CIPRODEX- ciprofloxacin and dexamethasone suspension

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:

Physicians Total Care, Inc.

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN HYDROCHLORIDE 3 mg in 1 mL

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CIPRODEX® Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Acute Otitis Media 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 in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . CIPRODEX® Otic 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.

Product summary:

CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension is supplied as follows: 7.5 mL fill in a DROP-TAINER® system. The DROP-TAINER® system consists of a natural polyethylene bottle and natural plug, with a white polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package. NDC 54868-4928-0,   7.5 mL fill Store at controlled room temperature, 15°C to 30°C (59°F to 86°F). Avoid freezing. Protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

CIPRODEX - CIPROFLOXACIN AND DEXAMETHASONE SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic
Suspension contains the
synthetic broad-spectrum antibacterial agent, ciprofloxacin
hydrochloride, combined with the anti-
inflammatory corticosteroid, dexamethasone, in a sterile, preserved
suspension for otic use. Each mL of
CIPRODEX® Otic contains ciprofloxacin hydrochloride (equivalent to 3
mg ciprofloxacin base), 1 mg
dexamethasone, and 0.1 mg benzalkonium chloride as a preservative. The
inactive ingredients are boric
acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid,
sodium acetate, edetate disodium,
and purified water. Sodium hydroxide or hydrochloric acid may be added
for adjustment of pH.
Ciprofloxacin, a fluoroquinolone is available as the monohydrochloride
monohydrate salt of 1-
cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic
acid. The empirical
formula is C
H FN O ·HCl·H O and the structural formula is:
Dexamethasone,
9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione,
is
an anti-inflammatory corticosteroid. The empirical formula is C
H FO and the structural formula is:
CLINICAL PHARMACOLOGY
Pharmacokinetics
Following a single bilateral 4-drop (total dose = 0.28 mL, 0.84 mg
ciprofloxacin, 0.28 mg
dexamethasone) topical otic dose of CIPRODEX® Otic to pediatric
patients after tympanostomy tube
insertion, measurable plasma concentrations of ciprofloxacin and
dexamethasone were observed at 6
hours following administration in 2 of 9 patients and 5 of 9 patients,
respectively.
Mean ± SD peak plasma concentrations of ciprofloxacin were 1.39 ±
0.880 ng/mL (n=9). Peak plasma
concentrations ranged from 0.543 ng/mL to 3.45 ng/mL and were on
average approximately 0.1% of
peak plasma concentrations achieved with an oral dose of 250-mg
. Peak plasma concentrations of
ciprofloxacin were observed within 15 minutes to 2 hours post dose
application.
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