Spectramast

Description

Ceftiofur hydrochloride is a cephalosporin antibiotic with the chemical name 5-Thia-1-azabicyclo 4.2.0 oct-2-ene-2-carboxylic acid, 7-[2-(2-amino-4-thiazolyl)-2-(methoxyimino)acetylamino]-3-[[2-furanylcarbonyl thio]methyl]-8-oxo, hydrochloride. SPECTRAMASTR LC Sterile Suspension is formulated as an oil-based sterile suspension. Each 10 mL PLASTETR Disposable Syringe contains 125 mg of ceftiofur equivalents (as the hydrochloride salt), 700 mg of microcrystalline wax, 500 mg of oleoyl polyoxylglyceride, and cottonseed oil as a quantity sufficient (q.s.) component.

Uses and Indications

SPECTRAMAST® LC (ceftiofur intramammary suspension) is indicated for use in lactating dairy cattle. This drug is indicated for the treatment of clinical mastitis associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli. Additionally, it is indicated for the treatment of diagnosed subclinical mastitis associated with coagulase-negative staphylococci and Streptococcus dysgalactiae.

Limitations of use: SPECTRAMAST® LC is specifically formulated for lactating dairy cattle and should not be used in other animal species or in non-lactating cattle.

Dosage and Administration

Healthcare professionals are advised to infuse one (1) syringe into each affected quarter. This treatment should be repeated after 24 hours. For patients requiring extended duration therapy, once daily treatment may be continued for up to 8 consecutive days.

Contraindications

The use of SPECTRAMAST LC Sterile Suspension is contraindicated in animals with a known hypersensitivity to the drug. This contraindication is based on the potential for severe allergic reactions in sensitized individuals.

Warnings and Precautions

Penicillins and cephalosporins are known to cause allergic reactions in individuals who are 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 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 known hypersensitivity to penicillin or cephalosporins should strictly avoid exposure to this product. In the event of accidental exposure, specific measures should be taken: if the product comes into contact with the eyes, it is essential to flush the eyes with water for at least 15 minutes. For skin exposure, the affected area should be washed thoroughly with soap and water, and any contaminated clothing should be removed immediately. Should an allergic reaction occur, characterized by symptoms such as skin rash, hives, or difficulty breathing, prompt medical attention is necessary.

For comprehensive occupational safety information, refer to the Safety Data Sheet. Copies of the Safety Data Sheet 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 contact the FDA at 1-888-FDA-VETS or visit www.fda.gov/reportanimalae.

Side Effects

Patients may experience a range of adverse reactions associated with the use of SPECTRAMAST LC Sterile Suspension. Notably, allergic reactions can occur in sensitized individuals, particularly among those with a known hypersensitivity to penicillins or cephalosporins. These reactions may vary in severity from mild to severe and can manifest as skin rashes, hives, or respiratory difficulties.

Topical exposure to ceftiofur, a component of this product, has been reported to elicit allergic reactions, and repeated or prolonged exposure may lead to sensitization. To minimize the risk of sensitization, it is advised that patients avoid direct contact with the product, including the skin, eyes, mouth, and clothing. Protective gloves should be worn to prevent skin sensitization.

In the event of accidental exposure, specific measures should be taken. For eye exposure, it is recommended to flush the eyes with water for 15 minutes. In cases of skin exposure, the affected area should be washed thoroughly with soap and water, and any contaminated clothing should be removed. Should an allergic reaction occur, immediate medical attention is necessary.

The use of SPECTRAMAST LC Sterile Suspension is contraindicated in individuals who have previously demonstrated hypersensitivity to the drug.

Drug Interactions

Penicillins and cephalosporins are known to elicit allergic reactions in individuals who are sensitized to these classes of antibiotics. It is imperative that individuals with a documented hypersensitivity to penicillin or cephalosporins refrain from exposure to this product to avoid potential adverse reactions.

In the context of drug and laboratory test interactions, it is essential to note that following intramammary infusion with antibiotics in lactating cows, any milk obtained during the treatment period, as well as during the subsequent milk discard period, must be properly discarded. This milk should not be fed to calves to prevent any unintended exposure to antibiotics.

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

Pediatric patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. During treatment and the subsequent milk discard period, any milk obtained should be properly discarded and not fed to calves, ensuring safety and compliance with treatment protocols.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns associated with SPECTRAMAST LC (ceftiofur hydrochloride suspension) as indicated in the prescribing information. Therefore, healthcare providers may administer this medication to geriatric patients without the need for modifications based on age. However, standard clinical judgment should be exercised when treating elderly patients, taking into account their overall health status and any concomitant medications.

Pregnancy

The use of SPECTRAMAST LC is contraindicated in pregnancy. There are no specific safety studies provided for the use of ceftiofur in pregnant animals, indicating potential risks to the fetus. Therefore, caution is advised when using this product in pregnant animals due to the lack of safety data. No dosage modifications are mentioned for use during pregnancy. Healthcare professionals should consider these factors when prescribing SPECTRAMAST LC to women of childbearing potential or in situations involving pregnant patients.

Lactation

Milk taken from cows during treatment with this product, as well as for 72 hours after the last treatment, must not be used for human consumption.

In lactating cows, following intramammary infusion with antibiotics, milk obtained during treatment and during the milk discard period should be properly discarded and not fed to calves.

