Rx Item-Ofloxacin 0.3% 10 ML Otic Sol by Amneal Pharma USA

Rx Item-Ofloxacin 0.3% 10 ML Sol by Amneal Pharma USA , Clinical Information:
Generic Code And Description: 48292 Ofloxacin Otic (Ear) Drops 0.3 %
Strength: 0.3 %
Dose Form: Drops
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 52040400 Antibacterials (Eent)
Active Ingredients: 3563 Ofloxacin 82419361
Inactive Ingredients: 3141 Benzalkonium Chloride 8001545 Drug Class: Drug Class: 52040400 Antibacterials (Eent) , OMP Family: , Temparature Zone: 10 Room Temperature, Unit Dose Indicator: NO, Item Size: 10ML, Brand Label Flag: GENERIC , Storage Temperature Zone: 10 Room Temperature, Item Size Code:10ML, Item Strength Code:0.3% , Item Abbreviation: Ofloxacin , Generic Form: DRP
DESCRIPTION
Ofloxacin otic solution, 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated ...
CLINICAL PHARMACOLOGY
Pharmacokinetics - Drug concentrations in serum (in subjects with tympanostomy tubes and perforated tympanic membranes), in otorrhea, and in mucosa of the middle ear (in subjects with perforated ...
INDICATIONS AND USAGE
Ofloxacin otic solution, 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa ...
CONTRAINDICATIONS
Ofloxacin otic solution, 0.3% is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.
WARNINGS
NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving ...
PRECAUTIONS
General - As with other anti-infective preparations, prolonged use may result in over-growth of non-susceptible organisms, including fungi. If the infection is not improved after one week ...
ADVERSE REACTIONS
Subjects - with Otitis Externa - In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with ...
DOSAGE AND ADMINISTRATION
Otitis Externa - The recommended dosage regimen for the treatment of otitis externa is: For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled ...
HOW SUPPLIED
Ofloxacin Otic Solution is a clear pale yellow to yellow color solution and is supplied in 5 mL and 10 mL LDPE white opaque bottle with LDPE white opaque nozzle and HDPE white opaque cap. Each mL ...
Patient Information
Ofloxacin (oh flox’ a sin) Otic Solution (0.3%) IMPORTANT PATIENT INFORMATION AND INSTRUCTIONS. READ BEFORE USE. What is ofloxacin otic solution? Ofloxacin otic solution is an antibiotic ...
PRINCIPAL DISPLAY PANEL
NDC 69238-1616-6 - Ofloxacin Otic Solution, 0.3% (10 mL) Rx Only - Amneal Pharmaceuticals LLC - NDC 69238-1615-3 - Ofloxacin Otic Solution, 0.3% (5 mL) Rx Only - Amneal Pharmaceuticals ...
INGREDIENTS AND APPEARANCE
Product Information

Ofloxacin Otic 0.3% 10 ML
Item No. RX957092, 957092, NDC No.: 69238-1616-06, 69238-616-06, 6923861606, 69238161606, 1616-06, 161606 UPC No. 3-69238-16166-3, 369238-161663, 369238161663

Ofloxacin Otic 0.3% 10 ML
Item No. RX957092, 957092, NDC No.: 69238-1616-06, 69238-616-06, 6923861606, 69238161606, 1616-06, 161606 UPC No. 3-69238-16166-3, 369238-161663, 369238161663

Ofloxacin Otic 0.3% 10 ML
Item No. RX957092, 957092, NDC No.: 69238-1616-06, 69238-616-06, 6923861606, 69238161606, 1616-06, 161606 UPC No. 3-69238-16166-3, 369238-161663, 369238161663

Rx Item-Ofloxacin 0.3% 10 ML Sol by Amne
Item No. RX957092, 957092, NDC No.: 69238-1616-06, 69238-616-06, 6923861606, 69238161606, 1616-06, 161606 UPC No. 3-69238-16166-3, 369238-161663, 369238161663

Rx Item-Ofloxacin 0.3% 10 ML Sol by Amne
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica