CIPROFLOXACIN AND DEXAMETHASONE- ciprofloxacin and

dexamethasone suspension/ drops

Sandoz Inc
----------

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 and dexamethasone 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 and dexamethasone 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. (2.2)

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 and dexamethasone 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 herpes simplex
infections and fungal otic infections. (4)

WARNINGS AND PRECAUTIONS

• Hypersensitivity and anaphylaxis have been reported with systemic use of quinolones. Discontinue
use if this occurs with use of ciprofloxacin and dexamethasone otic suspension. (5.1)
• Prolonged use may result in overgrowth of non-susceptible bacteria and fungi. (5.2)

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 Sandoz Inc., at 1-800-525-8747 or FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Dosage
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
5.2 Potential for Microbial Overgrowth with Prolonged Use
5.3 Continued or Recurrent Otorrhea
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Ciprofloxacin and dexamethasone 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.
2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

• Ciprofloxacin and dexamethasone otic suspension 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:

• Four drops [equivalent to 0.14 mL of ciprofloxacin and dexamethasone otic

suspension, (consisting of 0.42 mg of ciprofloxacin and 0.14 mg of
dexamethasone)] instilled into the affected ear twice daily for seven days.
• 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.
• The patient should lie with the affected ear upward, and then the drops should be
instilled.
• The tragus should then be pumped 5 times by pushing inward to facilitate
penetration of the drops into the middle ear.
• This position should be maintained for 60 seconds. Repeat, if necessary, for the
opposite ear.
• 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:

• Four drops [equivalent to 0.14 mL of ciprofloxacin and dexamethasone otic

suspension, (consisting of 0.42 mg ciprofloxacin and 0.14 mg dexamethasone)]
instilled into the affected ear twice daily for seven days.
• 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.
• The patient should lie with the affected ear upward, and then the drops should be
instilled.
• 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.
• Discard unused portion after therapy is completed.

3 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.
4 CONTRAINDICATIONS

• Ciprofloxacin and dexamethasone 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.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Ciprofloxacin and dexamethasone otic suspension 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 ciprofloxacin and dexamethasone otic suspension 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:

• Hypersensitivity Reactions [see Warnings and Precautions (5.1)]

• 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 ciprofloxacin
and dexamethasone otic suspension. 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 Incidence (N =
Reactions 400)
Ear discomfort 3.0%
Ear pain 2.3%
Ear precipitate 0.5%
(residue)
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 0.6%
infection
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).

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of
ciprofloxacin and dexamethasone otic suspension. Because these reactions are
reported voluntarily from a population of unknown size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug
exposure. These reactions include auricular swelling, headache, hypersensitivity,
otorrhea, skin exfoliation, rash erythematous, and vomiting.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
Risk Summary
There are no available data on ciprofloxacin and dexamethasone otic suspension use in
pregnant women to evaluate for a drug-associated risk of major birth defects,
miscarriage or adverse maternal, or fetal outcomes. Because of the minimal systemic
absorption of ciprofloxacin and dexamethasone following topical otic administration of
ciprofloxacin and dexamethasone otic suspension, this product is expected to be of
minimal risk for maternal and fetal toxicity when administered to pregnant women [see
Clinical Pharmacology (12.3)].
Animal reproduction studies have not been conducted with ciprofloxacin and
dexamethasone otic suspension. Oral administration of ciprofloxacin during
organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30
mg/kg to pregnant rabbits did not cause fetal malformations (see Data). These doses
were at least 200 times the recommended otic human dose (ROHD in mice, rats, and
rabbits, respectively, based on body surface area (BSA). With dexamethasone,
malformations have been observed in animal studies after ocular and systemic
administration.
The estimated background risk of major birth defects and miscarriage for the indicated
population is unknown. All pregnancies have a background risk of birth defect, loss, or
other adverse outcomes. In the U.S. general population, the estimated background risk
of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%
and of miscarriage is 15% to 20%, respectively.
Data
Animal Data
Ciprofloxacin
Developmental toxicology studies have been performed with ciprofloxacin in rats, mice,
and rabbits. The doses used in these studies are, at a minimum, approximately 200
times greater than the recommended otic human dose based on body surface area. In
rats and mice, oral doses up to 100 mg/kg administered during organogenesis
(Gestation Days [GD], 6-17) were not associated with adverse developmental outcomes,
including embryofetal toxicity or malformations. A 30 mg/kg oral dose was associated
with suppression of maternal and fetal body weight gain, but fetal malformations were
not observed. Intravenous administration of doses up to 20 mg/kg to pregnant rabbits
was not maternally toxic and neither embryo-fetal toxicity nor fetal malformations were
observed. To mitigate maternal toxicity in these studies, groups of rabbits received
ciprofloxacin for a different 5 day dosing period covering organogenesis (GD 6-18).
Dexamethasone
Dexamethasone has been shown to be teratogenic in mice and rabbits following topical
ophthalmic application. In a rat oral developmental toxicity study, no adverse effects
were observed at 0.01 mg/kg/day (0.1 times the ROHD based on BSA), although
embryotoxicity was observed at higher doses.

