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Metacam 0.5 mg/ml Oral Suspension for Cats

Presentation

Each ml of Metacam Oral Suspension for Cats contains 0.5 mg meloxicam as active ingredient (equivalent to 0.017 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 cats.
For alleviation of inflammation and pain in chronic musculo-skeletal disorders.

Dosage and Administration

Initial treatment is a single oral dose of 0.1 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 0.05 mg meloxicam/ kg bodyweight.
Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not be exceeded.
Shake well before use. To be administered orally either mixed with food or directly into the mouth. The suspension can be given using the drop dispenser of the bottle for cats of any bodyweight. Alternatively and for cats with a bodyweight of at least 2 kg, the Metacam measuring syringe (provided in the package) can be used.
Dosing procedure using the drop dispenser of the bottle.
Initial dose : 6 drops/kg bodyweight.
Maintenance dose : 3 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. Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
A clinical response is usually seen within 7 days. Treatment should be discontinued after 14 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.
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 hypersensitivity to the active substance or to any of the excipients.
Do not use in cats 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 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.
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. Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon. Metacam 0.5 mg/ml Oral Suspension for Cats should not be used following parenteral injection of meloxican or any other NSAID as appropriate dosage regimens for such follow-up treatments hav not been established in cats.
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. The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels. In case of overdose, adverse reactions as listed above are expected to be more severe and more frequent. In the case of overdosage 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 insert 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 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 (previously POM)

Packaging Quantities

Polyethylene bottles containing 15 ml with a polyethylene dropper, a tamper-proof child resistant closure and a polypropylene measuring syringe. The 1 ml measuring syringe has a kg-bodyweight scale for cats (2 to 10 kg) and has a pictogram showing a cat.

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 demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately 3 hours. If the animal is fed at the time of dosing, the absorption may be slightly delayed. There is a linear relationship between the dose administered and plasma concentration observed in th therapeutic dose range. Approximately 97% of meloxicam is bound to plasma proteins.
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. Due to the loading dose, steady state is reached after 2 days (48 h).

Metacam 1.5 mg/ml Oral Suspension for Dogs

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, or where there is evidence of individual hypersensitivity to the product.
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 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.
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.
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 (previously POM)

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 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. 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.

Metacam 5 mg/ml Solution for Injection for Dogs and Cats

Presentation

Each ml of the solution for injection contains 5 mg meloxicam as active ingredient and 150 mg anhydrous ethanol as preservative.

Uses

Metacam is a non-steroidal anti-inflammatory drug (NSAID) for use in dogs and cats.
Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

Dosage and Administration

Dogs
Musculo-skeletal disorders
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).
Metacam 1.5 mg/ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Reduction of post-operative pain
(over a period of 24 hours):
Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.
Cats
Reduction of post-operative pain
Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.
Particular care should be taken with regard to the accuracy of dosing.
Avoid introduction of contamination 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 animals less than 6 weeks of age nor in cats of less than 2 kg.
Do not use an oral follow-up therapy using meloxicam or other NSAIDs in cats, as no safe dosage for repeated oral administration has been established.
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported. In dogs, 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.
If side effects occur, treatment should be discontinued.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
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. Concurrent administration of potential nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
In the case of overdosage symptomatic treatment should be initiated.
For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia.
Operator warnings
Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package insert or label to the physician.
Disposal Advice
Any unused product or waste materials derived from the product should be disposed of in accordance with local requirements.
For animal treatment only.
Keep out of reach of children.

Pharmaceutical Precautions

Shelf life of broached vial: 28 days
Do not use after the expiry date stated on the carton and on the bottle.
Do not store above 25°C.

Legal category

POM-V (previously POM)

Packaging Quantities

Colourless glass injection vials of 10ml or 20ml sealed with a rubber stopper and aluminium cap.

Further information

Pharmacodynamic properties
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 demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Pharmacokinetic properties
Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 μg/ml in dogs and 1.1 μg/ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs. More than 97 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.
Metabolism
In dogs, 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 in dogs and 15 hours in cats. Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.

Metacam 15mg/ml Oral Suspension for Horses

Presentation

Each ml of Metacam 15 mg/ml oral suspension contains Meloxicam 15 mg as active substance and Sodium benzoate 1.5 mg

Uses

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.

Dosage and Administration

To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days. Where the product is mixed with food, it should be added to a small quantity of food, prior to feeding.
The suspension should be given using the Metacam measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale.
Shake well before use.
Avoid introduction of contamination during use.