Healthcare professionals should advise lactating mothers to adhere to these guidelines to ensure the safety of breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

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

Should an overdosage occur, it is recommended that healthcare providers assess the patient for any potential symptoms that may arise, although specific symptoms have not been detailed in the available literature.

Management of an overdosage situation should involve standard supportive care measures. This may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient’s safety. In cases where the overdosage is suspected, immediate consultation with a poison control center or a medical toxicologist is advised to determine the most appropriate course of action.

Healthcare professionals are encouraged to report any cases of overdosage to the relevant authorities to contribute to the ongoing assessment of the medication's safety profile.

Nonclinical Toxicology

A pivotal GLP udder irritation study was conducted in 40 cows to evaluate udder irritation following daily intramammary infusion of an oil-based suspension containing 125 mg of ceftiofur for up to 8 consecutive days. The study observed a transient and clinically insignificant rise in somatic cell count (SCC) to levels below 200,000 cells/mL in normal cows with very low pre-infusion SCC (less than 10,000 cells/mL). This elevation is consistent with the use of oil-based suspensions, and the duration of therapy did not influence this increase. Throughout the study, no clinical signs of udder irritation, such as swelling, pain, or redness, were noted, nor were there any changes in body temperature or milk production. This pivotal GLP study confirmed that the formulation is clinically safe and non-irritating to the udder of lactating dairy cows.

In addition, two clinical field efficacy studies involving 971 lactating dairy cows reported no instances of udder irritation or adverse events following infusion. Collectively, these three studies demonstrate that the intramammary infusion of an oil-based suspension containing 125 mg of ceftiofur once daily into all four quarters for up to 8 consecutive days is clinically safe and non-irritating to the udder of lactating dairy cows.

No data regarding teratogenic effects or nonclinical toxicology are available in the provided text.

Postmarketing Experience

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

In two clinical field efficacy studies involving 971 lactating dairy cows, no instances of udder irritation or other adverse events were reported following the infusion of an oil-based suspension containing 125 mg of ceftiofur. These studies collectively indicate that the intramammary infusion of the product, administered once daily into all four quarters for up to 8 consecutive days, is clinically safe and nonirritating to the udder of lactating dairy cows.

Patient Counseling

Healthcare providers should inform patients that federal law restricts the use of this drug to licensed veterinarians or their orders. It is crucial to emphasize that extra-label use in lactating dairy cattle for disease prevention, at unapproved doses, frequencies, durations, or routes of administration, and in unapproved major food-producing species or production classes is prohibited.

Patients should be advised to discard the empty container and not to reuse it. Additionally, it is important to keep the product out of reach of children.

Healthcare providers should discuss the potential for allergic reactions associated with penicillins and cephalosporins, particularly in sensitized individuals. They should inform patients that topical exposure to these antimicrobials, including ceftiofur, may lead to mild to severe allergic reactions, and that repeated or prolonged exposure could result in sensitization. To minimize the risk of sensitization, patients should avoid direct contact with the product and wear protective gloves.

In the event of accidental exposure, healthcare providers should instruct patients on the appropriate actions to take. For eye exposure, they should flush the eyes with water for 15 minutes. For skin exposure, they should wash the area with soap and water and remove any contaminated clothing. If an allergic reaction occurs, such as a skin rash, hives, or difficulty breathing, patients should seek medical attention immediately.

Healthcare providers should also provide patients with information on obtaining the Safety Data Sheet for more detailed occupational safety information. They can contact Zoetis Inc. at 1-888-963-8471 for a copy or to report adverse reactions. For additional information regarding adverse drug experience reporting for animal drugs, patients can reach out to the FDA at 1-888-FDA-VETS or visit www.fda.gov/reportanimalae.

Patients must be made aware that milk from treated cows should not be used for human consumption during treatment and for 72 hours after the last treatment, which includes a maximum of eight daily infusions. Following label use for up to eight consecutive days, a 2-day pre-slaughter withdrawal period is required. It is essential to note that using this product in a manner other than indicated under DOSAGE may result in violative residues.

Healthcare providers should clarify that SPECTRAMAST LC is intended solely for use in lactating dairy cattle with mastitis associated with the specified labeled pathogens. To ensure responsible antimicrobial drug use, it is expected that subclinical mastitis be diagnosed using a positive culture or other pathogen-specific tests, along with appropriate veterinary medical evaluation prior to treatment. Cows exhibiting systemic clinical signs due to mastitis should receive additional therapy under the guidance of a licensed veterinarian.

Finally, patients should be advised that after successful treatment, reinfection may occur unless good herd management, sanitation, and mechanical safety measures are implemented. Affected cows should be monitored closely for signs of recurrence of infection and potential spread to other animals.

Storage and Handling

The product is supplied in a configuration that includes syringes, which should be stored in their original carton or pail until ready for use. It is essential to maintain storage conditions at a controlled room temperature of 20° to 25° C (68° to 77° F). Additionally, the product must be protected from light to ensure its integrity and efficacy.

Additional Clinical Information

Patients receiving treatment should be administered an intramammary infusion of an oil-based suspension containing 125 mg of ceftiofur once daily into all four quarters for a duration of up to 8 consecutive days. There are no additional details available regarding laboratory tests, abuse information, 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)