Dogs and cats
Indications for use, specifying the target species
Treatment of gastrointestinal tract infections caused by Giardia spp. and Clostridia spp. (i.e. C. perfringens or C. difficile).
Treatment of infections of the urogenital tract, oral cavity, throat and skin caused by obligate anaerobic bacteria (e.g. Clostridia spp.) susceptible to metronidazole.
Do not use in cases of hepatic disorders. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Special precautions for use
Special precautions for use in animals
Due to the likely variability (time, geographical) in the occurrence of metronidazole resistant bacteria, bacteriological sampling and susceptibility testing are recommended. Whenever possible, the product should only be used based on susceptibility testing. Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used. In very rare cases, neurological signs may occur especially after prolonged treatment with metronidazole.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Metronidazole has confirmed mutagenic and genotoxic properties in laboratory animals as well as in humans. Metronidazole is a confirmed carcinogen in laboratory animals and has possible carcinogenic effects in humans. However, there is inadequate evidence in humans for the carcinogenicity of metronidazole. Metronidazole may be harmful for the unborn child. Impervious gloves should be worn during administration of the product to avoid skin and hand-to-mouth contact with the product. To avoid accidental ingestion, particularly by a child, unused part-tablets should be returned to the open blister space, inserted back into the outer packaging and kept in a safe place out of the sight and reach of children. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands thoroughly after handling the tablets. Metronidazole may cause hypersensitivity reactions. In case of known hypersensitivity to metronidazole, avoid contact with the veterinary medicinal product.
Adverse reactions (frequency and seriousness)
The following adverse reactions may occur after administration of metronidazole:
vomiting, hepatotoxicity, neutropenia and neurological signs.
Use during pregnancy, lactation or lay
Studies in laboratory animals have shown inconsistent results with regard to teratogenic/embryotoxic effects of metronidazole. Therefore, use of this product during pregnancy is not recommended. Metronidazole is excreted in milk and use during lactation is therefore not recommended.
Interaction with other medicinal products and other forms of interaction
Metronidazole may have an inhibitory effect on the degradation of other drugs in the liver, such as phenytoin, cyclosporine and warfarin. Cimetidine may decrease the hepatic metabolism of metronidazole resulting in increased serum concentration of metronidazole. Phenobarbital may increase hepatic metabolism of metronidazole resulting in decreased serum concentration of metronidazole.
Amounts to be administered and administration route
For oral administration.
The recommended dose is 50 mg metronidazole per kg bodyweight per day, for 5-7 days. The daily dose may be divided equally for twice daily administration (i.e. 25 mg/kg bodyweight twice daily).
To ensure administration of the correct dosage, bodyweight should be determined as accurately as possible.
Metrocare 250 mg Tablets (daily dose)
Metrocare 500 mg Tablets (daily dose)
Tablets can be divided into 2 or 4 equal parts to ensure accurate dosing. Place the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.
Halves: press down with your thumbs or fingers on both sides of the tablet.
Quarters: press down with your thumb or a finger in the middle of the tablet.
The remaining portion(s) should be given at the next administration(s).
Overdose (symptoms, emergency procedures, antidotes), if necessary
Adverse events are more likely to occur at doses and treatment durations in excess of the recommended treatment regimen. If neurological signs occur, treatment should be discontinued and the patient should be treated symptomatically.
Pharmacotherapeutic group: (nitro) imidazole derivatives
ATCvet code: QP51AA01
After metronidazole has penetrated the bacteria the molecule is reduced by the sensitive bacteria (anaerobe). The metabolites that are created have a toxic effect on the bacteria through binding to the bacterial DNA. In general metronidazole is bactericidal for sensitive bacteria in concentrations equal to or a little higher than the minimum inhibiting concentration (MIC).
Clinically metronidazole does not have any relevant effect on facultative anaerobes, obligate aerobes and microaerophilic bacteria.
Metronidazole is immediately and well absorbed after oral administration. The peak plasma concentration, Cmax was reached in dogs at between 0.75 and 2 hours after dosing and in cats at between 0.33 and 2 hours after dosing. The average terminal half life was 6.35 hours in dogs and 6.21 hours in cats. Metronidazole penetrates well into the tissues and bodily fluids, such as saliva, milk, vaginal secretions and semen. Metronidazole is primarily metabolised in the liver. Within 24 hours after oral administration, 35-65% of the administered dose (metronidazole and the metabolites thereof) is excreted in the urine.
List of excipients
Cellulose, microcrystalline, Sodium starch glycolate (type a), Yeast extract, Hydroxypropylcellulose, Magnesium stearate
Shelf life of the veterinary medicinal product as packaged for sale: 30 months
Special precautions for storage
Return any divided tablet to the blister and store protected from light.
Nature and composition of immediate packaging
PVC/Aluminium/Oriented polyamide /Aluminium blister packs. Cardboard box of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 25 or 50 blisters of 10 tablets giving pack sizes of 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 250 or 500 tablets
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials 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