NAXCEL- ceftiofur sodium powder

Naxcel by

Drug Labeling and Warnings

Naxcel by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • ANIMAL SAFETY

    Cattle

    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. Ceftiofur administered intramuscularly had no adverse systemic effects.

    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. 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. 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. The histopathological evaluations were conducted at posttreatment days 1, 3, 7 and 14.

    The injection of NAXCEL Sterile Powder at the recommended dose administered SC in the neck of cattle was well tolerated. 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. Also, one of the animals developed an abscess at the injection site.

    Swine

    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. Ceftiofur administered intramuscularly to pigs produced no overt adverse signs of toxicity.

    To determine the safety factor and to measure the muscle irritancy potential in swine, a safety/toxicity study was conducted. Five barrows and five gilts per group were intramuscularly administered formulated ceftiofur at 0, 2.27, 6.81 and 11.36 mg/lb of body weight for 15 days which is 0, 1, 3 and 5 times the highest recommended dose of 2.27 mg/lb of body weight/day and 5 times the recommended treatment length of 3 days. There were no adverse systemic effects indicating that formulated ceftiofur has a wide margin of safety when injected intramuscularly into feeder pigs at the highest recommended dose of 2.27 mg/lb/day for 3 days or at levels up to 5 times the highest recommended dose for 5 times the recommended length of treatment. 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. By day 10 post injection the muscle reaction was subsiding and at day 15 post injection there was little evidence of muscle damage in any of the pigs in any of the treatment groups.

    Sheep

    In a 15-day safety/toxicity study in sheep, three wether and three ewe lambs per group were given formulated ceftiofur sodium by the intramuscular route 0 (sterile water vehicle), 1, 3 or 5 times the recommended dose of 1.0 mg/lb/day for 3 times the recommended maximum duration of 5 days of treatment. There were no adverse systemic effects indicating that formulated ceftiofur is well tolerated and has a wide margin of safety in sheep. 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.

    Goats

    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. This constitutes 5 times the recommended dose for 3 times the recommended maximum duration of 5 days of treatment. There were no adverse systemic effects indicating that formulated ceftiofur is well tolerated and has a wide margin of safety in goats.

    Horses

    In a safety study, horses received a daily intramuscular injection of either 0 mg/lb/day (saline control), 1.0 mg/lb/day (50 mg/mL), 3.0 mg/lb/day (100 mg/mL), or 5.0 mg/lb/day (200 mg/mL) of an aqueous solution of ceftiofur sodium for 30 or 31 days. 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. No clinical evidence of irritation was noted at any dose. The drug-related changes detected in this study were limited to a transient decrease in food consumption in horses receiving 3.0 or 5.0 mg/lb/day ceftiofur, and general mild skeletal muscle irritation at the injection sites which resolved by regeneration of muscle fibers.

    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 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). 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. 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.

    Dogs

    Ceftiofur sodium was well tolerated at the therapeutic dose and is safe for the treatment of urinary tract infections in dogs. In the acute safety study, ceftiofur was well tolerated by dogs at the recommended level (1.0 mg/lb) for 5-14 days. When administered subcutaneously for 42 consecutive days, one of four females developed thrombocytopenia (15 days) and anemia (36 days). Thrombocytopenia and anemia also occurred at the 3× and 5× dose levels.

    In the reversibility phase of the study (5× 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. In the 15-day tolerance study in dogs, high subcutaneous doses (25 and 125 times the recommended therapeutic dose) produced a progressive and dose-related thrombocytopenia, with some dogs also exhibiting anemia and bone marrow changes. The hematopoietic changes noted in dogs treated with ceftiofur were similar to those associated with long-term cephalosporin administration in dogs and also man. The hematopoietic effects are not expected to occur as a result of recommended therapy.

    Day-Old Chicks

    In an acute toxicity study of ceftiofur in day-old chicks, a total of 60 male and 60 female chicks were each given single subcutaneous injections of 10, 100 or 1,000 mg/kg of body weight. 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. No meaningful differences were noted among the treated and control groups of chicks for the parameters evaluated. Histopathologic evaluation of all deaths and chicks surviving to termination did not reveal a target organ or tissue of potential toxicity of ceftiofur when administered at up to 20 times (100 mg/kg) the intended highest use dosage.

    Day-Old Turkey Poults

    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. Injection on day 1 was followed by 6 days of observation; body weight on days 1, 4, and 7; and selected hematology parameters on day 4. No meaningful differences were noted between the treated groups at 100 or 400 mg ceftiofur/kg and a negative control group for the parameters evaluated. Histopathologic evaluation of all deaths and poults surviving to termination did not reveal a target organ or tissue of potential toxicity of ceftiofur when administered at up to 50 times (400 mg/kg) the highest use dosage. A dose of 800 mg/kg (100 times the intended highest use dosage) was toxic, resulting in clinical signs and deaths accompanied by gross and microscopic morphologic tissue alterations.

