CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

ciprofloxacin (UNII: 5E8K9I0O4U) (ciprofloxacin - UNII:5E8K9I0O4U), fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M)

Disponible depuis:

Wilshire Pharmaceuticals

Mode d'administration:

AURICULAR (OTIC)

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 Ciprofloxaci

Descriptif du produit:

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 52536-080-14). 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.

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE- CIPROFLOXACIN AND
FLUOCINOLONE
ACETONIDE SOLUTION
WILSHIRE PHARMACEUTICALS
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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
_Hypersensitiv