Introduction

vet00301

Company name: Boehringer Ingelheim Limited

Address: Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

Telephone: Sales & Marketing Enquiries 01344 746959

Telephone: Technical Enquiries 01344 746957

Fax: 01344 741349

Presentation

Each ml of Metacam Oral Suspension for Dogs contains 1.5 mg meloxicam as active ingredient (equivalent to 0.05 mg per drop) and 1.5 mg sodium benzoate (equivalent to 0.05 mg per drop).

Uses

Metacam is a non-steroidal anti-inflammatory drug (NSAID) for use in dogs.

For alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.

Dosage and administration

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.

For longer term treatment, once clinical response has been observed (after > 4 days), the dose of Metacam can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing.

Shake well before use. To be administered orally either mixed with food or directly into the mouth. The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the Metacam measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle.

Initial dose : 4 drops/kg bodyweight.

Maintenance dose : 2 drops/kg bodyweight.

Dosing procedure using the measuring syringe.

The syringe fits onto the drop dispenser of the bottle and has a kg-bodyweight scale which corresponds to the maintenance dose (ie. 0.1 mg meloxicam/kg bodyweight). Thus for the first day of treatment, twice the maintenance volume will be required.

Alternatively, treatment may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is usually seen within 3-4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.

Avoid the introduction of contamination during use

Contra-indications, warnings, etc

Do not use in pregnant or lactating animals, as the safety of the product has not been established in these categories of animals.

Do not use in animals suffering from gastro-intestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. Do not use in case of hypersensitivy to the active substance or to any of the excipients.

Do not use in dogs less than 6 weeks of age.

Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood , apathy and renal failure have occasionally been reported. These adverse reactions 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.

If adverse reactions 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 renal toxicity. This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Metacam 0.5 mg/ml Oral Suspension for Cats should be used.

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Metacam 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.

In case of overdose, symptomatic treatment should be initiated.

User precautions

Individuals sensitive to NSAIDs should avoid contact with the product. In case of accidental self-administration, seek medical advice immediately and show the package insert or label to the Doctor.

Any unused product or waste materials should be disposed or in accordance with national requirements for pharmaceutical products.

For animal treatment only.

Keep out of reach of children.

Pharmaceutical precautions

After first opening the bottle, use contents within 6 months and then discard any remaining unused product.

Legal category

POM-V

Packaging Quantities

Polyethylene bottles containing 10 ml, 32 ml or 100 ml with a polyethylene dropper, a tamper-proof child resistant closure and a polypropylene measuring syringe.

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.

Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 4.5 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. 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 l/kg.

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. 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.