Orbifloxacin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Edzel Lorraine Co, DMD, MD[2]
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Overview
Orbifloxacin is a fluoroquinolone carboxylic acid derivatives that is FDA approved for the treatment of urinary tract infections (cystitis) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Proteus mirabilis, Escherichia coli and Enterococcus faecalis.. Common adverse reactions include In a field study, when the tablet formulation of orbifloxacin was administered at 2.5 mg/kg/day, no drug-related adverse reactions were reported. In a foreign field study using the oral suspension at 7.5 mg/kg/day, vomiting was reported for ORBAX® Oral Suspension and the comparator..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Orbifloxacin FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Orbifloxacin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
Orbifloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested, the dog being particularly sensitive to this side effect. Orbifloxacin is contraindicated in immature dogs during the rapid growth phase (between 2 and 8 months of age in small and medium-sized breeds, and up to 18 months of age in large and giant breeds).
Orbifloxacin is contraindicated in dogs known to be hypersensitive to quinolones.
Warnings
For use in animals only. Keep out of the reach of children.
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.
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 exposure.
Adverse Reactions
Clinical Trials Experience
In a field study, when the tablet formulation of orbifloxacin was administered at 2.5 mg/kg/day, no drug-related adverse reactions were reported. In a foreign field study using the oral suspension at 7.5 mg/kg/day, vomiting was reported for ORBAX® Oral Suspension and the comparator.
Postmarketing Experience
Vomiting, convulsions, depression/lethargy, anorexia
Drug Interactions
- Compounds (eg, sucralfate, antacids, and multivitamins) containing divalent and trivalent cations (eg, iron, aluminum, calcium, magnesium, and zinc) may substantially interfere with the absorption of quinolones resulting in a decrease in product bioavailability. Therefore, the concomitant oral administration of quinolones with foods, supplements, or other preparations containing these compounds should be avoided.
- The dosage of theophylline should be reduced when used concurrently with fluoroquinolones. Cimetidine has been shown to interfere with the metabolism of fluoroquinolones and should be used with care when used concurrently. Concurrent use of fluoroquinolones with oral cyclosporine is contraindicated. Concurrent administration of fluoroquinolones may increase the action of oral anticoagulants.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Orbifloxacin in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Orbifloxacin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Orbifloxacin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Orbifloxacin in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Orbifloxacin in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Orbifloxacin in geriatric settings.
Gender
There is no FDA guidance on the use of Orbifloxacin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Orbifloxacin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Orbifloxacin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Orbifloxacin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Orbifloxacin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Orbifloxacin in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Orbifloxacin Administration in the drug label.
Monitoring
There is limited information regarding Orbifloxacin Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Orbifloxacin and IV administrations.
Overdosage
There is limited information regarding Orbifloxacin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Orbifloxacin Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Orbifloxacin Mechanism of Action in the drug label.
Structure
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.
Pharmacodynamics
There is limited information regarding Orbifloxacin Pharmacodynamics in the drug label.
Pharmacokinetics
In fasted animals, orbifloxacin is rapidly and almost completely absorbed from the gastrointestinal tract following oral administration. The absolute bioavailability (F) of an oral dose is approximately 100%. The effects of concomitant feeding on the absorption of orbifloxacin have not been studied in the dog. Divalent cations are generally known to diminish the absorption of fluoroquinolones.
Distribution in the Body: Orbifloxacin penetrates into most tissues and body fluids following oral dosing. Particularly high levels of orbifloxacin are found in the prostate, kidneys, liver, bile, lungs, lymph nodes, small intestine, cartilage, muscle, salivary gland and testes.
Nonclinical Toxicology
There is limited information regarding Orbifloxacin Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Orbifloxacin Clinical Studies in the drug label.
How Supplied
ORBAX® Oral Suspension is supplied in a sealed bottle with a 20 mL deliverable volume.
Storage
Store between 2°C and 25°C (36°F and 77°F). ORBAX® Oral Suspension does not require refrigeration. Shake well before use. Store upright.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Orbifloxacin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Orbifloxacin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Orbifloxacin Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Orbifloxacin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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