Target species
Dogs and cats.
Indications for use for each target species
Dogs
For the treatment of respiratory tract infections including rhinitis, tonsillitis and bronchopneumonia caused by Bordetella bronchiseptica and Pasteurella spp. susceptible to doxycycline.
For the treatment of canine ehrlichiosis caused by Ehrlichia canis.
Cats
For the treatment of respiratory tract infections including rhinitis, tonsillitis and bronchopneumonia caused by Bordetella bronchiseptica and Pasteurella spp. susceptible to doxycycline.
Contra-indications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals with renal or hepatic insufficiency.
Do not use in animals with diseases associated with vomiting or dysphagia.
Do not use in animals with known photosensitivity.
Do not use in puppies and kittens before completion of teeth enamel formation.
Special warnings
Ehrlichia canis infection: treatment should be initiated at the onset of clinical signs. Complete eradication of the pathogen is not always achieved, but treatment for 28 days generally leads to a resolution of the clinical signs and a reduction of the bacterial load. A longer duration of treatment, based on a benefit/risk assessment by the responsible veterinarian, may be required particularly in severe or chronic ehrlichiosis. All treated animals should be regularly monitored, even after clinical cure.
Special precautions
Special precautions for safe use in the target species:
Tablets should be administered with food in order to avoid vomiting and to reduce the likelihood of oesophageal irritation.
The veterinary medicinal product should be administered 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 deviating from the instructions given in the summary of product characteristics (SPC) 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.
Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.
Special precautions to be taken by the person administering the product to animals
People with known hypersensitivity to doxycycline or other tetracyclines should avoid contact with the veterinary medicinal product.
Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product. In case of skin irritation, seek medical advice immediately and show the package leaflet or the label to the physician. Accidental ingestion, especially by children, may cause adverse events such as emesis. To avoid accidental ingestion, blisters should be inserted back into the outer packaging and kept in a safe place. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions
Dogs and cats.
Very rare (1 animal/ 10 000 animals treated including isolated reports) | Gastrointestinal disorders (e.g. vomiting, diarrhoea, hypersalivation, nausea and oesophagitis) Photosensitization (and photodermatitis)1 Dental discolouration2 |
1 After exposure to intense sunlight or ultraviolet light.
2 If used during the period of tooth development.
Reporting 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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic or embryotoxic effects of doxycycline. However, as there is no information available in the target species, the use is not recommended during pregnancy. Use only according to the benefit-risk assessment by the responsible veterinarian.
Interactions
Doxycycline should not be used concurrently with other antibiotics, especially bactericidal drugs such as the β-lactams. Cross-resistance to tetracyclines may occur. The half-life of doxycycline is reduced by concurrent administration of barbiturates, phenytoin and carbamazepine. Dosage adjustments may be necessary in subjects under anticoagulant therapy, as tetracyclines depress the plasma activity of prothrombin. Simultaneous administration of oral absorbents, antacids and preparations including multivalent cations should be avoided as they reduce doxycycline availability.
Administration routes and dosage
Oral use.
The dosage is 10 mg doxycycline per kg bodyweight per day corresponding to one 20 mg tablet per 2 kg bodyweight or one 100 mg tablet per 10 kg bodyweight. To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid overdosing or underdosing. To adjust the dosage, the tablets can be divided into two equal parts. The dosage can be divided into two daily administrations. The duration of treatment might be adapted depending on the clinical response, after benefit/risk assessment by the veterinarian.
Disease | Dosage regimen | Duration of treatment |
Respiratory tract infection | 10 mg/kg per day | 5-10 days |
Canine ehrlichiosis | 10 mg/kg per day | 28 days |
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Vomiting may occur in dogs with 5 times the recommended dose. Increased levels of ALT, GGT, ALP and total bilirubin were reported in dogs at 5-fold overdose.
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.