every 1-2 weeks until the optimalresponse is achieved.The usual maintenance dose to achieve optimalresponse is 1 to 5 mg/kg/day given once a day or in twodivided doses, with a maximum of 200 mg/day. Therecommended dose escalation for lamotrigine (lametec)for children aged 2-12 years (total daily dose in mg/kgbody weight/day) on combined drug therapy is givenbelow. The Swiss Pharmacy, Geneva Switzerland 8. Lamotrigine TabletsRecommended Dose Children (2 to 12 years of age):With AED regimen containing VPA:Weeks 1 & 2: 0.15mg/kg/day (1 or 2divided doses)Weeks 3 & 4: 0.3mg/kg/day (1 or 2divided doses)Usual Maintenance Dose: 1 mg to 5mg/kg/day (Maximum 200mg/day in Oneor Two divided doses).To achieve maintenence doses may beincresed by 0.5 - 1mg/kg/day every 1-2weeks The Swiss Pharmacy, Geneva Switzerland 9. Lamotrigine TabletsRecommended Dose Children (2 to 12 years of age):Added to EIAEDs and without VPA:Weeks 1 & 2: 0.6mg/kg/day (2 divided doses)Weeks 3 & 4: 1.2mg/kg/day (2 divided doses)Usual Maintenance Dose: 5mg - 15mg/kg/day(Maximum 400mg/day in One or Two divideddoses)To achieve maintenence doses may beincreased by 2 to 3 mg/kg/day every 1-2 weeksAfter initial 4 weeks of therapy, the daily dosageof Lametec DT may be doubled at weeklyintervals until an effective maintenance dosageof 200 mg daily is reached. The daily dosagesshould not exceed 200 mg daily. The Swiss Pharmacy, Geneva Switzerland 10. Lamotrigine TabletsRecommended Adult DosageBipolar Disorder Adults (18 years of age and over):Because of the risk of rash, the initial dose andsubsequent dose escalation should not be exceeded.Lamotrigine is recommended for use in bipolar patientsat risk for a future depressive episode. Therecommended initial adult dosage of Lametec DT is 25mg once daily for 2 weeks, followed by 50 mg once dailyfor 2 weeks.For Patients NOT TAKING Carbamazepine, Phenytoin,Phenobarbital, Primidone, or ValproateWeeks 1 and 2 25 mg dailyWeeks 3 and 4 50 mg dailyWeek 5 100 mg dailyWeek 6 and 7 200 mg daily The Swiss Pharmacy, Geneva Switzerland 11. Lamotrigine TabletsContraindicationsGeneric Lamotrigine Tablets (Lametec) iscontraindicated in patients with thefollowing conditions:Known hypersensitivity to Lamotrigine or anyinactive ingredient of this medication.Lamotrigine Tablets (Lametec) should not beused in pregnancy unless, in the opinion of thedoctor, the potential benefits of treatment to themother outweigh any possible risks to thedeveloping foetus. The Swiss Pharmacy, Geneva Switzerland 12. Lamotrigine TabletsSide Effects of Lamotrigine TabletsThe most common possible side effects ofGeneric Lamotrigine Tablets (Lametec) with anincidence rate of 10% or more in adultepilepsy clinical studies were dizziness,headache, diplopia, ataxia, nausea, blurredvision, somnolence, rhinitis, and rash.Additional adverse reactions (incidence rate of10% or more) reported in children in epilepsyclinical studies included vomiting, infection,fever, accidental injury, pharyngitis, abdominalpain, and tremor. The Swiss Pharmacy, Geneva Switzerland 13. Lamotrigine TabletsSide Effects of Lamotrigine TabletsThe most common possible sideeffects of Generic LamotrigineTablets (Lametec) with an incidencerate of greater than 5% in adultbipolar clinical studies were nausea,insomnia, somnolence, back pain,fatigue, rash, rhinitis, abdominalpain, and xerostomia. The Swiss Pharmacy, Geneva Switzerland 14. Lamotrigine TabletsWarnings And PrecautionsLife-threatening serious rash and/or rash-relateddeath may result.Fatal or life-threatening hypersensitivity reaction:Multiorgan hypersensitivity reactions, also known asDrug Reaction with Eosinophilia and SystemicSymptoms (DRESS), may be fatal or life threatening.Early signs may include rash, fever, andlymphadenopathy. These reactions may beassociated with other organ involvement, such ashepatitis, hepatic failure, blood dyscrasias, or acutemultiorgan failure. Lamotrigine tablets (Lametec)should be discontinued if alternate etiology for thisreaction is not found. The Swiss Pharmacy, Geneva Switzerland 15. Lamotrigine TabletsWarnings And PrecautionsBlood dyscrasias (e.g., neutropenia,thrombocytopenia, pancytopenia) may occur,either with or without an associatedhypersensitivity syndrome.Suicidal behavior and ideation.Clinical worsening, emergence of newsymptoms, and suicidal ideation/behaviors maybe associated with treatment of bipolar disorder.Patients should be closely monitored, particularlyearly in treatment or during dosage changes.Aseptic meningitis reported in pediatric and adultpatients. The Swiss Pharmacy, Geneva Switzerland 16. Lamotrigine TabletsWarnings And PrecautionsLamotrigine has been reported to pass into breast milk inhighly variable concentrations, resulting in total lamotriginelevels in infants of up to approximately 50% of the mothers.The potential benefits of breast feeding should be weighedagainst the potential risk of adverse effects occurring in theinfant.Lamotrigine is cleared primarily by metabolism in the liver.Lamotrigine (Lametec tablets) should be administered withcaution in patients with hepatic impairment as clearance isreduced.Medication errors involving Lamotrigine tablets (Lametec)have occurred. In particular the name Lamotrigine can beconfused with names of other commonly used medications.Medication errors may also occur between the differentformulations of Lamotrigine (Lametec tablets) . The Swiss Pharmacy, Geneva Switzerland 17. Lamotrigine TabletsOverdose SymptomsAcute ingestion of doses in excess of 10 to 30 timesthe maximum therapeutic dose of Lamotrigine, havebeen reported. Overdoses involving quantities up to15 g have been reported for lamotrigine, some ofwhich have been fatal.Overdose has resulted in symptoms includingnystagmus, ataxia, blurred vision, coma, dizziness,headache, impaired consciousness, increasedseizures, nystagmus, somnolence and vomiting.QRS broadening (intraventricular conduction delay)has also been observed in overdose patients. The Swiss Pharmacy, Geneva Switzerland 18. Lamotrigine TabletsOverdose TreatmentNo specific antidotes are available to treatoverdosage of Lamotrigine (Lametectablets).In the event of overdosage, the patientshould be admitted to hospital and givenappropriate supportive therapy.Measures should be taken to protect theairways, as consciousness may beimpaired. The Swiss Pharmacy, Geneva Switzerland 19. Lamotrigine TabletsLametec Tablets 25 mg, 50 mgand 100 mg manufactured byCipla Ltd., IndiaFor more information click here The Swiss Pharmacy, Geneva Switzerland