Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2018 Publisher: sanofi-aventis new zealand limited, Level 8, James and Wells Tower, 56 Cawley Street, Ellerslie, Auckland, Telephone: (09) 580 1810
Avomine should not be used in patients who are in a coma or suffering from CNS depression of any cause. It must not be given to patients hypersensitive to promethazine, phenothiazines or to any of the excipients listed in section 6.1. Avomine should be avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days.
Use in children: Avomine should not be used in children less than ten years of age.
Avomine may cause mild and temporary confusion or disorientation in certain individuals.
Avomine may thicken or dry lung secretions and impair expectoration, it should therefore be used with caution in patients with asthma, bronchitis or bronchiectesis. Use with care in patients with severe coronary artery disease, narrow angle glaucoma or epilepsy. Caution should be exercised in patients with bladder neck or pyloro-duodenal obstruction. Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs; e.g. salicylates.
It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.
Avomine may interfere with immunologic urine pregnancy tests to produce false-positive or false-negative results. Avomine should be discontinued at least 72 hours before the start of skin tests using allergen extracts as it may inhibit the cutaneous histamine response thus producing false-negative results.
In nausea and vomiting of unknown origin, it is essential to establish the diagnosis before giving an antiemetic, to ensure that a serious underlying condition is not masked.
There have been case reports of drug abuse with promethazine. The risk of abuse is greater in patients with a history of drug abuse,
As with neuroleptics, Neuroleptic Malignant Syndrome (NMS) characterised by hyperthermia, extrapyramidal disorders, muscle rigidity, altered mental status, autonomic nervous instability and elevated CPK, may occur. As this syndrome is potentially fatal, promethazine must be discontinued immediately and intensive clinical monitoring and symptomatic treatment should be initiated.
Due to the risk of photosensitivity, exposure to the sun or ultraviolet light should be avoided during or shortly after treatment.
Use with care in patients with hepatic insufficiency.
Use with care in patients with renal insufficiency.
See Section 4.8 Adverse Effects (Undesirable effects).
This product must not be used in children under 2 years of age, due to the potential for fatal respiratory depression (see Section 4.3). Excessive dosages of antihistamines in children may cause hallucinations, convulsions and sudden death. The use of Avomine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s Syndrome.
Avomine may interfere with immunologic urine pregnancy tests to produce false-positive or false-negative results.
Care is necessary with patients who take anticholinergic agents, tricyclic antidepressants, sedatives or hypnotics, as such agents are enhanced by Avomine.
Alcohol should be avoided during treatment. Combination with alcohol enhances the sedative effects of H1 antihistamines.
When given in high doses during late pregnancy, phenothiazines have caused prolonged extrapyramidal disturbances in the child. There is inadequate evidence of safety of the drug in human pregnancy, but it has been in wide use for many years without apparent ill consequence; animal studies having shown no hazard.
Promethazine should be used in pregnancy only if the potential benefits to the patient are weighed against the possible risk to the foetus.
Avomine is excreted in breastmilk. There are risks of neonatal irritability and excitement. Avomine is not recommended for use in breastfeeding.
No data available.
Avomine considerably affects the ability to drive a vehicle and operate machines.
Gastrointestinal disorders: Dry mouth, epigastric distress, loss of appetite, nausea, vomiting, diarrhoea, constipation.
Nervous system disorders: Sedation, restlessness, dizziness, lassitude, incoordination, fatigue.
Eye disorders: Blurred vision.
Cardiovascular: Tachycardia, bradycardia, faintness.
Skin and subcutaneous tissue disorders: Contact dermatitis (topical), urticaria, angioneurotic oedema.
Haematological: Leucopenia, agranulocytosis, aplastic anaemia, thrombocytopenic purpura.
Nervous system disorders: Tinnitus, euphoria, nervousness, insomnia, convulsive seizures, oculogyric crises, excitation, catatonic-like states, hysteria, tardive dyskinesia.
Respiratory: Marked irregular respiration.
Other: nightmares.
Skin and subcutaneous tissue disorders: Photosensitivity reaction
Hepatobiliary disorders: Jaundice
Renal and urinary disorders: Urinary retention
Nervous system disorders: Neuroleptic Malignant Syndrome, somnolence, headaches, ticlike movements of the head and face, extrapyramidal symptoms including muscle spasm, the elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine.
Immune system disorders: Allergic reactions, including urticaria, rash, pruritus, and anaphylactic reaction have been reported.
Metabolism and nutrition disorders: Anorexia
Blood and lymphatic system disorders: Blood dyscrasias including haemolytic anaemia, agranulocytosis.
Psychiatric disorders: Infants, newborns and premature are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation.
Cardiac disorders: Palpitations, arrhythmias.
Vascular disorders: Hypotension
General disorders and administration site conditions: Tiredness
Agranulocytosis. Care is needed in the intramuscular administration of promethazine to children. A severe neurological reaction resulting in coma is possible.
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions at https://nzphvc.otago.ac.nz/reporting/.
Not applicable.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
