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Uses
ORBAX® Oral Suspension is indicated for the treatment of urinary tract infections (cystitis) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Proteus mirabilis, Escherichia coli and Enterococcus faecalis. ORBAX® Oral Suspension is also indicated for skin and soft tissue infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, coagulase positive staphylococci, Pasteurella multocida, Proteus mirabilis, Pseudomonas spp., Klebsiella pneumoniae, Escherichia coli, Enterobacter spp., Citrobacter spp., Enterococcus faecalis, β-hemolytic streptococci (Group G) and Streptococcus equisimilis.
ORBAX® Oral Suspension is indicated for the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Staphylococcus aureus, Escherichia coli, and Pasteurella multocida.
History
There is currently no drug history available for this drug.
Other Information
Orbifloxacin is a synthetic broad-spectrum antibacterial agent from the class of fluoroquinolone carboxylic acid derivatives. Orbifloxacin is the international nonproprietary name for 1-cyclopropyl-5,6,8-trifluoro-1,4-dihydro-7-(cis-3,5-dimethyl-1-piperazinyl)-4-oxoquinoline-3-carboxylic acid. The chemical formula for orbifloxacin is C19H20F3N3O3 and its molecular weight is 395.38.
The compound is slightly soluble in water; however, solubility increases in both acidic and alkaline conditions. The compound has two dissociation constants (pKa's): 5.95 and 9.01.
ORBAX® Oral Suspension is a malt flavored antibiotic suspension containing 30 mg/mL of orbifloxacin and sorbic acid as a preservative.
FIGURE 1. Chemical structure of orbifloxacin
Orbifloxacin is a synthetic broad-spectrum antibacterial agent from the class of fluoroquinolone carboxylic acid derivatives. Orbifloxacin is the international nonproprietary name for 1-cyclopropyl-5,6,8-trifluoro-1,4-dihydro-7-(cis-3,5-dimethyl-1-piperazinyl)-4-oxoquinoline-3-carboxylic acid.
The chemical formula for orbifloxacin is C19H20F3N3O3 and its molecular weight is 395.38.
The compound is slightly soluble in water; however, solubility increases in both acidic and alkaline conditions. The compound has two dissociation constants (pKa's): 5.95 and 9.01.
ORBAX® Oral Suspension is a malt flavored antibiotic suspension containing 30 mg/mL of orbifloxacin and sorbic acid as a preservative.
FIGURE 1. Chemical structure of orbifloxacin.
Sources
Orbax Manufacturers
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Schering Corporation
Orbax | Schering Corporation
Shake Well Before Use. BEFORE INITIAL USE, remove the cap and insert the syringe adaptor by pressing firmly into top of bottle. Insert the syringe tip into the adaptor opening and invert the bottle. Withdraw the required amount of medication with the calibrated syringe. After use, replace cap, leaving adaptor in the bottle, and rinse the syringe with water.
The dose of ORBAX® Oral Suspension in the dog is 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/kg) of body weight administered once daily (See Drug interactions and Animal Safety). The determination of dosage for any particular patient must take into consideration such factors as the severity and nature of the infection, the susceptibility of the causative organism, and the integrity of the patient's host-defense mechanisms. Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. Therapy with ORBAX® Oral Suspension may be initiated before results of these tests are known. Once results become available, continue with appropriate therapy.
For the treatment of skin infections, ORBAX® Oral Suspension should be given for two (2) to three (3) days beyond the cessation of clinical signs to a maximum of 30 days. For the treatment of urinary tract infections, ORBAX® Oral Suspension should be administered for at least 10 consecutive days. If no improvement is seen within five (5) days, the diagnosis should be re-evaluated and a different course of therapy considered.
Shake Well Before Use. BEFORE INITIAL USE, remove the cap and insert the syringe adaptor by pressing firmly into top of bottle. Insert the syringe tip into the adaptor opening and invert the bottle. Withdraw the required amount of medication with the calibrated syringe. After use, replace cap, leaving adaptor in the bottle, and rinse the syringe with water.
In the cat, ORBAX® Oral Suspension and ORBAX® (orbifloxacin) Tablets are not bioequivalent. On a mg/kg basis, ORBAX® Oral Suspension provides lower and more variable plasma levels of orbifloxacin than ORBAX® (orbifloxacin) Tablets (See Clinical Pharmacology and Precautions). The dose of ORBAX® Oral Suspension in the cat is 3.4 mg/lb (7.5 mg/kg) of body weight administered once daily. DO NOT EXCEED 3.4 mg/lb (7.5 mg/kg) BODY WEIGHT PER DAY IN CATS. ORBAX® Oral Suspension should be given for two (2) to three (3) days beyond the cessation of clinical signs.
Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. Therapy with ORBAX® Oral Suspension may be initiated before results of these tests are known. Once results become available, continue with appropriate therapy. If no improvement is seen within 3 to 4 days, the diagnosis should be re-evaluated and a different course of therapy considered.
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Merck Sharp & Dohme Corp.
Orbax | Merck Sharp & Dohme Corp.
DOSAGE AND ADMINISTRATION: For routine out-patient treatment of infection caused by a susceptible organism, in an otherwise healthy dog or cat, the dose of ORBAX® (orbifloxacin) Tablets is 2.5 to 7.5 mg/kg of body weight administered once daily. (See DRUG INTERACTIONS and TARGET ANIMAL SAFETY). In the cat, ORBAX® (orbifloxacin) Tablets and ORBAX® (orbifloxacin) Oral Suspension are not bioequivalent. On a mg/kg basis, ORBAX® (orbifloxacin) Oral Suspension provides lower and more variable plasma levels of orbifloxacin than ORBAX® (orbifloxacin) Tablets. The determination of dosage for any particular patient must take into consideration such factors as the severity and nature of the infection, the susceptibility of the causative organism, and the integrity of the patient's host-defense mechanisms. Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. Therapy with ORBAX® (orbifloxacin) Tablets may be initiated before results of these tests are known. Once results become available, continue with appropriate therapy.
For the treatment of skin and associated soft tissue infections, ORBAX® (orbifloxacin) Tablets should be given for two (2) to three (3) days beyond the cessation of clinical signs to a maximum of 30 days. For the treatment of urinary tract infections, ORBAX® (orbifloxacin) Tablets should be administered for at least 10 consecutive days. If no improvement is seen within five (5) days, the diagnosis should be re-evaluated and a different course of therapy considered.
To administer a total daily dose of 2.5 mg/kg, ORBAX® (orbifloxacin) Tablets may be dispensed as indicated in Table 1.
Table 1: Dose Table for ORBAX® (orbifloxacin) Tablets (2.5 mg/kg total daily dose) WEIGHT OF DOG/CAT (lbs) 5 10 20 30 40 50 60 90 120 No. of 22.7 mg tablets ½ 1 1½ 2 2½ No. of 68 mg tablets ½ 1 1½ 2
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