CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

CIPROFLOXACIN (UNII: 5E8K9I0O4U) (CIPROFLOXACIN - UNII:5E8K9I0O4U), FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)

זמין מ:

Xspire Pharma, LLC

מסלול נתינה (של תרופות):

AURICULAR (OTIC)

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Ciprofloxacin and Fluocinolone Acetonide Otic Solution is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus , Streptococcus pneumoniae , Haemophilus influenzae , Moraxella catarrhalis , and Pseudomonas aeruginosa . Ciprofloxacin and Fluocinolone Acetonide Otic Solution is contraindicated in: - Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of Ciprofloxacin and Fluocinolone Acetonide Otic Solution. - Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections. Risk Summary Ciprofloxacin and Fluocinolone Acetonide Otic Solution is negligibly absorbed following otic administration and maternal use is not expected to result in fetal exposure to ciprofloxacin and fluocinolone acetonide [see Clinical Pharmacology (12.3)]. Risk Summary Ciprofloxacin and Fluocinolone Acetonide Otic Solution is negligibly absorbed by the mother following otic administration and breastfeeding is not expected to result in exposure of the infant to ciprofloxacin and fluocinolone acetonide [ see Clinical Pharmacology (12.3) ]. Ciprofloxacin and Fluocinolone Acetonide Otic Solution has been studied in patients as young as 6 months in adequate and well-controlled clinical trials. No major differences in safety and effectiveness have been observed between adult and pediatric patients [ see Indications and Usage (1)and Dosage and Administration (2)]. Clinical studies of Ciprofloxacin and Fluocinolone Acetonide Otic Solution did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Read this Instructions for Use that comes with Ciprofloxacin and Fluocinolone Acetonide Otic Solution before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. Important information about Ciprofloxacin and Fluocinolone Acetonide Otic Solution : - Ciprofloxacin and Fluocinolone Acetonide Otic Solution is for use in the ear only (otic use) . Do not inject Ciprofloxacin and Fluocinolone Acetonide Otic Solution or use Ciprofloxacin and Fluocinolone Acetonide Otic Solution in the eye. - Use Ciprofloxacin and Fluocinolone Acetonide Otic Solution exactly as your healthcare provider tells you to use it. How should I use Ciprofloxacin and Fluocinolone Acetonide Otic Solution? This Instructions for Use has been approved by the Food and Drug Administration.

leaflet_short:

How supplied Ciprofloxacin and Fluocinolone Acetonide Otic Solution, 0.3 %/0.025 %, is a sterile, preservative-free, clear otic solution supplied in blue translucent single-dose 0.25 mL vials. Fourteen single-dose vials are packaged in a protective foil pouch contained in a carton (NDC 42195-128-14). Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light; store unused vials in pouch and discard 7 days after opening the pouch. Do not open until ready to use. Discard vial after use.

מצב אישור:

New Drug Application Authorized Generic

מאפייני מוצר

CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE- CIPROFLOXACIN AND
FLUOCINOLONE ACETONIDE SOLUTION
XSPIRE PHARMA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPROFLOXACIN AND
FLUOCINOLONE ACETONIDE OTIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE OTIC SOLUTION.
CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE OTIC SOLUTION
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
Ciprofloxacin and Fluocinolone Acetonide Otic Solution is a
combination of ciprofloxacin, a fluoroquinolone
antibacterial, and fluocinolone acetonide, a corticosteroid, indicated
for the treatment of acute otitis media
with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months
and older) due to _Staphylococcus_
_aureus_, _Streptococcus pneumoniae_, _Haemophilus influenzae_,
_Moraxella catarrhalis_, and _Pseudomonas_
_aeruginosa ( 1)_
DOSAGE AND ADMINISTRATION
Ciprofloxacin and Fluocinolone Acetonide Otic Solution is for otic
administration only. It is not for
ophthalmic use, or for injection. ( 2)
Instill the contents of one single-dose vial (0.25 mL) into the
affected ear canal twice daily for 7 days. (
2)
Use this dosing regimen for patients aged 6 months and older. ( 2)
DOSAGE FORMS AND STRENGTHS
Otic Solution: Each single-dose vial of Ciprofloxacin and Fluocinolone
Acetonide Otic Solution (ciprofloxacin
0.3 % and fluocinolone acetonide 0.025 %) delivers 0.25 mL of solution
equivalent to ciprofloxacin 0.75 mg
and fluocinolone acetonide 0.0625 mg. (3)
CONTRAINDICATIONS
Ciprofloxacin and Fluocinolone Acetonide Otic Solution is
contraindicated in:
Patients with known hypersensitivity to fluocinolone acetonide or
other corticosteroids, ciprofloxacin or
other quinolones, or to any component of Ciprofloxacin and
Fluocinolone Acetonide Otic Solution. ( 4)
Viral infections of the external ear canal, including varicella and
herpes simplex infections and fungal
otic infections. ( 4)
WARNINGS AND PRECAUTIONS
_Hypersens