8.2 Lactation
Risk Summary
It is not known whether ciprofloxacin and dexamethasone are present in human milk
following topical otic administration.
Published literature reports the presence of ciprofloxacin in human milk after oral
administration to lactating women. However, because of the minimal systemic
absorption of ciprofloxacin following topical otic administration of ciprofloxacin and
dexamethasone otic suspension, breastfeeding is not expected to result in the exposure
of the infant to ciprofloxacin [see Clinical Pharmacology (12.3)].
Systemically administered corticosteroids appear in human milk. Dexamethasone in
breast milk could suppress growth, interfere with endogenous corticosteroid
production, or cause other untoward effects. However, it is not known whether topical
otic administration of ciprofloxacin or dexamethasone could result in systemic
absorption that is sufficient to produce detectable quantities of dexamethasone in
human milk.
There are no data on the effects of ciprofloxacin or dexamethasone on milk production.
The developmental and health benefits of breastfeeding should be considered along with
the mother’s clinical need for ciprofloxacin and dexamethasone otic suspension and any
potential adverse effects on the breast-fed child from ciprofloxacin and dexamethasone
otic suspension.

8.4 Pediatric Use

The safety and efficacy of ciprofloxacin and dexamethasone otic suspension have been
established in pediatric patients 6 months and older (937 patients) in adequate and well-
controlled clinical trials.
No clinically relevant changes in hearing function were observed in 69 pediatric patients
(age 4 to 12 years) treated with ciprofloxacin and dexamethasone otic suspension and
tested for audiometric parameters.

10 OVERDOSAGE
Due to the characteristics of this preparation, no toxic effects are to be expected with
an otic overdose of this product.

11 DESCRIPTION
Ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension contains the
quinolone antimicrobial, ciprofloxacin hydrochloride, combined with the corticosteroid,
dexamethasone, in a sterile, preserved suspension for otic use. Each mL of
ciprofloxacin and dexamethasone otic suspension 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 acetic acid, boric
acid, edetate disodium, hydroxyethyl cellulose, purified water, sodium acetate, sodium
chloride, and tyloxapol. Sodium hydroxide or hydrochloric acid may be added for
adjustment of pH.
Ciprofloxacin, a quinolone antimicrobial is available as the monohydrochloride
monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-
quinoline carboxylic acid. The empirical formula is C17H18FN3O 3·HCl·H2O. The molecular
weight is 385.82 g/mol and the structural formula is:
Dexamethasone, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-
3,20-dione, is a corticosteroid. The empirical formula is C22H29FO 5. The molecular weight
is 392.46 g/mol and the structural formula is:

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Ciprofloxacin is a fluoroquinolone antibacterial [see Microbiology (12.4)].
Dexamethasone, a corticosteroid, has been shown to suppress inflammation by
inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition,
capillary leakage, and migration of inflammatory cells.

12.3 Pharmacokinetics
Following a single bilateral 4-drop (total dose = 0.28 mL, 0.84 mg ciprofloxacin, 0.28 mg
dexamethasone) topical otic dose of ciprofloxacin and dexamethasone otic suspension
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.
Mean ± SD peak plasma concentrations of dexamethasone were 1.14 ± 1.54 ng/mL (n
= 9). Peak plasma concentrations ranged from 0.135 ng/mL to 5.10 ng/mL and were on
average approximately 14% of peak concentrations reported in the literature following
an oral 0.5-mg tablet dose. Peak plasma concentrations of dexamethasone were
observed within 15 minutes to 2 hours post dose application.
Dexamethasone has been added to aid in the resolution of the inflammatory response
accompanying bacterial infection (such as otorrhea in pediatric patients with AOMT).

