Loxicom 0,5 Mg/1,5 Mg Oral Suspension

    Loxicom 0,5 Mg/1,5 Mg Oral Suspension

    S3
    PDF Leaflet Revision Date: 05 July 2022


    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Alleviation of inflammation and pain in musculoskeletal disorders in dogs.

    Dosage (summary)

    Initial: 0.2 mg/kg; Maintenance: 0.1 mg/kg once daily.

    Onset of Action / Duration

    Onset: 3-4 days, Duration: 24 hours

    Special Populations

    • Animals < 6 weeks
    • Debilitated aged animals

    Pregnancy & Breastfeeding

    Contraindicated in pregnant or lactating dogs.

    Key Drug Interactions

    • Other NSAIDs
    • Glucocorticosteroids
    • Diuretics
    • Aminoglycoside antibiotics
    • Anticoagulants

    Contraindications

    • Hypersensitivity to meloxicam
    • Use in cats
    • Cardiac disease
    • Hepatic disease
    • Renal disease
    • Gastrointestinal ulceration

    Common side effects

    • Loss of appetite
    • Vomiting
    • Diarrhoea
    • Depression

    Counselling Points

    • Administer with food or directly
    • Monitor for gastrointestinal side effects
    • Follow veterinarian's instructions

    Serious warnings

    • Risk of renal toxicity in dehydrated animals
    • Discontinue if adverse reactions occur
    Important Disclaimer

    The Loxicom 0,5 Mg/1,5 Mg Oral Suspension professional information leaflet below is the property of Biotech Laboratories and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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    Clinical Particulars

    Section 4 of the official insert — extracted exactly as issued, no alterations

    4.1 Indications

    Indicated for the alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders such as disco-spondylitis, arthropathy and soft tissue injuries in dogs.

    4.2 Contraindications

    Do not use in case of hypersensitivity to meloxicam or to any of the excipients.

    Loxicom Oral Suspension should not be used in cats.

    Do not use in pregnant or lactating dogs (see PREGNANCY AND LACTATION).

    The use of Loxicom Oral Suspension is contraindicated in animals suffering from cardiac, hepatic or clinical renal disease, gastrointestinal ulceration and haemorrhagic diathesis.

    4.3 Warnings and special precautions

    If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

    The use of Loxicom Oral Suspension 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 is required.

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

    Special precautions to be taken by the person administering Loxicom Oral Suspension to animals People with known hypersensitivity to meloxicam or other non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with Loxicom Oral Suspension. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to your doctor or pharmacist.

    4.4 Interactions

    Loxicom Oral Suspension should not be administered concurrently or following pre-treatment with other steroidal or non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticosteroids, diuretics, aminoglycoside antibiotics or anticoagulant agents and substances with high protein binding, which may compete for protein binding and thus lead to toxic effects.

    Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly, a treatment-free period with such medicines should be observed for at least 24 hours prior to commencement of treatment. The treatment-free period should take into account the pharmacological properties of the products used previously.

    4.5 Pregnancy and lactation

    Do not use in pregnant or lactating dogs (see CONTRAINDICATIONS).

    4.6 Dosage and directions for use

    For oral use only. Shake well before use. Loxicom Oral Suspension should be administered orally either mixed with food or directly into the mouth.

    Initial treatment is a single dose of 0,2 mg/kg body weight (i.e. 4 ml/10 kg bodyweight of Loxicom 0,5 mg/ml Oral Suspension or 1,33 ml/10 kg body weight of Loxicom 1,5 mg/ml Oral Suspension) on the first day. Treatment is to be continued by once daily oral administration (at 24-hour intervals) at a maintenance dose of 0,1 mg/kg (i.e. 4 ml/10 kg bodyweight of Loxicom 0,5 mg/ml Oral Suspension or 0,667 ml/10 kg body weight of Loxicom 1,5 mg/ml Oral Suspension) for medium to long-term use.

    For longer-term treatment, once clinical response has been observed (after u2265 4 days) the dose of Loxicom Oral Suspension can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculoskeletal disorders may vary over time.

    Particular care should be given 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 per kg bodyweight). Thus for the first day, twice the maintenance volume will be required. Alternatively therapy may be initiated with meloxicam 5 mg/ml solution for injection. Follow the instructions of the veterinarian. 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.

    The lowest effective dose depends on the individual clinical response of the animal and should be monitored by the veterinarian. Avoid introduction of contamination during use.

    4.7 Side effects

    Side effects may include loss of appetite, vomiting, diarrhoea, occult blood in the faeces and depression. In very rare cases, haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported. Gastrointestinal side effects are in most cases transient and disappear following termination of treatment, but in rare cases may be serious.

    If gastrointestinal side effects occur treatment should be discontinued and the advice of a veterinarian should be sought.

    4.8 Known symptoms of overdose and particulars of its treatment

    In the case of overdosing, symptomatic treatment should be initiated.

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