Target species
Dogs and cats.
Indications for use for each target species
Dogs
∙ For the treatment and prevention of nausea induced by chemotherapy.
∙ For the prevention of vomiting except that induced by motion sickness.
∙ For the treatment of vomiting, in combination with other supportive measures.
∙ For the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the μ-opiate receptor agonist morphine.
Cats
∙ For the prevention of vomiting and the reduction of nausea, except that induced by motion sickness.
∙ For the treatment of vomiting, in combination with other supportive measures.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed.
Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting.
The use of this veterinary medicinal product against vomiting due to motion sickness is not recommended.
Dogs
Although maropitant has been demonstrated to be effective in both the treatment and prevention of emesis induced by chemotherapy, it was found more efficacious if used preventively. Therefore, it is recommended to administer the veterinary medicinal product prior to administration of the chemotherapeutic agent.
Cats
The efficacy of maropitant in the reduction of nausea was demonstrated in studies using a model (xylazine-induced nausea).
Special precautions for use
Special precautions for safe use in the target species:
The safety of maropitant has not been established in dogs less than 8 weeks of age, or in cats less than 16 weeks of age, and in pregnant or lactating dogs and cats. Use only according to the benefit-risk assessment by the responsible veterinarian.
Maropitant is metabolised in the liver and therefore should be used with caution in patients with hepatic disease. As maropitant is accumulated in the body during a 14-day treatment period due to metabolic saturation, careful monitoring of liver function and any adverse events should be implemented during long term treatment.
The veterinary medicinal product should be used with caution in animals suffering from or with predisposition for cardiac diseases as maropitant has affinity to Ca- and K-ion channels. Increases of approximately 10% in the QT interval of the ECG were observed in a study on healthy beagle dogs administered 8 mg/kg orally; however, such an increase is unlikely to be of clinical significance.
Due to the frequent occurrence of transient pain during subcutaneous injection, appropriate animal restraining measures may have to be applied. Injecting the product at refrigerated temperature may reduce pain at injection.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product may cause nausea, dizziness, drowsiness, and respiratory distress in case of accidental self-injection.
Care should be taken to avoid accidental self-injection. In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
This product may cause skin sensitisation. People with known hypersensitivity to maropitant or benzyl alcohol should administer this product with caution. If you develop symptoms such as a rash after accidental exposure, seek medical advice and show the physician this warning.
This product may be an irritant to the skin and eyes.
Take care to avoid skin and eye contact. In case of accidental skin contact, wash the exposed area immediately with large amounts of water.
In case of accidental contact of the product with eyes, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dogs and cats:
Very common (>1 animal / 10 animals treated): | Injection site pain1,2 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylactic-type reaction (e.g. allergic oedema, urticaria, erythema, collapse NOS, dyspnoea, pale mucous membranes) Lethargy Neurological disorder (e.g. ataxia, convulsion, seizure, muscle tremor) |
1When injected subcutaneously.
2A moderate to severe response can be observed in approximately one third of cats.
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 the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Use only according to the benefit-risk assessment by the responsible veterinarian
Interaction with other medicinal products and other forms of interaction
This veterinary medicinal product should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.
Maropitant is highly bound to plasma proteins and may compete with other highly bound medicines
Administration routes and dosage
For subcutaneous or intravenous use in dogs and cats.
The veterinary medicinal product should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg/kg bodyweight (1 ml/10 kg bodyweight) for up to 5 consecutive days. Intravenous administration of the veterinary medicinal product should be given as a single bolus without mixing the product with any other fluids.
To ensure a correct dosage, body weight should be determined as accurately as possible.
To prevent vomiting, the veterinary medicinal product should be administered more than 1 hour in advance. The effect duration is approximately 24 h and therefore treatment can be given the night before administration of an agent that may cause emesis e.g. chemotherapy.
As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily repeated administration, lower doses than recommended might be sufficient in some individuals and when repeating the dose.
For administration by subcutaneous injection, see also “Special precautions for use”.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Apart from transient reactions at the injection site following subcutaneous administration, maropitant was well tolerated in dogs and young cats injected daily with up to 5 mg/kg (5 times the recommended dose) for 15 consecutive days (3-times the recommended duration of administration). No data have been presented on overdoses in adult cats.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable