Lamotrigine Tablets (Generic Lamictal) - Product information and Uses

Lamotrigine, which is marketed as Lamictal by GlaxoSmithKline, is an anticonvulsant drug that is used in the treatment of epilepsy and bipolar disorder. Lamotrigine is also used as an adjunct in treating depression, though this is considered off-label usage.
In the treatment of epilepsy, it is used to treat partial seizures, primary and secondary tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Similar to the properties of many other anticonvulsant medicines, Lamotrigine also seems to act as an effective mood stabilizer, and along with lithium is the only medication approved by U.S. Food and Drug Administration (FDA) for this purpose.It is approved for the maintenance treatment of bipolar disorder type I in patients 18 years of age and above.
Lamotrigine is approved by the US FDA for the treatment of partial seizures. Lamotrigine is one among a small number of FDA-approved therapies for seizures associated with Lennox-Gastaut syndrome (LGS), a severe form of epilepsy. Lamotrigine significantly reduces the frequency of LGS seizures, and is one of two medications known to decrease the severity of drop attacks. Combination of Lamotrigine Tablets with valproate is common, but this increases the risk of lamotrigine-induced rash, and necessitates reduced dosing due to the interaction of these drugs.
Lamotrigine is approved in the US for maintenance treatment of Bipolar I disorder. Lamotrigine tablets have proven to be most effective for preventing the recurrent depressive episodes of bipolar disorder.
Off-label uses of Lamotrigine include the treatment of peripheral neuropathy, trigeminal neuralgia, cluster headaches, migraines, and reducing neuropathic pain. Off-label psychiatric usage includes the treatment of depersonalization disorder, bipolar II disorder and other bipolar disorders, schizoaffective disorder, borderline personality disorder and post-traumatic stress disorder.

Lamotrigine Tablets - Availability And Packaging

Lamotrigine Tablets is available as Generic Lamictal which is packaged in 25 mg, 50 mg and 100 mg tablets

Side Effects of Lamotrigine Tablets

A black box warning about life-threatening skin reactions, including Stevens-Johnson syndrome, DRESS syndrome and toxic epidermal necrolysis are included in the Lamotrigine prescribing information. As per the manufacturer 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.
The possible Side effects of Lamotrigine (Generic Lamictal) include loss of balance or coordination, double vision, crossed eyes, blurred vision, dizziness and lack of coordination, drowsiness, insomnia, anxiety, vivid dreams or nightmares, dry mouth, mouth ulcers, memory and cognitive problems, mood changes, runny nose, cough, nausea, indigestion, abdominal pain, weight loss, missed or painful menstrual periods, and vaginitis. The side effect profile varies as per different patient populations.
Side effects such as rash, fever, and fatigue are very serious, as they may indicate incipient Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome or aseptic meningitis. In rare cases, lamotrigine has been known to cause the dangerous drug eruptions DRESS syndrome, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The rash is more common in children, so this medication is often reserved for adults. There is also an increased incidence of these eruptions in patients who are currently on, or recently discontinued a valproate-type anticonvulsant drug.

Lamotrigine Tablets During Pregnancy and Breastfeeding

Use of Lamotrigine Tablets during pregnancy and breastfeeding is recommended only if benefits outweigh potential risks. Lamotrigine is rated Pregnancy Category Risk C.
The US FDA has issued a warning stating that taking lamotrigine during the first trimester of pregnancy may increase the risk for cleft lip and palate malformation in newborns. Since Lamotrigine is found in breast milk, the manufacturer does not recommend breastfeeding during treatment.

Lamotrigine Tablets (Generic Lamictal) - Dosage

The dosage for Lamotrigine must be titrated carefully based on the specific condition of the patient. The dosages mentioned below are just an example and may not be appropriate for all cases. Please consult your doctor for exact dosing instructions.
The normal adult starting dose of Lamotrigine Tablets (Generic Lamictal) is 25 mg a day week 1-2, which may be increased 50 mg a day a week 2-3, 100 mg week 5 and 200 mg week 6. If the patient also takes valproate the dosage should be halved; if Generic Lamictal is taken with carbamazepine the dosage needs to be doubled since they both interfere with lamotrigine's metabolism.
The normal adult maintenance dose for bipolar depression is 200 mg, but some patients may require up to 600 mg a day. Some patients who cannot tolerate 200 mg have to take a lower dose. Too high starting doses and fast dose increase increases the risk of developing serious rashes and in worst case Stevens-Johnson syndrome. Pediatric patients have a higher risk of developing rashes and bad skin reactions.

Overdosage and Overdose Symptoms of Generic Lamictal

Overdoses that have involved up to 15 grams have been reported for Lamictal, some of which have been fatal. Lamictal Overdose has resulted in ataxia, nystagmus, increased seizures, decreased level of consciousness, coma, and intraventricular conduction delay.
There being no specific antidotes for Lamictal overdose, hospitalization of the patient is advised. it is recommended that frequent monitoring of vital signs and close observation of the patient be done. If required emesis should be induced or gastric lavage should be performed. The usual precautions should be taken to protect the airway.

Additional Information

Additional Info: Prescribing Information