Introduction

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

Chewable tablets, which are honey flavoured, pale-yellow, single scored, oval chewable tablets containing either 1.0 mg or 2.5 mg meloxicam. The tablets have an embedded code MO1 ( 1.0 mg) and MO2 (2.5 mg) on one side of the tablet.

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 body weight on the first day, which can be given orally or alternatively using Metacam 5 mg/ml solution for injection. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam body weight. Each chewable contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively. Each chewable tablet can be halved for accurate dosing according to the individual body weight of the animal. Metacam chewable tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.

Dose scheme for the maintenance dose:

Body weight	Number of Chewable Tablets		mg/kg
	1 mg	2.5 mg
4.0 - 7.0	½		0.13 - 0.1
7.1 - 10.0	1		0.14 - 0.1
10.1 - 15.0	1½		0.15 - 0.1
15.1 - 20.0	2		0.13 - 0.1
20.1 - 25.0		1	0.12 - 0.1
25.1 - 35.0		1½	0.15 - 0.1
35.1 - 50.0		2	0.14 - 0.1

The use of Metacam Oral Suspension for dogs may be considered for an even more precise dosing. For dogs weighing less than 4 kg the use of Metacam Oral Suspension is recommended.

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.

Contra-indications, warnings, etc

Do not use in pregnant or lactating 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 dogs less than 6 weeks of age or less than 4 kg bodyweight.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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

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. Any oral follow-up therapy using meloxicam or other NSAIDs should not be administered in cats, as appropriate dosage regimens for such follow-up treatments have not been established.

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 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.

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

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 Doctor.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed or in accordance with local requirements.

For animal treatment only.

Keep out of reach and sight of children.

Pharmaceutical precautions

Store in the original package in order to protect from light.

1 mg chewable tablets : Do not store above 30°C

2.5 mg chewable tablets : Do not store above 25°C

Legal category

POM-V

Packaging Quantities

Metacam chewable tablets are supplied in:

Child resistant blisters with 10, 20, 100 or 500 tablets packed in cardboard boxes. Not all pack sizes may be marketed.

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.

Marketing authorisation number

Metacam 1 mg chewable tablets for dogs.

EU/2/97/004/024 - 10 tablets.

EU/2/97/004/017 - 20 tablets.

EU/2/97/004/018 - 100 tablets.

EU/2/97/004/019 - 500 tablets.

Metacam 2.5 mg chewable tablets for dogs.

EU/2/97/004/025 - 10 tablets.

EU/2/97/004/021 - 20 tablets.

EU/2/97/004/022 - 100 tablets.

EU/2/97/004/023 - 500 tablets.

Marketing authorisation holder

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

Germany