12.4 Microbiology
Mechanism of Action
The bactericidal action of ciprofloxacin results from interference with the enzyme, DNA
gyrase, which is needed for the synthesis of bacterial DNA.
Resistance
Cross-resistance has been observed between ciprofloxacin and other fluoroquinolones.
There is generally no cross-resistance between ciprofloxacin and other classes of anti-
bacterial agents, such as beta-lactams or aminoglycosides.
Antimicrobial Activity
Ciprofloxacin has been shown to be active against most isolates of the following
microorganisms, both in vitro and clinically in otic infections [see Indications and Usage
(1)].
Aerobic Bacteria
Gram-positive Bacteria

• Staphylococcus aureus
• Streptococcus pneumoniae

Gram-negative Bacteria

• Haemophilus influenzae
• Moraxella catarrhalis
• Pseudomonas aeruginosa

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis
Long-term carcinogenicity studies in mice and rats have been completed for
ciprofloxacin. After daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were
administered for up to 2 years, there was no evidence that ciprofloxacin had any
carcinogenic or tumorigenic effects in these species. No long-term studies of
ciprofloxacin and dexamethasone otic suspension have been performed to evaluate
carcinogenic potential.
Long-term studies have not been performed to evaluate the carcinogenic potential of
topical otic dexamethasone.
Mutagenesis
Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test
results are listed below:
 • Salmonella/Microsome Test (Negative)
• E. coli DNA Repair Assay (Negative)
• Mouse Lymphoma Cell Forward Mutation Assay (Positive)
• Chinese Hamster V79 Cell HGPRT Test (Negative)
• Syrian Hamster Embryo Cell Transformation Assay (Negative)
• Saccharomyces cerevisiae Point Mutation Assay (Negative)
• Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative)
• Rat Hepatocyte DNA Repair Assay (Positive)

Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems
gave negative results:

• Rat Hepatocyte DNA Repair Assay

• Micronucleus Test (Mice)
• Dominant Lethal Test (Mice)

Dexamethasone has been tested for in vitro and in vivo genotoxic potential and shown
to be positive in the following assays: chromosomal aberrations, sister-chromatid
exchange in human lymphocytes, and micronuclei and sister-chromatid exchanges in
mouse bone marrow. However, the Ames/Salmonella assay, both with and without S9
mix, did not show any increase in His+ revertants.
Impairment of Fertility
Fertility studies performed in male and female rats at oral doses of ciprofloxacin up to
100 mg/kg (approximately 482 times the ROHD of ciprofloxacin based on BSA) revealed
no evidence of impairment. Male rats received oral ciprofloxacin for 10 weeks prior to
mating and females were dosed for 3 weeks prior to mating through GD 7.
The effect of dexamethasone on fertility has not been investigated following topical otic
application. However, the lowest toxic dose of dexamethasone identified following topical
dermal application was 1.802 mg/kg in a 26-week study in male rats and resulted in
changes to the testes, epididymis, sperm duct, prostate, seminal vesicle, Cowper's
gland, and accessory glands. The relevance of this study for short-term topical otic use
is unknown.

13.2 Animal Toxicology and/or Pharmacology

Guinea pigs dosed in the middle ear with ciprofloxacin and dexamethasone otic
suspension for one month exhibited no drug-related structural or functional changes of
the cochlear hair cells and no lesions in the ossicles.

