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For: Cattle
DESCRIPTION:
A180 is a sterile solution containing danofloxacin mesylate, a synthetic fluoroquinolone antimicrobial agent. Danofloxacin mesylate is the non-proprietary designation for (1S)-1cyclopropyl-6-fluoro-1,4-dihydro-7-(5-methyl-2,5-diazabicyclo [2.2.1]hept-2-yl)-4-oxo-3-quinolone carboxylic acid monomethanesulfonate. The empirical formula is C19H20FN3O3 � CH3SO3H and the molecular weight is 453.49.
INGREDIENT(S):
Each mL contains 180.0 mg of danofloxacin as the mesylate salt, 200.0 mg 2-pyrrolidone, 50.0 mg polyvinyl pyrrolidone, 20.3 mg heavy magnesium oxide, 2.5 mg phenol, 5.0 mg monothioglycerol, hydrochloric acid or sodium hydroxide as needed to adjust pH, nitrogen headspace and water for injection, q.s.
CLINICAL PHARMACOLOGY:
Danofloxacin distributes extensively throughout the body, as evidenced by a steady state volume of distribution (VDss) exceeding 1 L/kg. Danofloxacin concentrations in the lung homogenates markedly exceed those observed in plasma, further suggesting extensive distribution to the indicated site of infection. Danofloxacin is rapidly eliminated from the body (apparent terminal elimination T1/2 ranging from 3-6 hours), and therefore negligible accumulation is expected to occur when animals are dosed with a q48h-dosing regimen.
Danofloxacin is rapidly absorbed and is highly bioavailable when administered as a subcutaneous injection in the neck. No statistically significant gender difference was observed in peak or total systemic exposure following subcutaneous administration. Linear pharmacokinetics has been demonstrated when danofloxacin is administered by subcutaneous injection at doses up to 10 mg/kg. Pharmacokinetic parameter values associated with a 6-mg/kg dose are provided in Table 1.
USES AND INDICATIONS:
A180 (danofloxacin) injectable solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia (Pasteurella) haemolytica and Pasteurella multocida.
CONTRAINDICATIONS AND PRECAUTION:
The effects of danofloxacin on bovine reproductive performance, pregnancy, and lactation have not been determined.
Subcutaneous injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.
Quinolone-class drugs should be used with caution in animals with known or suspected central nervous system (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation, which may lead to convulsive seizures.
Quinolone-class drugs have been shown to produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature, rapidly growing animals of various species
ADVERSE EFFECTS AND WARNINGS:
A hypersensitivity reaction was noted in 2 healthy calves treated with A180 in a laboratory study. In one location of a multi-site field trial, one out of the 41 calves treated with 6 mg/kg q 48 hours showed lameness on Day 6 only. In this same field trial location one of 38 calves treated with 8 mg/kg once became lame 4 days after treatment and remained lame on the last day of the study (Day 10). Another calf in the same treatment group developed lameness on the last day of the study.
For use in animals only. Keep out of reach of children. Animals intended for human consumption must not be slaughtered within 4 days from the last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water. Consult a physician if irritation persists following ocular or dermal exposures. Individuals with a history of hypersensitivity to quinolones should avoid this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.
DOSAGE AND ADMINISTRATION:
A180 is administered as a subcutaneous dose of 6 mg/kg of body weight (1.5 mL/100 lb). Treatment should be repeated once approximately 48 hours following the first injection. Care should be taken to dose accurately. Administered dose volume should not exceed 15 mL per injection site.
STORAGE:
Store at or below 30°C (86°F). Protect from light. Protect from freezing. The color is yellow to amber and does not affect potency.
MANUFACTURER: Pfizer Animal Health
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