Spectramast

Description

Ceftiofur hydrochloride is a cephalosporin antibiotic characterized by its complex chemical structure, designated as U-64279A. The chemical name is 5-Thia-1-azabicyclo4.2.0oct-2-ene-2-carboxylic acid, 7-[2-(2-amino-4-thiazolyl)-2-(methoxyimino)acetylamino]-3-[[2-furanyl-carbonylthio]methyl]-8-oxo, hydrochloride.

Ceftiofur Hydrochloride Sterile Suspension is formulated as an oil-based sterile suspension. Each 10 mL PLASTET® Disposable Syringe contains 500 mg of ceftiofur equivalents (as the hydrochloride salt), along with 700 mg of microcrystalline wax, 500 mg of oleoyl polyoxylglyceride, and cottonseed oil as a quantity sufficient (q.s.) component.

Uses and Indications

This drug is indicated for the treatment of subclinical mastitis in dairy cattle associated with Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis. It is specifically recommended for administration at the time of dry off.

Limitations of use include its application solely in dairy cattle and the specified bacterial pathogens.

Dosage and Administration

At the time of dry off, one (1) syringe should be infused into each affected quarter.

For full insertion, the red end cap must be removed by pulling it straight up. The full cannula should then be gently inserted into the teat canal, followed by careful infusion of the product.

In cases requiring partial insertion, the red end cap should similarly be removed by pulling it straight up. The exposed white tip should be gently inserted into the teat canal, and the product should be carefully infused.

Contraindications

The use of SPECTRAMAST® DC Sterile Suspension is contraindicated in animals with a known hypersensitivity to the drug. Due to the potential for severe allergic reactions, administration in these cases should be avoided.

Warnings and Precautions

Penicillins and cephalosporins are known to cause allergic reactions in individuals who have been sensitized. Topical exposure to these antimicrobials, including ceftiofur, may result in allergic reactions ranging from mild to severe. Repeated or prolonged exposure can lead to increased sensitization. Therefore, it is imperative to avoid direct contact of the product with the skin, eyes, mouth, and clothing. To minimize the risk of skin sensitization, the use of protective gloves is strongly recommended.

Individuals with a documented hypersensitivity to penicillin or cephalosporins should strictly avoid any exposure to this product. In the event of accidental exposure, specific measures should be taken: for eye exposure, it is essential to flush the eyes with water for at least 15 minutes; for skin exposure, wash the affected area thoroughly with soap and water and remove any contaminated clothing. Should an allergic reaction occur, characterized by symptoms such as skin rash, hives, or difficulty breathing, immediate medical attention is required.

For comprehensive occupational safety information, the Safety Data Sheet (SDS) should be consulted. Copies of the SDS can be obtained by contacting Zoetis Inc. at 1-888-963-8471. Additionally, to report adverse reactions or for further information regarding adverse drug experience reporting for animal drugs, healthcare professionals may reach out to the FDA at 1-888-FDA-VETS or visit www.fda.gov/reportanimalae.

Side Effects

Patients receiving SPECTRAMAST® DC Sterile Suspension may experience adverse reactions, particularly those related to hypersensitivity. Allergic reactions can occur in sensitized individuals, including mild to severe responses following topical exposure to the product. It is important to note that repeated or prolonged exposure may lead to sensitization.

To minimize the risk of allergic reactions, patients should avoid direct contact with the product, including the skin, eyes, mouth, and clothing. The use of protective gloves is recommended to prevent skin sensitization. In individuals with a known hypersensitivity to penicillins or cephalosporins, exposure to this product should be strictly avoided.

In the event of accidental exposure, specific measures should be taken. For eye exposure, it is advised to flush the eyes with water for 15 minutes. If the product comes into contact with the skin, the affected area should be washed with soap and water, and any contaminated clothing should be removed. Should an allergic reaction occur, characterized by symptoms such as skin rash, hives, or difficulty breathing, immediate medical attention is necessary.

The use of SPECTRAMAST® DC Sterile Suspension is contraindicated in animals that have previously demonstrated hypersensitivity to the drug.

