CIPRODEX- ciprofloxacin and dexamethasone suspension

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U), DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Disponible des:

Rebel Distributors Corp

Designació comuna internacional (DCI):

CIPROFLOXACIN HYDROCHLORIDE

Composición:

CIPROFLOXACIN 3 mg in 1 mL

Vía de administración:

AURICULAR (OTIC)

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. The safety and efficacy of CIPRODEX® Otic have been established in pediatric patients 6 months and older (937 patients) in adequate and well-controlled clinical trials. Although no data are available

Resumen del producto:

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 21695-969-75, 7.5 mL fill Storage: Store at controlled room temperature, 15°C to 30°C (59°F to 86°F). Avoid freezing. Protect from light.

Estat d'Autorització:

New Drug Application

Informació per a l'usuari

CIPRODEX- CIPROFLOXACIN AND DEXAMETHASONE SUSPENSION
Rebel Distributors Corp
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PATIENT INFORMATION
CIPRODEX® (CI-PRO-DEX)
(ciprofloxacin 0.3% and dexamethasone 0.1%)
Sterile Otic Suspension
IMPORTANT PATIENT INFORMATION AND INSTRUCTIONS. READ BEFORE USE.
What is CIPRODEX® Otic?
CIPRODEX® Otic is an antibiotic/steroid combination product in a
sterile suspension used to treat:
• Middle Ear Infection with Drainage Through a Tube in Children 6
months and older: A middle ear
infection is a bacterial infection behind the eardrum. People with a
tube in the eardrum may notice
drainage from the ear canal.\
• Outer Ear Canal Infection in Patients 6 months and older: An outer
ear canal infection, also known as
"Swimmer's Ear", is a bacterial infection of the outer ear canal. The
ear canal and the outer part of the ear
may swell, turn red, and be painful. Also, a fluid discharge may
appear in the ear canal.
Who should NOT use CIPRODEX® Otic?
• Do not use this product if allergic to ciprofloxacin or to other
quinolone antibiotics.
• Do not use this product if allergic to dexamethasone or to other
steroids.
• Do not give this product to pediatric patients who are less than 6
months old.
How often should CIPRODEX® Otic be given?
CIPRODEX® Otic ear drops should be given 2 times each day (about 12
hours apart, for example, 8 AM
and 8 PM) in each infected ear unless the doctor has instructed
otherwise. The best times to use the ear
drops are in the morning and at night. It is very important to use the
ear drops for as long as the doctor has
instructed, even if the symptoms improve. If CIPRODEX® Otic ear drops
are not used for as long as the
doctor has instructed, the infection may return.
What if a dose is missed?
If a dose of CIPRODEX® Otic is missed, it should be given as soon as
possible. If it is almost time for
the next dose, skip the missed dose and go back to the regular dosing
schedule. Do not use a double dose
unless the doctor has instructed you to do so. If the infection is not
improved after

Fitxa tècnica

CIPRODEX- CIPROFLOXACIN AND DEXAMETHASONE SUSPENSION
REBEL DISTRIBUTORS CORP
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CIPRODEX®
(CIPROFLOXACIN 0.3% AND DEXAMETHASONE 0.1%)
STERILE OTIC SUSPENSION
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-qui
nolinecarboxylic 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-di
ene-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.
17
18
3
3
2
22
29
5
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 [1].
Peak plasma concentration