Mezacar

Mezacar Adverse Reactions

carbamazepine

Manufacturer:

Kusum

Distributor:

JDS
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: Particularly at the start of treatment with Carbamazepine, or if the initial dosage is too high, or when treating elderly patients, certain types of adverse reaction occur very commonly or commonly, e.g. CNS adverse reactions (dizziness, headache, ataxia, drowsiness, fatigue, diplopia); gastrointestinal disturbances (nausea, vomiting), as well as allergic skin reactions.
The dose-related adverse reactions usually abate within a few days, either spontaneously or after a transient dosage reduction. The occurrence of CNS adverse reactions may be a manifestation of relative overdosage or significant fluctuation in plasma levels. In such cases it is advisable to monitor the plasma levels and divide the daily dosage into smaller (i.e. 3-4) fractional doses.
Summary of adverse drug reactions compiled from clinical trials and from spontaneous reports: Adverse drug reactions from clinical trials are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Blood and lymphatic system disorders: Very common: Leucopenia.
Common: Thrombocytopenia, eosinophilia.
Rare: Leucocytosis, lymphadenopathy.
Very rare: Agranulocytosis, aplastic anaemia, pancytopenia, aplasia pure red cell, anaemia, anaemia megaloblastic, reticulocytosis, haemolytic anaemia.
Not known: Bone marrow depression.
Immune system disorders: Rare: A delayed multi-organ hypersensitivity disorder with fever, rashes, vasculitis, lymphadenopathy, pseudo lymphoma, arthralgia, leucopenia, eosinophilia, hepato-splenomegaly, abnormal liver function tests and vanishing bile duct syndrome (destruction and disappearance of the intrahepatic bile ducts) occurring in various combinations. Other organs may also be affected (e.g. liver, lungs, kidneys, pancreas, myocardium, colon).
Very rare: Anaphylactic reaction, oedema angioedema, hypogammaglobulinaemia.
Not known**: Drug Rash with Eosinophilia and Systemic Symptoms (DRESS).
Infections and infestations: Not known**: Reactivation of Human herpes virus 6 infection.
Endocrine disorders: Common: Oedema, fluid retention, weight increase, hyponatraemia and blood osmolarity decreased due to an antidiuretic hormone (ADH)-like effect, leading in rare cases to water intoxication accompanied by lethargy, vomiting, headache, confusional state, neurological disorders.
Very rare: Galactorrhoea, gynaecomastia.
Metabolism and nutrition disorders: Rare: Folate deficiency, decreased appetite.
Very rare: Porphyria acute (acute intermittent porphyria and variegate porphyria), porphyria non-acute (porphyria cutanea tarda).
Psychiatric disorders: Rare: Hallucinations (visual or auditory), depression, aggression, agitation, restlessness, confusional state.
Very rare: Activation of psychosis.
Nervous system disorders: Very common: Ataxia, dizziness, somnolence.
Common: Diplopia, headache.
Uncommon: Abnormal involuntary movements (e.g. tremor, asterixis, dystonia, tics), nystagmus.
Rare: Dyskinesia, eye movement disorder, speech disorders (e.g. dysarthria or slurred speech), choreoathetosis, neuropathy peripheral, paraesthesia, and paresis.
Very rare: Neuroleptic malignant syndrome, aseptic meningitis with myoclonus and peripheral eosinophilia, dysgeusia.
Not known**: Sedation, memory impairment.
Eye disorders: Common: Accommodation disorders (e.g. blurred vision).
Very rare: Lenticular opacities, conjunctivitis.
Ear and Labyrinth disorders: Very rare: Hearing disorders, e.g. tinnitus, hyperacusis, hypoacusis, change in pitch perception.
Cardiac disorders: Rare: Cardiac conduction disorders.
Very rare: Arrhythmia, atrioventricular block with syncope, bradycardia, cardiac failure congestive, coronary artery disease aggravated.
Vascular disorders: Rare: Hypertension or hypotension.
Very rare: Circulatory collapse, embolism (e.g. pulmonary embolism), thrombophlebitis.
Respiratory, thoracic and mediastinal disorders: Very rare: Pulmonary hypersensitivity characterized e.g. by fever, dyspnea, pneumonitis or pneumonia.
Gastrointestinal disorders: Very common: Vomiting, nausea.
Common: Dry mouth, with suppositories rectal irritation may occur.
Uncommon: Diarrhea, constipation.
Rare: Abdominal pain.
Very rare: Pancreatitis, glossitis, stomatitis.
Not known: Colitis.
Hepatobiliary disorders: Rare: Hepatitis of cholestatic, parenchymal (hepatocellular) or mixed type, vanishing bile duct syndrome, jaundice.
Very rare: Hepatic failure, granulomatous liver disease.
Skin and subcutaneous tissue disorders: Very common: Urticaria, which may be severe dermatitis allergic.
Uncommon: Dermatitis exfoliative.
Rare: Systemic lupus erythematosus, pruritus.
Very rare: Stevens-Johnson syndrome*, toxic epidermal necrolysis, photosensitivity reaction, erythema multiforme, erythema nodosum, pigmentation disorder, purpura, acne, hyperhidrosis, alopecia, hirsutism.
Not known**: Acute Generalized Exanthematous Pustulosis (AGEP)**, lichenoid keratosis, onychomadesis.
Musculoskeletal and connective tissue disorders: Rare: Muscular weakness.
Very rare: Bone metabolism disorders (decrease in plasma calcium and blood 25-hydroxy-cholecalciferol) leading to osteomalacia/osteoporosis, arthralgia, myalgia, muscle spasms.
Not known**: Fracture.
Renal and urinary disorders: Very rare: Tubulointerstitial nephritis, renal failure, renal impairment (e.g. albuminuria, haematuria, oliguria and blood urea/ azotaemia), urinary retention, urinary frequency.
Reproductive System: Very rare: Sexual disturbances/erectile dysfunction spermatogenesis abnormal (with decreased sperm count and/or motility).
General disorders and administration site conditions: Very common: Fatigue.
Investigations: Very common: Gamma-glutamyltransferase increased (due to hepatic enzyme induction), usually not clinically relevant.
Common: Blood alkaline phosphatase increased.
Uncommon: Transaminases increased.
Rare: Systemic lupus erythematosus, pruritus.
Very rare: Intraocular pressure increased, blood cholesterol increased, high density lipoprotein increased, blood triglycerides increased. Thyroid function test abnormal: decreased L-Thyroxin (free thyroxine, thyroxine, tri-iodothyronine) and increased blood thyroid stimulating hormone, usually without clinical manifestations, blood prolactin increased.
Not known**: Bone density decreased.
Injury, poisoning and procedural complication: Not known: Fall (associated with Mezacar treatment induced ataxia, dizziness, somnolence, hypotension, confusional state, sedation) (see Precautions).
* In some Asian countries also reported as rare.
**Additional adverse drug reactions from spontaneous reports (frequency not known): There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with carbamazepine. The mechanism by which carbamazepine affects bone metabolism has not been identified.
There is increasing evidence regarding the association of genetic markers and the occurrence of cutaneous ADRs such as SJS, TEN, DRESS, AGEP and maculopapular rash. In Japanese and European patients, these reactions have been reported to be associated with the use of carbamazepine and the presence of the HLA-A* 3101 allele. Another marker, HLA-B*1502 has been shown to be strongly associated with SJS and TEN among individuals of Han Chinese, Thai and some other Asian ancestry.
Adverse Drug Reaction: Inform doctors about unexpected reactions after using drugs.
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