VETRIMOXIN L.A.

VETRIMOXIN L.A. is a sterile, long-acting injectable suspension formulated for intramuscular administration in cattle and pigs ¹. The active pharmaceutical ingredient is amoxicillin, present at a concentration of 150 mg/ml as the trihydrate salt ¹. This formulation is specifically indicated for the treatment of respiratory infections in these target species, offering a convenient and effective therapeutic option for veterinary practitioners ¹. The extended duration of action associated with this product allows for less frequent administration, which can be beneficial in managing livestock health ⁷.

Product Overview

Presentation and Composition

VETRIMOXIN L.A. is a cream-beige suspension designed for intramuscular injection ². Each milliliter of the suspension contains 150 mg of amoxicillin, provided in a stable and readily absorbed trihydrate form ¹. The formulation also includes excipients such as anhydrous colloidal silica and sorbitan oleate, which contribute to the product’s stability, ease of suspension, and injectability ¹. The availability of the product in multiple vial sizes, including 100 ml, 250 ml, and potentially 500 ml, allows veterinarians to select packaging that best suits the scale of their practice and the number of animals requiring treatment ⁷. The use of micronized raw material in the formulation process facilitates easier resuspension and ensures smooth passage through needles of various gauges, a notable advantage particularly in swine where smaller needles are often preferred ¹¹.

Mechanism of Action

Amoxicillin, the active component of VETRIMOXIN L.A., is a semi-synthetic antibiotic belonging to the penicillin family and exhibits a broad spectrum of bactericidal activity ⁷. Its primary mode of action involves the disruption of bacterial cell wall synthesis ¹². Specifically, amoxicillin binds to essential penicillin-binding proteins (PBPs) located within the bacterial cell wall ¹³. These PBPs are crucial enzymes responsible for the transpeptidation reactions necessary for cross-linking peptidoglycan chains, which provide structural integrity and rigidity to the bacterial cell wall ¹⁵. By inhibiting these transpeptidases, amoxicillin prevents the formation of a stable cell wall, leading to cell lysis and subsequent bacterial death ¹⁵. Amoxicillin demonstrates efficacy against a range of Gram-positive bacteria, characterized by a thick peptidoglycan layer, and also against certain Gram-negative bacteria, which possess an additional outer membrane ¹³. It is important to note that the effectiveness of aminopenicillins like amoxicillin can be compromised by the production of beta-lactamase enzymes by some bacteria, which can hydrolyze the beta-lactam ring structure essential for the antibiotic’s activity ¹³. Therefore, VETRIMOXIN L.A. is indicated for use against bacteria that are susceptible to amoxicillin ¹.

Indications for Use

VETRIMOXIN L.A. is indicated for the treatment of respiratory infections in cattle and pigs caused by bacteria susceptible to amoxicillin ¹.

In cattle: It is specifically indicated for the treatment of respiratory infections caused by Mannheimia haemolytica and Pasteurella multocida ¹. These bacterial species are commonly implicated in Bovine Respiratory Disease (BRD), a significant health concern in cattle production ⁸.

In pigs: VETRIMOXIN L.A. is indicated for the treatment of respiratory infections caused by Pasteurella multocida ¹. Pasteurella multocida is a key pathogen associated with respiratory illnesses in swine.

While some sources suggest broader applications for treating diseases caused by amoxicillin-sensitive organisms in other livestock species such as sheep and goats, as well as potentially addressing neonatal diseases ⁷, the primary and consistently documented indications remain the treatment of specific respiratory infections in cattle and pigs. The suitability of VETRIMOXIN L.A. for managing BRD underscores its importance in bovine medicine, offering a reliable first-line antibiotic option for this prevalent and economically impactful condition.

Dosage and Administration

VETRIMOXIN L.A. is exclusively for intramuscular injection ¹. Prior to administration, the suspension must be thoroughly shaken to ensure a uniform distribution of the active ingredient ¹. The recommended dosage is 15 mg of amoxicillin per kilogram of body weight, which is equivalent to 1 ml of VETRIMOXIN L.A. for every 10 kg of the animal’s weight ¹. The administration should be repeated after an interval of 48 hours ¹. This long-acting formulation is designed to maintain effective therapeutic concentrations of amoxicillin over this period.

