Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL Suspension/ Drops, 1 bottle
Other active recalls for Ciprofloxacin And Dexamethasone (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Fluoroquinolone Antibacterial class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Ciprofloxacin and dexamethasone otic is used to treat outer ear infections in adults and children and acute (suddenly occurring) middle ear infections in children with ear tubes. Ciprofloxacin is in a class of medications called quinolone antibiotics. Dexamethasone is in a class of medications called corticosteroids. The combination of ciprofloxacin and dexamethasone works by killing the bacteria that cause infection and reducing swelling in the ear.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $13.23 | $99.21 / 7.5 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 00781-6186-67 | Sandoz | 1 bottle | $6.945 | AB | Availability likely | — |
| Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 00832-1430-75 | Upsher-Smith | 1 bottle | $6.945 | AB | Availability likely | — |
| Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 16714-0628-01 | NorthStar | 1 bottle | $6.945 | AB | Availability likely | — |
| Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 43598-0326-75 | Dr. | 1 bottle | $6.945 | AB | Availability likely | — |
| Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 53746-0831-53 | Amneal | 1 bottle | $6.945 | AB | Availability likely | — |
| Ciprofloxacin and dexamethasone 3 mg/mL; 1 mg/mL 62756-0427-90 | Sun | 1 bottle | $6.945 | AB | Availability likely | — |
| Ciprofloxacin and dexamethasone 3 mg/mL; 1 mg/mL 70244-0033-01 | Sentiss | 1 bottle | $6.945 | AB | Availability likely | — |
| Ciprofloxacin and dexamethasone 3 mg/mL; 1 mg/mL 72485-0625-13 | ARMAS | 1 bottle | $6.945 | AB | Availability likely | — |
| Ciprofloxacin and dexamethasone 3 mg/mL; 1 mg/mL 67296-1943-08 | Redpharm | 1 bottle | — | AB | FDA listed | — |
| Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mLthis 67296-2257-08 | Redpharm | 1 bottle | — | AB | FDA listed | — |
| Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 68071-3804-07 | NuCare | 1 bottle | — | AB | FDA listed | — |
| Ciprofloxacin and dexamethasone 3 mg/mL; 1 mg/mL 68071-3977-07 | NuCare | 1 bottle | — | AB | FDA listed | — |
| Ciprofloxacin and Dexamethasone 3 mg/mL; 1 mg/mL 85766-0245-75 | Sportpharm | 1 bottle | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 67296-2257-08 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (67296-2257-8) / 7.5 mL in 1 BOTTLE, DROPPER | 2022-08-01 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 )
2.1Important 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.
2.2Dosage 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.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Otic Suspension: Each mL of ciprofloxacin and dexamethasone otic suspension USP, contains ciprofloxacin hydrochloride USP 0.3% (equivalent to 3 mg ciprofloxacin base) and dexamethasone USP, 0.1% equivalent to 1 mg dexamethasone. 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 ▾
4 CONTRAINDICATIONS 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)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • 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)
5.1Hypersensitivity 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.
5.2Potential 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.
5.3Continued 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.
🤒 Adverse Reactions ▾
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)] 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 .
6.1Clinical 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).
6.2Postmarketing 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
8.2Lactation 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 b…
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric 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.
🆘 Overdosage ▾
10 OVERDOSAGE Due to the characteristics of this preparation, no toxic effects are to be expected with an otic overdose of this product.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.3Pharmacokinetics Following a single bilateral 4-drop (total dose = 0.28 mL, 0.84 mg ciprofloxacin, 0.28 mg dexamethasone) topical otic dose of ciprofloxacin 0.3% and dexamethasone 0.1% 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).
12.4Microbiology 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
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied: Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension USP, is white to off-white suspension supplied as follows: 7.5 mL fill in 10 mL low density polyethylene bottle. The packaging system consists of a 10 mL low density polyethylene plastic squeeze bottle, a natural low density polyethylene dropper tip and a high density polyethylene tamper evident screw cap for dropper bottle. 7.5 mL fill, NDC 16714-628-01 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.
📋 Description ▾
11 DESCRIPTION Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension USP, contains the quinolone antimicrobial, ciprofloxacin hydrochloride USP, combined with the corticosteroid, dexamethasone USP, in a sterile, preserved suspension for otic use. Each mL of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension contains ciprofloxacin hydrochloride USP (equivalent to 3 mg ciprofloxacin base), 1 mg dexamethasone USP, and 0.1 mg benzalkonium chloride as a preservative. The inactive ingredients are acetic acid, boric acid, edetate disodium, hydroxyethyl cellulose, sodium acetate, sodium chloride, tyloxapol and water for injection.
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 C 17 H 18 FN 3 O 3 ·HCl·H 2 O.
The molecular weight is 385.82 g/mol and the structural formula is: Figure 1: Structure of Ciprofloxacin Dexamethasone, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The empirical formula is C 22 H 29 FO 5 . The molecular weight is 392.46 g/mol and the structural formula is: Figure 2: Structure of Dexamethasone ciprostructure dexstructure
💬 Information for Patients ▾
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 0.3% and dexamethasone 0.1% 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 )].