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
Updated September 16, 2015
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- SPL UNCLASSIFIED SECTION
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:
Resistant Intermediate Susceptible ≤ 10 mm 11–12 mm ≥ 13 mm
- 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.
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
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 12 Syringe Carton
LACTATING COW FORMULA
Caution: Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
12 single-dose (10 mL),
NADA #55-070, Approved by FDA
Schering-Plough Animal Health Corp.
INGREDIENTS AND APPEARANCE
cloxacillin sodium suspension
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0061-6280 Route of Administration INTRAMAMMARY Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cloxacillin Sodium (UNII: 65LCB00B4Y) (Cloxacillin - UNII:O6X5QGC2VB) Cloxacillin 200 mg in 10 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0061-6280-01 12 in 1 CARTON 1 10 mL in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA055070 12/23/1977 Labeler - Merck Sharp & Dohme Corp. (001317601)