Target species
Doxybactin 50 mg: dogs and cats.
Doxybactin 200 mg and 400 mg: dogs.
Indications for use
Treatment of the following conditions caused by bacteria sensitive to doxycycline:
Dogs:
Rhinitis caused by Bordetella bronchiseptica and Pasteurella spp.;
Bronchopneumonia caused by Bordetella spp. and Pasteurella spp.;
Interstitial nephritis caused by Leptospira spp.
Cats:
Respiratory infections caused by Bordetella bronchiseptica, Chlamydophila felis and Pasteurella spp.
Contraindications
Do not use in cases of hypersensitivity to tetracyclines or to any of the excipients.
Special warnings
none
Special precautions for use
Special precautions for safe use in the target species:
The veterinary medicinal product should be administered with caution to animals with dysphagia or diseases accompanied with vomiting, since administration of doxycycline hyclate tablets has been associated with oesophageal erosion.
In order to reduce the likelihood of oesophageal irritation as well as other gastrointestinal side effects, the veterinary medicinal product should be administered together with food.
Special care should be taken when administering the veterinary medicinal product to animals with liver disease, since increases in hepatic enzymes have been documented in some animals after doxycycline treatment.
The veterinary medicinal product should be administerd with caution to young animals, since tetracyclines as a class may cause permanent discolouration of the teeth, when administered during tooth development. However, human literature indicates that doxycycline is less likely than other tetracyclines to cause these abnormalities, due to its reduced ability to chelate calcium.
Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogens. If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at local/regional level. Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies. Use of the veterinary medicinal product deviating from the instructions given in this datasheet may increase the prevalence of bacteria resistant to doxycycline and may decrease the effectiveness of treatment with other tetracyclines, due to the potential for cross-resistance.
As tablets are flavoured store tablets out of reach of the animals in order to avoid accidental ingestion.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Tetracyclines may cause hypersensitivity (allergy) reactions.
People with known hypersensitivity to tetracyclines should avoid contact with the veterinary medicinal product.
If you develop symptoms following exposure such as skin rash, seek medical advice immediately and show the package leaflet to the physician.
Doxycycline may cause gastrointestinal disturbances after accidental ingestion, especially by children. To avoid accidental ingestion, particularly by a child, unused tablet parts should be returned to the open blister space and inserted back into the carton. In case of accidental ingestion, particularly by children, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions
Dogs, cats:
Very rare (<1 animal/10 000 animals treated, including isolated reports): | Gastrointestinal disorder (e.g. Vomiting, Diarrhoea, Oesophagitis), Dental discolourationa Hypersensitivity reaction Photosensitivityb, Photodermatitisb Developmental bone and joint disordersc |
a In very young animals. By the formation of a tetracycline-calcium phosphate complex.
b after exposure to intense daylight.
c Retardation of skeletal growth of young animals (reversible upon discontinuation of therapy) is known to occur with use of other tetracyclines and might occur following administration of doxycycline.
Reporting of adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. reports should be sent, preferably via a veterinarian to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Pregnancy and lactation:
Tetracyclines as a class can retard foetal skeletal development (fully reversible) and cause discolouration of the deciduous teeth. However, evidence from human literature suggests that doxycycline is less likely to cause these abnormalities than other tetracyclines. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interactions with other medicinal products and other forms of interaction
Do not administer concurrently with bactericidal antibiotics such as penicillins and cephalosporins. Oral absorbents and substances containing multivalent cations such as antacids and iron salts should not be used from 3 hours before to 3 hours after the administration of doxycycline. The half-life of doxycycline is reduced by concurrent administration of antiepileptic drugs such as phenobarbital and phenytoin.
Administration route and dosage
Oral use.
The recommended dose for dogs and cats is 10 mg doxycycline per kg body weight per day. The majority of routine cases are expected to respond after between 5 and 7 days of therapy. Therapy should continue for 2-3 days beyond the clinical cure for acute infections. In chronic or refractory cases, a longer course of therapy, up to 14 days, may be required. In dogs with interstitial nephritis due to leptospirosis, treatment for 14 days is recommended. In cats with C. felis infections, it is recommended to administer treatment for a minimum period of 28 days in order to ensure elimination of the organism. To ensure a correct dosage body weight should be determined as accurately as possible. Tablets should be administered together with the food (see Special precautions for use in animals).
TABLE A is intended as a guide to dispensing the veterinary medicinal product at the standard dose rate of 10 mg per kg body weight per day.
TABLE A Body weight (kg) | Dose mg | Doxybactin 50 mg number of tablets daily | | Doxybactin 200 mg number of tablets daily | | Doxybactin 400 mg number of tablets daily |
0.75 - 1.25 | 12.5 | ¼ | | | | |
> 1.25 - 2.5 | 25 | ½ | | | | |
> 2.5 - 3.75 | 37.5 | ¾ | | | | |
> 3.75 - 5 | 50 | 1 | | | | |
> 5 - 6.25 | 62.5 | 1¼ | | | | |
> 6.25 - 7.5 | 75 | 1½ | | | | |
> 7.5 - 10 | 100 | 2 | | | | |
> 10 - 12.5 | 125 | 2½ | | | | |
> 12.5 - 15 | 150 | 3 | | | | |
> 15 - 20 | 200 | | | 1 | | |
> 20 - 25 | 250 | 1 | AND | 1 | | |
> 25 - 30 | 300 | | | 1½ | | |
> 30 - 35 | 350 | | | 1¾ | | |
> 35 - 40 | 400 | | | | | 1 |
> 40 - 45 | 450 | 1 | AND | | | 1 |
> 45 - 50 | 500 | | | ½ | AND | 1 |
> 50 - 60 | 600 | | | 1 | AND | 1 |
> 60 - 70 | 700 | | | 1½ | AND | 1 |
> 70 - 80 Table wide | 800 | | | | | 2 |
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.
2 equal parts: press down with your thumbs on both sides of the tablet.
4 equal parts: press down with your thumb in the middle of the tablet.
Symptoms of overdose (and where applicable, emergency procedure and antidotes)
In cases of overdose no symptoms are to be expected other than those mentioned in Adverse reactions.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable