Chemical formula: C₁₅H₂₃NO Molecular mass: 233.355 g/mol
Reproductive studies in animal have shown no evidence of teratogenic effect. No experience is available in human beings.
Meptazinol should not be used during pregnancy, unless considered essential by the physician.
Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate.
If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.
Meptazinol may be secreted in breast milk and may cause respiratory depression in the infant.
Meptazinol should not be used during breast-feeding.
Since dizziness and occasionally drowsiness have been reported, patients should be cautioned against driving or operating machinery until it is established that they do not become dizzy or drowsy whilst taking meptazinol.
| System Organ Class | Very Common (≥1/10) | Uncommon (≥1/1,000 to ≤1/100) | Unknown (frequency cannot be estimated from the available data) |
|---|---|---|---|
| Psychiatric disorders | Drug dependence (see section 4.4) | ||
| Nervous system disorders | dizziness, headache, vertigo, somnolence, drowsiness | ||
| Vascular disorders | hypotension | ||
| Respiratory, thoracic and mediastinal disorders | respiratory depression | ||
| Gastrointestinal disorders | abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting | ||
| Skin and subcutaneous tissue disorders | increased sweating, rash | ||
| General disorders and administration site conditions | drug withdrawal syndrome |
For very rare reports of psychiatric disorders (hallucination, confusion, depression), causal relationship with meptazinol has not been established and therefore omitted from the above table.
Reactions not already stated which are attributable to opioid analgesics include difficulty with micturition, ureteric or biliary spasm, dry mouth, facial flushing, bradycardia, tachycardia, palpitations, hypothermia, dysphoria, mood changes, miosis, decreased libido or potency, urticaria and pruritus.
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