Orbifloxacin

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Orbifloxacin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

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

This image is provided by the National Library of Medicine.


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

This image is provided by the National Library of Medicine.
File:Orbifloxacin suspension2.png
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

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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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