Medicine guide

Ciprofloxacin and Dexamethasone

3 mg/mL + 1 mg/mL · Suspension/ Drops

Prescription only
Corticosteroid

Active substance: Ciprofloxacin and Dexamethasone
Used in: Antibiotics, antivirals and antifungals taken into the body
Made by: NorthStar RxLLC
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-11-01

What it is

Corticosteroid

Used for

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…

Do not take it if

Ciprofloxacin 0.3% and dexamethasone 0.1% 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…

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-01

10other products contain Ciprofloxacin and Dexamethasone — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Ciprofloxacin 0.3% and dexamethasone 0.1% 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 . Ciprofloxacin 0.3% and dexamethasone 0.1% 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 )

From the official label · 2024-11-01 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-11-01

Do not take it if

Ciprofloxacin 0.3% and dexamethasone 0.1% 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.
Ciprofloxacin 0.3% and dexamethasone 0.1% 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)

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Ciprofloxacin 0.3% and dexamethasone 0.1% 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 ) 2.1 Important Administration Instructions
Ciprofloxacin 0.3% and dexamethasone 0.1% 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 0.3% and dexamethasone 0.1% 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 0.3% and dexamethasone 0.1% 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Hypersensitivity and anaphylaxis have been reported with systemic use of quinolones. Discontinue use if this occurs with use of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension. ( 5.1)
Prolonged use may result in overgrowth of non-susceptible bacteria and fungi. ( 5.2) 5.1 Hypersensitivity Reactions Ciprofloxacin 0.3% and dexamethasone 0.1% 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 0.3% and dexamethasone 0.1% 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.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary There are no available data on ciprofloxacin 0.3% and dexamethasone 0.1% 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 0.3% and dexamethasone 0.1% 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 0.3% and dexamethasone 0.1% 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 embryofetal 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.
IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary There are no available data on ciprofloxacin 0.3% and dexamethasone 0.1% 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 0.3% and dexamethasone 0.1% 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 0.3% and dexamethasone 0.1% 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 embryofetal 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 0.3% and dexamethasone 0.1% 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 0.3% and dexamethasone 0.1% otic suspension 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 0.3% and dexamethasone 0.1% otic suspension and any potential adverse effects on the breast-fed child from ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension.
8.4 Pediatric Use The safety and efficacy of ciprofloxacin 0.3% and dexamethasone 0.1% 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 0.3% and dexamethasone 0.1% otic suspension and tested for audiometric parameters.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Side effects

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)] Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%). (6) To report SUSPECTED ADVERSE REACTIONS, contact NorthStar RxLLC, at 1-800-206- 7821or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 0.3% and dexamethasone 0.1% 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. Ad v erse Reactions In cidence (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. Ad v erse Reactions In cidence (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). 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of ciprofloxacin 0.3% and dexamethasone 0.1% 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.

Quoted from the official label, section “Adverse Reactions”.

Details

Made by	NorthStar RxLLC
Active substance	Ciprofloxacin and Dexamethasone
Used in	Antibiotics, antivirals and antifungals taken into the body
Strength	3 mg/mL + 1 mg/mL
Form	Suspension/ Drops
Route	Auricular (otic)
Packs	1 BOTTLE, DROPPER in 1 CARTON / 7.5 mL in 1 BOTTLE, DROPPER
NDC	16714-628

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

12 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Suspension/ Drops11 products
- 3 mg/mL + 1 mg/mL11
  3 mg/mL + 1 mg/mL · 11 companies
  - Amneal Pharmaceuticals of New York LLC
  - ARMAS PHARMACEUTICALS INC.
  - Dr. Reddy's Laboratories, Inc.
  - NorthStar RxLLC · this page
  - NuCare Pharmaceutical, Inc.
  - NuCare Pharmaceuticals, Inc.
  - Redpharm Drug
  - Sandoz Inc
  +3 more
Suspension1 products
- 3 mg/mL + 1 mg/mL

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Ciprofloxacin and Dexamethasone