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Lamictal

Clinical Pharmacology
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Clinical Pharmacology

Pediatric Study Population Number
of
Subjects
Tmax
(h)

(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
Brand Name: Lamictal
Generic Name: Lamotrigine
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