Larogen (Lamotrigine): A Guide to Use, Dosage, and Rash Warnings

MEDICAL INFORMATION: This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

Larogen® (Lamotrigine)

Summary

Larogen is an antiepileptic medication containing the active ingredient Lamotrigine. It is primarily used to treat various types of seizures in adults and children, including partial seizures and those associated with Lennox-Gastaut syndrome. It works by stabilizing electrical activity in the brain. Larogen is also used in the treatment of Bipolar I Disorder. This medication carries a significant warning regarding the risk of serious, life-threatening skin rashes, and it is crucial that dosage instructions are followed precisely to minimize this risk.

Manufacturer

Delta Pharma, Egypt.

Category & Active Ingredient

• Category: Antiepileptic, Phenyltriazine derivative.
• Active Ingredient: Lamotrigine.

Available Forms & Strengths in Egypt

Larogen is available as oral tablets in the following strengths:

• Larogen 25 mg Tablets
• Larogen 100 mg Tablets

Properties and Mechanism of Action

Lamotrigine is believed to work by inhibiting voltage-sensitive sodium channels in the brain's neurons. This action stabilizes the neuronal membranes and reduces the release of excitatory neurotransmitters, particularly glutamate, which is involved in initiating seizures. By calming this excessive electrical activity, Lamotrigine helps to prevent seizures from occurring.

Indications for Larogen®

Larogen is indicated for several conditions:

• Epilepsy (Add-on Therapy): Used in combination with other antiepileptic drugs for partial seizures and primary generalized tonic-clonic seizures in adults and children (typically aged 2 and older).
• Epilepsy (Monotherapy): Used for converting adult patients with partial seizures from a single enzyme-inducing antiepileptic drug (EIAD) to Lamotrigine alone.
• Lennox-Gastaut Syndrome: Used as add-on therapy for the seizures associated with this severe form of epilepsy.
• Bipolar I Disorder: Used for the maintenance treatment to delay the time to occurrence of mood episodes (depression, mania, hypomania) in adults.

Dosage and Administration

Dosage of Larogen is highly complex and must be followed exactly as prescribed by a physician. The dose depends on the patient's age and, most importantly, on the other antiepileptic drugs they are taking (especially valproate). Incorrect dosing, particularly starting too high or increasing the dose too quickly, significantly increases the risk of serious rash.

• Add-on with Valproate: Requires a much lower starting dose and slower titration (e.g., 25 mg every other day for adults).
• Add-on with EIADs (e.g., Carbamazepine, Phenytoin): Requires a higher starting dose (e.g., 50 mg/day for adults).
• Children (2-12 years): Dosing is calculated based on body weight (mg/kg) and is also dependent on concomitant medications.

Side Effects

Common side effects of Larogen include:

• Neurological: Dizziness, headache, drowsiness, insomnia, coordination problems (ataxia), double vision (diplopia), blurred vision.
• Gastrointestinal: Nausea, vomiting.
• Other: Tiredness, rash.

Contraindications

Larogen is contraindicated in patients with a known hypersensitivity to Lamotrigine or any of the tablet's other ingredients.

BLACK BOX WARNING: SERIOUS SKIN RASHES

Larogen can cause severe, life-threatening skin rashes, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The risk is highest in the first 2-8 weeks of treatment and is significantly increased by:

• Rapid dose escalation (increasing the dose too quickly).
• Exceeding the recommended initial dose.
• Taking it concurrently with valproate (e.g., Depakine®), which increases lamotrigine levels.

Discontinue Larogen and contact your doctor immediately at the first sign of any rash, unless it is clearly not drug-related.

Other Precautions & Warnings

• Aseptic Meningitis: Larogen can cause a non-infectious inflammation of the membrane surrounding the brain and spinal cord. Symptoms include headache, fever, stiff neck, nausea, vomiting, and sensitivity to light. Seek immediate medical attention if these occur.
• Suicidal Thoughts and Behavior: Like other antiepileptic drugs, Larogen may increase the risk of suicidal thoughts or behavior. Patients and caregivers should be alert for any changes in mood or behavior.
• Discontinuation: Do not stop taking Larogen abruptly, as this can provoke rebound seizures. The dose should be tapered off gradually over at least 2 weeks under a doctor's supervision.

Frequently Asked Questions (FAQ)

What is the most important thing to know about Larogen?
The most critical information is the risk of serious skin rash. You must follow your doctor's dosing schedule precisely and never increase the dose on your own. Report any rash to your doctor immediately.

Why is the dose different if I'm taking valproate (Depakine®)?
Valproate significantly slows down the elimination of lamotrigine from the body, effectively doubling its concentration. Therefore, a much lower dose of Larogen is required to avoid dangerously high levels and reduce the risk of rash.

Can Larogen be used for conditions other than epilepsy?
Yes, it is widely used as a mood stabilizer for the maintenance treatment of Bipolar I Disorder in adults to help prevent episodes of depression and mania.

References

1. U.S. Food and Drug Administration (FDA): For prescribing information and black box warnings for Lamotrigine. FDA Lamotrigine Label
2. National Institute for Health and Care Excellence (NICE): For UK-based guidelines on epilepsy and bipolar disorder treatment. NICE Website
3. Product Information: Key information is also sourced from the internal leaflet provided by Delta Pharma for the Larogen® brand.