Introduction

vet00501

Company name: CEVA Animal Health Ltd

Address: 90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

Telephone: 01494 781510

Fax: 01494 781519

Email: cevauk@ceva.com

Website: www.ceva.uk.com

Presentation

A pale yellow suspension containing 1.5 mg/ml meloxicam as active ingredient and 2 mg/ml of sodium benzoate as a preservative. For oral application to food.

Uses

Meloxidyl® is a non-steroidal anti-inflammatory drug (NSAID) for use in the alleviation of inflammation and pain in acute and chronic musculo-skeletal disorders in dogs.

Dosage and administration

To be administered orally via mixing with food. Shake well before use. Initial treatment is a single dose of 0.2 mg meloxicam/kg bodyweight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg bodyweight.

Particular care should be taken with regard to the accuracy of dosing. The suspension can be given using the measuring syringes provided in the package. The syringe fits onto the bottle and has a kg-body weight scale, which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg bodyweight). Thus, for the first day, twice the maintenance volume will be required.

The suspension could be administered using the smallest syringe for dogs less than 7 kg bodyweight (one graduation corresponding to 0.5 kg of bodyweight) or the largest syringe for dogs over 7 kg body weight (one graduation corresponding to 2.5 kg of bodyweight).

A clinical response is normally seen within 3 – 4 days. Treatment should be discontinued after 10 days if no clinical improvement is apparent.

Avoid the introduction of contaminants during use.

Contra-indications, warnings, etc

Do not use in pregnant or lactating animals.

Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of individual hypersensitivity to the product. Do not use in dogs less than 6 weeks of age.

Special precautions for use in animals

If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity. In the case of overdose, symptomatic treatment should be initiated.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.

Adverse reactions (frequency and seriousness)

Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported. These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment, but in very rare cases may be serious or fatal.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antimicrobials and substances with high protein binding may compete for binding and thus lead to toxic effects. The product must not be administered in conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.

For animal use only. Keep out of reach and sight of children.

Pharmaceutical precautions

After broaching the container, the contents should be used within 6 months. If any unused product remains after this time, it should be disposed of in accordance with national regulations.

Legal category

POM-V

Packaging Quantities

High density polyethylene bottle containing 10, 32 and 100 ml, with a polyethylene syringe insert and polypropylene measuring syringes.

Further information

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In-vitro and in-vivo studies have demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

Absorption

Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 7.5 hours. When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 litre/kg.

Metabolism

Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.