DOXYBACTIN 400MG 10 TABLETS | FOR RHINITIS AND BRONCHOPNEUMONIA

doxybactin

400 mg tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 tablet contains:

Active substance:

400 mg doxycycline as doxycycline hyclate

Excipient(s):

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

pill.

Flavored tablet, yellow with brown dots, round and convex, with a cross-shaped score to divide it on one side. The tablets can be divided into 2 or 4 equal parts.

4. CLINICAL DATA

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

Treatment of the following diseases caused by bacteria sensitive to doxycycline:

Rhinitis caused by Bordetella bronchiseptica and Pasteurella spp.;

Bronchopneumonia caused by Bordetella spp. and Pasteurella spp.;

Interstitial nephritis caused by Leptospira spp.

4.3 Contraindications

Do not use in case of hypersensitivity to tetracyclines or to any of the excipients.

4.4 Special warnings for each target species

None.

4.6 Adverse reactions (frequency and seriousness)

Gastrointestinal disorders such as vomiting, diarrhea and oesophagitis have been reported as adverse effects after doxycycline therapy.

In very young animals, pigmentation of the teeth can be produced by the formation of a complex of tetracycline and calcium phosphate.

After exposure to strong sunlight, hypersensitivity reactions, photosensitivity reactions and, in rare cases, photodermatitis may occur.

It is known that the use of other tetracyclines causes a delay in skeletal growth in young animals (reversible after discontinuation of therapy). This delay can also occur after doxycycline administration.

4.11 Waiting time(s)

Not applicable

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: antibacterials for systemic use, tetracyclines

ATC vet code: QJ01AA02

5.1 Pharmacodynamic properties

Doxycycline is a second generation tetracycline. The veterinary medicinal product is mainly bacteriostatic; it inhibits bacterial protein synthesis by blocking the binding of transfer RNA to the messenger RNA-ribosome complex. The effects of doxycycline are time dependent and intensify with concentration, with AUC/MIC being the main pharmacodynamic parameter.

Resistance is primarily mediated by efflux pumps or ribosomal protection proteins. Cross-resistance between tetracyclines is common, but depends on resistance mechanisms: e.g. For example, a mutation in the efflux pumps that produces resistance to tetracycline remains sensitive to doxycycline. However, induction of ribosomal protection proteins confers cross-resistance to doxycycline.

Bacterial species/group and origin MIC90 Resistant

(%)

Value of

used cut

Pasteurella spp.

P. multocida (ED 2010) 0,5 µg/ml

P. multocida (FR, 2013) 15% 8 µg/ml#

Bordetella bronchiseptica

B. bronchiseptica (DE 2010-2011) 1 µg/ml

# According to the recommendations of the French CA-SFM (Comité de l'Antibiogramme de la Société

French de Microbiologie)

5.2 Pharmacokinetic data

After oral administration, the absorption of doxycycline occurs mainly in the duodenum and jejunum. After oral administration, the bioavailability is > 50%.

Doxycycline is distributed throughout the body, and accumulates intracellularly in, for example, leukocytes. It is deposited in active bone tissue and teeth. Doxycycline is eliminated primarily in the feces by direct intestinal excretion and, to a lesser extent, by glomerular elimination and biliary secretion.

6. PHARMACEUTICAL DATA

6.1 List of excipients

Sodium starch glycolate (type A)

Silica, colloidal anhydrous

Microcrystalline cellulose

Dry yeast)

chicken flavor

Magnesium stearate

6.2 Main incompatibilities

Not applicable

6.3 Validity period

Shelf-life of the veterinary medicinal product packaged for sale: 30 months

Shelf-life of divided tablets: 3 days.

6.4. Special storage precautions

Store at a temperature below 30 ºC.

DATA SHEET 

DOXYBACTIN