CIPROFLOXACIN OTIC- ciprofloxacin solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U)

Available from:

Xspire Pharma, Llc

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN 0.5 mg in 0.25 mL

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

New Drug Application

Summary of Product characteristics

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 IN SP