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Therios Palatable Tablets for Cats & Dogs

Item Number: THERIOS

Therios Palatable Tablets for Cats & Dogs

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Description

Target species:
Dogs

Indications for use:
For the treatment of bacterial skin infections in dogs (including deep and superficial pyoderma) caused by organisms sensitive to cefalexin.

For the treatment of urinary tract infections in dogs (including nephritis and cystitis) caused by organisms sensitive to cefalexin.

Contra-indications:
Do not use in animals which are known to be hypersensitive to penicillins.

Do not use in case of severe renal failure

Do not use in rabbits, guinea pigs, hamsters and gerbils.

Special warnings for each target species:
None

Special precautions for use:
As with other antibiotics which are excreted mainly by the kidneys, systemic accumulation may occur when renal function is impaired. In case of known renal insufficiency the dose should be reduced.

The product is not recommended for use in dogs less than 2.5 kg bodyweight.

Wherever possible, the use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies

Safety of the excipient, ammonium glycyrrhizate, has not been established in dogs less than 1 year old.

Adverse reactions:
Vomiting and diarrhoea have been observed in dogs. In rare cases hypersensitivity can occur.

Use during pregnancy or lactation:
Do not use in pregnant or lactating bitches.

Interactions:
In order to ensure efficacy, the product should not be used in combination with bacteriostatic antibiotics.

Concurrent use of first generation cephalosporins with aminoglycoside antibiotics or some diuretics such as furosemide can enhance nephrotoxicity risks

Amounts to be administered and administration route:
For oral administration. 15 mg cefalexin per kg body weight twice daily (equivalent to 30 mg per kg body weight per day) for duration of:

- 14 days in cases of urinary tract infection

- At least 15 days in cases of superficial infectious dermatitis

- At least 28 days in cases of deep infectious dermatitis

In severe or acute conditions the dose may be safely doubled to 30 mg/kg twice daily. To allow for accuracy of dosing, tablets can be halved or quartered.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid under dosing.

Therios tablets are well accepted by dogs but may be crushed or added to a small quantity of food immediately prior to feeding if necessary

Overdose:
Trials performed on animals with up to 5 times the recommended twice daily dosage of 15 mg/kg demonstrated that cefalexin was well tolerated.

Pharmacological particulars

Pharmacodynamic properties:

Cefalexin acts by inhibiting the nucleopeptide synthesis of the bacterial wall. Cephalosporins interfere with transpeptidation by acylating the enzyme making it unable to cross-link muramic acid-containing peptidoglycan strands. The inhibition of the biosynthesis of the material required to build the cell wall results in a defective cell wall and consequently osmotically unstable to protoplasts. The combined action results in cell lysis and filament formation. Cefalexin is active against Gram positive and Gram negative bacteria such as Staphylococcus spp (including penicillin-resistant strains), Streptococcus spp.,., Escherichia .coli, and Klebsiella spp, . Cefalexin is not inactivated by beta-lactamases produced by Gram positive bacteria. However, beta-lactamases produced by gram-negative bacteria can inhibit cefalexin by hydrolysis of the beta-lactam cycle. Resistance is transmitted by plasmidic or chromosomic route.

Cefalexin is not inactivated by the staphylococcal beta-lactamases but has a moderate activity against non-transferable (chromosomal) beta-lactamase producing gram-negative enterobacteriacceae and fastidious gram-negatives. No antibacterial activity is obtained against Enterobacter spp., P. aeruginosa and Serratia spp.

Cefalexin has a time-dependent bactericidal activity against Staphylococcus spp and Pasteurella multocida..

The cefalexin critical breakpoints (MIC value) for pathogens of veterinary importance were set up at:

-Susceptible: = 8 mg/L

-Resistant: > 32 mg/L

Staphylococcus spp, Streptococcus spp, E. coli and Klebsiella spp and P. multocida are susceptible to cefalexin. MIC90 values for cefalexin determined in target bacterial strains isolated from diseased dogs in Europe and in the USA are:

-S. pseudintermedius: 2 µg/mL

-S. aureus: 8 µg/mL

-S. canis = 0.5 µg/mL

-Beta-hemolytic Streptococcus spp: 2 µg/mL

-E. coli: 16 µg/mL

-P. multocida: 2µg/mL

-Klebsiella. spp: 4µg/mL

Resistance to cefalexin may be due to one of the following mechanisms of resistance. Firstly, the production of various beta-lactamases (cephalosporinase), that inactivate the antibiotic, is the most prevalent mechanism among gram-negative bacteria. Secondly, a decreased affinity of the PBPs (penicillin-binding proteins) for beta-lactam drugs is frequently involved for beta -lactam resistant gram-positive bacteria. Lastly, efflux pumps, extruding the antibiotic from the bacterial cell, and structural changes in porins, reducing passive diffusion of the drug through the cell wall, may contribute to improve the resistant phenotype of a bacterium.

Well-known cross-resistance (involving the same resistance mechanism) exists between antibiotics belonging to the beta -lactam group due to structural similarities. It occurs with b-lactamases enzymes, structural changes in porins or variations in efflux pumps. Co-resistance (different resistance mechanisms involved) has been described in E.coli due to a plasmid harbouring various resistance genes.

Pharmacokinetic properties:

After single oral administration of the recommended dosage of 15 mg cefalexin per kg bodyweight to Beagle dogs, plasma concentrations were observed within 30 minutes. The plasma peak was observed at 1.33 h with a plasma concentration of 21.2µg/ml. The bioavailability of the active was over 90%. Cefalexin was detected until 24 hours after the administration. The first urine specimen was collected within 2 to 12 hours with peak concentrations of cefalexin measured at 430 to 2758 µg / ml within 12 hours.

After repeated oral administration of the same dosage, twice a day for 7 days, plasma peaks occurred 2 hours later with a concentration of 20µg/ml. Over the treatment period concentrations were maintained above 1 µg/ml. The mean elimination half life is 2 hours. Skin levels were around 5.8 to 6.6 µg /g 2 hours after treatment.

Pharmaceutical particulars:

Excipients:
Croscarmellose sodium, Silica (colloidal anhydrous), Magnesium stearate, Yeast dried, Biscuit flavour F07012, Ammonium glycyrrhizate, Macrogol 6000.

Major incompatibilities:
None known

Shelf life:
Therios 300 mg and 750 mg: 3 years

Shelf-life after first opening the immediate packaging: 48 hours. Any divided tablet portions remaining after 48 hours should be discarded.

Special precautions for storage:
Do not store above 25 °C. Divided tablets should be stored in the blister pack.

Immediate packaging:
Therios 300 mg Tablets: Polyvinylchloride blister heat sealed with an aluminium cover foil.

Pack sizes: Cardboard box with 1 blister of 10 tablets; Cardboard box with 20 blisters of 10 tablets.

Therios 750 mg Tablets: Polyvinylchloride blister heat sealed with an aluminium cover foil.

Pack sizes: Cardboard box with 1 blister of 10 tablets; Cardboard box with 20 blisters of 10 tablets.

Not all pack sizes may be marketed.

Disposal:
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements



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