Description

XCEFT Injection

Ceftiofur Sodium Sterile Powder for Injection

Ceftiofur Sodium Injection for Cattle, Horse, Swine, Sheep, Goat, and Dog

Manufactured/Marketed by: Alembic Pharmaceuticals Ltd.

Dosage form: Powder for Injection

Presentation: 

250 mg, 500 mg and 1000 mg vials

Ingredients & Composition:

Each vial contains:

Ceftiofur Sodium IP
equivalent to Ceftiofur         1 g / 500 mg / 250 mg
with water for injection 20 ml, 10 ml and 5 ml, respectively.

After reconstitution in given water for injection, each ml product solution will contain 50 mg Ceftiofur

Description / Action: 

Xceft injection contains ceftiofur sodium a third generation Cephalosporin group of antibiotics with broad spectrum bactericidal activity.

Physical And Chemical Characteristics:

Sterile Ceftiofur sodium is off white to yellow coloured crystalline powder, and hygroscopic in nature. It is soluble in water (pH 5.5-7.5). Each mi of the reconstituted drug contains Ceftiofur sodium equivalent to 50 mg Ceftiofur. The pH is adjusted with potassium dihydrogen phosphate.

Pharmacokinetics:

Bioavailability of Ceftiofur sodium in sheep and cattle:

The Bioavailability of Ceftiofur sodium and metabolites in sheep was established in a pharmacokinetic study that compared to plasma concentrations of Ceftiofur and desfuroylceftiofur metabolites after intravenous or intramuscular administration of 1.1 or 2.2 mg Ceftiofur/kg of body weight. Data from this pharmacokinetics study were compared to similar data generated in cattle. Plasma concentrations of Ceftiofur and desfuroylceftiofur metabolites in sheep and cattle were comparable at 24 hours (the dosing interval approved for Ceftiofur Sodium in cattle and the dosing interval proposed for the drug in Sheep). Due to an increased total body clearance in sheep as compared to cattle, the maximum serum concentration in sheep was less than maximum serum concentration in cattle. However, plasma concentrations at 24 hours were several folds above the MIC for the target pathogens (0.06 mcg/ml) in both sheep and cattle.

The dosage regimen of 1.1 to 2.2 mg/kg, of body weight in sheep provides therapeutic plasma concentrations for the target pathogens for the dosing interval (24 hr). The pharmacokinetic data from sheep were compared to historical cattle pharmacokinetic data (pharmacokinetic values were compared after intramuscular administration of Ceftiofur sodium in sheep and in cattle).

Pharmacodynamics:

In vitro susceptibility of sheep respiratory diseases bacterial pathogens to Ceftiofur sodium was established and expressed as Minimum Inhibitory Concentrations for 90% of the isolates (MIC). Test pathogens were isolated from the lungs and from trachea washes from sheep in a two country five location clinical study. The MIC of Ceftiofur against P. multocida isolates (n = 23) was 0.031 mcg/ml and against P haemolytica isolates (n=39) was 0.125mcg/ml. These data provide evidence of the susceptibility of sheep respiratory disease pathogens to Ceftiofur. MIC values for Ceftiofur against P. multocida and P. haemolytica from a four-year survey of antimicrobial susceptibility trends for isolates from bovine respiratory diseases in North America shows no changes in the susceptibility of these pathogens to Ceftiofur. Over the four years of this survey the MIC for these pathogens continues to be 0.06 mcg/ml. This study included 318 isolates of the P. multocida and 461 isolates of P. haemolytica that had been recovered from the lungs of cattle that had expired from acute BRD. The efficacy of Ceftiofur Sodium Injection for the treatment of bovine respiratory disease associated with Pasteurella haemolytica, Pasteurella multocida and Haemophilus somnus is documented.

Antimicrobial Activity:

The broad-spectrum bactericidal activity of Ceftiofur results from inhibition of bacterial cell wall synthesis. Ceftiofur demonstrates high degree of stability in the presence of b-lactamases both penicillinases and cephalosporinases of gram- positive and gram-negative bacteria.
A wide range of gram positive and gram-negative organisms are sensitive to XCEFT (Ceftiofur Sodium injection).

