Lamictal (Lamotrigine)

Lamictal Review

Lamictal is used in combination with other anti-seizure drugs in the treatment of some types of seizures. It also is used alone for treating partial seizures in patients of 16 years old and older when converting from the anti-epileptic drug valproate.

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Lamictal Drug Class and Mechanism

One proposed mechanism of action for lamotrigine involves an effect on sodium channels, although this remains to be established in humans. In vitro pharmacological studies suggest that lamotrigine inhibits voltage-sensitive sodium channels, thereby stabilizing neuronal membranes and consequently modulating presynaptic transmitter release of excitatory amino acids (for example glutamate and aspartate).

Lamictal Uses

The initial dose of lamictal in patients, not taking valproic acid (Depakote), is 50 mg once daily for two weeks, followed by 100 mg daily, given in two divided doses for two weeks. Thereafter, the usual maintenance dose is 300 to 500 mg daily, given in two divided doses. In patients taking valproic acid, the initial dose of lamictal is 25 mg every other day for two weeks, then 25 mg once daily for two weeks, slowly increasing the dose (by 25 to 50 mg per day) every one to two weeks) until a dose of 100 to 150 mg daily is reached. Standard doses of lamictal are given twice daily.

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Lamictal Side Effects

Lamotrigine prescribing information has a black box warning about life threatening skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. The manufacturer states that nearly all cases appear in the first 2 to 8 weeks of therapy and if medication is suddenly stopped then resumed at the normal dosage. Patients should seek medical attention for any unexpected skin rash as its presence is an indication of a possible serious or even deadly side effect of the drug. Not all rashes that occur while taking lamotrigine progress to Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis Cognitive side effects are common with doses over 50mg qid (quater in die - four times daily), as shown in the 2001-2003 Glaxo-sponsored Clinical Trials comparing quality of life between Topiramate and Lamotrigine in healthy volunteers (unpublished).[citation needed] Common side effects include headaches, dizziness and insomnia. Other side effects may include acne and skin irritation, vivid dreams or nightmares, night sweats, body aches and cramps, fatigue, memory and cognitive problems, irritability, weight changes, hair loss, changes in libido, frequent urination, nausea, and other side effects. In very rare cases, Lamotrigine has been known to cause the development of a dangerous rash called Stevens-Johnson syndrome (or SJS). The rash is more common in children, so this medication is often reserved for adults. There is also an increased incidence of this rash in patients who are currently on, or recently discontinued a valproate-type anticonvulsant drug, as these medications interact in such a way that the clearance of both is decreased and the effective dose of lamotrigine is increased. Muscle aches are another fairly common side effect, and there are occasional reports of dry mouth. In clinical trials women were more likely than men to have side effects. This is the opposite of most other anticonvulsants and antipsychotics. It has been suggested that genetic background makes a difference in dosages, with those of non-Caucasian background typically needing lower doses.[citation needed] Lamotrigine binds to melanin-containing tissues such as the iris of the eye. The long-term consequences of this are unknown. Use during pregnancy is recommended only if benefits outweigh potential risks. It was also reported on CNN in September 2006 that taking Lamictal during the first trimester of pregnancy can lead to a cleft palate in babies. Lamotrigine is found in breast milk; breastfeeding is not recommended during treatment.

Lamictal Pregnancy

Pregnancy Category C. No evidence of teratogenicity was found in mice, rats, or rabbits when lamotrigine was orally administered to pregnant animals during the period of organogenesis at doses up to 1.2, 0.5, and 1.1 times, respectively, on a mg/m? basis, the highest usual human maintenance dose (i.e., 500 mg/day). However, maternal toxicity and secondary fetal toxicity producing reduced fetal weight and/or delayed ossification were seen in mice and rats, but not in rabbits at these doses. Teratology studies were also conducted using bolus intravenous administration of the isethionate salt of lamotrigine in rats and rabbits. In rat dams administered an intravenous dose at 0.6 times the highest usual human maintenance dose, the incidence of intrauterine death without signs of teratogenicity was increased. A behavioral teratology study was conducted in rats dosed during the period of organogenesis. At day 21 postpartum, offspring of dams receiving 5 mg/kg per day or higher displayed a significantly longer latent period for open field exploration and a lower frequency of rearing. In a swimming maze test performed on days 39 to 44 postpartum, time to completion was increased in offspring of dams receiving 25 mg/kg per day. These doses represent 0.1 and 0.5 times the clinical dose on a mg/m? basis, respectively. Lamotrigine did not affect fertility, teratogenesis, or postnatal development when rats were dosed prior to and during mating, and throughout gestation and lactation at doses equivalent to 0.4 times the highest usual human maintenance dose on a mg/m? basis. When pregnant rats were orally dosed at 0.1, 0.14, or 0.3 times the highest human maintenance dose (on a mg/m? basis) during the latter part of gestation (days 15 to 20), maternal toxicity and fetal death were seen. In dams, food consumption and weight gain were reduced, and the gestation period was slightly prolonged (22.6 vs. 22.0 days in the control group). Stillborn pups were found in all 3 drug-treated groups with the highest number in the high-dose group. Postnatal death was also seen, but only in the 2 highest doses, and occurred between day 1 and 20. Some of these deaths appear to be drug-related and not secondary to the maternal toxicity. A no-observed-effect level (NOEL) could not be determined for this study.

Lamictal Overdose

Overdoses involving quantities up to 15 g have been reported for LAMICTAL, some of which have been fatal. Overdose has resulted in ataxia, nystagmus, increased seizures, decreased level of consciousness, coma, and intraventricular conduction delay.

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