Contra-indications, warnings, etc

Do not use in pregnant or lactating mares.
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 horses less than 6 weeks of age.
Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible.
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.
Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. However, no data have been generated in horses. Therefore the use in this species is not recommended during pregnancy and lactation.
Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
In the case of overdosage symptomatic treatment should be initiated.
Withdrawal period
Meat and offal: 3 days.
Operator warnings
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 insert or the label to the physician.
Disposal Advice
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
For animal treatment only.
Keep out of reach and sight of children.

Pharmaceutical Precautions

Use within 6 months of first opening.
Do not use after the expiry date stated on the carton and on the bottle.

Legal category

POM-V (previously POM)

Packaging Quantities

Polyethylene bottle containing 100 ml with a polyethylene tip adapter, 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 also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.
Absorption
When the product is used according to the recommended dosage regime the oral bioavailability is approximately 98%. Maximal plasma concentrations are obtained after approximately 2 - 3 hours. The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.
Distribution
Approximately 98% of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg
Metabolism
The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively there are differences. The major metabolites found in all species were the 5-hydroxy- and 5-carboxy-metabolites and the oxalyl-metabolite. The metabolism in horses was not investigated. All major metabolites have been shown to be pharmacologically inactive.
Elimination
Meloxicam is eliminated with a terminal half-life of 7.7 hours.

Metacam 20 mg/ml Solution for Injection for Cattle, Pigs and Horses

Presentation

Each ml of the solution for injection contains 20 mg meloxicam and 150 mg ethanol (as preservative).

Uses

Metacam 20 mg/ml solution is a non-steroidal anti-inflammatory drug (NSAID) for use in cattle, pigs and horses.
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 non-infectious 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 musculo-skeletal disorders.
For the relief of pain associated with equine colic

Dosage and Administration

Cattle: Single subcutaneous or intravenous injection at a dose rate of 0.5mg meloxicam/kg bodyweight (i.e. 2.5 ml/100 kg bodyweight) in combination with antibiotic therapy or with oral rehydration therapy as appropriate.
Pigs: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg bodyweight (i.e. 2.0ml/100kg bodyweight) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours.
Horses: Single intravenous injection at a dosage of 0.6 meloxicam/kg bodyweight (i.e. 3.0ml/100kg bodyweight). Metacam 15mg/ml oral suspension may be used for the continuation of treatment at a dosage of 0.6 mg meloxicam/kg bodyweight, 24 hours after administration of the injection.

Contra-indications, warnings, etc

Do not use in horses less than 6 weeks of age.
Do not use in pregnant or lactating mares.
Do not use in horses producing milk for human consumption.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastro-intestinal lesions or individual hypersensitivity to the product.
For the treatment of diarrhoea, do not use in animals less than one week of age.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of increased renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention,
Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
In horses, anaphylactoid reactions can occur and should be treated symptomatically. A transient swelling at the injection site can occur but resolves without intervention.
In case of overdosage, symptomatic treatment should be initiated.
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought
Operator warnings
Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package insert or label to the physician.
Disposal Advice
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
For animal treatment only.
Keep out of reach of children.
Withdrawal Period
Cattle:
Meat and offal – 15 days.
Milk – 5 days.
Pigs:
Meat and offal – 5 days.
Horses:
Meat and offal - 5 days.

Pharmaceutical Precautions

Shelf life of broached vial: 28 days
Do not use after the expiry date stated on the carton and on the bottle.
Avoid introduction of contamination during use.

Legal category

POM-V (previously POM)

Packaging Quantities

Colourless glass injection vials of 50 ml, sealed with a rubber stopper and aluminium cap.

Further information

Pharmacodynamic properties
Meloxicam is a non-steroidal anti inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic properties. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.
Pharmacokinetic properties
Absorption
After a single subcutaneous dose of 0.5mg meloxicam/kg, Cmax values of 2.1μg/ml and 2.7μg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively. After two intramuscular doses of 0.4mg meloxicam/kg, a Cmax value of 1.9 μg/ml was reached after 1 hour in pigs.
Distribution
More than 98% of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.
Metabolism
Meloxicam is predominately found in plasma. In cattle, meloxicam is also a major excretion product in milk and bile where as urine contains only traces of the parent compound. In pigs, bile and urine contain 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. The metabolism in the horse has not been investigated.
Elimination
Meloxicam is eliminated with a half life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively. In pigs, after intramuscular injection, the mean plasma elimination half life is approximately 2.5 hours. In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours. Approximately 50% of the administered dose is eliminated via urine and the remainder via faeces.

Metacam Chewable Tablets for Dogs

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:

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.
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 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.
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.
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 insert 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 (previously POM)

Packaging Quantities

Metacam chewable tablets are supplied in:
Child resistant blisters with 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 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. 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.