Pisadrax

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

FORMULA:

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

PHYSICO-CHEMICAL CHARACTERISTICS:

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

MECHANISM OF ACTION:

Macrolides are bacteriostatic antibiotics and 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 tissue distribution, and slow elimination, which collectively contribute to high and sustained lung concentrations.

In cattle after subcutaneous administration, Tulathromycin is rapidly and almost completely absorbed (bioavailability > 90%). The volume of distribution is very large (approximately 11L/kg); this extensive volume of distribution is largely responsible for the long elimination half-life of the compound. 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 through biliary excretion.
 

INDICATIONS PER SPECIES:

PISADRAX® is indicated in the treatment and management of beef cattle with bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni (Haemophilus somnus), and Mycoplasma bovis. Treatment of interdigital necrobacillosis associated with Fusobacterium necrophorum and Porphyromonas levii. And as a treatment for Bovine Infectious Keratoconjunctivitis (BIK) associated with Moraxella bovis.
 

ROUTE OF ADMINISTRATION.

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

DOSAGE:

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 disease 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.
• Should not be administered to dairy cows 20 months of age or older.
• Do not use in calves intended for veal.
   

OVERDOSAGE:

In cattle, at doses 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 simultaneously with antimicrobials with a similar mode of action, such as other macrolides or lincosamides.
 

WARNINGS:

• Product for exclusive use in veterinary medicine, not for human use.
• Keep out of reach of children.
• Store at room temperature not exceeding 30°C.
• Do not administer to cattle whose milk is intended for human consumption.
• Once opened, the product must be used within 30 days.
   

PRECAUTIONS:

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

WITHDRAWAL PERIOD:

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

PRESENTATION:

One bottle with 20 mL, 50 mL, 100 mL, 250 mL, and 500 mL.
Consult a Veterinary Zootechnician
Information exclusive for Veterinary Zootechnicians.
Requires a prescription for sale.
 

CONSULT A VETERINARY ZOOTECHNICIAN

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

Content responsible.
Technical Department, PiSA Agropecuaria S.A. de C.V.
 

Comparative pharmacokinetic test

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

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

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, as there was no significant statistical 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.