Label: LINCOMIX- lincomycin injection

  • NDC Code(s): 54771-0617-1, 54771-3256-1
  • Packager: Zoetis Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated June 6, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Lincomix®

    brand of lincomycin injection

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    For Intramuscular Use in Swine Only

    LINCOMIX Injectable contains lincomycin hydrochloride, an antibiotic produced by Streptomyces lincolnensis var. lincolnensis, which is chemically distinct from all other clinically available antibiotics and is isolated as a white crystalline solid.

  • INDICATIONS FOR SWINE

    LINCOMIX Injectable is indicated for the treatment of infectious forms of arthritis caused by organisms sensitive to its activity. This includes most of the organisms responsible for the various infectious arthritides in swine, such as the staphylococci, streptococci, Erysipelothrix and Mycoplasma spp.

    It is also indicated for the treatment of mycoplasma pneumonia.

  • CONTRAINDICATIONS

    As with all drugs, the use of LINCOMIX Injectable is contraindicated in animals previously found to be hypersensitive to the drug.

  • WARNING

    Swine intended for human consumption should not be slaughtered within 48 hours of latest treatment. Not for human use.

  • CAUTION

    If no improvement is noted within 48 hours, consult a veterinarian.

  • ADVERSE REACTIONS

    The intramuscular administration to swine may cause a transient diarrhea or loose stools. Although this effect has rarely been reported, one must be alert to the possibility that it may occur.

    Should this occur, it is important that the necessary steps be taken to prevent the effects of dehydration.

  • DOSAGE AND ADMINISTRATION

    For arthritis or mycoplasma pneumonia—5 mg per pound of body weight intramuscularly once daily for three to seven days as needed. When using LINCOMIX Injectable containing 100 mg/mL, 1 mL/20 lb body weight will provide 5 mg/lb. When using LINCOMIX Injectable containing 300 mg/mL, 1 mL/60 lb body weight will provide 5 mg/lb.

    For optimal results, initiate treatment as soon as possible.

    As with any multi-dose vial, practice aseptic techniques in withdrawing each dose. Adequately clean and disinfect the vial closure prior to entry with a sterile needle and syringe. No vial closure should be entered more than 20 times.

  • HOW SUPPLIED

    LINCOMIX Injectable is available in two concentrations: 300 mg/mL and 100 mg/mL.

    300 mg/mL: For use in swine weighing 300 pounds or more. Each mL contains lincomycin hydrochloride equivalent to lincomycin, 300 mg; also Benzyl Alcohol, 9.45 mg added as preservative. Supplied in 100 mL vials.

    100 mg/mL: Each mL contains lincomycin hydrochloride equivalent to lincomycin, 100 mg; also Benzyl Alcohol, 9.45 mg added as preservative. Supplied in 100 mL vials.

    Store at controlled room temperature 20°-25°C (68°- 77°F), with excursions between 15°- 40°C (59°- 104°F).

    Use contents within 28 days of first vial broach.

  • SPL UNCLASSIFIED SECTION

    Approved by FDA under NADA # 034-025

    zoetis

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    Revised: June 2022

    40039342

  • PRINCIPAL DISPLAY PANEL - 100 mg Vial Label

    100 mg Vial Label

  • PRINCIPAL DISPLAY PANEL - 300 mg vial label

    300 mg Vial Label

  • INGREDIENTS AND APPEARANCE
    LINCOMIX 
    lincomycin injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54771-0617
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9.45 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-0617-1100 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA03402506/06/1967
    LINCOMIX 
    lincomycin injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54771-3256
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN300 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) 9.45 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-3256-1100 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA03402506/06/1967
    Labeler - Zoetis Inc. (828851555)