Accurate determination of the animal’s body weight is paramount to ensure the correct dosage is administered. Underdosing can lead to ineffective treatment and may contribute to the development of antimicrobial resistance ¹. To minimize the risk of local irritation and to facilitate proper drug absorption, the volume administered at a single injection site should not exceed 20 ml in cattle and 6 ml in pigs ¹. A separate injection site should be used for each administration ¹. Standard aseptic techniques should be employed during the injection process to prevent the introduction of infection at the injection site ¹. If a satisfactory clinical response is not observed following the second injection, it is crucial to re-evaluate the initial diagnosis and consider alternative treatment options ¹. To maintain the sterility of the product and prevent contamination, it is advised not to puncture the vial more than 10 times. If frequent use is necessary, the use of automatic syringes is recommended ¹.

Table 1: Dosage and Administration Guidelines for VETRIMOXIN L.A.

Contraindications

VETRIMOXIN L.A. is contraindicated in animals with a known history of hypersensitivity to penicillins, cephalosporins, or any of the excipients present in the formulation ¹. Its use is also contraindicated in animals suffering from severe renal dysfunction accompanied by anuria and oliguria ¹. The product should not be administered in cases of infection caused by beta-lactamase-producing bacteria, as amoxicillin’s efficacy would be significantly reduced ¹. Furthermore, VETRIMOXIN L.A. is contraindicated for use in rabbits, hares, hamsters, guinea pigs, and other small herbivores due to the potential for severe disturbances to their gastrointestinal flora ¹. Similarly, administration to Equidae (horses, donkeys, and related species) is not recommended as amoxicillin, like other aminopenicillins, can adversely affect the bacterial balance within the caecum ¹. Animals with known sensitivity or resistance to beta-lactam antibiotics, which include both penicillins and cephalosporins, should not be treated with this product ⁴. Finally, some sources also list rodents as a general contraindication ⁴. These contraindications highlight the importance of careful consideration of an animal’s medical history and species before administering VETRIMOXIN L.A. to avoid potentially harmful adverse reactions or ineffective treatment.

Warnings and Precautions

Special Warnings for Each Target Species

The available information does not specify any particular warnings unique to either cattle or pigs regarding the use of VETRIMOXIN L.A¹..

Special Precautions for Use

The use of VETRIMOXIN L.A. in a manner inconsistent with the instructions provided in the Summary of Product Characteristics may elevate the risk of bacteria developing resistance to amoxicillin. This can also potentially lead to cross-resistance with other penicillin antibiotics, diminishing their effectiveness in future treatments ¹. To promote responsible antibiotic usage, the selection of amoxicillin should ideally be guided by bacterial susceptibility testing whenever feasible, and should take into account official antimicrobial guidelines at national and regional levels ¹⁰. It is crucial to adhere to the recommended maximum injection volumes per site: 20 ml for cattle and 6 ml for pigs. If a noticeable clinical improvement is not evident after the second dose, a thorough re-evaluation of the initial diagnosis and a potential change in the treatment strategy are necessary ¹.

Special Precautions to be Taken by the Person Administering the Veterinary Medicinal Product to Animals

Penicillins and cephalosporins are known to cause allergic reactions in humans through accidental exposure, including injection, inhalation, or absorption through the skin. These reactions can range from mild skin irritations to severe, potentially life-threatening anaphylactic shock ¹. Individuals with a known hypersensitivity to penicillin may also exhibit cross-sensitivity to cephalosporins, and vice versa ¹. To minimize the risk of exposure, direct contact of VETRIMOXIN L.A. with the skin or mucous membranes should be avoided. The product should be handled with utmost care to prevent accidental exposure ¹. It is recommended to wear gloves during administration and to wash hands thoroughly with soap and water after use ¹. In the event of contact with skin or eyes, the affected area should be rinsed immediately with plenty of water ¹. It is also advisable to refrain from smoking, eating, or drinking while handling the veterinary medicinal product ¹. Should symptoms of an allergic reaction develop following exposure, such as a skin rash, immediate medical attention should be sought, and the product packaging or leaflet should be shown to the treating physician. More severe symptoms, including swelling of the face, lips, and eyes, or difficulty breathing, require urgent medical intervention ¹. These precautions are essential to ensure the safety of individuals involved in the administration of VETRIMOXIN L.A.

Adverse Reactions

In some instances, local irritation may occur at the site of injection following the administration of amoxicillin ¹. The likelihood of this adverse reaction can be reduced by adhering to the recommended maximum volume of injection per site ¹. Allergic reactions, varying in severity from mild skin manifestations like urticaria to the more severe anaphylactic shock, have also been reported with penicillin-based antibiotics, although the frequency specifically associated with VETRIMOXIN L.A. is not detailed as common in the provided sources ¹. Veterinary professionals should be aware of the potential for both local and systemic adverse reactions when using this product.

