Repeated or prolonged exposure may lead to sensitization. NAXCEL Sterile Powder is indicated for treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Ceftiofur has also been approved in various countries for early mortality infections in day-old chicks and turkey poults. USA.gov. Comparison of plasma pharmacokinetics and bioequivalence of ceftiofur sodium in cattle after a single intramuscular or subcutaneous injection. These data collectively support a 4-day pre-slaughter withdrawal period in swine when used according to label directions. Available for Android and iOS devices. NAXCEL Sterile Powder is indicated for the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old turkey poults. As with any parenteral injection, localized post-injection bacterial infections may result in abscess formation.  |  Taverne FJ, van Geijlswijk IM, Heederik DJ, Wagenaar JA, Mouton JW. Pharmacokinetics of ceftiofur in llamas and alpacas. Twelve (12) lactating dairy goats (46-71 kg body wt at study initiation) were divided into four treatment groups and dosed with ceftiofur sodium at 1.1 mg ceftiofur free acid equivalents (CFAE)/kg or 2.2 CFAE/kg using a complete two route (intravenous, i.v. NLM The 30 µg ceftiofur sodium disk should give the following zone diameters and the ceftiofur sodium standard reference powder (or disk) should provide the following MIC values for the reference strain. One udder half of each goat was infused twice with 125 mg ceftiofur with a 24-h interval between infusions. goats at doses up to 2.2 mg ceftiofur free acid equivalents/kg body weight, neither a milk discard period nor a pre-slaughter withdrawal period is required. NAXCEL Sterile Powder contains the sodium salt of ceftiofur which is a broad spectrum cephalosporin antibiotic active against gram-positive and gram-negative bacteria including β-lactamase-producing strains. Treatment should be repeated at 24-hour intervals for a total of three con- secutive days. Based on the pharmacokinetic studies of ceftiofur in swine and cattle after a single intramuscular injection of 1.36 to 2.27 mg ceftiofur equivalents/lb (3.0 to 5.0 mg/kg) BW (swine) or 0.5 to 1.0 mg ceftiofur equivalents/lb (1.1 to 2.2 mg/kg) BW (cattle) and the MIC and disk (30 µg) diffusion data, the following breakpoints are recommended by CLSI. Ceftiofur sodium disks or powder reference standard is appropriate for both ceftiofur salts. NAXCEL Sterile Powder is indicated for treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida. Each mL of the resulting solution contains ceftiofur sodium equivalent to 50 mg ceftiofur. Ceftiofur is poorly absorbed orally, and must be given as an injection. KEEP OUT OF REACH OF CHILDREN. Administer to goats by intramuscular injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Goats. J Vet Pharmacol Ther. This is a one-time only salvage procedure for the remaining product. This site needs JavaScript to work properly. NAXCEL Sterile Powder is indicated for treatment of respiratory infections in horses associated with Streptococcus zooepidemicus. Prevention and treatment information (HHS). The boluses should be repackaged into smaller dosages for sheep and lambs. There were no adverse systemic effects indicating that the formulated ceftiofur has a wide margin of safety when injected intramuscularly into the feeder calves at 10 times (10 mg/lb/day) the recommended dose for three times (15 days) the recommended three to five days of therapy. Additional treatments may be administered on days four and five for animals that do not show a satisfactory response (not recovered) after the initial three treatments. Fernández-Varón E, Cárceles-García C, Serrano-Rodríguez JM, Cárceles-Rodríguez CM. Use of dosages in excess of those indicated or by unapproved routes of administration, such as intramammary, may result in illegal residues in edible tissues and/or in milk. In a 15-day safety/toxicity study, five steer and five heifer calves per group were intramuscularly administered formulated ceftiofur at 0 (vehicle control), 1, 3, 5 and 10 times the highest recommended dose of 1.0 mg/lb/day to determine the safety factor. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments. The goats from the 2.2 mg/kg multiple dose group were dried off and the i.v. kinetic study repeated. 2004 Feb;27(1):13-20. doi: 10.1046/j.0140-7783.2003.00542.x. In the acute safety study, ceftiofur was well tolerated by dogs at the recommended level (1.0 mg/lb) for 5-14 days. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. Select one or more newsletters to continue. The material safety data sheet contains more detailed occupational safety information. However, a several square centimeter area of yellow-red discoloration resulting from a single SC injection persisted in many of the cattle beyond 4.5 days post-injection. MOM (Milk of Magnesia) – 15 cc per 60 lbs. Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure. NAXCEL Sterile Powder should be reconstituted as follows: 1 gram vial - Reconstitute with 20 mL Sterile Water for Injection. In the dose proportionality study, 48 animals received daily i.m. Attention to hygienic procedures can minimize their occurrence. Ceftiofur sodium- 1mg/ml - Rx. Each mL of the resulting solution contains ceftiofur sodium equivalent to 50 mg ceftiofur. Adult goats should have a dose of 5 to 10 cc orally. Results from a five-day tolerance study in normal feeder pigs indicated that formulated ceftiofur was well tolerated when administered at 57 mg/lb (more than 25 times the highest recommended daily dosage of 2.27 mg/lb of body weight) for five consecutive days. COWP are available as a copper supplement for cattle (12.5 and 25 g) and goats (2 and 4 g). bioavailability of ceftiofur sodium in goats was 100%, and the AUC0–∞ was dose-proportional from 1.1–2.2 mg CFAE/kg body weight. Administer by intramuscular or subcutaneous administration at the dosage of 1 to 2 mL per 100 lbs. Following subcutaneous administration of ceftiofur sodium in the neck of cattle, small areas of discoloration at the site may persist beyond five days, potentially resulting in trim loss of edible tissues at slaughter. of body weight for five consecutive days. Goats. ** Quality control ranges are applicable only to tests performed by disk diffusion test using a chocolate Mueller-Hinton agar, incubated in 5-7% CO2 for 20-24 hours. Keep in mind that overdosing can lead to constipation. Effects of age on the pharmacokinetics of single dose ceftiofur sodium administered intramuscularly or intravenously to cattle. A list of labeled uses of FDA-approved food animal drugs for Goats from the Veterinarian's Guide to Residue Avoidance Management (VetGRAM) Administer to horses by intramuscular injection at the dosage of 1.0 to 2.0 mg ceftiofur per pound (2.2 to 4.4 mg/kg) of body weight (2-4 mL reconstituted sterile solution per 100 lbs body weight). One mL of the 50 mg/mL reconstituted solution will treat approximately 100 to 294 day-old turkey poults. Antibiotics: Brand Name Approval Dosage Route Frequency Withdrawal Time Meat Milk. In this study, cattle received an intramuscular injection of 1.0 mg of ceftiofur per lb body weight (2.2 mg of ceftiofur per kg body weight) for five consecutive days. 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)(methoxyimino)-acetyl]amino]-3-[ [(2-furanylcarbonyl) thio] methyl]-8-oxo-, monosodium salt, [6R-[6α,7β(Z)]]-. Treatment should be repeated at 24-hour intervals for a total of three consecutive days. Also, one of the animals developed an abscess at the injection site. Milk samples were collected twice body weight (BW). After all injections, blood samples were obtained serially for determination of combined serum concentrations of ceftiofur and metabolites. twice daily; Milk withholding time: None; Notes: Naxel is often used on conjunction with penicillin. Treatment on day 1 was followed by 6 days of observation; body weight was determined on days 1, 4 and 7; and selected hematology parameters were evaluated on day 4. Every effort has been made to ensure the accuracy of the Naxcel information published above. Selection of dosage (0.5 to 1.0 mg/lb) should be based on the practitioner’s judgement of severity of disease (i.e., extent of elevated body temperature, depressed physical appearance, increased respiratory rate, coughing and/or loss of appetite). Ceftiofur pharmacokinetics in Nile tilapia Oreochromis niloticuswere studied following single intracardiac (i.c.) We comply with the HONcode standard for trustworthy health information -, Direction and dosage information for Naxcel. The adverse effects were most severe a few days after dosing was initiated and tended to become less severe toward the end of the 10-day dosing period. After all injections, blood samples were obtained serially for determination of combined serum concentrations of ceftiofur and metabolites. For horses, the typical dose is 1 - 2 mg/lb (2.2 - 4.4 mg/kg) every 24 hours intramuscularly. There were no adverse systemic effects indicating that formulated ceftiofur is well tolerated and has a wide margin of safety in sheep. Make sure you know the cause of the diarrhea before beginning any course of treatment. Like other cephalosporins, ceftiofur is bactericidal in vitro, resulting from inhibition of cell wall synthesis. Penicilllins (PCN) and ampicillin are in the same class because they work the same way. Therefore, only the 1 gram vial is approved for use in dogs. There is no slaughter withdrawal [2]. The susceptible only category is used for populations of organisms (usually one species) for which regression analysis (disk vs. MIC) cannot be performed. After all injections, blood samples were