ciprofloxacin 3 mg/mL
Ciprofloxacin · SOLUTION · Advanced Rx of Tennessee, LLC
ciprofloxacin is a solution containing ciprofloxacin at 3 mg/mL, taken ophthalmic. Manufactured by Advanced Rx of Tennessee, LLC.
Key Facts
- Brand Name
- ciprofloxacin
- Generic Name
- Ciprofloxacin
- NDC Code (Product)
80425-0499- Manufacturer
- Advanced Rx of Tennessee, LLC
- Strength
- 3 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA077568
- Marketing Start
- 03/20/2025
Recall History
Mylan Pharmaceuticals Inc.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Direct Rx
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
West-ward Pharmaceutical Corp.
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
FDC Limited
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Sandoz Inc
Temperature Abuse
FDC Limited
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Actavis Pharma Inc
Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Dr. Reddy's Laboratories, Inc.
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aeruginosa Serratia marcescens * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group) * Conjunctivitis: Haemophilus influenzae Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections.
Dosage & Administration
DOSAGE AND ADMINISTRATION Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialisation has not occurred. Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
Contraindications
CONTRAINDICATIONS A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication to its use. A history of hypersensitivity to other quinolones may also contraindicate the use of ciprofloxacin.
Drug Interactions
Drug Interactions: Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant, warfarin, and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.
Adverse Reactions
ADVERSE REACTIONS The most frequently reported drug related adverse reaction was local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in approximately 17% of patients ( see Precautions ). Other reactions occurring in less than 10% of patients included lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia and a bad taste following instillation. Additional events occurring in less than 1% of patients included corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision. To report SUSPECTED ADVERSE REACTIONS, contact LEADING PHARMA AT 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Frequently Asked Questions
What is ciprofloxacin used for?
ciprofloxacin contains Ciprofloxacin. It is a solution taken ophthalmic. Consult your doctor for specific uses.
Is ciprofloxacin a controlled substance?
ciprofloxacin is not classified as a controlled substance by the DEA.
What is the generic name for ciprofloxacin?
The generic name for ciprofloxacin is Ciprofloxacin. There are 9 other brand versions of Ciprofloxacin.
What is the NDC code for ciprofloxacin 3 mg/mL?
The NDC (National Drug Code) for ciprofloxacin 3 mg/mL is 80425-0499, listed by Advanced Rx of Tennessee, LLC.
Other ciprofloxacin Dosages
Other Ciprofloxacin Brands
See all →- Ciprofloxacin500 mg/172162-1741
- Ciprofloxacin Hydrochloride500 mg/180425-0493
- Ciprofloxacin Hydrochloride3 mg/mL50090-0882
- Ciprofloxacin250 mg/150090-4600
- Ciprofloxacin250 mg/158657-675
- Ciprofloxacin500 mg/160687-860
- Ciprofloxacin750 mg/161442-224
- Ciprofloxacin500 mg/163629-1010
- Ciprofloxacin Hydrochloride500 mg/167296-2208
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)