Drug Interactions

Penicillins and cephalosporins are known to elicit allergic reactions in individuals who have previously been sensitized. It is imperative that individuals with a documented hypersensitivity to either penicillin or cephalosporins refrain from using this product to avoid potential adverse reactions.

In terms of laboratory test interactions, adherence to standardized procedures is essential. For both standardized diffusion and dilution techniques, the use of laboratory control organisms is required. Specifically, the 30 μg ceftiofur sodium disk should yield specific zone diameters, while the ceftiofur sodium standard reference powder or disk must provide designated minimum inhibitory concentration (MIC) values for the reference strain. This ensures the accuracy and reliability of laboratory results.

Packaging & NDC

The table below lists each NDC Code for Spectramast (ceftiofur hydrochloride) veterinary formulations. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

The prescribing information does not include specific details regarding pediatric use, such as recommended ages, dosing differences, safety concerns, or special precautions for children. A general warning is provided, stating "KEEP OUT OF REACH OF CHILDREN," which serves as a precautionary measure but does not elaborate on pediatric considerations. Therefore, healthcare professionals should exercise caution when considering this medication for pediatric patients, as no specific guidance is available.

Geriatric Use

Elderly patients may not require specific dosage adjustments or safety considerations when using SPECTRAMAST DC (ceftiofur hydrochloride), as the provided drug insert does not indicate any unique geriatric use considerations. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general principles of pharmacotherapy in older adults. It is advisable to assess the overall health status and comorbidities of geriatric patients to ensure safe and effective use of the medication.

Pregnancy

The use of SPECTRAMAST DC is contraindicated in pregnant animals. There are no specific safety studies available regarding the use of ceftiofur hydrochloride in pregnant animals, which suggests potential risks to the fetus. Due to the absence of safety data, caution is advised when considering the use of this drug in pregnant animals. No dosage modifications are indicated for use during pregnancy. Healthcare professionals should weigh the potential risks against the benefits when prescribing this medication to pregnant patients.

Lactation

Ceftiofur has the potential for excretion in breast milk. The safety and effectiveness of ceftiofur in nursing mothers have not been established. Caution should be exercised when administering ceftiofur to nursing mothers due to the potential for adverse effects on the breastfed infant.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population.

Overdosage

In the absence of specific information regarding overdosage, it is essential for healthcare professionals to remain vigilant and exercise caution when administering the medication.

Should an overdosage occur, the following general recommendations should be considered:

Recommended Actions Healthcare professionals are advised to monitor the patient closely for any signs of adverse effects. In the event of suspected overdosage, immediate medical attention should be sought.

Potential Symptoms While specific symptoms related to overdosage are not detailed, it is prudent to be aware of common signs that may indicate an adverse reaction to excessive dosing. These may include, but are not limited to, alterations in vital signs, neurological disturbances, or gastrointestinal symptoms.

Management Procedures Management of overdosage should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of antidotes. Healthcare providers should consult established clinical guidelines and toxicology resources for further information on managing potential overdosage scenarios.

In summary, due to the lack of specific overdosage information, healthcare professionals should prioritize patient safety through careful monitoring and prompt intervention when necessary.

Nonclinical Toxicology

The teratogenic potential of the substance has not been evaluated, as no information is available regarding teratogenic effects.

In studies assessing non-teratogenic effects, no adverse formulation-related events were observed throughout the duration of the study. There were no clinical signs indicative of udder irritation, such as swelling, pain, or redness, nor were there any changes in rectal temperature or milk production noted. Daily visual observations conducted over the 14 days following treatment did not report any instances of udder irritation or adverse reactions. Collectively, these findings indicate that the intramammary infusion of an oil-based sterile suspension containing 500 mg of ceftiofur, administered once into all four quarters at the end of lactation, is clinically safe and non-irritating to the udder of non-lactating dairy cows.

An udder irritation study was performed involving 22 healthy lactating dairy cows to evaluate the potential for udder irritation following a single intramammary infusion of a sterile oil-based suspension containing 500 mg of ceftiofur into all four quarters, with milk-out occurring 12 hours post-infusion. During the 10-day observation period following treatment, there was a clinically insignificant increase in somatic cell count (SCC), with mean levels rising to less than 200,000 cells/mL from a pre-infusion level of less than 69,000 cells/mL.

