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Lamictal

Clinical Pharmacology
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Clinical Pharmacology

Lamictal

The pharmacokinetics of lamotrigine have been studied in patients with epilepsy, healthy young and elderly volunteers, and volunteers with chronic renal failure. Lamotrigine pharmacokinetic parameters for adult and pediatric patients and healthy normal volunteers are summarized in Tables 1 and 2.

Table 1. Mean* Pharmacokinetic Parameters in Healthy Volunteers and Adult Patients
With Epilepsy

Adult Study Population Number of
Subjects		 Tmax: Time of
Maximum
Plasma
Concentration
(h)		 t½:
Elimination
Half-life
(h)		 Cl/F:
Apparent
Plasma
Clearance
(mL/min/kg)
Healthy volunteers taking no other medications:
Single-dose LAMICTAL 179 2.2
(0.25-12.0)		 32.8
(14.0-103.0)		 0.44
(0.12-1.10)
Multiple-dose LAMICTAL 36 1.7
(0.5-4.0)		 25.4
(11.6-61.6)		 0.58
(0.24-1.15)
Healthy volunteers taking valproate:
Single-dose LAMICTAL 6 1.8
(1.0-4.0)		 48.3
(31.5-88.6)		 0.30
(0.14-0.42)
Multiple-dose LAMICTAL 18 1.9
(0.5-3.5)		 70.3
(41.9-113.5)		 0.18
(0.12-0.33)
Patients with epilepsy taking valproate only:
Single-dose LAMICTAL
Patients with epilepsy taking
carbamazepine, phenytoin,
phenobarbital, or primidone†
plus valproate:		 4 4.8
(1.8-8.4)		 58.8
(30.5-88.8)		 0.28
(0.16-0.40)
Single-dose LAMICTAL
Patients with epilepsy taking
carbamazepine, phenytoin,
phenobarbital, or primidone† :		 25 3.8
(1.0-10.0)		 27.2
(11.2-51.6)		 0.53
(0.27-1.04)
Single-dose LAMICTAL 24 2.3
(0.5-5.0)		 14.4
(6.4-30.4)		 1.10
(0.51-2.22)
Multiple-dose LAMICTAL 17 2.0
(0.75-5.93)		 12.6
(7.5-23.1)		 1.21
(0.66-1.82)
* The majority of parameter means determined in each study had coefficients of variation between 20% and 40% for half-life and Cl/F and between 30% and 70% for Tmax. The overall mean values were calculated from individual study means that were weighted based on the number of volunteers/patients in each study. The numbers in parentheses below each parameter mean represent the range of individual volunteer/patient values across studies.
† 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).
Absorption
Brand Name: Lamictal
Generic Name: Lamotrigine
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