Gram-negative
Pasteurella haemolytica
Pasteurella multocida
Hemophilus somnus
Fusobacterium necrophorum
Actinobacillus pleuropneumoniae
Moraxella bovis
Bacteroides melaninogenicus

Gram-positive
Staphylococcus aureus
Staphylococcus agalactiae
Staphylococcus dysgalactiae
Streptococcus uberis
Streptococcus bovis
Streptococcus zooepidemicus
Actinomyces pyogenes

Class: Antibiotics (Third generation Cephalosporin)

Indication / Uses:

Cattle:

Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Pasteurella hemolytica, P. multocida and Haemophiles somnus in cattle. Also, for the treatment of acute interdigital necrobacillosis associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. Post-parturient diseases like metritis, pyometra, vaginitis, cervicitis, retention of placenta are also highly effective in Ceftiofur sodium treatment. The Diseases is manifested most often in cattle when animals are subjected to stressful situations such as weaning, housing in drafty or poorly ventilated buildings exposure to severe weather conditions, transport to feed lots and malnutrition.

Pneumonic pasteurellosis (bacterial pneumonia) is characterized in cattle by elevated temperature ocular and nasal discharge, depression, cough, respiratory stress, anorexia, reluctance to move and ultimately mortality in 1 to 5% of affected animals unless medical intervention occurs.

Swine:

For treatment and control of swine bacterial respiratory disease (Swine bacterial Pneumonia) associated with Actinobacillus (Haemophiles) Pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis Type 2.

Horses:

For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.

Dogs:

Treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis.

Sheep:

For treatment of sheep respiratory disease (Pneumonia) associated with Pasteurella hemolytica or P. multocida.

Dosage and administration:

Cattle, Sheep & Goat: 1.1 to 2.2 mg / kg. b.wt. or 1 to 2 ml (after reconstitution)/45.45 kg b.wt. i/m. use only, once daily for 3 to 5 days

Dog: 2.2 mg/kg b. wt. or 2 ml (after reconstitution)/45.45 kg. S/c. once daily for 5 to 14 days

Horse: 2.2 to 4.4 mg/kg. b.wt. or 1 to 2 ml (after reconstitution) /22.72 kg. b.wt. i/m. once daily for 3 to 5 days

Swine: 3 to 5 mg/kg.b.wt. or 1 to 1.7 ml. (after reconstitution)/16.66kg. b.wt. i/m., once daily for 3 to 5 days

Route(s):

Intramuscular: Cattle/Swine/Horse/Sheep/Goat.
Subcutaneous: Dog.

Direction for Reconstitution:

Shake the vial to loosen powder. Break the flip off seal.
Open the ampoule of Sterile Water for Injections IP given with this pack.
Pull out Sterile Water for Injections IP given with this pack with the help of syringe.
Slowly add sterile WFI into the vial with the help of syringe.
Shake the vial vigourously.

Overdoses / Side effects / Contraindications /Warnings:

Ceftiofur is contraindicated in animals with known history of allergy to Cephalosporins group of antibiotics.

Pharmaceutical precautions / Instructions: 

Store unreconstituted product at a temperature not exceeding 25°C. Store reconstituted product either in refrigerator 2°-8°C for upto 7 days or at controlled room temperature (15°-30°C) for upto 12 hours.
Keep the medicine out of reach of children. For veterinary use. Not for human use.
For the use of a Registered Veterinary Practitioner or a farm or a Laboratory.

Important: – Even visible damage to vial caused during transit, storage or handling may result in contamination. Do not use, if any foreign particle is visible in the vial.

Safety: Age / Pregnancy/ Withdrawal:

No information was available with the product.

Withdrawal Period: Cattle, Goat & Pig: Milk-0 days, Meat-04 days

Substitute: Updating Soon