obtained serially for determination of combined serum concentrations of ceftiofur and metabolites. Table 2. A maximum of 10 mL may be administered per injection site. The pH was … No clinical evidence of irritation was noted at any dose. COVID-19 is an emerging, rapidly evolving situation. Decreased food consumption, a loss of body weight, hematologic changes related to acute inflammation and stress, and serum chemistry changes related to decreased food consumption and diarrhea were also associated with treatment at these doses. In a tolerance study, horses received a single daily intravenous infusion of either 0 (saline), 10.0 or 25.0 mg/lb/day of an aqueous solution (50 mg/mL) of ceftiofur for 10 days. The effects of ceftiofur on the reproductive performance, pregnancy, and lactation of cattle, swine, sheep, and goats have not been determined. Distributed by: Zoetis Inc., Kalamazoo, MI 49007, Copyright © 2021 Animalytix LLC. Ceftiofur sodium was well tolerated when administered intramuscularly to male and female horses at doses up to 5.0 mg/lb/day for 30 or 31 days. Based on the pharmacokinetic studies of ceftiofur in horses after a single intramuscular injection of 1 mg ceftiofur equivalents/lb (2.2 mg/kg) BW, clinical effectiveness data and MIC data, the following breakpoint is recommended by CLSI. Cephalosporins are beta lactam antiobioics, beta lactam drugs kill bacteria by interfering with an enzyme (beta lactam) the bacteria needs to build its cell wall. NAXCEL Sterile Powder is available in the following package sizes: 1 Clinical and Laboratory Standards Institute (CLSI). Based on examination of injection sites from study days 9, 11, 13 and 15, a low incidence of visual changes and histopathologic findings of mild, reversible inflammation from all groups including the controls indicated that the formulation is a slight muscle irritant. Six nonlactating and six lactating adult female goats received a single subcutaneous injection of ceftiofur crystalline free acid (CCFA) at a dosage of 6.6 mg/kg. Wang J, Schneider BK, Xue J, Sun P, Qiu J, Mochel JP, Cao X. Like other cephalosporins, ceftiofur is bactericidal in vitro, resulting from inhibition of cell wall synthesis. After five daily i.m. 1999 Feb;22(1):35-40. doi: 10.1046/j.1365-2885.1999.00182.x. NAXCEL Sterile Powder is also indicated for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. Administer by subcutaneous injection in the neck region of day-old chicks at the dosage of 0.08 to 0.20 mg ceftiofur/chick. Using twice the labeled dose is recommended in goats for routine worming. The formulation was shown to be a slight muscle irritant based on results of histopathological evaluation of the injection sites at 1 and 3 times the highest recommended dose of 1.0 mg/lb/day. When administered subcutaneously for 42 consecutive days, one of four females developed thrombocytopenia (15 days) and anemia (36 days). Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared and should not exceed 10 days. These breakpoints will permit detection of strains with decreased susceptibility as compared to the original population. In case of accidental skin exposure, wash with soap and water. A report of “Intermediate” is a technical buffer zone and isolates falling into this category should be retested. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert. Remove contaminated clothing. Color of the cake may vary from off-white to a tan color. Each mL of the reconstituted drug contains ceftiofur sodium equivalent to 50 mg ceftiofur.  |  Typically, lambs are given a 0.5 to 1 g, while ewes are given a 1-2 g dosage. The appropriate IM dosage is 4 cc's per 100 lbs. Use of dosages in excess of those indicated or by unapproved routes of administration, such as intramammary, may result in illegal residues in edible tissues and/or in milk. The study will also elucidate the effect of mastitis on the pharmacokinetics of these drugs. For intramuscular and subcutaneous injection in cattle only. In case of accidental eye exposure, flush with water for 15 minutes. The formulation was shown to be a slight muscle irritant based on results of histopathological evaluation of the injection sites at posttreatment days 1, 2, 3 and 4. In a 15-day safety/toxicity study 5 lactating does, 5 dry does, and 5 wethers were given formulated ceftiofur by the intramuscular route with 11 mg/kg/day for 15 days. Using three times the labeled dose is recommended for treating tapworm infections. Ceftiofur administered intramuscularly to pigs produced no overt adverse signs of toxicity. Use of dosages in excess of those indicated or by unapproved routes of administration may result in illegal residues in edible tissues. Horses usually receive 2 doses, 4 days apart, at the rate of 1.5 ml per 100 lbs body weight, given by intramuscular (IM) injection. In the reversibility