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Brand Name :
Xtoro
Synonyms :
finafloxacin otic
Class :
Antibiotics, Quinolones; Otic
Dosage Forms & Strengths
Otic suspension
0.3%
Instil 4 drops from the vial into the affected ear 2 times daily
Continue the therapy for 7 days
In the case when otowick is utilized, double the initial dose to 8 drops
Dosage Forms & Strengths
Otic solution
0.3%
For less than 1 year of age, safety and efficacy are not seen
For more than 1 year of age, instil 4 drops into the affected ear twice daily
Extend the therapy for a week
In the case when otowick is utilized, double the initial dose to 8 drops
Refer to the adult dosing
Actions and Spectrum:
Actions:
finafloxacin is a fluoroquinolone antibiotic that exerts its antibacterial effects by inhibiting the activity of bacterial DNA gyrase and topoisomerase IV enzymes. These enzymes are essential for bacterial DNA replication, transcription, and repair. By interfering with these processes, finafloxacin disrupts bacterial cell growth and division, leading to the death of susceptible bacteria.
Spectrum:
finafloxacin has a broad spectrum of activity against both Gram-positive and Gram-negative bacteria commonly associated with ear infections. The spectrum of finafloxacin otic includes the following pathogens:
Gram-Positive Bacteria- Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pneumoniae, Streptococcus pyogenes (Group A streptococcus), Gram-Negative Bacteria- Haemophilus influenzae, Pseudomonas aeruginosa, Moraxella catarrhalis
Frequency defined
1-10%
Nausea (1%)
Pruritis (1%)
Black Box Warning:
None
Contraindication/Caution:
Contraindications
Cautions
Pregnancy consideration:
Category C
Breastfeeding warnings:
Exercise caution if the drug is administered in nursing mother.
Pregnancy category:
Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: No data is available for the drug under this category.
Pharmacology:
finafloxacin is a fluoroquinolone antibiotic that works by inhibiting the activity of bacterial DNA gyrase and topoisomerase IV enzymes. These enzymes are essential for bacterial DNA replication, transcription, and repair. By interfering with these processes, finafloxacin disrupts bacterial cell growth and division, leading to the death of susceptible bacteria. Pharmacodynamics:
The pharmacodynamics of finafloxacin otic highlight its ability to target bacterial DNA synthesis and cause cell death, with concentration-dependent killing and enhanced activity in acidic conditions. This allows for the effective eradication of bacterial pathogens responsible for ear infections.
It’s important to note that the pharmacodynamic properties of finafloxacin otic may vary depending on factors such as the specific bacteria involved, individual patient factors, and the local environment of the infection.
Pharmacokinetics:
Absorption
Limited systemic absorption occurs following the application of finafloxacin otic. The majority of the medication remains in the ear canal.
Distribution
finafloxacin does not distribute widely in the body since it primarily stays at the site of application in the ear.
Metabolism
finafloxacin undergoes minimal metabolism and is primarily eliminated unchanged from the body.
Elimination and Excretion
The medication is excreted through both renal (urinary) and non-renal (fecal) routes.
Administration:
Before administration, wash your hands thoroughly with soap and water to maintain proper hygiene. Position yourself or the person receiving the medication comfortably and stable.
Tilting the head sideways with the affected ear facing upward is often helpful. For children, gently holding the earlobe and pulling it backward and upward can help straighten the ear canal.
Before administration, gently clean the outer ear with a clean cloth or tissue. Hold the finafloxacin otic container or bottle and warm it to body temperature by rolling it between your hands. Cold drops can cause discomfort. Carefully remove the cap from the bottle.
Tilt the head slightly backward and gently pull the earlobe upward and backward to straighten the ear canal. With your other hand, hold the finafloxacin otic bottle upside down over the ear canal and squeeze the droplets into the ear.
Avoid touching the dropper tip to the ear or any other surface to prevent contamination. After administering the drops, keep the head tilted for a few minutes. This allows the medication to enter the ear canal fully.
Patient information leaflet
Generic Name: finafloxacin otic
Pronounced: fin-ah-FLOCKS-a-sin OH-tic
Why do we use finafloxacin otic?
finafloxacin otic is an antibiotic medication specifically formulated for ear infections caused by susceptible bacteria. It is effective against the bacteria commonly associated with ear infections, including Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pneumoniae, Streptococcus pyogenes (Group A streptococcus), Haemophilus influenzae, Pseudomonas aeruginosa, and Moraxella catarrhalis.
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