GENESIS 1mg TAB (30s)

Description

Product Overview:

GENESIS 1 mg Tablet contains Lamotrigine, an anticonvulsant and mood-stabilizing medication commonly used in the management of epilepsy and bipolar disorder. Lamotrigine works by stabilizing electrical activity in the brain and modulating neurotransmitter release, which helps prevent seizures and stabilize mood in patients with bipolar disorder. It is often used as part of combination therapy and can be effective for both adults and children with certain types of epilepsy, including focal seizures and generalized seizures.

Therapeutic Class:

Anticonvulsant, Mood Stabilizer

Active Ingredient:

Lamotrigine 1 mg per tablet

Indications:

GENESIS 1 mg Tablet is primarily used for:

• Epilepsy: Treatment of partial (focal) seizures, generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome.
• Bipolar Disorder: Maintenance treatment for bipolar disorder to prevent depressive episodes and mood stabilization, especially in patients with bipolar I disorder.
• Adjunctive Therapy: As an adjunct to other antiepileptic drugs for the treatment of seizures.
• Treatment of seizures in children: In pediatric epilepsy as part of combination therapy.

Mechanism of Action:

Lamotrigine works by inhibiting the release of excitatory neurotransmitters, including glutamate, and by stabilizing neuronal membranes by blocking voltage-gated sodium channels. This helps reduce abnormal electrical activity in the brain that can lead to seizures or mood instability in bipolar disorder. It also works to prevent excessive neuronal firing during manic or depressive episodes in bipolar patients.

Dosage and Administration:

• Initial Dose:
  The usual starting dose for adults is 25 mg once daily for the first two weeks, gradually increasing based on clinical response.
• For Epilepsy:
  • The dosage will typically range from 100 mg to 400 mg per day, divided into two doses.
• For Bipolar Disorder:
  • Typically starts with 25 mg once daily, with gradual titration based on the response and tolerability. The usual dose ranges from 100 mg to 200 mg daily.
• For Children:
  • Dosage is adjusted based on age, weight, and the type of seizure disorder. A healthcare provider will determine the appropriate dose.
• Administration:
  Lamotrigine tablets should be taken orally with or without food. The tablets should be swallowed whole with a glass of water.
• Important Notes:
  It’s important to follow a strict titration schedule to minimize the risk of side effects, particularly skin rashes, which can be serious in some cases. Gradual dose escalation is recommended to help prevent this risk.

Contraindications:

• Hypersensitivity to Lamotrigine or any of the excipients in the formulation.
• History of a serious rash or Stevens-Johnson syndrome with prior use of lamotrigine.
• Pregnancy (use during pregnancy should only be considered if clearly needed and prescribed by a healthcare provider).

Warnings and Precautions:

• Skin Rash:
  A serious and potentially life-threatening skin rash can occur, particularly in children or during the first 8 weeks of therapy. If a rash develops, prompt medical evaluation is necessary. The risk is higher when starting with higher doses or when combined with valproic acid.
• Pregnancy and Lactation:
  Lamotrigine should be used during pregnancy only if the benefit outweighs the potential risk to the fetus. It is secreted in breast milk, and caution should be taken when used during breastfeeding.
• Suicidal Thoughts:
  As with other antiepileptic drugs, lamotrigine has been associated with an increased risk of suicidal thoughts and behavior. Patients should be monitored for signs of depression or suicidal tendencies.
• Drug Interactions:
  Lamotrigine can interact with other medications such as valproic acid (which can increase lamotrigine levels) and carbamazepine (which can decrease lamotrigine levels). Dosing adjustments may be necessary when used with other antiepileptic drugs.

Adverse Effects:

Common Side Effects:

• Headache
• Dizziness or lightheadedness
• Nausea or vomiting
• Insomnia
• Blurred vision
• Tremors

Serious Side Effects:

• Severe skin rash (including Stevens-Johnson syndrome)
• Blood dyscrasias (e.g., thrombocytopenia, leukopenia)
• Liver dysfunction
• Allergic reactions (e.g., angioedema, anaphylaxis)
• Suicidal thoughts and behavior

Drug Interactions:

• Valproic Acid: Increases lamotrigine levels, increasing the risk of side effects.
• Carbamazepine, Phenytoin: Decreases lamotrigine levels, reducing its effectiveness.
• Oral Contraceptives: May decrease lamotrigine levels due to enzyme induction.
• Other anticonvulsants or antidepressants: Caution is advised when using other drugs that affect neurotransmitter function.

Storage:

• Store at room temperature, below 30°C (86°F).
• Protect from moisture and light.
• Keep out of reach of children.