Metacam 1.0 mg Chewable Tablets (Canada)

Company: Boehringer Ingelheim Animal Health

1.0 mg Chewable Tablets for Dogs DIN 02318997

2.5 mg Chewable Tablets for Dogs DIN 02319004

Meloxicam

Veterinary Use Only

Metacam 1.0 mg Chewable Tablets Indications

Metacam^® 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 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/kg body weight.

Each chewable tablet contains either 1.0 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.

Tablets are scored and dosage should be calculated in half-tablet increments. Improvement is normally seen within 3-4 days.

Treatment should be discontinued after 10 days at the latest if no improvement is apparent.

Owners should be advised when their dog has received a meloxicam injection, and be informed of the potential for adverse reactions and clinical signs associated with NSAID intolerance. Always provide client information sheet with prescription.

Dogs undergoing prolonged treatment with Metacam should be monitored periodically.

Palatability:

A controlled palatability study demonstrated free choice acceptance of 98.2% for the 1 mg chewable tablet, and of 99.5% for the 2.5 mg chewable tablet; the placebo was a treat type dog biscuit and had an acceptance of 100%.

Contraindications

Metacam^® 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. Pre-treatment 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.

Do not use if there is evidence of dehydration, hypovolemia or hypotension, because of the increased risk of renal injury caused by the destruction of protective prostaglandins secreted by the kidneys in this risk situation.

Cautions:

Not approved for use in cats. Metacam^® 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.

If vomiting, inappetence, lethargy, diarrhea, increased drinking, increased or inappropriate urination or other suspected adverse reactions occur, IMMEDIATELY discontinue treatment and seek the advice of a veterinarian (see Adverse Reactions).

As for all NSAIDs, use in any animal less than 6 weeks of age or in debilitated aged animals may involve additional risk. To optimize dosing accuracy in higher risk patients, it is recommended that consideration be given to prescribe Metacam^® Oral Suspension (DIN 02237715), a formulation that allows for more accurate body weight dosing, in animals less than 6 weeks of age and/or less than 5 kg body weight and/or in debilitated aged animals and/or in patients at greatest risk for gastrointestinal and/or renal toxicity. If use of Metacam® Chewable Tablets in such animals cannot be avoided, a reduced dosage and careful clinical management may be required.

Warnings

- Keep out of reach of children.

- People with known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) should not handle this product.

- Pregnant women should not handle this product unless adequate exposure protection can be assured.

- Caution should be taken to avoid accidental ingestion.

Adverse Reactions

Postmarketing reports of suspected adverse drug reactions (SADRs) following field use of Metacam^® (meloxicam) have been monitored worldwide since 1995.

Typical adverse reactions of NSAIDs, such as loss of appetite, vomiting, diarrhea, apathy or polyuria and polydipsia associated with renal failure have occasionally been reported. These adverse effects are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

Although not all adverse reactions are reported, the following adverse reaction information is based on voluntary post-approval drug experience reporting by veterinarians and pet owners/caregivers. It should be noted that suspected adverse drug reactions listed here reflect reporting and not causality. The categories of adverse reactions are listed in decreasing order of frequency by body system. In rare cases, death has been associated with some of these adverse reactions.

Digestive tract disorders: Vomiting, diarrhea, melena, hematemesis, ulceration.

Systemic disorders: Inappetence, lethargy, jaundice.

Neurological disorders: Ataxia, seizures, trembling.

Behavioural disorders: Behavioural disorder (not otherwise specified), hyperactivity.

Renal and urinary disorders: Acute renal failure.

Investigations: Elevated creatinine and BUN, elevated liver enzymes.

Skin and appendages disorders: Pruritus, eczema, alopecia local, moist dermatitis (hot spots), allergic dermatitis.

Immune system disorders: Urticaria, immune mediated hemolytic anemia, immune mediated thrombocytopenia.

Information for Dog Owners: Metacam^® (meloxicam) is a nonsteroidal anti-inflammatory drug (NSAID) and as with other drugs in this group, adverse reactions may occur in treated dogs. The most common adverse effects reported involve the gastrointestinal tract or the kidneys and usually occur within the first week of treatment. Typical symptoms include loss of appetite, vomiting, diarrhea, dark stools, depression, increased drinking and increased inappropriate urination. It is important in these situations to IMMEDIATELY discontinue treatment and contact your veterinarian. In most cases, the adverse reactions are transient and disappear after termination of treatment but in rare instances may be serious especially if treatment is not discontinued.

Target Animal Safety:

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.

Storage

Store at 15-25°C. Store in the original package.

Protect from moisture.

Metacam^® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.

Boehringer Ingelheim Animal Health Canada Inc., 5180 South Service Road, Burlington ON Ontario L7L 5H4

Revised: 11-2022

159655-003

Presentation: Cartons of 84 tablets per blister pack.

CPN: 1182186.0