Marbocyl 20mg 10 tabs

Exp :- 2/9/2024



USES
Pharmacodynamic properties:
Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group which acts by inhibition of the DNA gyrase. It is effective against a wide range of Gram positive bacteria ( in particular staphylococci streptococci ) and Gram negative bacteria (Escherichia coli, Salmonella typhimurium, Citrobacter freundii, Enterobacter cloacae.
Serratia marcescens, Morganella morganii, Proteus spp.
Klebsiella spp. Shigella spp, Pasteurella spp,
Haemophilus spp, Moraxella spp, Pseudomonas spp,
Brucella canis) as well as Mycoplasma spp.

Pharmacokinetic properties:

After oral administration in dogs and cats at the recommended dose of 2 mg/kg, marbofloxacin is readily absorbed and reaches maximal plasma concentrations of 1.5 mg/ml within 2 hours.
Its bioavailability is close to 100 %.
It is weakly bound to plasma proteins (less than 10%), extensively distributed and in most tissues (liver, kidney, skin, lung, bladder, digestive tract) it achieves higher concentrations than in plasma.

Marbofloxacin is eliminated slowly (t1/2= 12-14 h in dogs and 8-10 h in cats) predominantly in the active form in urine (2/3) and faeces (1/3).

INDICATIONS

Infections caused by susceptible strains of organisms.

IN DOGS: Marbocyl P is indicated in the treatment of: Skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis). Urinary tract infections (UTI) associated or not with prostatitis.
Respiratory tract infections.
In cats: Marbocyl P is indicated in the treatment of : Skin and soft tissue infections (wounds, abscesses).
Upper respiratory tract infections.

DOSAGE AND ADMINISTRATION

Recommended dose rate:

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing. 2 mg/kg/day in dogs and cats in a single daily administration by oral route. The daily dose is achieved as follows:

Cats and small dogs:
MARBOCYLP5 mg-1 tablet per 2.5 kg bw
Medium dogs:
MARBOCYL P 20 mg-1 tablet per 10 kg bw

Duration of treatment:
DOGS:
- In skin and soft tissue infections, treatment duration is at least 5 days. Depending on the course of the disease, it may be extended up to 40 days
- In urinary tract infections, treatment duration is at least 10 days. Depending on the course of the disease, it may be extended up to 28 days.
-In respiratory infections, treatment duration is at least 7 days and, depending on the course of the disease, it may be extended up to 21 days

CATS:
-For skin and soft tissue infections (wounds, abscesses, phlegmons) treatment duration is 3 to 5 days.

- For upper respiratory infections treatment duration is 5 days. To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.

CONTRA-INDICATIONS AND WARNINGS
Marbofloxacin should not be used in dogs aged less than 12 months, or less than 18 months for exceptionally large breeds of dogs, such as Great Danes, Briards, Bernese Bouviers and Mastiffs, with a longer growth period. Not recommended for use in cats aged less than 16 weeks.

Not suitable for infections resulting from strict anaerobes, yeast or fungi. At the therapeutic recommended dosage, no severe side-effects are to be expected in dogs and cats. In particular, no lesions of the articular joints were encountered in clinical studies at the recommended dose rate. Mild side effects such as vomiting, softening of faeces, modification of thirst or transient increase in activity may occasionally occur. These signs cease spontaneously after treatment and do not necessitate cessation of treatment.
The fluoroquinolones have been shown to induce erosion of articular cartilage in juvenile dogs and care should be taken to dose accurately especially in young animals. The fluoroquinolones are also known for their potential neurological side effects. Cautious use is recommended in dogs and cats diagnosed as suffering from epilepsy. A low urinary pH could have an inhibitory effect on the activity of marbofloxacin Fluoroquinolones are known to interact with orally administered cations (Aluminium, Calcium, Magnesium, Iron). In such cases, the bioavailability may be reduced. Overdosage may cause acute signs in the form of neurological disorders, which should be treated symptomatically.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly to other classes of antimicrobials.
Whenever possible, use of fluoroquinolones should be based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease effectiveness of treatment with other quinolones due to the potential for
cross-resistance.

OPERATOR WARNINGS
People with known hypersensitivity to fluoroquinolones should avoid using this product.
In case of accidental ingestion, seek medical attention and show product label and/or package leaflet to the doctor. Wear gloves when handling or dividing tablets. Wash hands after use.
Do not use Marbocyl P 20 mg or Marbocyl P 80 mg tablets in cats. For the treatment of this species the 5 mg tablet should be used.
Studies in pregnant rats and rabbits showed no side effects on pregnancy. However no specific studies have been carried out in pregnant cats and dogs.
FURTHER INFORMATION
At the therapeutic recommended dosage, no severe side-effects are to be expected in dogs and cats. In particular, no lesions of the articular joints were encountered in clinical studies at the recommended dose rate.