Lamotrigine Chewable Dispersible
Generic Name: lamotrigine chewable dispersible
Brand Names:
Lamotrigine
11. DESCRIPTION Lamotrigine tablets for oral suspension USP (chewable dispersible tablets), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as -triazine, its molecular formula is C 9 H 7 N 5 Cl 2 , and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pK a of 5.7.
Overview
11. DESCRIPTION Lamotrigine tablets for oral suspension USP (chewable dispersible tablets), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as -triazine, its molecular formula is C 9 H 7 N 5 Cl 2 , and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pK a of 5.7.
Uses
1. INDICATIONS AND USAGE Lamotrigine tablet for oral suspension USP (chewable dispersible tablet) is indicated for: Epilepsy - adjunctive therapy in patients aged 2 years and older: · partial-onset seizures. · primary generalized tonic-clonic seizures. · generalized seizures of Lennox-Gastaut syndrome. (1.1) Epilepsy - monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, phenytoin, primidone, or valproate as the single AED. (1.1) Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.
Dosage
2. DOSAGE AND ADMINISTRATION · Dosing is based on concomitant medications, indication, and patient age. (2.1, 2.2, 2.3, 2.4) · To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations should not be exceeded. (2.1) · Do not restart lamotrigine in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks. (2.1, 5.1) · Adjustments to maintenance doses will be necessary in most patients starting or stopping estrogen-containing oral contraceptives. (2.1, 5.7) · Discontinuation: Taper over a period of at least 2 weeks (approximately 50% dose reduction per week). (2.1, 5.8) Epilepsy: · Adjunctive therapy - See Table 1 for patients older than 12 years and Tables 2 and 3 for patients aged 2 to 12 years.
Side Effects
6. ADVERSE REACTIONS The following adverse reactions are described in more detail in the Warnings and Precautions section of the label: Serious skin rashes [see Warnings and Precautions (5.1)] Multiorgan hypersensitivity reactions and organ failure [see Warnings and Precautions (5.2)] Blood dyscrasias [see Warnings and Precautions (5.3)] Suicidal behavior and ideation [see Warnings and Precautions (5.4)] Aseptic meningitis [see Warnings and Precautions (5.5)] Withdrawal seizures [see Warnings and Precautions (5.8)] Status epilepticus [see Warnings and Precautions (5.9)] Sudden unexplained death in epilepsy [see Warnings and Precautions (5.10)] Epilepsy: Most common adverse reactions (incidence ≥10%) in adults were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, r...
Interactions
7. DRUG INTERACTIONS Significant drug interactions with lamotrigine are summarized in this section. Additional details of these drug interaction studies are provided in the Clinical Pharmacology section [see Clinical Pharmacology (12.3)] . Table 13. Established and Other Potentially Significant Drug Interactions Concomitant Drug Effect on Concentration of Lamotrigine or Concomitant Drug Clinical Comment Estrogen-containing oral contraceptivepreparation containing 30 mcg ethinylestradiol and 150 mcg levonorgestrel ↓ lamotrigine ↓ levonorgestrel Decreased lamotrigine levels approximately 50%. Decrease in levonorgestrel component by 19%.
Warnings
WARNING: SERIOUS SKIN RASHES Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving lamotrigine. 5. WARNINGS AND PRECAUTIONS Phenylketonurics: Phenylalanine is a component of aspartame. Each lamotrigine tablets for oral suspension USP (chewable dispersible tablets) 5 mg and 25 mg contains 1.4 mg and 0.98 mg of phenylalanine, respectively. •Life-threatening serious rash and/or rash-related death: Discontinue at the first sign of rash, unless the rash is clearly not drug related. (Boxed Warning, 5.1) •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. 4. CONTRAINDICATIONS Lamotrigine is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning, Warnings and Precautions (5.1), (5.2) ] . Hypersensitivity to the drug or its ingredients. (Boxed Warning, 4)
Pregnancy
8.1. Pregnancy As with other AEDs, physiological changes during pregnancy may affect lamotrigine concentrations and/or therapeutic effect. There have been reports of decreased lamotrigine concentrations during pregnancy and restoration of pre-partum concentrations after delivery. Dosage adjustments may be necessary to maintain clinical response. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In animal studies, lamotrigine was developmentally toxic at doses lower than those administered clinically.
Storage
16. HOW SUPPLIED/STORAGE AND HANDLING Lamotrigine tablets for oral suspension USP (chewable dispersible tablets), 5 mg White to off white, caplet-shaped tablets debossed with ‘L217’ on one side and plain on other side.
Frequently Asked Questions
What is Lamotrigine Chewable Dispersible used for?▼
1. INDICATIONS AND USAGE Lamotrigine tablet for oral suspension USP (chewable dispersible tablet) is indicated for: Epilepsy - adjunctive therapy in patients aged 2 years and older: · partial-onset seizures. · primary generalized tonic-clonic seizures. · generalized seizures of Lennox-Gastaut syndrome. (1.1) Epilepsy - monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, phenytoin, primidone, or valproate as the single AED. (1.1) Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.
What are the side effects of Lamotrigine Chewable Dispersible?▼
6. ADVERSE REACTIONS The following adverse reactions are described in more detail in the Warnings and Precautions section of the label: Serious skin rashes [see Warnings and Precautions (5.1)] Multiorgan hypersensitivity reactions and organ failure [see Warnings and Precautions (5.2)] Blood dyscrasias [see Warnings and Precautions (5.3)] Suicidal behavior and ideation [see Warnings and Precautions (5.4)] Aseptic meningitis [see Warnings and Precautions (5.5)] Withdrawal seizures [see Warnings and Precautions (5.8)] Status epilepticus [see Warnings and Precautions (5.9)] Sudden unexplained death in epilepsy [see Warnings and Precautions (5.10)] Epilepsy: Most common adverse reactions (incidence ≥10%) in adults were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, r...
Can I take Lamotrigine Chewable Dispersible during pregnancy?▼
8.1. Pregnancy As with other AEDs, physiological changes during pregnancy may affect lamotrigine concentrations and/or therapeutic effect. There have been reports of decreased lamotrigine concentrations during pregnancy and restoration of pre-partum concentrations after delivery. Dosage adjustments may be necessary to maintain clinical response. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In animal studies, lamotrigine was developmentally toxic at doses lower than those administered clinically.
What are the important warnings for Lamotrigine Chewable Dispersible?▼
WARNING: SERIOUS SKIN RASHES Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving lamotrigine. 5. WARNINGS AND PRECAUTIONS Phenylketonurics: Phenylalanine is a component of aspartame. Each lamotrigine tablets for oral suspension USP (chewable dispersible tablets) 5 mg and 25 mg contains 1.4 mg and 0.98 mg of phenylalanine, respectively. •Life-threatening serious rash and/or rash-related death: Discontinue at the first sign of rash, unless the rash is clearly not drug related. (Boxed Warning, 5.1) •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. 4. CONTRAINDICATIONS Lamotrigine is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning, Warnings and Precautions (5.1), (5.2) ] . Hypersensitivity to the drug or its ingredients. (Boxed Warning, 4)
Related Medications
Mentha Oil (arvensis)
mentha oil (arvensis)
Dosage form: OIL. Active ingredients: MENTHA ARVENSIS LEAF OIL (25 kg/25kg). Category: DRUG FOR FURTHER PROCESSING.
Chlorphentermine Hydrochloride
chlorphentermine hydrochloride
Manufactured by PARKE DAVIS. Dosage form: TABLET. Route: ORAL. Active ingredients: CHLORPHENTERMINE HYDROCHLORIDE (EQ 65MG BASE). Application: NDA014696.
Eucalyptol, Menthol, Methyol Salicylate, Thymol
eucalyptol, menthol, methyol salicylate, thymol
Purpose Antigingivitis, Antiplaque
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.