CIPRODEX- ciprofloxacin and dexamethasone suspension/ drops

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:

Proficient Rx LP

Vía de administración:

AURICULAR (OTIC)

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

CIPRODEX 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 . Teratogenic Effects. Pregnancy Category C: No adequate and well controlled studies with CIPRODEX have been performed in pregnant women. Caution should be exercised when CIPRODEX is used by a pregnant woman. Animal reproduction studies have not been conducted with CIPRODEX. Reproduction studies with ciprofloxacin have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (IV) doses up to 30 mg/kg, and have revealed no evidence of harm to the fetus.

Resumen del producto:

How Supplied: CIPRODEX (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension is a white-to off-white suspension 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. 7.5 mL fill          NDC 71205-309-75 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.

Estat d'Autorització:

New Drug Application

Fitxa tècnica

CIPRODEX- CIPROFLOXACIN AND DEXAMETHASONE SUSPENSION/ DROPS
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPRODEX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CIPRODEX.
CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE), OTIC SUSPENSION
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Dosage and Administration, Important Administration Instructions (2.1)
2/2019
INDICATIONS AND USAGE
CIPRODEX 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:
•
•
DOSAGE AND ADMINISTRATION
CIPRODEX IS FOR OTIC USE (EARS) ONLY, NOT FOR OPHTHALMIC USE, OR FOR
INJECTION. (2.1)
3.
4.
DOSAGE FORMS AND STRENGTHS
Otic Suspension: Each mL of CIPRODEX contains ciprofloxacin
hydrochloride 0.3% (equivalent to 3 mg ciprofloxacin
base) and dexamethasone 0.1% (equivalent to 1 mg dexamethasone). (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Most common adverse reactions were ear discomfort (3%), ear pain
(2.3%), and ear pruritus (1.5%). (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVARTIS
PHARMACEUTICALS CORPORATION AT 1-888-669-
6682 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 3/2020
FULL PRESCRIBING INFORMATION: CONTENTS* ®
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)
Shake well immediately before use. (2.1)
Instill four drops into the affected ear twice daily, for se