No information is available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has been evaluated through voluntary reports and surveillance programs. The Safety Data Sheet provides comprehensive occupational safety information and can be obtained by contacting Zoetis Inc. at 1-888-963-8471. For reporting adverse reactions, individuals may also reach out to the FDA at 1-888-FDA-VETS or visit www.fda.gov/reportanimalae.

During the postmarketing period, no adverse formulation-related events were reported throughout the study. Additionally, daily visual observations conducted over a 14-day period following treatment did not indicate any reports of udder irritation or other adverse reactions.

Patient Counseling

Healthcare providers should inform patients that federal law restricts the use of this drug to administration by or on the order of a licensed veterinarian. It is important to emphasize that federal law prohibits extra-label use of this drug in dry dairy cattle for disease prevention purposes, as well as at unapproved doses, frequencies, durations, or routes of administration, and in unapproved major food-producing species or production classes.

Patients should be advised to wash teats thoroughly with warm water containing a suitable dairy antiseptic and to dry the teats completely before treatment. They should ensure that the udder is completely milked out prior to application. Using the provided alcohol pad, patients should wipe off the end of the affected teat, utilizing a separate pad for each teat. When administering the drug, patients should choose the desired insertion length (full or partial), insert the tip into the teat canal, and push the plunger to dispense the entire contents. It is recommended to massage the quarter to distribute the suspension into the milk cistern.

Patients should be made aware that after successful treatment, reinfection may occur unless good herd management, sanitation, and mechanical safety measures are practiced. They should monitor affected cows closely for any signs of recurrence of infection and potential spread to other animals.

Healthcare providers should discuss the potential for allergic reactions associated with penicillins and cephalosporins, particularly in sensitized individuals. Patients should be cautioned that topical exposure to these antimicrobials, including ceftiofur, may elicit mild to severe allergic reactions. Repeated or prolonged exposure may lead to sensitization, and direct contact of the product with the skin, eyes, mouth, and clothing should be avoided. To minimize the risk of sensitization, patients should wear protective gloves.

Individuals with a known hypersensitivity to penicillin or cephalosporins should be advised to avoid exposure to this product. In the event of accidental eye exposure, patients should flush the eyes with water for 15 minutes. For accidental skin exposure, they should wash the affected area with soap and water and remove any contaminated clothing. If an allergic reaction occurs, such as skin rash, hives, or difficulty breathing, patients should seek medical attention immediately.

Patients should be informed that the Safety Data Sheet contains more detailed occupational safety information, and they can obtain a copy or report adverse reactions by calling Zoetis Inc. at 1-888-963-8471. For additional information regarding adverse drug experience reporting for animal drugs, they can contact the FDA at 1-888-FDA-VETS or visit www.fda.gov/reportanimalae.

Finally, patients should be instructed to discard the empty container and not to reuse it, and to keep the product out of reach of children.

Storage and Handling

The product is supplied in a carton containing plastets. It is essential to store the plastets at a controlled room temperature of 20° to 25° C (68° to 77° F). To ensure product integrity, it must be protected from light and should remain in the carton until ready for use.

Additional Clinical Information

Standardized procedures for laboratory tests involving ceftiofur sodium (SPL code 34075-2) necessitate the use of laboratory control organisms for both standardized diffusion and dilution techniques. Specifically, a 30 μg ceftiofur sodium disk should yield defined zone diameters, while the ceftiofur sodium standard reference powder or disk should provide specific MIC values for the reference strain. It is important to note that the ceftiofur sodium disks or standard reference powder are also suitable for use with ceftiofur hydrochloride.

No additional information is available regarding abuse, route, method, frequency of administration, patient counseling, or postmarketing experience.

Drug Information (PDF)

This document includes the full labeling information for Spectramast, as submitted by Zoetis Inc. for veterinary use. It may include dosage by species, withdrawal periods, and administration instructions.

View veterinary label (PDF)