Lamictal

Lamictal Adverse Reactions

lamotrigine

Manufacturer:

GlaxoSmithKline Indonesia
Full Prescribing Info
Adverse Reactions
The undesirable effects have been divided into epilepsy and bipolar specific sections based on the data currently available. However, both sections should be consulted when considering the overall safety profile of Lamictal. Adverse reactions identified through post-marketing surveillance are included in the Epilepsy section.
The following convention has been utilised for the classification of undesirable effects: Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000), very rare (<1/10,000).
Epilepsy: Skin and Subcutaneous Tissue Disorders: Very Common: Skin rash. Rare: Stevens-Johnson syndrome. Very Rare: Toxic epidermal necrolysis.
In double-blind, add-on clinical trials in adults, skin rashes occurred in up to 10% of patients taking Lamictal and in 5% of patients taking placebo. The skin rashes led to the withdrawal of Lamictal treatment in 2% of patients. The rash, usually maculopapular in appearance, generally appears within 8 weeks of starting treatment and resolves on withdrawal of Lamictal (see Precautions).
Rarely, serious potentially life-threatening skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome) have been reported. Although the majority recover on drug withdrawal, some patients experience irreversible scarring and there have been rare cases of associated death (see Precautions).
The overall risk of rash appears to be strongly associated with high initial doses of Lamictal and exceeding the recommended dose escalation of Lamictal therapy; concomitant use of valproate (see Dosage & Administration).
Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms (see Immune system disorders**).
Blood and Lymphatic System Disorders: Very Rare: Haematological abnormalities (including, neutropenia, leucopenia, anaemia, thrombocytopenia, pancytopenia, aplastic anaemia, agranulocytosis), lymphadenopathy.
Haematological abnormalities may or may not be associated with the hypersensitivity syndrome (see Immune system disorders**).
Immune System Disorders: Very Rare: Hypersensitivity syndrome** [including symptoms eg, fever, lymphadenopathy, facial oedema, abnormalities of the blood and liver, disseminated intravascular coagulation (DIC), multiorgan failure].
**Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedema and abnormalities of the blood and liver. The syndrome shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation (DIC) and multiorgan failure. It is important to note that early manifestations of hypersensitivity (eg, fever, lymphadenopathy) may be present even though rash is not evident. If such signs and symptoms are present the patient should be evaluated immediately and Lamictal discontinued if an alternative aetiology cannot be established.
Psychiatric Disorders: Common: Aggression, irritability. Very Rare: Tics, hallucinations, confusion.
Nervous System Disorders: During Monotherapy Clinical Trials: Very Common: Headache. Common: Somnolence, insomnia, dizziness, tremor. Uncommon: Ataxia. Rare: Nystagmus.
During Other Clinical Experience: Very Common: Somnolence, ataxia, headache, dizziness. Common: Nystagmus, tremor, insomnia. Rare: Aseptic meningitis (see Precautions). Very Rare: Agitation, unsteadiness, movement disorders, worsening of Parkinson's disease, extrapyramidal effects, choreoathetosis, increasedseizure frequency.
There have been reports that Lamictal may worsen parkinsonian symptoms in patients with preexisting Parkinson's disease, and isolated reports of extrapyramidal effects and choreoathetosis in patients without this underlying condition.
Eye Disorders: During Monotherapy Clinical Trials: Uncommon: Diplopia, blurred vision.
During Other Clinical Experience: Very Common: Diplopia, blurred vision. Rare: Conjunctivitis.
Gastrointestinal Disorders: During Monotherapy Clinical Trials: Common: Nausea, vomiting, diarrhea. During Other Clinical Experience: Very Common: Nausea, vomiting. Common: Diarrhoea.
Hepatobiliary Disorders: Very Rare: Increased liver function tests, hepatic dysfunction, hepatic failure.
Hepatic dysfunction usually occurs in association with hypersensitivity reactions but isolated cases have been reported without overt signs of hypersensitivity.
Musculoskeletal and Connective Tissue Disorders: Very Rare: Lupus-like reactions.
General Disorders and Administration Site Conditions: Common: Tiredness.
Bipolar Disorder: The undesirable effects below should be considered alongside those seen in epilepsy for an overall safety profile of Lamictal.
Skin and Subcutaneous Tissue Disorders: During Bipolar Disorder Clinical Trials: Very Common: Skin rash. Rare: Stevens-Johnson syndrome.
When all bipolar disorder studies (controlled and uncontrolled) conducted with Lamictal are considered, skin rashes occurred in 12% of patients on Lamictal. Whereas, in controlled clinical trials with bipolar disorder patients, skin rashes occurred in 8% of patients taking Lamictal and in 6% of patients taking placebo.
Nervous System Disorders: During Bipolar Disorder Clinical Trials: Very Common: Headache. Common: Agitation, somnolence, dizziness.
Musculoskeletal and Connective Tissue Disorders: During Bipolar Disorder Clinical Trials: Common: Arthralgia.
General Disorders and Administration Site Conditions: During Bipolar Disorder Clinical Trials: Common: Pain, back pain.
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