Use During Pregnancy and Lactation

While laboratory studies in rats and rabbits have not demonstrated any teratogenic, foetotoxic, or maternotoxic effects attributable to amoxicillin ¹, the safety and tolerance of VETRIMOXIN L.A. specifically in pregnant and lactating cattle and pigs have not been fully established through dedicated studies ¹. Therefore, the use of this veterinary medicinal product during pregnancy and lactation in these species should only be considered following a careful benefit/risk assessment conducted by a qualified veterinarian. This assessment should weigh the potential therapeutic benefits for the animal against any possible risks to the developing fetus or to the nursing offspring via milk transfer ¹.

Interaction with Other Medicinal Products

VETRIMOXIN L.A. should not be administered concurrently with antibiotics that inhibit bacterial protein synthesis, such as chloramphenicol, macrolides, sulphonamides, and tetracyclines ¹. These types of antibiotics can interfere with the bactericidal action of penicillins, potentially reducing the overall effectiveness of the treatment. Veterinarians should exercise caution when considering the concurrent use of VETRIMOXIN L.A. with other antimicrobial agents and ensure that potential antagonistic interactions are avoided to optimize therapeutic outcomes.

Withdrawal Periods

Following the administration of VETRIMOXIN L.A., specific withdrawal periods must be observed before animals can be slaughtered for meat or their milk can be used for human consumption. These periods are crucial to ensure that antibiotic residues in food products do not exceed safe levels. The withdrawal periods for VETRIMOXIN L.A. are as follows:

Table 2: Withdrawal Periods for VETRIMOXIN L.A.

It is important to note that variations in withdrawal periods may exist across different regions due to differing regulatory requirements. Therefore, it is imperative that users always consult the specific product label and adhere to the local regulations applicable in their region to ensure compliance and food safety.

Storage Conditions and Shelf Life

VETRIMOXIN L.A. should be stored at a temperature that does not exceed 25°C or 30°C, depending on the specific labeling and regional guidelines ⁴. Some sources recommend avoiding refrigeration and protecting the product from frost ¹⁰. The shelf life of the veterinary medicinal product as packaged for sale is typically 2 years from the date of manufacture ¹⁰. After the vial has been broached for the first time, the remaining contents should be used within 28 days ⁴. Any unused portion remaining after this period should be discarded appropriately. To protect the active ingredient from light exposure, the vial should be kept in its original outer carton ¹⁰. The product should not be used beyond the expiry date printed on the label ⁴. As a general precaution, all veterinary medicinal products should be stored out of the reach and sight of children ²¹. Adherence to these storage recommendations is essential for maintaining the quality and efficacy of VETRIMOXIN L.A.

Manufacturer Information

VETRIMOXIN L.A. is a product of Ceva Animal Health ¹. In the United Kingdom, Ceva Animal Health Ltd. can be contacted at telephone number 01628 334056, via their website at www.ceva.com, or by email at cevauk@ceva.com ¹. Contact details for other regional offices may vary. VETRIMOXIN L.A. is presented in Ceva’s patented CLAS® container, which offers several advantages including enhanced handling due to its ergonomic shape, increased shock resistance compared to glass vials, and a lighter weight ⁷. The formulation of VETRIMOXIN L.A. is specifically designed for excellent resuspension and syringeability, even when using needles with smaller diameters ⁸.

Conclusion

VETRIMOXIN L.A. provides veterinary professionals with a reliable long-acting antibiotic solution for treating common respiratory infections in cattle and pigs caused by amoxicillin-susceptible bacteria. Its formulation is designed for ease of use and sustained therapeutic action. However, it is crucial for practitioners to adhere strictly to the recommended dosage and administration guidelines, be aware of the contraindications and potential drug interactions, and emphasize the importance of observing the correct withdrawal periods to ensure animal and public health. Responsible use of this antibiotic, guided by susceptibility testing and consideration of antimicrobial policies, is essential to maintain its effectiveness and mitigate the risk of antimicrobial resistance. The safety of individuals administering the product must also be prioritized through adherence to the recommended handling precautions. By considering all aspects of this comprehensive product description, veterinary professionals can make informed decisions regarding the appropriate use of VETRIMOXIN L.A. in their clinical practice.