OTOVEL (- ciprofloxacin and fluocinolone acetonide solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Arbor Pharmaceuticals

ІПН (Міжнародна Ім'я):

CIPROFLOXACIN

Склад:

CIPROFLOXACIN 872.5 ug in 0.25 mL

Адміністрація маршрут:

AURICULAR (OTIC)

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

OTOVEL 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 . OTOVEL is contraindicated in: - Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of OTOVEL. - Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections. Risk Summary OTOVEL 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 OTOVEL 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 Phar

Огляд продуктів:

How supplied OTOVEL (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 24338-080-14). 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.

Статус Авторизація:

New Drug Application

Характеристики продукта

OTOVEL- (CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE) SOLUTION
ARBOR PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OTOVEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OTOVEL.
OTOVEL (CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE) OTIC SOLUTION
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
OTOVEL 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
OTOVEL 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 OTOVEL (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
OTOVEL is contraindicated in:
Patients with known hypersensitivity to fluocinolone acetonide or
other corticosteroids, ciprofloxacin or other
quinolones, or to any component of OTOVEL. (4)
Viral infections of the external ear canal, including varicella and
herpes simplex infections and fungal otic infections. (4)
WARNINGS AND PRECAUTIONS
_Hypersensitivity_: Discontinue use at the first appearance of a skin
rash or any other sign of hypersensitivity. (_5.1_)
Potential for Microbial Overgrowth: Prolonged use may result in the
overgrowth of non-susceptible bacteria and fungi.
If such infections occur, discontinue use and institute alternative
therapy. (_5.2_)
ADVERSE REACTIONS
The most common adverse reactions