Metacam 1 mg for dogs 1 chewable tablet
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs / Meloxicam
Metacam 1 mg chewable tablets for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF Metacam
One chewable tablet contains:
Meloxicam 1 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM OF Metacam
Round mottled beige biconvex tablet, scored on the upper side with embedded code either "M10" or "M25" on one side.
The tablet can be divided into equal halves.
4.CLINICAL PARTICULARS OF Metacam
4.1. Target species
4.2. Indications for use, specifying the target species
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal 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 body weight.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
4.4. Special warnings
4.5. Special precautions for use
Special precautions for use in animals
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have 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.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
common (more than 1 but less than 10 animals in 100 animals)
uncommon (more than 1 but less than 10 animals in 1,000 animals)
rare (more than 1 but less than 10 animals in 10,000 animals)
very rare (less than 1 animal in 10,000 animals, including isolated reports).
4.7. Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).
4.8. Interaction with other medicinal products and other forms of interaction
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 veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
4.9. Amounts to be administered and administration route
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 for dogs and cats.
Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.
Each chewable tablet 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 dog. 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 (kg): Number of chewable tablets (1 mg); mg/kg
4.0–7.0: ½; 0.13–0.1
7.1–10.0: 1; 0.14–0.1 1
0.1–15.0: 1½; 0.15–0.1
15.1–20.0: 2; 0.13–0.1
Body weight (kg): Number of chewable tablets (2.5 mg); mg/kg
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 for dogs is recommended.
A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days if no clinical improvement is apparent.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose symptomatic treatment should be initiated.
4.11 Withdrawal period
5. PHARMACOLOGICAL PROPERTIES OF Metacam
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams). ATCvet code: QM01AC06.
5.1. 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).
5.2. Pharmacokinetic particulars
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 in faeces and the remainder in urine.
6. PHARMACEUTICAL PARTICULARS OF Metacam
6.1. List of excipients
Sodium citrate dihydrate
Iron oxide brown
Iron oxide yellow
Meat Dry Flavour
Silica, colloidal anhydrous
6.3. Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
6.4. Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.