Country: United States
Language: English
Source: NLM (National Library of Medicine)
CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U)
Xspire Pharma, Llc
CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN 0.5 mg in 0.25 mL
AURICULAR (OTIC)
PRESCRIPTION DRUG
Ciprofloxacin Otic Solution 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 is contraindicated in persons with a history of hypersensitivity to ciprofloxacin. Pregnancy Category C. Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (IV) doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed. Animal reproduction studies have not been conducted with Ciprofloxacin Otic Solution. No adequate and well-controlled studies have been performed in pregnant women. Caution should be exercised when Ciprofloxacin Otic Solution is used by a pregnant woman. Ciprofloxacin is excreted in human milk with systemic use. It is not known whether ciprofloxacin is excreted in human milk following otic use. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The safety and effectiveness of Ciprofloxacin Otic Solution in infants below one year of age have not been established. The efficacy of Ciprofloxacin Otic Solution in treating otitis externa in pediatric patients one year or older has been demonstrated in controlled clinical trials (see Section 14 Clinical Studies). There is no evidence that the otic administration of quinolones has any effect on weight bearing joints, even though systemic administration of some quinolones has been shown to cause arthropathy in immature animals. No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Ciprofloxacin Otic Solution is a clear, colorless, sterile, preservative-free solution. Ciprofloxacin Otic Solution is supplied as a 0.2% otic solution in a low-density polyethylene (LDPE) single use container. Each single use container delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin; 14 single use containers are packaged in a foil overwrap pouch in a carton (NDC 42195-550-14). Store at 15ºC to 25ºC (59ºF to 77ºF). Discard used containers. Store unused containers in pouch to protect from light.
New Drug Application
CIPROFLOXACIN OTIC- CIPROFLOXACIN SOLUTION/ DROPS XSPIRE PHARMA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CIPROFLOXACIN OTIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN OTIC SOLUTION. CIPROFLOXACIN OTIC SOLUTION, 0.2% INITIAL U.S. APPROVAL: 1987 INDICATIONS AND USAGE Ciprofloxacin Otic Solution is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of _Pseudomonas aeruginosa_or _Staphylococcus aureus_. ( 1) DOSAGE AND ADMINISTRATION Contents of one single use container should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days. ( 2) DOSAGE FORMS AND STRENGTHS Ciprofloxacin Otic Solution is a sterile, preservative-free otic solution of ciprofloxacin hydrochloride equivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25 mL) in each single use container. ( 3) CONTRAINDICATIONS History of hypersensitivity to ciprofloxacin. ( 4) WARNINGS AND PRECAUTIONS Ciprofloxacin Otic Solution 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 may result in overgrowth of nonsusceptible organisms. ( 5.3) ADVERSE REACTIONS The most common adverse reactions reported in 2-3% of patients treated with Ciprofloxacin Otic Solution were application site pain, ear pruritus, fungal ear superinfection, and headache. ( _6_) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT XSPIRE PHARMA AT 1-888-252-3901 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_. SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 8/2012 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Otic Use Only 5.2 Hypersensitivity 5.3 Growth of Resistant Organisms with Prolonged Use 5.4 Lack of Clinical Response 6 ADVERSE REACTIONS 8 USE Read the complete document