CIPRODEX

CIPRODEX- ciprofloxacin hydrochloride and dexamethasone suspension/ drops
Proficient Rx LP

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

•

CIPRODEX is for otic use (ears) only, and not for ophthalmic use, or for injection.

•

Shake well immediately before use.

2.2 Dosage

For the Treatment of Acute Otitis Media in Pediatric Patients (age 6 months and older) With Tympanostomy Tubes

The recommended dosage regimen through tympanostomy tubes is as follows:

1.

Four drops [equivalent to 0.14 mL of CIPRODEX, (consisting of 0.42 mg of ciprofloxacin and 0.14 mg of dexamethasone)] instilled into the affected ear twice daily for seven days.

2.

The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension.

3.

The patient should lie with the affected ear upward, and then the drops should be instilled.

4.

The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear.

5.

This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear.

6.

Discard unused portion after therapy is completed.

For the Treatment of Acute Otitis Externa (age 6 months and older)

The recommended dosage regimen is as follows:

1.

Four drops [equivalent to 0.14 mL of CIPRODEX, (consisting of 0.42 mg ciprofloxacin and 0.14 mg dexamethasone)] instilled into the affected ear twice daily for seven days.

2.

The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension.

3.

The patient should lie with the affected ear upward, and then the drops should be instilled.

4.

This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.

5.

Discard unused portion after therapy is completed.

3 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.

4 CONTRAINDICATIONS

•

CIPRODEX 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.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

CIPRODEX should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal, or facial edema), airway obstruction, dyspnea, urticaria, and itching.

5.2 Potential for Microbial Overgrowth With Prolonged Use

Prolonged use of CIPRODEX may result in overgrowth of non-susceptible, bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

5.3 Continued or Recurrent Otorrhea

If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

1.

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]

2.

Potential for Microbial Overgrowth with Prolonged Use [see Warnings and Precautions (5.2)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In Phases II and III clinical trials, a total of 937 patients were treated with CIPRODEX. This included 400 patients with acute otitis media with tympanostomy tubes (AOMT) and 537 patients with AOE. The reported adverse reactions are listed below:

Acute Otitis Media in Pediatric Patients With Tympanostomy Tubes

The following adverse reactions occurred in 0.5% or more of the patients with non-intact tympanic membranes.

Adverse Reactions	Incidence (N = 400)
Ear discomfort	3.0%
Ear pain	2.3%
Ear precipitate (residue)	0.5%
Irritability	0.5%
Taste Perversion	0.5%

The following adverse reactions were each reported in a single patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis; crying; dizziness; and erythema.

Acute Otitis Externa

The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic membranes.

Adverse Reactions	Incidence (N = 537)
Ear pruritus	1.5%
Ear debris	0.6%
Superimposed ear infection	0.6%
Ear congestion	0.4%
Ear pain	0.4%
Erythema	0.4%

The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).