14 CLINICAL STUDIES
In a randomized, multicenter, controlled clinical trial, ciprofloxacin and dexamethasone
otic suspension dosed 2 times per day for 7 days demonstrated clinical cures in the per
protocol analysis in 86% of AOMT patients compared to 79% for ofloxacin solution,
0.3%, dosed 2 times per day for 10 days. Among culture positive patients, clinical cures
were 90% for ciprofloxacin and dexamethasone otic suspension compared to 79% for
ofloxacin solution, 0.3%. Microbiological eradication rates for these patients in the same
clinical trial were 91% for ciprofloxacin and dexamethasone otic suspension compared
to 82% for ofloxacin solution, 0.3%.
In 2 randomized multicenter, controlled clinical trials, ciprofloxacin and dexamethasone
otic suspension dosed 2 times per day for 7 days demonstrated clinical cures in 87%
and 94% of per protocol evaluable AOE patients, respectively, compared to 84% and
89%, respectively, for otic suspension containing neomycin 0.35%, polymyxin B 10,000
units/mL, and hydrocortisone 1.0% (neo/poly/HC). Among culture-positive patients,
clinical cures were 86% and 92% for ciprofloxacin and dexamethasone otic suspension
compared to 84% and 89%, respectively, for neo/poly/HC. Microbiological eradication
rates for these patients in the same clinical trials were 86% and 92% for ciprofloxacin
and dexamethasone otic suspension compared to 85% and 85%, respectively, for
neo/poly/HC.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied
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 system consisting 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 0781-6186-67
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C
(59°F and 86°F) [see USP Controlled Room Temperature].
Avoid freezing. Protect from light.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and
Instructions for Use).
For Otic Use Only
Advise patients that ciprofloxacin and dexamethasone otic suspension is for otic use
(ears) only. This product must not be used in the eye [see Dosage and
Administration (2.2)].
Administration Instructions
Instruct patients to warm the bottle in their hand for one to two minutes prior to use
and shake well immediately before using [see Dosage and Administration (2.1, 2.2)].
Allergic Reactions
Advise patients to discontinue use immediately and contact their physician, if rash or
allergic reaction occurs [see Warnings and Precautions (5.1)].
Avoid Contamination of the Product
Advise patients to avoid contaminating the tip with material from the ear, fingers, or
other sources [see Instructions for Use].
Duration of Use
Advise patients that it is very important to use the eardrops for as long as their doctor
has instructed, even if the symptoms improve [see Patient Information].
Protect from Light
Advise patients to protect the product from light [see How Supplied/Storage and
Handling (16)].
Unused Product
Advise patients to discard unused portion after therapy is completed [see Dosage and
Administration (2.2)].
Distributed by: Sandoz Inc., Princeton, NJ 08540
T2020-148

PATIENT INFORMATION
CIPROFLOXACIN AND DEXAMETHASONE
(sih-proe-FLOX-ah-sin) and (dex-ah-METH-ah-sone)
OTIC SUSPENSION

What is CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION?

CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION is a prescription
medicine used in the ear only (otic use) that contains 2 medicines, a quinolone
antibiotic medicine called ciprofloxacin and a corticosteroid medicine called
dexamethasone. CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION is
used in adults and children 6 months of age or older to treat certain types of
infections caused by certain germs called bacteria. These bacterial infections
include:
• middle ear infection (known as acute otitis media or AOM) in people who have a
tube in their eardrum known as a tympanostomy to prevent having too much fluid
in the middle ear
• outer ear canal infection (known as acute otitis externa or AOE)
It is not known if CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION is
safe and effective in children under 6 months of age.

Who should not use CIPROFLOXACIN AND DEXAMETHASONE OTIC

SUSPENSION?

Do not use CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION if you:

• are allergic to ciprofloxacin, quinolones, or any of the ingredients in

CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION. See the end of this
Patient Information leaflet for a complete list of ingredients in CIPROFLOXACIN AND
DEXAMETHASONE OTIC SUSPENSION.
• have an outer ear canal infection caused by certain viruses, including the herpes
simplex virus.
• have an ear infection caused by a fungus.

What should I tell my doctor before using CIPROFLOXACIN AND

DEXAMETHASONE OTIC SUSPENSION?
DEXAMETHASONE OTIC SUSPENSION?
Before using CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION, tell
your doctor about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if CIPROFLOXACIN AND

DEXAMETHASONE OTIC SUSPENSION will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if CIPROFLOXACIN AND
DEXAMETHASONE OTIC SUSPENSION passes into your breast milk. Talk to your
doctor about the best way to feed your baby during treatment with
CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION.
Tell your doctor about all the medicines you take, including prescription and over-
the-counter medicines, vitamins, and herbal supplements.

How should I use CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION?

• Read the detailed Instructions for Use that come with CIPROFLOXACIN AND
DEXAMETHASONE OTIC SUSPENSION.
• Use CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION exactly as your
doctor tells you to.
• CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION is for use in
the ear only (otic use). Do not use CIPROFLOXACIN AND
DEXAMETHASONE OTIC SUSPENSION in the eye or inject CIPROFLOXACIN
AND DEXAMETHASONE OTIC SUSPENSION.
• Apply 4 drops of CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION into
the affected ear 2 times a day for 7 days.
• Do not stop using CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION
unless your doctor tells you to, even if your symptoms improve.
If your symptoms do not improve after 7 days of treatment with CIPROFLOXACIN
AND DEXAMETHASONE OTIC SUSPENSION, call your doctor.
• Call your doctor right away if:

o you have fluid that continues to drain from your ear (otorrhea) after you have
finished your treatment with CIPROFLOXACIN AND DEXAMETHASONE OTIC
SUSPENSION
o you have fluid that drains from your ear 2 or more times within 6 months
after you stop treatment with CIPROFLOXACIN AND DEXAMETHASONE OTIC
SUSPENSION