phase of the study (5X dose), the thrombocytopenia reversed within 8 days, and of the two anemic animals the male recovered within 6 weeks and the female was sacrificed due to the severity of the anemia. Dosage is based on age not weight. Usage in goats is "off-label" or "extra-label," but this antibiotic is being used in goats by some veterinarians. It is used to treat a variety of infections in poultry. Brown SA, Hanson BJ, Mignot A, Millérioux L, Hamlow PJ, Hubbard VL, Callahan JK, Kausche FM. J Vet Pharmacol Ther. Blood samples were collected from the jugular vein before and at multiple time points after CCFA administration. administration of ceftiofur sodium (NAX- CEL ® ) in a dose of 5 mg ceftiofur kg −1 body weight. Would you like email updates of new search results? 1996 Feb;19(1):32-8. doi: 10.1111/j.1365-2885.1996.tb00005.x. Ready-to-use suspension. Protect from light. Treatment should be repeated at 24-hour intervals for a total of three consecutive days. dose of 2.2 mg/kg in non-lactating does was 254 min. Summaries of MIC data are presented in Tables 1 and 2. A report of “Resistant” indicates that the achievable drug concentrations are unlikely to be inhibitory and other therapy should be selected. BMC Vet Res. Administer to sheep by intramuscular injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). The i.m. The results indicated that ceftiofur administered intravenously at a dose of 10.0 or 25.0 mg/lb/day apparently can change the bacterial flora of the large intestine thereby leading to inflammation of the large intestine with subsequent diarrhea and other clinical signs (loose feces, eating bedding straw, dehydration, rolling or colic and a dull, inactive demeanor). Any underlying disease that results in metritis should be treated. After intravenous doses of 1.1 and 2.2 mg/kg, the harmonic means of the terminal phase half-lives were 171.8 and 233 min, respectively, for lactating does. To determine the safety factor and to measure the muscle irritancy potential in swine, a safety/toxicity study was conducted. The goats from the 2.2 mg/kg multiple dose group were dried off and the i.v. For lactating does, the high end of the dose range is recommended. Results from a five-day tolerance study in normal feeder calves indicated that formulated ceftiofur was well tolerated at 25 times (25 mg/lb/day) the highest recommended dose of 1.0 mg/lb/day for five consecutive days. eCollection 2019. A report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally achievable blood levels. Swine: When used according to label indications, dosage and route of administration, treated pigs must not be slaughtered for 4 days following the last treatment. In this study, pigs received 2.27 mg of ceftiofur per lb body weight (5 mg of ceftiofur per kg body weight) per day for three consecutive days. Please enable it to take advantage of the complete set of features! For subcutaneous injection only in dogs, day-old chickens and day-old turkey poults. Six nonlactating and six lactating adult female goats received a single subcutaneous injection of ceftiofur crystalline free acid (CCFA) at a dosage of 6.6 mg/kg. In an acute toxicity study of ceftiofur in day-old turkey poults, a total of 30 male and 30 female poults were each administered single subcutaneous injections of 100, 400 or 800 mg/kg body weight. AB - Six nonlactating and six lactating adult female goats received a single subcutaneous injection of ceftiofur crystalline free acid (CCFA) at a dosage of 6.6 mg/kg. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Ceftiofur sodium administered as a single dose (2.2 mg/kg, IV and SC) resulted in plasma concen-trations of active drug similar to those achieved with the approved IM route. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Ceftiofur Naxcel® APPROVED 0.5-1 mg/lb IM Once a day 0 days 0 days Neomycin Biosol® and other products. kinetic study repeated. Doses may vary in different species, when the … Rapid freezing or thawing may result in vial breakage. To use this salvaged product at any time during the 8-week storage period, hold the vial under warm running water, gently swirling the container to accelerate thawing, or allow the frozen material to thaw at room temperature. Testing followed Clinical and Laboratory Standards Institute (CLSI) Guidelines. Administer to goats by intramuscular injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). given orally and for a few kid friendly dosages it could be broke down as follows: 7 ½ cc per 30 lbs. The pH was adjusted with sodium hydroxide and monobasic potassium phosphate. For intramuscular injection in swine, sheep, goats and horses. Sheep: Neither a pre-slaughter drug withdrawal interval nor a milk discard time is required when this product is used according to label indications, dosage, and route of administration.