Target species
Dogs and cats.
Indications for use, specifying the target species
Symptomatic treatment of vomiting and reduced gastro-intestinal motility associated with gastritis, pyloric spasm, chronic nephritis and digestive intolerance to some drugs.
Contraindications
Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
Do not use in cases of gastro-intestinal perforation or obstruction.
Do not use in the case of gastro-intestinal haemorrhage.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
The dosage must be adapted in animals with renal or hepatic insufficiency (due to an increase in the risk of side effects). Avoid administration to animals with epilepsy. The dosage should be carefully observed, especially in cats and small breed dogs.
Following prolonged vomiting, consideration should be given to fluid and electrolyte replacement therapy.
In case of vomiting after intake of the oral solution, maintain the usual interval between two administrations before administering the product again.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental ingestion, especially by children, seek medical advice immediately and show the package leaflet or the label to the physician.
In case of accidental exposure by spillage onto the skin or eyes, wash immediately with abundant water. If adverse effects appear, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after administration to the animal.
Special precautions for the protection of the environment:
Not applicable.
Other precautions
Not applicable
Adverse reactions (frequency and seriousness)
Dogs, cats:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Agitation1, Aggression1, Vocalisation1 Ataxia1, Abnormal movement NOS1, Tremor1, Prostration1 |
1 These observed extrapyramidal effects are transient and disappear when treatment is stopped.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the last section ‘Contact details’ of the package leaflet
Use during pregnancy, lactation or lay
Laboratory studies in laboratory animals have not produced any evidence of teratogenic or foetotoxic effects. However, studies on laboratory animals are limited and the safety of the active substance has not been evaluated in the target species. The use of the product during pregnancy and lactation must be made according to the benefit/risk assessment carried out by the veterinarian.
Interaction with other medicinal products and other forms of interaction
In cases of gastritis, avoid the co-administration of anticholinergic drugs (atropine) as they may counteract the effects of metoclopramide on gastrointestinal motility.
In cases of simultaneous diarrhoea, there is no contra-indication to the use of anticholinergic drugs.
Concurrent use of metoclopramide with neuroleptics derivated from phenothiazine (acepromazine) and butyrophenones increases the risk of extrapyramidal effects (see Adverse reactions).
Metoclopramide can potentiate the action of central nervous system depressants. If used concurrently, it is advised to use the lowest dosage of metoclopramide to avoid excessive sedation.
Amounts to be administered and administration route
Oral use. Administer the product directly into the mouth.
0.5 to 1 mg of metoclopramide hydrochloride per kg of body weight per day administered as either:
2.5 to 5.0 mg/10 kg (equivalent to 2.5 to 5 ml/10 kg), twice daily
or
1.7 to 3.3 mg/10 kg (equivalent to 1.7 to 3.3 ml/10 kg), three times daily.
Oral administrations can be repeated with interval of 6 hours.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Most of the clinical signs reported after an overdosage are well known extrapyramidal side effects (see Adverse reactions).
In the absence of a specific antidote, it is recommended to offer a calm environment to the animal until extrapyramidal side effects disappear.
Metoclopramide being rapidly metabolised and eliminated, side effects generally disappear quickly.
Withdrawal period
Not applicable.