  • TISSUE RESIDUE DEPLETION

    Cattle

    A radiolabeled residue metabolism study established tolerances for ceftiofur residues in cattle kidney, liver and muscle. These tolerances of ceftiofur residues are 0.4 ppm in kidney, 2.0 ppm in liver, 1.0 ppm in muscle, and 0.1 ppm in milk.

    A pivotal tissue residue decline study was conducted in cattle. 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. Ceftiofur residues in tissues were less than the tolerances for ceftiofur residues in tissues such as kidney, liver and muscle by 4 days after dosing. These data collectively support a 4-day pre-slaughter withdrawal period in cattle when used according to label directions.

    Swine

    Radiolabeled residue metabolism studies established tolerances for ceftiofur residues in swine kidney, liver, and muscle. These tolerances of ceftiofur residues are 0.25 ppm in kidney, 3.0 ppm in liver and 2.0 ppm in muscle.

    A pivotal tissue residue decline study was conducted in swine. 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. Ceftiofur residues in tissues were less than the tolerances for ceftiofur residues in tissues such as kidney, liver and muscle by 4 days after dosing. These data collectively support a 4-day pre-slaughter withdrawal period in swine when used according to label directions.

  • STORAGE CONDITIONS

    Store unreconstituted product at controlled room temperature 20° to 25° C (68° to 77° F).

    Store reconstituted product either in a refrigerator 2° to 8° C (36° to 46° F) for up to 7 days or at controlled room temperature 20° to 25° C (68° to 77° F) for up to 12 hours.

    Protect from light. Color of the cake may vary from off-white to a tan color. Color does not affect potency.

    ONE-TIME SALVAGE PROCEDURE FOR RECONSTITUTED PRODUCT

    At the end of the 7-day refrigeration or 12-hour room temperature storage period following reconstitution, any remaining reconstituted product may be frozen for up to 8 weeks without loss in potency or other chemical properties. This is a one-time only salvage procedure for the remaining product. 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. Rapid freezing or thawing may result in vial breakage. Any product not used immediately upon thawing should be discarded.

  • HOW SUPPLIED

    NAXCEL Sterile Powder is available in the following package sizes:

    •   1 gram vial
    •   4 gram vial
  • SPL UNCLASSIFIED SECTION

    NADA # 140-338, Approved by FDA

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    Revised: January 2014

    30146300

  • PRINCIPAL DISPLAY PANEL - 1 g 12 Vial Carton

    12 — 1 gram vials

    Naxcel® 1 gram

    (ceftiofur sodium sterile powder)
    Sterile Powder

    Protect from light

    For intramuscular and subcutaneous injection in cattle only.
    For intramuscular injection in swine, sheep, goats, and horses.
    For subcutaneous injection only in dogs, day-old chickens, and
    day-old turkey poults.
    May Be Used in Lactating Dairy Cattle, Sheep, and Goats.

    Caution: Federal (USA) law restricts this drug to use by or on the order of a
    licensed veterinarian. Federal law prohibits extra-label use of this drug in cattle,
    swine, chickens and turkeys for disease prevention purposes; at unapproved
    doses, frequencies, durations, or routes of administration; and in
    unapproved major food producing species/production classes.

    NADA #140-338, Approved by FDA

    zoetis

    PRINCIPAL DISPLAY PANEL - 1 g 12 Vial Carton
  • PRINCIPAL DISPLAY PANEL - 4 g 6 Vial Carton

    6 — 4 gram vials

    Naxcel® 4 grams

    (ceftiofur sodium sterile powder)
    Sterile Powder

    Protect from light

    For intramuscular and subcutaneous injection in cattle only.
    For intramuscular injection in swine, sheep, goats, and horses.
    For subcutaneous injection only in day-old chickens, and day-old
    turkey poults.
    May Be Used in Lactating Dairy Cattle, Sheep, and Goats.

    Caution: Federal (USA) law restricts this drug to use by or on the order
    of a licensed veterinarian. Federal law prohibits extra-label use of this
    drug in cattle, swine, chickens and turkeys for disease prevention
    purposes; at unapproved doses, frequencies, durations, or routes
    of administration; and in unapproved major food producing
    species/production classes.

    NADA #140-338, Approved by FDA

    zoetis

    PRINCIPAL DISPLAY PANEL - 4 g 6 Vial Carton
  • INGREDIENTS AND APPEARANCE
    NAXCEL 
    ceftiofur sodium powder
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC: 54771-3362
    Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ceftiofur sodium (UNII: NHI34IS56E) (ceftiofur - UNII:83JL932I1C) ceftiofur1000 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    sodium hydroxide (UNII: 55X04QC32I)  
    potassium phosphate, monobasic (UNII: 4J9FJ0HL51)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 54771-3362-112 in 1 CARTON
    11 g in 1 VIAL
    2NDC: 54771-3362-26 in 1 CARTON
    24 g in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14033801/25/1988
    Labeler - Zoetis Inc. (828851555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmacia and Upjohn Company829076566MANUFACTURE, API MANUFACTURE

  • Trademark Results [Naxcel]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NAXCEL
    NAXCEL
    73665148 1471940 Live/Registered
    UPJOHN COMPANY, THE
    1987-06-08

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