Composition:
Each tablet contains: Doxycycline monohydrate - 50 mg, Excipient q.s.f 1 tablet

Indications:
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.

Target Species: Dogs and cats.

Pharmacodynamics:

• Doxycycline is a broad-spectrum tetracycline-class antibiotic active against a large number of gram-positive and gram-negative bacteria including both aerobic and anaerobic species.
• Doxycycline inhibits bacterial protein synthesis by binding to the 30-S ribosomal subunits. This interferes with the binding of aminoacetyl-tRNA to the acceptor site on the mRNA ribosome complex and prevents coupling of amino acids to the elongating peptide chains; doxycycline has a predominantly bacteriostatic activity.
• The penetration of doxycycline into the bacterial cell takes place by both active transport and passive diffusion.
• The main mechanisms of acquired resistance to tetracycline-class antibiotics include active efflux and ribosomal protection. A third mechanism is enzymatic degradation. The genes mediating resistance may be carried on plasmids or transposons, as for example, tet(M), tet(O), and tet(B) that can be found in both gram-positive and gram-negative organisms including clinical isolates.
• Cross-resistance to other tetracyclines is common but depends on the mechanism conferring resistance. Due to the greater liposolubility and greater ability to pass through cell membranes (in comparison to tetracycline), doxycycline retains a certain degree of efficacy against microorganisms with acquired resistance to tetracyclines via efflux pumps. However, resistance mediated by ribosomal protection proteins confers cross-resistance to doxycycline.

Pharmacokinetics:

• After oral administration, doxycycline is mainly absorbed from the duodenum and jejunum. Following oral administration, the bioavailability is > 50%. Doxycycline is widely distributed throughout the body and can accumulate intracellularly, for example in leukocytes. It is deposited in active bone tissue and teeth. Doxycycline is primarily eliminated through faeces by direct intestinal excretion and to a lesser extent by glomerular excretion and biliary secretion.

Dosage and Administration:
Oral use: The recommended dose for dogs and cats is 10 mg (5–10) doxycycline per kg bodyweight per day. The majority of routine cases are expected to respond after between 5 and 7 days of therapy. Therapy should continue for 2 to 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 to avoid underdosing.

Contra-Indication:
Do not use in cases of hypersensitivity to tetracyclines or to any of the excipients.

Withdrawal Period:
Not applicable.

Adverse Reactions (Frequency and Seriousness):

• Gastrointestinal disorders such as vomiting, diarrhoea and oesophagitis have been reported as side effects following doxycycline therapy very rarely.
• In very young animals, discoloration of the teeth may occur very rarely by the formation of a tetracycline-calcium phosphate complex.
• Hypersensitivity reactions, photosensitivity and in exceptional cases photodermatitis may occur very rarely after exposure to intense daylight.
• Retardation of skeletal growth of young animals (reversible upon discontinuation of therapy) is known to occur very rarely with use of other tetracyclines and might occur following administration of doxycycline.

Special Precautions for Use in Animals:

• The product should be administered with caution to animals with dysphagia or diseases accompanied by 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 product should be administered together with food. Special care should be taken when administering the product to animals with liver disease, since increases in hepatic enzymes have been documented in some animals after doxycycline treatment.
• 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 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 product should be in accordance with official, national and regional antimicrobial policies.
• Use of the product deviating from the instructions given in the 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.

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. Wash hands after use.

Action on Pregnancy and Lactating Animals:
The safety of the veterinary medicinal product has not been established during 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.

Interaction with Other Medicinal Products and Other Forms of Interaction:
Do not administer concurrently with bactericidal antibiotics such as penicillin 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.

Storage:
Store in a cool, dark place, protected from light.

Shelf-Life:
24 months.

Presentation:
Blisters of 10 tablets; cartons of 10 or 50 blisters.