ciprofloxacin and dexamethasone
Pharmaranks rates Ciprofloxacin and Dexamethasone 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Ciprofloxacin and Dexamethasone is a combination medicine containing Ciprofloxacin and Dexamethasone.
Generic · by Amneal
Generic of Ciprodex
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Ciprofloxacin and Dexamethasone
- Form
- Suspension, Drops
- Strength
- Ciprofloxacin 0.3%; Dexamethasone 0.1%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Amneal
- Half-life
- about 4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$3.71 for 30 — not your price
- FDA application
- ANDA216501
What is Ciprofloxacin and Dexamethasone?
From the FDA label:Ciprofloxacin and Dexamethasone 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 and dexamethasone otic suspension, USP 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 (as dihydrate), hydroxyethyl cellulose, sodium acetate trihydrate, sodium chloride, tyloxapol and water for injection, USP. 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 molecular 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 USP, (11β,16α)-9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The molecular 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 structure 1 structure 2
How to use
Ciprofloxacin and Dexamethasone is sold in more than one form (Suspension and Drops), and each is dosed differently. The instructions below come from the FDA label for application ANDA216501 — follow the label that came with the product you were actually prescribed.
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 ) 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 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.
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 Amneal Pharmaceuticals at 1-877-835-5472 or 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 537 patients were treated with ciprofloxacin and dexamethasone otic suspension with AOE. The reported adverse reactions are listed below: 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). 6.2 Postmarketing…
Warnings
Important safety information
Hypersensitivity and anaphylaxis have been reported with systemic use of quinolones. Discontinue use if this occurs with use of ciprofloxacin and dexamethasone. ( 5.1 ) Prolonged use may result in overgrowth of non-susceptible bacteria and fungi. ( 5.2 ) 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.
Who should not take Ciprofloxacin and Dexamethasone
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. 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 )
Overdose — what happens if you take too much
Due to the characteristics of this preparation, no toxic effects are to be expected with an otic overdose of this product.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Ciprofloxacin and Dexamethasone stay in your body?
The elimination half-life of ciprofloxacin and dexamethasone is about 4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the serum elimination half-life in adults with normal kidney function; it is slightly longer when kidney function is reduced and about 20% longer in older adults, and no metabolite has a materially longer half-life.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: CIPROFLOXACIN HYDROCHLORIDE tablet - DailyMed (FDA label).
Dosage forms
Suspension and Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- How is Ciprofloxacin and Dexamethasone rated?
- pharmaranks gives Ciprofloxacin and Dexamethasone a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Ciprofloxacin and Dexamethasone cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $3.71 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Ciprofloxacin and Dexamethasone?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ciprofloxacin and Dexamethasone. To pay less, Ciprofloxacin and Dexamethasone is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ciprofloxacin and Dexamethasone?
- Ciprofloxacin and Dexamethasone is marketed by Amneal. You can see Amneal's full profile, rating, and other products on pharmaranks.
- Is Ciprofloxacin and Dexamethasone a brand-name or generic drug?
- Ciprofloxacin and Dexamethasone is a generic medication; its active ingredient is Ciprofloxacin and Dexamethasone. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Ciprofloxacin and Dexamethasone available over the counter?
- No. Ciprofloxacin and Dexamethasone is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ciprofloxacin and Dexamethasone come in?
- Ciprofloxacin and Dexamethasone is currently marketed as suspension and drops, per the FDA's National Drug Code Directory.
- Is Ciprofloxacin and Dexamethasone FDA-registered?
- Ciprofloxacin and Dexamethasone is on record with the U.S. FDA under application number ANDA216501. You can verify this on its official FDA label.
- Has Ciprofloxacin and Dexamethasone been recalled by the FDA?
- Ciprofloxacin and Dexamethasone has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Ciprofloxacin and Dexamethasone safe?
- There's no single safe-or-not verdict. pharmaranks gives Ciprofloxacin and Dexamethasone a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Ciprofloxacin and Dexamethasone?
- Ciprofloxacin and Dexamethasone's side effects are taken directly from its FDA label. From the label: 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%),… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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ciprofloxacin and dexamethasone
70/100