Label: DARICLOX- cloxacillin sodium suspension

  • NDC Code(s): 0061-6280-01
  • Packager: Merck Sharp & Dohme Corp.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated September 16, 2015

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  • SPL UNCLASSIFIED SECTION

    F-27865500

    LACTATING COW FORMULA
    (FÓRMULA PARA VACAS LACTANTES)

    Intramammary Infusion
    (Infusión intramamaria)

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

  • DESCRIPTION

    DESCRIPTION: Dariclox (sodium cloxacillin) is a stable, nonirritating suspension of sodium cloxacillin containing the equivalent of 200 mg of cloxacillin in saturated vegetable oils per disposable syringe. Dariclox is manufactured by a nonsterilizing process.

    Cloxacillin is a semisynthetic penicillin derived from the penicillin nucleus, 6-amino-penicillanic acid. Sodium cloxacillin is the monohydrate sodium salt of 5-methyl-3-(o-chlorophenyl)-4-isoxazolyl penicillin.

  • MECHANISM OF ACTION

    ACTION: Sodium cloxacillin is bactericidal in action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. It is active against most gram-positive organisms associated with mastitis. It is effective against Streptococcus agalactiae and nonpenicillinase-producing Staphylococcus aureus, and there is laboratory evidence that indicates cloxacillin is resistant to destruction by penicillinase-producing organisms. Milk cultures and antibiotic susceptibility testing is recommended when using this product.

  • SPL UNCLASSIFIED SECTION

    SUSCEPTIBILITY TEST: The Kirby-Bauer1 procedure, utilizing antibiotic susceptibility disks, is a quantitative method that may be adapted to determining the sensitivity of bacteria in milk to Dariclox.

    For testing the effectiveness of Dariclox in milk, follow the Kirby- Bauer procedure using the 1 mcg oxacillin susceptibility disk. Zone diameters for interpreting susceptibility are:

    ResistantIntermediateSusceptible
    ≤ 10 mm11–12 mm≥ 13 mm

    1
    Bauer AW, Kirby WMM, Sherris JC, et al: Antibiotic testing by a standardized single disk method, Am J Clin Path 45:493, 1966. Standardized Disk Susceptibility Test, Federal Register 37:20527–29, 1972.
  • INDICATIONS & USAGE

    INDICATIONS: Dariclox is indicated in the treatment of bovine mastitis in lactating cows due to Streptococcus agalactiae and nonpenicillinase-producing Staphylococcus aureus.

    Clinical experience indicates that antibiotic efficacy in the treatment of mastitis in lactating cows is directly related to the duration of infection. Therefore, treatment should be instituted as early as possible after detection.

  • WARNINGS

    WARNINGS: Milk taken from animals during treatment and for 48 hours (4 milkings) after the last treatment must not be used for food. Treated animals must not be slaughtered for food purposes within 10 days after the last treatment.

  • PRECAUTIONS

    PRECAUTION: Because it is a derivative of 6-amino-penicillanic acid, Dariclox has the potential for producing allergic reactions. Such reactions are rare; however, should they occur, the subject should be treated with the usual agents (antihistamines, pressor amines).

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Milk out udder completely. Wash udder and teats thoroughly with warm water containing a suitable dairy antiseptic. Dry thoroughly. Clean and disinfect the teat with alcohol swabs provided in the carton. Remove the syringe tip cover and insert the tip of the syringe into the teat orifice. Express the suspension into the quarter with gentle and continuous pressure. Withdraw the syringe and grasp the end of the teat firmly. Massage the medication up into the milk cistern.

    For optimum response the drug should be administered by intramammary infusion in each infected quarter as described above. Treatment should be repeated at 12-hour intervals for a total of 3 doses. The treated quarter should be milked out at the next routine milking.

    Each carton contains 12 alcohol swabs to facilitate proper cleaning and disinfecting of the teat orifice.

  • HOW SUPPLIED

    HOW SUPPLIED: Dariclox is supplied in cartons of 12 single-dose syringes with 12 alcohol swabs. Each 10-mL, disposable syringe contains sodium cloxacillin equivalent to 200 mg of cloxacillin.

    Do Not Store Above 24°C (75°F)

  • SPL UNCLASSIFIED SECTION

    NADA #55-070, Approved by FDAeye
    Manufactured by:
    G.C. Hanford Mfg. Co.
    Syracuse, NY 13201

    Copyright © 2003, Schering-Plough Animal Health Corp.,
    Union, NJ 07083. All rights reserved.
    10/03
    B-27865500

    INS15476 01
    Printed in USA

  • PRINCIPAL DISPLAY PANEL - 12 Syringe Carton

    Dariclox®
    (sodium cloxacillin)

    LACTATING COW FORMULA

    Intramammary Infusion

    short tip

    48-HOUR MILKOUT

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

    12 single-dose (10 mL),
    disposable syringes

    NADA #55-070, Approved by FDA

    Schering-Plough Animal Health Corp.

    PRINCIPAL DISPLAY PANEL - 12 Syringe Carton
  • INGREDIENTS AND APPEARANCE
    DARICLOX 
    cloxacillin sodium suspension
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0061-6280
    Route of AdministrationINTRAMAMMARY
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cloxacillin Sodium (UNII: 65LCB00B4Y) (Cloxacillin - UNII:O6X5QGC2VB) Cloxacillin200 mg  in 10 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0061-6280-0112 in 1 CARTON
    110 mL in 1 SYRINGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA05507012/23/1977
    Labeler - Merck Sharp & Dohme Corp. (001317601)