Apo-Meloxicam (Canada)This page contains information on Apo-Meloxicam for veterinary use.
The information provided typically includes the following:
- Apo-Meloxicam Indications
- Warnings and cautions for Apo-Meloxicam
- Direction and dosage information for Apo-Meloxicam
Apo-MeloxicamThis treatment applies to the following species:
Meloxicam Oral Suspension, 1.5 mg/mL
Veterinary Use Only
CompositionEach mL contains 1.5 mg meloxicam in a yellowish green suspension.
Presentation: Plastic squeeze dropper bottle containing either 10, 32, 100 or 180 mL. A measuring syringe is also provided in the pack.
APO-MELOXICAM is a nonsteroidal anti-inflammatory drug (NSAID) of the oxicam group for use in dogs. It acts by inhibition of prostaglandin synthesis and is indicated for the alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Dosage: APO-MELOXICAM Oral Suspension should be administered mixed with food. On the first day of treatment, a single dose of 0.2 mg meloxicam/kg body weight should be given. 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.
Instructions for use: Particular care should be given with regard to the accuracy of dosing. The suspension can be given using either the drop dispenser (for very small breeds) - which provides 0.05 mg meloxicam per drop - or the measuring syringe provided in the package (see below). The syringe fits on to the bottle and has a kg-body weight scale designed for the maintenance dose (i.e. 0.1 mg meloxicam/kg body weight). Thus twice the volume should be administered on the first day as the initial dose. Shake well before use. Please carefully follow the instructions of the veterinarian.
Dosing procedure using the measuring syringe:
1. Remove cap.
2. Place syringe onto bottle spout and press until fully sealed.
1. Turn the bottle upside down.
2. Grasp bottle and syringe firmly in one hand.
3. With other hand pull the plunger back to the approximate volume required.
4. Adjust dosage volume to the corresponding body weight.
Twist the bottle and the syringe in opposite directions and pull apart.
Empty the contents of the syringe over the feed.
Improvement is normally seen within 3-4 days. Treatment should be discontinued after 10 days at the latest if no improvement is apparent.
APO-MELOXICAM should not be administered if gastric or intestinal ulceration or bleeding is suspected; if there is evidence of cardiac, hepatic or renal disease; or if there is evidence of a haemorrhagic disorder or individual hypersensitivity to the product. Do not administer concurrently, other steroidal or nonsteroidal anti-inflammatory drugs (NSAIDs), aminoglycoside antibiotics or anticoagulant agents. Pretreatment with other steroidal or nonsteroidal anti-inflammatory drugs (NSAIDs) may result in additional or increased effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment depending on the pharmacokinetic properties of the products used previously.
Not approved for use in cats. APO-MELOXICAM should not be administered to breeding, pregnant or lactating dogs. Do not exceed the stated dose. In case of overdosing, symptomatic treatment should be initiated.
Animals being treated with meloxicam should be monitored for the occurrence of side effects as susceptibility varies with the individual.
Adverse reactions reported with the NSAID class of drugs include gastrointestinal signs, renal and hepatic toxicity as well as hematological, neurological and dermatological abnormalities.
If gastrointestinal or other side effects occur, treatment should be discontinued.
As for all NSAIDs, use in any animal less than 6 weeks of age or in debilitated aged animals may involve additional risk. If use in such animals cannot be avoided, a reduced dosage and careful clinical management may be required.
Warning: Keep out of reach of children.
Adverse Effects: The safety profile of meloxicam has been evaluated in well controlled target animal safety studies in the dog. Dogs treated with placebo, 1X, 3X and 5X label dosages were closely monitored over a 180 day (26 weeks) period. The study determined that there were no drug related adverse effects on clinical observations, normal body weight gain, food consumption, physical and ophthalmic examinations, clotting times, mucosal bleeding times or on a panel of clinical pathology parameters monitored throughout the study.
Postmarketing reports of suspected adverse drug reactions (SADRs) following field use of meloxicam have been monitored worldwide since 1995.
Based on case reports received under a voluntary reporting system by veterinarians or pet owners/caregivers, the most important affected body system was the gastrointestinal tract followed in decreasing order by central nervous system/behavioural signs, renal and dermatological system. Case reports often did not provide sufficient information to establish cause of the signs observed. In most cases, adverse effects were transient and disappeared after termination of treatment. In rare cases however, death has been associated with some of these adverse reactions. The following suspected adverse effects have been reported:
Gastrointestinal: Vomiting, diarrhea, inappetence, melena, hematemesis, ulceration.
Central Nervous System/Behavioural: Ataxia, personality change, seizures, sleepiness, hyperactivity, depression, trembling.
Renal: Elevated creatinine and BUN, acute renal failure.
Dermatologic: Pruritus, eczema, focal alopecia, moist dermatitis (hot spots).
Hypersensitivity: Urticaria, allergic dermatitis.
Hematologic: Immune mediated hemolytic anemia, immune mediated thrombocytopenia.
Hepatic: Elevated liver enzymes, jaundice.
Information for Pet Owners: APO-MELOXICAM (meloxicam oral suspension) is a nonsteroidal anti-inflammatory drug (NSAID) and as with others in this group, side effects may occur in treated dogs. The most common adverse effects reported involve the gastro-intestinal tract and usually occur within the first week of treatment. Typical symptoms include loss of appetite, vomiting, diarrhea, dark stools and depression. It is important in these situations to discontinue treatment and contact your veterinarian. In most cases, the side effects are transient and disappear after termination of treatment but in rare instances may be serious. Dogs undergoing prolonged treatment with APO-MELOXICAM should be monitored periodically. Consult your veterinarian.
Shake well before using.
Product is stable for 24 hours when held in dosage syringe and protected from light.
Store at room temperature 15-30°C (59-86°F).
Manufactured by: Groupe Parima, Montreal, Quebec
Manufactured for: Apotex Inc., Toronto, Ontario
CANADA’S PHARMACEUTICAL COMPANY
Last revised: November 09, 2012
Distributed by GREY WOLF ANIMAL HEALTH INC.
65 FRONT STREET EAST, SUITE 201, TORONTO, ON, M5E 1B5
|Every effort has been made to ensure the accuracy of the Apo-Meloxicam information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.|
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