Cefabactin 250 mg Tablets for Dogs and Cats

Composition

Each tablet contains:

Active substance:

Cefalexin (as cefalexin monohydrate) 250 mg

Excipient(s):

For the full list of excipients, see section 6.1

6.1 List of excipients

Lactose monohydrate

Potato Starch

Silica, colloidal hydrated

Yeast (dried)

Chicken Flavour

Magnesium stearate

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Pharmaceutical form

Tablet.

Light brown with brown spots, round and convex, flavoured tablet with a cross-shaped break line on one side.

Tablets can be divided into 2 or 4 equal parts.

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Pharmacological properties

Pharmacotherapeutic group: Antibacterial for systemic use, first-generation cephalosporins

ATCvet code: QJ01DB01

5.1 Pharmacodynamic properties

The mechanism of action of cephalosporins resembles that of the penicillins, in particular that of ampicillin (common beta-lactam ring). Cephalosporins especially has a time-dependent bactericidal effect in dividing bacteria. They bind irreversibly with 'penicillin-binding proteins (PBPs’), enzymes that are needed for the cross-coupling of peptidoglycan strands during the synthesis of the bacterial cell wall. This interferes with the cross-linkage of peptidoglycan chains necessary for bacterial cell strength and rigidity, and results in abnormal cell growth and cell lysis. Cephalexin is active against both gram positive and some gram negative bacteria.

The following CLSI cephalothin veterinary breakpoints are available for dogs CLSI VET01S ed. 5, November 2020).

Cephalothin can be used as indicator of first generation cephalosporins.

Skin and soft tissue infections:

Urinary tract infections:

Bacterial species | Susceptible | Resistant

E. coli, Klebsiella pneumoniae and Proteus mirabilis | ≤ 16 μg/ml | ≥ 32 μg/ml

As with penicillins resistance to cefalexin may be due to one of the following mechanisms of resistance: the production of various beta-lactamases, encoded on plasmids or not encoded or by multistage mutations. In the first case, there is almost always cross-resistance with ampicillin; in the other cases there is partial or complete cross-resistance to all penicillins and cephalosporins. Conversely, methicillin-resistant staphylococci are unsusceptible to cephalosporins.

5.2 Pharmacokinetic particulars

After administration of cephalexin monohydrate cephalexin rapidly and almost completely absorbed in the gastrointestinal tract. Absorption is delayed by food (lower blood levels). Protein plasma binding is approximately 20%.

Single oral administration of 20 mg of cephalexin per kg body weight to dogs resulted in a Tmax of approximately 1-1.5 hours, a Cmax in plasma of about 15 µg/ml and an elimination half-life of about 2 hours (bioavailability = 75% -80%). The volume of distribution is 1.62 l/kg.

Single oral administration of 15 mg cefalexin per kg body weight to cats gave a Tmax of approximately 1.5-2 hours, a Cmax in plasma of about 20 µg/ml and an elimination half-life of appr. 2 hours (bioavailability = 56%). The volume of distribution is 0.83 l/kg.

After absorption, cephalexin is well distributed in the extracellular fluids of the body, however, the passage of biological membranes is limited. The concentrations of cephalexin are highest in the kidneys (urine), and bile, followed by the liver, lungs, heart, skeletal muscle and spleen.

Hardly any metabolism occurs in the liver. Elimination is almost entirely via the kidneys by tubular excretion and glomerular filtration. Cephalexin is also excreted in the bile in a concentration that is equal or somewhat higher than in the blood.

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Target species

Dogs and cats.

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Indications

For the treatment of:

- Respiratory tract infections, especially bronchopneumonia, caused by Staphylococcus aureus, Streptococcus spp., Escherichia coli and Klebsiella spp.

- Urinary tract infections caused by Escherichia coli, Proteus spp. and Staphylococcus spp.

- Skin infections in cats caused by Staphylococcus spp. and Streptococcus spp. and skin infections in dogs caused by Staphylococcus spp.

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Dosage

For oral use.

The recommended dose is 15-30 mg cefalexin per kg body weight twice a day, during at least 5 consecutive days. An extended course of treatment may be prescribed by the responsible veterinarian in cases of, for example, urinary tract infections or bacterial dermatitis.

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

The following table is intended as a guide to dispensing the veterinary medicinal product at a dose rate of 15 mg cefalexine per kg body weight twice a day.

ADMINISTRATION TWICE DAILY

= ¼ Tablet = ½ Tablet = ¾ Tablet = 1 Tablet

Tablets can be divided into 2 or 4 equal parts to ensure accurate dosing. Place the tablet on a flat surface with its scored side facing up.

Halves: press down with your thumbs on both sides of the tablet.

Quarters: press down with your thumb in the middle of the tablet.

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Contraindications

Do not use in cases of hypersensitivity to the active substance, to other cephalosporins, to other substances of the β-lactam group or to any of the excipients. Do not use in known cases of resistance to cephalosporins or penicillins.

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

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Adverse reactions

Dogs:

Rare (1 to 10 animals / 10,000 animals treated):

Hypersensitivity reactiona

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Vomiting b, Diarrhoea b,

Lethargy

a The treatment should be discontinued.

b In case of recurrence, the treatment should be discontinued and the advice of the attending veterinarian sought.

Cats:

Very common (>1 animal / 10 animals treated):

Vomitinga, Diarrhoeaa

Rare (1 to 10 animals / 10,000 animals treated):

Hypersensitivity reactionb

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Lethargy

a Mild and transient. The symptoms were reversible in most cats without symptomatic treatment.

b The treatment should be discontinued.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for use in animals

Due to the likely variability (time, geographical) in the occurrence of cefalexin resistant bacteria, bacteriological sampling and susceptibility testing are recommended.

The veterinary medicinal product should only be used based on susceptibility testing of the bacteria isolated from the animals. If this is not possible, therapy should be based on local epidemiological information.

Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.

Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to cefalexin and may decrease the effectiveness of treatment with other beta-lactam antibiotics due to the potential for cross-resistance.

In case of chronic renal insufficiency the dose should be reduced or the dosage interval should be increased.

The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross-reactions to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this veterinary medicinal product if you know you are sensitised or if you have been advised not to be in contact with such substances.

Handle this veterinary medicinal product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.

To avoid accidental ingestion of the veterinary medicinal product by a child, divided or unused tablets should be returned to the open blister pocket and placed back in the outer carton.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

Special precautions for the protection of the environment

Not applicable.

Other precautions

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Laboratory studies in rats and mice have not produced any evidence of teratogenic effects.

The safety of the veterinary medicinal product in dogs and cats has not been established during pregnancy and lactation. Use only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

In order to ensure efficacy, the veterinary medicinal product should not be used in combination with bacteriostatic antibiotics (macrolides, sulfonamides and tetracyclines). Concurrent use of first generation cephalosporins with aminoglycoside antibiotics or some diuretics such as furosemide can enhance nephrotoxicity risks.

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Overdose

No other known side effects than those under section 4.6.

In the event of overdose, treatment should be symptomatic.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

Aluminium - PVC/PE/PVDC blister.

Cardboard box of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 25 blisters of 10 tablets.

Cardboard box containing 10 separate cardboard boxes, each containing 1 blister of 10 tablets.

Not all pack sizes may be marketed.

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Storage

Do not store above 25 °C.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life of divided tablets: 4 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

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

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Additional information

Vm 41821/5016

9 DATE OF FIRST AUTHORISATION

22 September 2016

10 DATE OF REVISION OF THE TEXT

March 2024

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ or ‘PID’ on www.gov.uk.

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Registration holder

Le Vet Beheer B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

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