Apo-Lamotrigine

Apo-Lamotrigine Adverse Reactions

lamotrigine

Manufacturer:

Apotex

Distributor:

Pharmaforte
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 Apo-Lamotrigine.
The following convention has been utilised for the classification of undesirable effects: Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000).
Epilepsy: Skin and Subcutaneous Tissue Disorders: During Monotherapy Clinical Trials: Very Common: Skin rash.
During Other Clinical Experience: Very Common: Skin rash. Rare: Stevens-Johnson syndrome. Very Rare: Toxic epidermal necrolysis.
In double-blind, add-on clinical trials, skin rashes occurred in up to 10% of patients taking Apo-Lamotrigine and in 5% of patients taking placebo. The skin rashes led to the withdrawal of Apo-Lamotrigine treatment in 2% of patients. The rash, usually maculopapular in appearance, generally appears within 8 weeks of starting treatment and resolves on withdrawal of Apo-Lamotrigine (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 Apo-Lamotrigine and exceeding the recommended dose escalation of Apo-Lamotrigine therapy (see Dosage & Administration); 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* as follows).
Blood and Lymphatic System Disorders: Very Rare: Haematological abnormalities including neutropenia, leucopenia, anaemia, thrombocytopenia, pancytopenia, aplastic anaemia, agranulocytosis, haemophagocytic lymphohistiocytosis.
Haematological abnormalities may or may not be associated with the hypersensitivity syndrome (see Immune System Disorders* as follows).
Immune System Disorders: Very Rare: Hypersensitivity syndrome* [including such symptoms as fever, lymphadenopathy, facial oedema, abnormalities of the blood and liver, disseminated intravascular coagulation (DIC), multi-organ 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 DIC and multi-organ 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 Apo-Lamotrigine discontinued if an alternative aetiology cannot be established.
Psychiatric Disorders: Common: Irritability. Uncommon: Aggression. Very Rare: Tics, hallucinations, confusion.
Nervous System Disorders: During Monotherapy Clinical Trials: Very Common: Headache. Common: Drowsiness, insomnia, dizziness, tremor. Uncommon: Ataxia.
During Other Clinical Experience: Very Common: Headache, dizziness. Common: Nystagmus, tremor, ataxia, drowsiness, insomnia. Very Rare: Agitation, unsteadiness, movement disorders, worsening of Parkinson's disease, extrapyramidal effects, choreoathetosis, increase in seizure frequency.
There have been reports that Apo-Lamotrigine 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: Very Common: Diplopia, blurred vision. Rare: Conjunctivitis.
Gastrointestinal Disorders: During Monotherapy Clinical Trials: Common: Nausea.
During Other Clinical Experience: Common: Gastrointestinal disturbance (including vomiting and 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 following undesirable effects should be considered alongside those seen in epilepsy for an overall safety profile of Apo-Lamotrigine.
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 Apo-Lamotrigine are considered, skin rashes occurred in 14% of patients on Apo-Lamotrigine. Whereas, in controlled clinical trials with bipolar disorder patients, skin rashes occurred in 9% of patients taking Apo-Lamotrigine and in 8% of patients taking placebo.
Nervous System Disorders: During Bipolar Disorder Clinical Trials: Very Common: Headache. Common: Agitation, somnolence, dizziness. Frequency not known: Aseptic meningitis.
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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