Rx Item-Otovel ciprofloxacin HCl/fluocinolone OTIC DR 0.3-0.025% 14X0.25 Otic

for: Acute Otitis Media with Tympanostomy Tubes Otovel otic solution (ciprofloxacin and fluocinolone acetonide) is a fluoroquinolone antibacterial and corticosteroid combination indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients. 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 that occurred in ?1 patient were otorrhea, excessive granulation tissue, ear infection, ear pruritus, tympanic membrane disorder, auricular swelling and balance disorder (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Arbor Pharmaceuticals at 1-866-516-4950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 5/2016

RX ITEM-Otovel DR 0.3-0.025% 14X0.25 Oti
Otovel ciprofloxacin HCl/fluocinolone OTIC DR 0.3-0.025% 14X0.25 Otic BY ARBOR item No.:RX24338-0080-14 NDC No.RX24338008014 24338-0080-14 24338-0080-14 24338-0080-14 UPC No.:324338080146 3-24338-

Otovel DR 0.3-0.025% 14X0.25 Otic
BRAND: OCTOVEL NDC: RX24338-0080-14 ,RX24338008014 UPC: 324338-080146,324338080146 Generic Name: CIPROFLOXACIN HCL/FLUOCINOLONE NDC Code(s): 24338-080-01, OTHER: 24338-080-14 Packager: Arbor P

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