CIPROFLOXACIN AND DEXAMETHASONE suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ciprofloxacin Hydrochloride (UNII: 4BA73M5E37) (Ciprofloxacin - UNII:5E8K9I0O4U), Dexamethasone (UNII: 7S5I7G3JQL) (Dexamethasone - UNII:7S5I7G3JQL)

Available from:

NorthStar RxLLC

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CIPROFLOXACIN AND DEXAMETHASONE- CIPROFLOXACIN AND
DEXAMETHASONE SUSPENSION/ DROPS
NORTHSTAR RXLLC
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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