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Lamictal
Clinical Pharmacology
Lamictal
| Pediatric Study Population | Number of Subjects |
Tmax (h) |
t½ (h) |
Cl/F (mL/min/kg) |
| Ages 10 months-5.3 years | ||||
| Patients taking carbamazepine, phenytoin, phenobarbital, or primidone* |
10 | 3.0 (1.0-5.9) |
7.7 (5.7-11.4) |
3.62 (2.44-5.28) |
| Patients taking antiepileptic drugs (AEDs) with no known effect on the apparent clearance of lamotrigine | 7 | 5.2 (2.9-6.1) |
19.0 (12.9-27.1) |
1.2 (0.75-2.42) |
| Patients taking valproate only | 8 | 2.9 (1.0-6.0) |
44.9 (29.5-52.5) |
0.47 (0.23-0.77) |
| Ages 5-11 years | ||||
| Patients taking carbamazepine, phenytoin, phenobarbital, or primidone* |
7 | 1.6 (1.0-3.0) |
7.0 (3.8-9.8) |
2.54 (1.35-5.58) |
| Patients taking carbamazepine, phenytoin, phenobarbital, or primidone* plus valproate |
8 | 3.3 (1.0-6.4) |
19.1 (7.0-31.2) |
0.89 (0.39-1.93) |
| Patients taking valproate only† | 3 | 4.5 (3.0-6.0) |
65.8 (50.7-73.7) |
0.24 (0.21-0.26) |
| Ages 13-18 years | ||||
| Patients taking carbamazepine, phenytoin, phenobarbital, or primidone* |
11 | ‡ | ‡ | 1.3 |
| Patients taking carbamazepine, phenytoin, phenobarbital, or primidone* plus valproate |
8 | ‡ | ‡ | 0.5 |
| Patients taking valproate only | 4 | ‡ | ‡ | 0.3 |
| * Carbamazepine, phenobarbital, phenytoin,
and primidone have been shown to increase the apparent clearance of lamotrigine.
Estrogen-containing oral contraceptives and rifampin have also been shown
to increase the apparent clearance of lamotrigine (see CLINICAL
PHARMACOLOGY: Drug Interactions and PRECAUTIONS:
DRUG INTERACTIONS). † Two subjects were included in the calculation for mean Tmax. ‡ Parameter not estimated. |
||||
Elderly
The pharmacokinetics of lamotrigine following a single 150-mg dose of LAMICTAL were evaluated in 12 elderly volunteers between the ages of 65 and 76 years (mean creatinine clearance = 61 mL/min, range = 33 to 108 mL/min). The mean half-life of lamotrigine in these subjects was 31.2 hours (range, 24.5 to 43.4 hours), and the mean clearance was 0.40 mL/min/kg (range, 0.26 to 0.48 mL/min/kg).
Gender
The clearance of lamotrigine is not affected by gender. However, during dose escalation of LAMICTAL in one clinical trial in patients with epilepsy on a stable dose of valproate (n = 77), mean trough lamotrigine concentrations, unadjusted for weight, were 24% to 45% higher (0.3 to 1.7 mcg/mL) in females than in males.
Race
Generic Name: Lamotrigine
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