Meloxyl 0.5 mg/ml Oral Suspension for Cats

Composition

One ml contains:

Active substance

Meloxicam 0.5 mg

Excipient

Sodium benzoate 1.5 mg

For the full list of excipients, see section 6.1.

6.1 List of excipients

Sodium benzoate

Glycerol

Citric acid monohydrate

Xanthan gum

Povidone

Sodium dihydrogen phosphate monohydrate

Simethicone emulsion

Honey flavour

Silica, colloidal anhydrous

Water, purified

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Pharmaceutical form

Oral suspension.

A smooth light yellow suspension.

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Pharmacological properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams)

ATC vet 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

Absorption

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.

Distribution

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.

Metabolism

Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Five major metabolites were detected all having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21% of the recovered dose is eliminated in urine (2% as unchanged meloxicam, 19% as metabolites) and 79% in the faeces (49% as unchanged meloxicam, 30% as metabolites).

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Target species

Cats

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Indications

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.

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

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Dosage

Oral use.

Post-operative pain and inflammation following surgical procedures:

After initial treatment with a suitable 5 mg/ml meloxicam solution for injection for cats, continue treatment 24 hours later with Meloxyl 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight (0.1 ml /kg). The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.

Acute musculo-skeletal disorders:

Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight (0.4 ml/kg) on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a dose of 0.05 mg meloxicam/kg body weight (0.1 ml /kg) for as long as acute pain and inflammation persist.

Chronic musculo-skeletal disorders:

Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight (0.2 ml/kg) 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 body weight (0.1 ml /kg). A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.

Route and method of administration

A one ml syringe is provided with the product. To be administered orally either mixed with food or directly into the mouth. Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not be exceeded.

Advice on correct administration

Shake well before use.

Avoid introduction of contamination during use.

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Contraindications

Do not use in pregnant or lactating animals.

Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

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

Do not use in cats less than 6 weeks of age.

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Adverse reactions

In cats, typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have very rarely been reported. Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases.

These side effects 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 treated displaying adverse reactions)

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

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Warnings

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

Post-operative use:

In case additional pain relief is required, multimodal pain therapy should be considered.

Chronic musculoskeletal disorders:

Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

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. Accidental ingestion of the product by a child may cause gastro-intestinal effects, such as nausea and gastric pain.

Any uneaten medicated food must be disposed of immediately and the bowl washed thoroughly.

Do not leave an unattended filled syringe in the sight or reach of children. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

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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).

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Interactions

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Meloxyl must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided.

In cats, 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.

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Overdose

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 in section 4.6, are expected to be more severe and more frequent. In case of overdose symptomatic treatment should be initiated.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

White high density polyethylene bottle containing 10 ml or 15 ml with a tamper proof child resistant closure.

White polypropylene bottle containing 3 ml or 5 ml with a tamper proof child resistant closures.

Each bottle is packed in a cardboard box with a 1 ml measuring syringe (barrel in polypropylene and plunger/piston in high density polyethylene).

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale:

3 ml and 5 ml bottle: 30 months

10 ml and 15 ml bottle: 3 years

Shelf life after first opening the immediate packaging:

3 ml and 5 ml bottle: 14 days

10 ml and 15 ml bottle: 6 months

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Disposal of unused product

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

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Additional information

Vm 08749/5139

9 DATE OF FIRST AUTHORISATION

05 May 2022

10 DATE OF REVISION OF THE TEXT

October 2025

PROHIBITION OF SALE, SUPPLY AND/OR USE

To be supplied only on veterinary prescription.

Gavin Hall Approved: 15 October 2025

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Registration holder

Chanelle Pharmaceuticals Manufacturing Ltd

Loughrea

Co. Galway

H62 FH90

Ireland

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