Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
Ciprofloxacin Hydrochloride (UNII: 4BA73M5E37) (Ciprofloxacin - UNII:5E8K9I0O4U), Dexamethasone (UNII: 7S5I7G3JQL) (Dexamethasone - UNII:7S5I7G3JQL)
NorthStar RxLLC
AURICULAR (OTIC)
PRESCRIPTION DRUG
Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: - Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis , and Pseudomonas aeruginosa. - Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . - Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. - Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections. Risk Summary There are no available data on ciprofloxacin 0.3% and de
How Supplied: Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension USP, is white to off-white suspension supplied as follows: 7.5 mL fill in 10 mL low density polyethylene bottle. The packaging system consists of a 10 mL low density polyethylene plastic squeeze bottle, a natural low density polyethylene dropper tip and a high density polyethylene tamper evident screw cap for dropper bottle. 7.5 mL fill, NDC 16714-628-01 Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]. Avoid freezing. Protect from light.
Abbreviated New Drug Application
CIPROFLOXACIN AND DEXAMETHASONE- CIPROFLOXACIN AND DEXAMETHASONE SUSPENSION/ DROPS NORTHSTAR RXLLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION. CIPROFLOXACIN AND DEXAMETHASONE, OTIC SUSPENSION INITIAL U.S. APPROVAL: 2003 INDICATIONS AND USAGE Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: • Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to _Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis_, and _Pseudomonas aeruginosa._ (1) • Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to _Staphylococcus aureus_ and _Pseudomonas aeruginosa_. (1) DOSAGE AND ADMINISTRATION Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is for otic use (ears) only, not for ophthalmic use, or for injection. (2.1) • Shake well immediately before use. (2.1) • Instill four drops into the affected ear twice daily, for seven days. (2) DOSAGE FORMS AND STRENGTHS Otic Suspension: Each mL of ciprofloxacin and dexamethasone otic suspension contains ciprofloxacin hydrochloride 0.3% (equivalent to 3 mg ciprofloxacin base) and dexamethasone 0.1% (equivalent to 1 mg dexamethasone). (3) CONTRAINDICATIONS • Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. (4) • Use of this product is contraindicated in viral infections of the external canal, including he Lestu allt skjalið