Lametec Tablets (Lamotrigine Tablets or Generic Lamotrigine) – Product Information
Lametec Tablets is used as adjunctive therapy for partial seizures, primary generalized tonic-clonic seizures and generalized seizures of Lennox-Gastaut syndrome in patients of 2 years of age or more. Lamotrigine is indicated for conversion to monotherapy in adults (patients 16 years of age and older) with partial seizures who are receiving treatment with a single EIAED (e.g., carbamazepine, phenytoin, phenobarbital, etc.) or valproate. Each dispersible tablet of Lametec contains Lamotrigine 25 mg, 50 mg or 100 mg respectively.
We also stock Olanzapine tablets (Oleanz 2.5 mg, 5 mg, 7.5 mg & 10 mg tablets) which are used in the treatment of Bipolar Disorder, Depression and Schizophrenia.
Name of Drug
Lametec Tablets (Generic Lamotrigine) .
Manufacturer Of Lametec Tablets
Cipla Ltd.
Website:www.cipla.com
Active Pharmaceutical Ingredient in Lametec Tablets
The active pharmaceutical ingredient present in Lametec Tablets is Lamotrigine.
Uses of Lametec Tablets
Lametec Tablets (Lamotrigine Tablets) is used to treat the below mentioned indications.
Adjunctive Use: Lametec DT is used as adjunctive therapy for partial seizures in adults and paediatric patients (greater than 2 years of age). Lametec DT is also used as adjunctive therapy for the generalized seizures of Lennox-Gastaut syndrome in adult and paediatric patients (greater than 2 years of age).
Monotherapy Use: Lametec DT is indicated for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single EIAED (e.g., carbamazepine, phenytoin, phenobarbital, etc.) or valproate.
Lametec Tablets (Lamotrigine) – Dosage
Therapy with Lamotrigine (Lametec Tablets) should be started slowly to avoid the occurrence of rash and should be gradually decreased when it is to be discontinued to prevent rebound seizures. Lamotrigine tablets should be swallowed with water.
Monotherapy with Lametec in patients 16 years of age or older:
Lametec is to be titrated to the targeted dose of 50 mg/day while maintaining the dose of the EIAEDs at a fixed level. The EIAEDs are then gradually withdrawn over a period of 4 weeks.The recommended maintenance dose of Lametec DT as monotherapy is 500 mg/day given in two divided doses.
Bipolar Disorder:
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.
The recommended adult (over 12 years) dosage for Lamotrigine tablets (mg/day) is given below
Weeks 1 & 2 | Weeks 3 & 4 | Usual Maintenance Dose | |
With enzyme-inducing antiepileptic drugs(EIAEDs) & No Valproic acid (VPA) | 50mg/day (Once a day) | 100mg/day (Two divided doses) | 300mg to 500mg/day (Two divided doses). To achieve maintenence doses may be incresed by 100mg/day every 1-2 weeks |
EIAEDs & Valproic acid (VPA) | 25 mg every other day | 25mg (Once a day) | 100mg to 400mg/day (Two divided doses). To achieve maintenence doses may be incresed by 25 mg – 50mg/day every 1-2 weeks |
As there exists a risk of rash the initial dose and subsequent dose escalation should not be exceeded.
The recommended dose escalation for Lamotrigine Tablets (Lametec) for children aged 2-12 years (total daily dose in mg/kg body weight/day) on combined drug therapy is given below.
Weeks 1 & 2 | Weeks 3 & 4 | Usual Maintenance Dose | |
With AED regimen containing VPA | 0.15mg/kg/day (1 or 2 divided doses) | 0.3mg/kg/day (1 or 2 divided doses) | 1mg – 5mg/kg/day (Maximum 200mg/day in One or Two divided doses)To achieve maintenence doses may be incresed by 0.5 – 1mg/kg/day every 1-2 weeks |
Added to EIAEDs and wirhout VPA | 0.6mg/kg/day (2 divided doses) | 1.2mg/kg/day (2 divided doses) | 5mg – 15mg/kg/day (Maximum 400mg/day in One or Two divided doses)To achieve maintenence doses may be incresed by 2 – 3mg/kg/day every 1-2 weeks |
After initial 4 weeks of therapy, the daily dosage of Lametec DT may be doubled at weekly intervals until an effective maintenance dosage of 200 mg daily is reached. The daily dosages should not exceed 200 mg daily.
Drug Class and Mechanism
Lamotrigine (Lametec) is a member of the sodium channel blocking class of antiepileptic drugs.Studies have suggested that lamotrigine acts presynaptically on voltage-gated sodium channels to decrease glutamate release. Lamotrigine has been shown to act at voltage-sensitive sodium channels, stabilizing neural membranes and inhibiting the release of excitatory neural transmitters.
Missed Dose
Take the missed dose of Lametec Tablets as soon as you remember.
Storage Instructions for Lametec Tablets
Lametec Tablets should be kept at room temperature, 15-30°C (59-86°F) in a light-resistant, tight container. Keep Lamotrigine Tablets away from children.
Warnings and Precautions when using Lamotrigine Tablets (Lametec)
The Precautions when using Lamotrigine Tablets are given below
- 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 (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 Lametec should be discontinued if alternate etiology for this reaction is not found.
- 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.
Side Effects of Lametec Tablets
The most common side effects of Lametec Tablets with an incidence rate of 10% or more in adult epilepsy clinical studies were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, and rash. Additional adverse reactions (incidence rate of 10% or more) reported in children in epilepsy clinical studies included vomiting, infection, fever, accidental injury, pharyngitis, abdominal pain, and tremor. • Other common adverse effects of Lamotrigine (rate of 5% or more) in adult include bipolar clinical studies were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia.
Lamotrigine Tablets Contraindications
Lamotrigine (Lametec Tablets) is contraindicated in patients with hypersensitivity to lamotrigine or any inactive ingredient of Lametec Tablets. It is also contraindicated in patients with Hepatic impairment.
Lamotrigine Tablets (Lametec) Overdose
Overdoses of Lamotrigine Tablets involving quantities up to 15 g have been reported for Lametec, some of these have resulted in fatalities. Lamotrigine Overdose has resulted in ataxia, nystagmus, increased seizures, decreased level of consciousness, coma, and intraventricular conduction delay. There is no specific antidote for Lamotrigine Tablets and hospitalization is advised.
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