Loxicom
Authorised
This medicine is authorised for use in the European Union
meloxicam
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Loxicom is a medicine that contains the active substance meloxicam. It is available as oral suspensions (0.5 mg/ml and 1.5 mg/ml), as oral paste (50 mg/g), as chewable tablets (1 mg and 2.5 mg) and solutions for injection (5 mg/ml, and 20 mg/ml).
Loxicom is a ‘generic’ which means that Loxicom is similar to a ‘reference veterinary medicine’ already authorised in the EU (Metacam).
Loxicom oral suspensions are used to relieve inflammation and pain in cats and dogs. They can be used for chronic (long-term) musculoskeletal disorders, and in dogs it can also be used for acute (sudden and short-lived) musculoskeletal disorders, for instance, due to injury.
Loxicom oral paste (50 mg/g) is used to relieve inflammation and pain in both acute and chronic musculoskeletal disorders in horses.
Loxicom chewable tablets can be used in dogs to relieve inflammation and pain in chronic musculoskeletal disorders as well as in acute disorders.
Loxicom solution for injection (5 mg/ml) can be used to relieve inflammation and pain in dogs following surgery involving the bones or soft tissue and in cats following ovariohysterectomy (spaying) and minor soft-tissue surgery.
Loxicom solution for injection (20 mg/ml) is used in cattle, together with appropriate antibiotic therapy, to reduce clinical signs in acute respiratory infections (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder). It can be used in combination with oral rehydration therapy (medicines given by mouth to restore water levels in the body) for diarrhoea in calves of over one week of age and in young, non-lactating cattle.
Loxicom solution for injection (20 mg/ml) is used in pigs to reduce the symptoms of lameness and inflammation in noninfectious locomotor disorders (diseases that affect the ability to move) and for the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome), together with appropriate antibiotic therapy. Septicaemia and toxaemia are conditions where bacteria circulate in the blood and produce harmful substances.
Loxicom solution for injection (20 mg/ml) is used in horses to relieve colic (abdominal pain) and the inflammation and pain in acute and chronic musculoskeletal disorders.
Loxicom contains meloxicam, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins. As prostaglandins trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Since Loxicom is a generic medicine, studies have been conducted to determine that it is bioequivalent to the reference medicine, Metacam. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Based on the findings of the studies, Loxicom was considered to be bioequivalent to the reference medicinal product. Consequently, Loxicom’s benefit is taken as being the same as that of the reference medicinal product.
Side effects sometimes seen with other NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal (kidney) failure and apathy (lack of vitality) are occasionally seen with Loxicom in dogs and cats. These generally occur within the first week of treatment and usually disappear once treatment has stopped. In very rare cases they may be serious or fatal.
In horses given the oral paste, isolated cases of slight urticarial (itchy rash) and diarrhoea were observed in clinical trials which were reversible. Commonly, a reduction in the concentration of the blood protein albumin will occur during treatment.
A slight temporary swelling at the injection site following injection under the skin was observed in cattle. In horses, a temporary swelling at the injection site can occur but resolves without intervention.
In very rare cases, potentially serious or fatal anaphylactoid reactions (similar to severe allergic reactions) may occur following administration of the solution for injection and should be treated symptomatically.
Loxicom must not be used in animals with liver, heart or kidney problems, bleeding disorders, or suffering from irritation or ulcers of the gut. It must not be used in animals which are hypersensitive (allergic) to the active substance or to any of the other ingredients.
Loxicom must not be used in pregnant or lactating horses, cats and dogs, but it can be used during pregnancy and lactation for cattle and pigs.
Loxicom must not be used in dogs or horses less than six weeks of age or in cattle less than one week of age when used for the treatment of diarrhoea. It must not be used in cats weighing less than 2 kg.
The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption. It is also the time allowed after administration of the medicine before the milk can be used for human consumption.
Cattle
The withdrawal period is 15 days for meat and five days for milk.
Pigs
For meat, the withdrawal period is five days.
Horses
For the 20-mg/ml solution for injection, the meat withdrawal period is five days, and for the 50-mg/ml oral paste, it is three days. The medicine is not authorised for use in horses producing milk for human consumption.
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Loxicom. If someone swallows or accidentally injects themselves with the medicine, the advice of a doctor should be sought immediately.
The CVMP considered that, in accordance with EU requirements, Loxicom has been shown to be bioequivalent to Metacam. Therefore the CVMP’s view was that, as for Metacam, Loxicom’s benefits are greater than its risks when used for the approved indications. The Committee recommended that Loxicom be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.
The European Commission granted a marketing authorisation valid throughout the European Union for Loxicom on 10 February 2009. Information on the prescription status of this product may be found on the label of the carton.
Product information
Latest procedure affecting product information:
IB/0040
04/02/2022
Product details
- Name of medicine
- Loxicom
- Active substance
- meloxicam
- International non-proprietary name (INN) or common name
- meloxicam
- Species
- Dogs
- Cats
- Cattle
- Pigs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QM01AC06
Pharmacotherapeutic group
Anti-inflammatory and anti-rheumatic products, non-steroidsTherapeutic indication
Dogs
Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders. To reduce postoperative pain and inflammation following orthopaedic and soft-tissue surgery.
Cats
Alleviation of inflammation and pain in chronic musculoskeletal disorders in cats. To reduce postoperative pain after ovariohysterectomy and minor soft-tissue surgery.
Cattle
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
Pigs
For use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Horses
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders.
For the relief of pain associated with equine colic.
News on Loxicom
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