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Date: Tuesday, March 5, 2024 3:19

Release 2.160
Loxicom 0.5 mg/ml Oral Suspension for Dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Oral: Other NSAIDs
Active ingredient: Meloxicam
Product:Loxicom 0.5 mg/ml Oral Suspension for Dogs
Product index: Loxicom 0.5 mg/ml Oral Suspension Dogs
Incorporating:
Qualitative and quantitative composition
Each ml contains:
Active Substance: Meloxicam 0.5 mg
Excipients: Sodium benzoate 1.5 mg
Pharmaceutical form
Pale yellow oral suspension.
Clinical particulars
Target species
Dogs.
Indications for use, specifying the target species
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Contraindications
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 case of hypersensitivity to the active substance or to any of the excipients
Do not use in dogs less than 6 weeks of age.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
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.
This product for dogs should not be used in cats due to the different dosing devices. In cats, Loxicom 0.5mg/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.
Adverse reactions (frequency and seriousness)
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases, haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.
These adverse reactions 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 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).
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see contraindications)
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. Loxicom 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 pharmacokinetic properties of the products used previously.
Amounts to be administered and administration route
Oral use.
To be administered with food or directly into the mouth.
Shake well before use.
Initial treatment is a single dose of 0.2 mg meloxicam/kg bodyweight (i.e. 4 ml/10 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 (i.e. 2 ml/10 kg bodyweight).
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose 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.
The suspension can be given using either of the two measuring syringes provided in the package. The syringes fit onto the bottle and have a kg-bodyweight scale which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg bodyweight). Thus for the first day, twice the maintenance volume will be required. Alternatively therapy may be initiated with Loxicom 5 mg/ml solution for injection.
A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Avoid introduction of contamination during use.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In the case of overdose, symptomatic treatment should be initiated.
Pharmacological particulars
Pharmacotherapeutic Group: Anti-inflammatory and anti-rheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06
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 particulars
Absorption
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.
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. The volume of distribution is 0.3 l/kg.
Metabolism
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. Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.
Pharmaceutical particulars
List of excipients
Sodium Benzoate
Glycerol
Povidone K30
Xanthan Gum
Disodium Phosphate Dihydrate
Sodium Dihydrogen Phosphate Dihydrate
Citric Acid Anhydrous
Simethicone Emulsion
Purified water
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.
Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 18 months
Shelf-life after first opening the immediate packaging: 6 months
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Nature and composition of immediate packaging
The veterinary medicinal product is presented in 15 ml and 30 ml polyethylene screw bottles with HDPE/LDPE child resistant caps. Two polyethylene/polypropylene measuring syringes, a 1 ml and a 5 ml syringe, are supplied with each bottle to ensure accurate dosing of small and large dogs. Each syringe is graduated in bodyweight, the 1 ml syringe is graduated from 0.25 kg to 5.0 kg and the 5 ml syringe for 1 kg to 25 kg.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Norbrook Laboratories (Ireland) Limited, Rossmore Industrial Estate, Monaghan, Ireland
Marketing Authorisation Number
UK(GB): Vm 02000/5001
UK(NI): EU/2/08/090/001, EU/2/08/090/002
Significant changes
Date of the first authorisation or date of renewal
Date of first authorisation: 10/02/2009
Date of last renewal: 23/01/2019
Date of revision of the text
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
January 2019
Any other information
Nil.
Legal category
Legal category: POM-V
GTIN
GTIN description:Loxicom 0.5mg/ml Oral Dogs 15ml
GTIN:5023534007975