Pisadrax

PISADRAX® is an injectable antibiotic of the macrolide class, characterized by its efficacy, prolonged activity and slow elimination, used for the treatment of bovine respiratory disease and infectious bovine keratoconjunctivitis; as well as in the treatment of porcine respiratory disease.

FORMULA:

Each mL contains: Tulathromycin Excipients q.s.
100.0 mg. 1.0 mL.

PHYSICAL-CHEMICAL CHARACTERISTICS:

PISADRAX® is a semi-synthetic macrolide antimicrobial agent, structurally unique because it has three amino groups, therefore, it has been given the chemical subclass designation “triamilide”.

MECHANISM OF ACTION:

Macrolides are bacteriostatic antibiotics that inhibit the biosynthesis of essential proteins by selectively binding to bacterial ribosomal RNA. They act by stimulating the dissociation of peptidyl-rRNA from the ribosome during translocation processes.

PHARMACOKINETICS:

PISADRAX® when administered to cattle is characterized by rapid absorption from the injection site, extensive distribution in tissues, and slow elimination that collectively contribute to high and sustained pulmonary concentrations.

In cattle, following subcutaneous administration, tulathromycin is rapidly and almost completely absorbed (bioavailability > 90%). The volume of distribution is very large (approximately 11 L/kg), which is largely responsible for the compound's long elimination half-life. In plasma, the elimination half-life is approximately 2.75 days, but in lung tissue, it is approximately 8.75 days. PISADRAX® is primarily eliminated unchanged via biliary excretion.

INDICATIONS BY SPECIES:

PISADRAX® is indicated for the treatment and management of beef cattle with bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni (Haemophilus somnus), and Mycoplasma bovis . It is also used for the treatment of interdigital necrobacillosis associated with Fusobacterium necrophorum and Porphyromonas levii, and for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

ADMINISTRATION ROUTE.

In cattle, the recommended route of administration is subcutaneous in the neck area.

DOSE:

Beef cattle: administer 2.5 mg/kg of body weight, equivalent to 1 mL of PISADRAX® per 40 kg of body weight, as a single injection.



If clinical signs of respiratory illness persist after 48 hours, it is suggested to change the treatment using another antibiotic until the signs disappear.

CONTRAINDICATIONS:

• Contraindicated in animals with hypersensitivity to macrolide antibiotics.
• It should not be administered to dairy cows 20 months of age or older.
• Do not use on calves that are to be processed for beef.
  

OVERDOSE:

In cattle, at doses of three, five, or ten times the recommended dose, transient signs attributed to discomfort at the injection site were observed.

DRUG INTERACTIONS:

Cross-resistance exists with other macrolides. Do not administer concurrently with antimicrobials with a similar mode of action, such as other macrolides or lincosamides.

WARNINGS :

• Product for exclusive use in veterinary medicine, do not use on humans.
• Keep out of reach of children.
• Store at room temperature no higher than 30°C.
• Do not administer to cattle whose milk is intended for human consumption.
• Once opened, the product should be used within the next 30 days.
  

PRECAUTIONS :

In cattle, do not inject more than 7.5 mL per injection site.

RETIREMENT PERIOD:

Beef cattle: 18 days
Its use is not intended in cattle whose milk is intended for human consumption.

PRESENTATION:

A bottle containing 20 mL, 50 mL, 100 mL, 250 mL and 500 mL.
Consult a Veterinarian.
Exclusive information for Veterinary Zootechnicians.
Its sale requires a medical prescription.

CONSULT A VETERINARIAN OR ZOOTECHNICIAN

Any adverse reaction should be reported to the Veterinary Pharmacovigilance Unit of PiSA Agropecuaria.

Those responsible for the content.
Technical Department, PiSA Agropecuaria SA de CV

Comparative pharmacokinetic test

At the PiSA AGROPECUARIA experimental ranch, a comparative, randomized, prospective, single-blind study was conducted evaluating the Pisadrax® treatment (Tulathromycin 100 mg/mL from PiSA AGROPECUARIA) vs. the reference product treatment (Tulathromycin 100 mg/mL patent product), comparing pharmacokinetic variables at a dose of 2.5 mg/kg of weight.

Six male cattle of similar phenotype and breed, approximately 10 months old, were selected per treatment group and administered a dose of Tulathromycin subcutaneously, according to the label instructions. Blood samples were taken during the period determined in the test, and the plasma concentration of Tulathromycin was subsequently evaluated in each treatment group.

The results in Table 1 show that the pharmacokinetic values ​​of the plasma concentration of the Pisadrax® product are statistically similar to those of the reference product, since there was no statistically significant difference in the values ​​obtained. Therefore, it is expected that, in everyday treatment situations, or metaphylaxis in high-risk cattle, in a production unit, the performance of Pisadrax® will be the same as that of the reference product.