DARICLOX- cloxacillin sodium suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Cloxacillin Sodium (UNII: 65LCB00B4Y) (Cloxacillin - UNII:O6X5QGC2VB)

Available from:

Merck Sharp & Dohme Corp.

INN (International Name):

Cloxacillin Sodium

Composition:

Cloxacillin 200 mg in 10 mL

Administration route:

INTRAMAMMARY

Prescription type:

PRESCRIPTION

Therapeutic indications:

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.

Product summary:

HOW SUPPLIED: Dariclox is supplied in cartons of 12 single-dose syringes with 12 alcohol swabs. Each 10-mL, disposable syringe contains cloxacillin sodium equivalent to 200 mg of cloxacillin. Do Not Store Above 24°C (75°F)

Authorization status:

New Animal Drug Application

Summary of Product characteristics

DARICLOX- CLOXACILLIN SODIUM SUSPENSION
MERCK SHARP & DOHME CORP.
----------
DARICLOX
(CLOXACILLIN SODIUM INTRAMAMMARY INFUSION)
191399 R1
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: Dariclox (cloxacillin sodium intramammary infusion) is a
stable,
nonirritating suspension of cloxacillin sodium 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. Cloxacillin sodium is the monohydrate sodium salt
of 5-methyl-3-(o-
chlorophenyl)-4-isoxazolyl penicillin.
ACTION: Cloxacillin sodium 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.
SUSCEPTIBILITY TEST: The Kirby-Bauer 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
1
INDICATIONS: Dariclox is indicated in the treatment of bovine mastitis
in lactating cows
due to _Streptococcus agalactiae_ and nonpenicillinase-producing
_Staphylococ