Ciprofloxacin Otic Solution, 0.2%

Prescription

商品名： Ciprofloxacin Otic Solution, 0.2%

剤形

Drops

投与経路

AURICULAR (OTIC)

製造会社

Virtus Pharmaceuticals, LLC

About This Medication

11 DESCRIPTION Ciprofloxacin otic solution, 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. Ciprofloxacin otic solution, 0.2% is a sterile, preservative-free solution for otic use. Each single-dose container of ciprofloxacin otic solution, 0.2% delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH. Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C 17 H 18 FN 3 O 3 •HCl•H 2 O, and molecular weight is 385.82. The chemical structure of ciprofloxacin hydrochloride is: Chemical Structure

有効成分

成分	含有量
Ciprofloxacin	-

適応症と用法

1 INDICATIONS AND USAGE Ciprofloxacin otic solution, 0.2% is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus . Ciprofloxacin otic solution, 0.2% is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus . ( 1 )

作用のしくみ

12.1 Mechanism of Action Ciprofloxacin is a fluoroquinolone antimicrobial (see 12.4 Clinical Pharmacology, Microbiology ).

用量と投与方法

2 DOSAGE AND ADMINISTRATION The contents of one single-dose container (deliverable volume: 0.25 mL) should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days. Wash hands before use. The solution should be warmed, by holding the container in the hands for at least 1 minute, to minimize the dizziness that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the solution should be instilled. This position should be maintained for at least 1 minute to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear. Discard unused portion. Contents of one single-dose container should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days. ( 2 )

Side Effects Overview

6 ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. In a randomized, active-controlled clinical trial, approximately 300 patients with clinical signs and symptoms of otitis externa were treated with ciprofloxacin otic solution, 0.2%. The most frequently reported adverse reactions were application site pain, ear pruritus, fungal ear superinfection, and headache, each reported in approximately 2-3% of patients. The most common adverse reactions reported in 2-3% of patients treated with ciprofloxacin otic solution, 0.2% were application site pain, ear pruritus, fungal ear superinfection and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

警告と注意事項

5 WARNINGS AND PRECAUTIONS Ciprofloxacin otic solution, 0.2% is for otic use only. ( 5.1 ) Hypersensitivity: discontinue at the first appearance of a skin rash or any other sign of hypersensitivity. ( 5.2 ) Use of ciprofloxacin otic solution, 0.2% may result in overgrowth of nonsusceptible organisms. ( 5.3 ) 5.1 Otic Use Only Ciprofloxacin otic solution, 0.2% is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use. 5.2 Hypersensitivity Ciprofloxacin otic solution, 0.2% should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. 5.3 Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, use of ciprofloxacin otic solution, 0.2% may result in overgrowth of nonsusceptible organisms, including yeast and fungi. If super-infection occurs, discontinue use and institute alternative therapy. 5.4 Lack of Clinical Response If the infection is not improved after one week of therapy, cultures may help guide further treatment.

禁忌

4 CONTRAINDICATIONS Ciprofloxacin otic solution, 0.2% is contraindicated in persons with a history of hypersensitivity to ciprofloxacin. History of hypersensitivity to ciprofloxacin. ( 4 )

薬物動態

12.3 Pharmacokinetics The plasma concentrations of ciprofloxacin were not measured following administration of 0.25 mL ciprofloxacin otic solution, 0.2% (total dose: 0.5 mg ciprofloxacin). However, the maximum plasma concentration of ciprofloxacin is anticipated to be less than 5 ng/mL.

Frequently Asked Questions

1 INDICATIONS AND USAGE Ciprofloxacin otic solution, 0.2% is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus . Ciprofloxacin otic solution, 0.2% is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus . ( 1 )

2 DOSAGE AND ADMINISTRATION The contents of one single-dose container (deliverable volume: 0.25 mL) should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days. Wash hands before use. The solution should be warmed, by holding the container in the hands for at least 1 minute, to minimize the dizziness that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then …

5 WARNINGS AND PRECAUTIONS Ciprofloxacin otic solution, 0.2% is for otic use only. ( 5.1 ) Hypersensitivity: discontinue at the first appearance of a skin rash or any other sign of hypersensitivity. ( 5.2 ) Use of ciprofloxacin otic solution, 0.2% may result in overgrowth of nonsusceptible organisms. ( 5.3 ) 5.1 Otic Use Only Ciprofloxacin otic solution, 0.2% is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use. 5.2 Hypersensitivity …

4 CONTRAINDICATIONS Ciprofloxacin otic solution, 0.2% is contraindicated in persons with a history of hypersensitivity to ciprofloxacin. History of hypersensitivity to ciprofloxacin. ( 4 )

Ciprofloxacin Otic Solution, 0.2% is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Ciprofloxacin Otic Solution, 0.2% drug label (National Library of Medicine)
• openFDA — Ciprofloxacin Otic Solution, 0.2% label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 848956 (NLM Normalized Drug Names)
• NDC Directory — Ciprofloxacin Otic Solution, 0.2% (FDA National Drug Code)

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データソース： DailyMed (NLM), openFDA, MFDS