What are the possible side effects of CIPROFLOXACIN AND DEXAMETHASONE

OTIC SUSPENSION?
CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION may cause
serious side effects, including:

• allergic reactions. Stop using CIPROFLOXACIN AND DEXAMETHASONE OTIC

SUSPENSION and call your doctor or go to the nearest emergency room if you
have any of the following signs or symptoms of an allergic reaction:

o hives (urticaria) o trouble breathing

o swelling of your o dizziness, fast

 face, lips, mouth, or heartbeat, or pounding
tongue in your chest

o rash

o itching

The most common side effects of CIPROFLOXACIN AND DEXAMETHASONE

OTIC SUSPENSION include:

• ear discomfort
• ear pain
• ear itching (pruritus)
These are not all the possible side effects of CIPROFLOXACIN AND
DEXAMETHASONE OTIC SUSPENSION. Call your doctor for medical advice about
side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CIPROFLOXACIN AND DEXAMETHASONE OTIC

SUSPENSION?

• Store CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION at room

temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION.
• Keep CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION out of light.

Keep CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION and all

medicines out of the reach of children.
General information about the safe and effective use of CIPROFLOXACIN
AND DEXAMETHASONE OTIC SUSPENSION.
Medicines are sometimes prescribed for purposes other than those listed in a Patient
Information leaflet. Do not use CIPROFLOXACIN AND DEXAMETHASONE OTIC
SUSPENSION for a condition for which it was not prescribed. Do not give
CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION to other people, even if
they have the same symptoms that you have. It may harm them. You can ask your
pharmacist or doctor for information about CIPROFLOXACIN AND DEXAMETHASONE
OTIC SUSPENSION that is written for health professionals.

What are the ingredients in CIPROFLOXACIN AND DEXAMETHASONE OTIC

SUSPENSION?
Active ingredients: ciprofloxacin hydrochloride, dexamethasone, and
benzalkonium chloride as a preservative
Inactive ingredients: acetic acid, boric acid, edetate disodium, hydroxyethyl
cellulose, purified water, sodium acetate, sodium chloride, and tyloxapol. Sodium
hydroxide or hydrochloric acid may be added for adjustment of pH.

Distributed by: Sandoz Inc., Princeton, NJ 08540

This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: November 2020
T2020-149

INSTRUCTIONS FOR USE

CIPROFLOXACIN AND DEXAMETHASONE
(sih-proe-FLOX-ah-sin) and (dex-ah-METH-ah-sone)
OTIC SUSPENSION
This “Instructions for Use” contains information on how to use
CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION.
Important Information You Need to Know Before Using CIPROFLOXACIN AND
DEXAMETHASONE OTIC SUSPENSION.
Read this Instructions for Use that comes with CIPROFLOXACIN AND DEXAMETHASONE
OTIC SUSPENSION before you start using it and each time you get a refill. There may be
new information. This information does not take the place of talking with your doctor
about your medical condition or treatment.

• Use CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION exactly

as your doctor tells you to use it.
• CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION is for use in
the ear only (otic use). Do not inject CIPROFLOXACIN AND DEXAMETHASONE
OTIC SUSPENSION or use CIPROFLOXACIN AND DEXAMETHASONE OTIC
SUSPENSION in the eye.
• Shake CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION well
before each use.
• Do not touch your ear, fingers, or other surfaces with the tip of the
CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION bottle. You
may get bacteria on the tip of the bottle that can cause you to get another
infection.

How should I use CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION?

Step 1. Wash your hands with soap and water (see Figure A).
Figure A

Step 2. Warm the bottle of CIPROFLOXACIN AND DEXAMETHASONE OTIC

SUSPENSION by rolling the bottle between your hands for 1 to 2 minutes (see
Figure B).Shake the bottle of CIPROFLOXACIN AND DEXAMETHASONE OTIC
SUSPENSION well.
Figure B

Step 3. Remove the CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION cap.

