Dogs and cats.

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.

For the treatment of respiratory tract infections including rhinitis, tonsillitis and bronchopneumonia caused by Bordetella bronchiseptica and Pasteurella spp. susceptible to doxycycline.

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 (see adverse reactions section).

Do not use in animals with known photosensitivity (see adverse reactions section).

Do not use in puppies and kittens before completion of teeth enamel formation.

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 patients should be regularly monitored, even after clinical cure.

Tablets should be administered with food in order to avoid vomiting and to reduce the likelihood of oesophageal irritation.

The 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.

People with known hypersensitivity to doxycycline or other tetracyclines should avoid contact with the veterinary medicinal product and 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 reactions 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.

Gastrointestinal adverse reactions including vomiting, nausea, salivation, oesophagitis and diarrhoea have been reported very rarely in spontaneous reports. Photosensitivity and photodermatitis can occur following tetracycline therapy, after exposure to intense sunlight or ultraviolet light. (See also contra-indications). Use of tetracycline during the period of tooth development may lead to tooth discolouration.

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, use is not recommended during pregnancy. Use only according to the benefit-risk assessment by the responsible veterinarian.

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.

For 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 of the animals should be determined as accurately as possible to avoid overdosing or underdosing. In order 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.

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.