Lametec (Lamotrigine Tablets)

Lamotrigine Tablets

Clearsky Pharmacy

Lametec (Lamotrigine Tablets) is an antiepileptic drug (AED) used for adjunctive therapy for Epilepsy in patients 2 years of age and above, Epilepsy monotherapy in patients 16 years of age and above and Bipolar Disorder in patients 18 years of age and above.

Lametec Tablets

Clearsky Pharmacy

Lametec Tablets are manufactured by Cipla Ltd., India. (Website: www.cipla.com)

Levothyroxine Sodium Tablets Brand Names

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Lamotrigine tablets are available as Lamictal, Lametec, Lametec-DT , Lametec, Lamosyn, Favlam, Lamorig, Lamitor-DT, Lamitor-OD and Lamidus.

Active Ingredient

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The active ingredient contained in Lametec tablets is Lamotrigine. Each Lametec tablet contains 25 mg, 50 mg or 100 mg of Lamotrigine.

Chemical Structure

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The structure of Lamotrigine is given below:

Uses of Lametec Tablets

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Lametec (Lamotrigine Tablets) are used for conversion to monotherapy in adults (16 years of age or older) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone or valproate as the single AED.

Lametec Tablets are used as adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures, generalized seizures of the Lennox-Gastaut syndrome in patients above 2 years of age.

Uses of Lametec Tablets

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Lametec Tablets are used for the maintenance treatment of bipolar 1 disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (18 years of age or older) treated for acute mood episodes with standard therapy.

Lamotrigine Dosage

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Dosage for Treatment of Epilepsy Add-On Therapy In Adults (over 12 years of age): In patients taking valproate with/without any other anti-epileptic drug (AED), the initial Generic Lamotrigine Tablets (Lametec) dose 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 a maximum of 25-50 mg every 1 to 2 weeks until the optimal response is achieved. The usual maintenance dose to achieve optimal response is 100-200 mg/day given once a day or in two divided doses.

The Oral dosage of Lametec tablets (Lamotrigine) for adults is given below:

Lamotrigine Dosage

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In those patients taking enzyme inducing AEDs or other medications that induce lamotrigine glucuronidation with/without other AEDs (except valproate), the initial Generic Lamotrigine Tablets (Lametec) dose is 50 mg once a day for two weeks, followed by 100 mg/day given in two divided doses for two weeks.

Thereafter, the dose should be increased by a maximum of 100 mg every 1-2 weeks until the optimal response is achieved.

The usual maintenance dose to achieve optimal response is 200- 400 mg/day given in two divided doses. Some patients have required 700 mg/day of Lamotrigine to achieve the desired response.

The adult dosage of Lametec (Lamotrigine Tablets) is given below:

Lametec Dosage

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Dosage for Bipolar Disorder Adults (18 years of age and over): Because of the risk of rash, the initial dose and subsequent dose escalation should not be exceeded. Lamotrigine is recommended for use in bipolar patients at risk for a future depressive episode.

The recommended initial adult dosage of Lametec DT is 25 mg once daily for 2 weeks, followed by 50 mg once daily for 2 weeks.

For Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate

Weeks 1 and 2: 25 mg daily

Weeks 3 and 4: 50 mg daily

Week 5: 100 mg daily

Week 6 and 7: 200 mg daily

The adult dosage of Lametec (Lamotrigine Tablets) is given below:

Storage Instructions

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Lametec (Lamotrigine Tablets) have to be stored at controlled room temperature i.e. from 20C to 25C (68F to 77F) with excursions permitted between 15 to 30C (59 to 86F). Protect from moisture and light.Keep this as well as all other medicines away from children and pets.

Warnings

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Life threatening serious rash and/or rash-related death may result.

Fatal or life-threatening hypersensitivity reaction: Multiorgan hypersensitivity reactions, also known as drug reaction with Eosinophilia and systemic symptoms, 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. Generic Lamictal Tablets should be discontinued if alternate cause for this reaction is not found.

Warnings

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Blood dyscrasias (e.g., neutropenia, thrombocytopenia, pancytopenia May occur, either with or without an associated hypersensitivity syndrome.Suicidal behavior and ideation.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. Aseptic meningitis reported in pediatric and adult patients.

Lametec Tablets

Clearsky Pharmacy

Contraindications

Lametec is contraindicated in patients with a hypersensitivity to Lamotrigine or any other component of this medication.

Lamotrigine Side Effects

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The common side effects with an incidence rate of 10% or more reported in patients treated with Lametec (Lamotrigine Tablets) in adult epilepsy clinical studies were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, and rash.

Additional adverse reactions (incidence rate 10% or more) reported in children in epilepsy clinical studies included vomiting, infection, fever, accidental injury, pharyngitis, abdominal pain, and tremor.

Most common adverse effects with an incidence rate of 5% or more in adult bipolar clinical studies were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia.

Lamotrigine Overdose

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Overdoses that have involved up to 15 grams have been reported for Lamotrigine Tablets, some of which have been fatal. Lamotrigine Overdose has resulted in ataxia, nystagmus, increased seizures, decreased level of consciousness, coma, and intraventricular conduction delay.

Lamotrigine Overdose

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There being no specific antidotes for Lamotrigine overdose, hospitalization of the patient is advised. It is recommended that frequent monitoring of vital signs and close observation of the patient be done. If required emesis should be induced or gastric lavage must be performed. The usual precautions should be taken to protect the airway.

Lamotrigine During Pregnancy

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Lametec (Lamotrigine Tablets) has been classified by the US FDA as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. In animal studies, Lamotrigine was found to be developmentally toxic at doses lower than those administered clinically. Lamotrigine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lametec Tablets

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Clearsky Pharmacy

Lametec (Lamotrigine Tablets) by Cipla Limited, India .