Put the cap in a clean and dry area. Do not let the tip of the bottle touch your ear,
fingers or other surfaces.
Step 4. Lie down on your side so that the affected ear faces upward(see Figure C).
Figure C

Step 5. Hold the bottle of CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION

between your thumb and index finger (see Figure D). Place the tip of the bottle close to
your ear. Be careful not to touch your fingers or ear with the tip of the
bottle.
Figure D
Step 6. Gently squeeze the bottle and let 4 drops of CIPROFLOXACIN AND
DEXAMETHASONE OTIC SUSPENSION fall into the affected ear. If a drop misses your
ear, follow the instructions in Step 5 again.
Step 7. Stay on your side with the affected ear facing upward(see Figure C).
It is important that you follow the instructions below for your specific ear
infection,to allow CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION to enter
the affected part of your ear.
Step 8.
If you use CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION to treat a
middle ear infection, and you have a tube in your eardrum known as a
tympanostomy:

• Gently press the part of the ear known as the tragus (see Figure E) 5
times using a pumping motion (see Figure E). This will allow the drops of
CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION to enter your middle
ear.
• Remain on your side with the affected ear facing upward (see Figure C) for 1
minute.

Figure E

If you use CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION to treat an

outer ear canal infection:

• Gently pull the outer ear lobe upward and backward (see Figure F). This will allow
the drops of CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION to enter
 your ear canal.
• Remain on your side with the affected ear facing upward (see Figure C) for 1
minute.

Figure F

Step 9. If your doctor has told you to use CIPROFLOXACIN AND DEXAMETHASONE
OTIC SUSPENSION in both ears, repeat steps 5-8 for your other ear.
Step 10. Put the cap back on the bottle and close it tightly.
Step 11. After you have used all of your CIPROFLOXACIN AND DEXAMETHASONE OTIC
SUSPENSION doses, there may be some CIPROFLOXACIN AND DEXAMETHASONE OTIC
SUSPENSION left in the bottle. Throw the bottle away.

How should I store CIPROFLOXACIN AND DEXAMETHASONE OTIC

SUSPENSION?

• Store CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION at room

temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION.
• Keep CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION out of light.

Keep CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION and all

medicines out of the reach of children.
If you would like more information, talk with your doctor. You can ask your pharmacist
or doctor for more information about CIPROFLOXACIN AND DEXAMETHASONE OTIC
SUSPENSION that is written for health professionals.

Distributed by: Sandoz Inc., Princeton, NJ 08540

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: November 2020
T2020-150
774101 USG

PRINCIPAL DISPLAY PANEL

NDC 0781-6186-67

Ciprofloxacin 0.3%
and
Dexamethasone 0.1%
STERILE
OTIC SUSPENSION
Rx Only

7.5 mL
FOR USE IN
EARS ONLY
SANDOZ

PRINCIPAL DISPLAY PANEL

NDC 0781-6186-67
Ciprofloxacin 0.3%
And
Dexamethasone 0.1%
STERILE
OTIC SUSPENSION
Rx Only
7.5ml
FOR USE IN
EARS ONLY

CIPROFLOXACIN AND DEXAMETHASONE

ciprofloxacin and dexamethasone suspension/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-6186

Route of Administration AURICULAR (OTIC)

Active Ingredient/Active Moiety

Basis of
Ingredient Name Strength
Strength
CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - 3 mg
CIPROFLOXACIN
UNII:5E8K9I0O4U) in 1 mL
1 mg
Dexamethasone (UNII: 7S5I7G3JQL) (Dexamethas one - UNII:7S5I7G3JQL) Dexamethas one
in 1 mL

Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Boric Acid (UNII: R57Z HV85D4)
Sodium Chloride (UNII: 451W47IQ8X)
Hydroxyethyl Cellulose (1500 Mpa.s At 1%) (UNII: L605B5892V)
Tyloxapol (UNII: Y27PUL9H56)
Acetic Acid (UNII: Q40Q9N063P)
Sodium Acetate (UNII: 4550K0SC9B)
Edetate Disodium (UNII: 7FLD91C86K)
Water (UNII: 059QF0KO0R)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydrochloric Acid (UNII: QTT17582CB)

Packaging
Marketing Start Marketing End
# Item Code Package Description
Date Date
NDC:0781-
1 1 in 1 CARTON 08/10/2020
6186-67
7.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a
1
Combination Product

Marketing Information
Marketing Application Number or Monograph Marketing Start Marketing End
Category Citation Date Date
NDA authorized
NDA021537 08/10/2020
generic

Labeler - Sandoz Inc (005387188)

Revised: 11/2020 Sandoz Inc