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Ronaxan 100 mg Tablet

Information leaflet

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1.     NAME OF THE VETERINARY MEDICINAL PRODUCT

       RONAXAN 100mg Tablet

2.     QUALITATIVE AND QUANTITATIVE COMPOSITION

       Each tablet contains:

       Active substance :

       Doxycycline                       100 mg
       (as doxycycline hyclate)

       For full list of excipients, see section 6.1.

3.     PHARMACEUTICAL FORM

       Round, biconvex, light yellow to yellow tablet.

4.     CLINICAL PARTICULARS


4.1    Target species

       Dogs.

4.2    Indications for use specifying the target species

       Treatment of respiratory tract infections including rhinitis, tonsillitis and
       bronchopneumonia in dogs due to organisms sensitive to doxycycline including:
       Pasteurella spp., Bordetella bronchiseptica, Staphylococcus aureus and other
       Staphylococcus spp, and Streptococcus spp.

4.3    Contra-indications

       Do not use in pregnant animals.

       Do not use in known cases of hypersensitivity to the active ingredient.

       Vomiting, oesophagitis and oesophageal ulcerations have been reported as side
       effects following doxycycline therapy, and Ronaxan should not therefore be
       administered to patients with dysphagia or diseases accompanied by vomiting.

4.4    Special warnings for each target species

       None known.

4.5    Special precautions for use

       (i) Special precautions for use in animals.

       Do not exceed the recommended dosage.

       Tablets should be administered at feeding time.
       (ii) Special precautions to be taken by the person administering the medicinal
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       product to the animals

       Wash hands thoroughly after use. Handle the tablets with care if you know you are
       hypersensitive (allergic) to tetracycline. In the case of accidental ingestion, seek
       medical advice.

4.6    Adverse reactions (frequency and seriousness)

       Photodermatitis has occurred following tetracycline therapy after exposure to intense
       sunlight or ultraviolet light.

       Use of tetracycline during the period of tooth development may lead to tooth
       discolouration. Doxycycline, because of its lower affinity for calcium, carries a lower
       risk than other tetracyclines.

       Refer also to section 4.3.

4.7    Use during pregnancy, lactation or lay

       Laboratory studies have not revealed any teratogenic, or embryotoxic effect of
       doxycycline in the rat and rabbit. However, as there is no information available in the
       target species, use is not recommended during pregnancy.

4.8    Interaction with other medicinal products and other forms of interaction

       Cross resistance to other tetracyclines can occur.

       Doxycycline should not be used concurrently with other antibiotics especially
       bactericidal drugs such as the ß-lactams.

       The half life of doxycycline is reduced by concurrent administration of barbiturates or
       phenytoin.

       Simultaneous administration of oral absorbents, iron preparations and antacids
       should be avoided as they reduce doxycycline availability.

4.9    Amounts to be administered and administration route

       The tablets are for oral administration. The dosage is 10 mg doxycycline per
       kilogram bodyweight (one tablet per 10 kg bodyweight) administered daily for up to
       five days.

       Tablets should be administered at feeding time.
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4.10   Overdose (symptoms, emergency procedures, antidotes), if necessary

       Raised levels of SGPT, GGT, SAP and total bilirubin were noted in dogs which
       received three or five times the recommended dose. Some vomiting can occur in
       dogs with five times the recommended dosage.

4.11   Withdrawal periods

       Not applicable.

5.     PHARMACOLOGICAL PROPERTIES

       Summary presentation of the active ingredient

       Doxycycline is a second generation, broad spectrum cycline belonging to the
       tetracycline family.

       ATC Vet Code:

       QJ01AA02

5.1    Pharmacodynamic properties

       It is active against a large number of Gram positive and Gram negative pathogens
       including strains resistant to first generation tetracyclines.
       It is essentially bacteriostatic; it inhibits the bacterial protein synthesis by blocking
       binding of transfer RNA to the messenger RNA-ribosome complex.

5.2    Pharmacokinetic properties

       After an intravenous administration of doxycycline in dogs, the volume of distribution
       (1.72 L/kg) is high.

       When orally administered in a single dose in dogs, doxycycline is rapidly absorbed;
       the maximum concentration in serum is attained after a delay of three hours.
       Administered at the recommended dosage regime (10 mg/kg/24 hr over 5 days) the
       absolute bioavailability is 45%.

       Doxycycline is extensively eliminated in the urine.

6.     PHARMACEUTICAL PARTICULARS


6.1    List of excipients

       Silica Colloidal Anhydrous
       Magnesium Stearate
       Microcrystalline Cellulose
       Maltodextrin Saccharose
       Lactose Monohydrate

6.2    Major incompatibilities

       None known.
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