Ciprofloxacin Hydrochloride
Tablet, Film Coated · Oral, Ophthalmic
Uses
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 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-epithelialization 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.
Warnings
WARNINGS NOT FOR INJECTION INTO THE EYE. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated. Remove contact lenses before using.
Precautions
General As with other antibacterial preparations, prolonged use of ciprofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction. In clinical studies of patients with bacterial corneal ulcer, a white crystalline precipitate located in the superficial portion of the corneal defect was observed in 35 (16.6%) of 210 patients. The onset of the precipitate was within 24 hours to 7 days after starting therapy. In one patient, the precipitate was immediately irrigated out upon its appearance. In 17 patients, resolution of the precipitate was seen in 1 to 8 days (seven within the first 24 to 72 hours), in five patients, resolution was noted in 10 to 13 days. In nine patients, exact resolution days were unavailable; however, at follow-up examinations, 18 to 44 days after onset of the event, complete resolution of the precipitate was noted. In three patients, outcome information was unavailable. The precipitate did not preclude continued use of ciprofloxacin, nor did it adversely affect the clinical course of the ulcer or visual outcome [see Adverse Reactions ] . Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution. 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. Carcinogenesis, Mutagenesis, Impairment of Fertility 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 V 79 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, two of the eight tests were positive, but the results of the following three in vivo test systems gave negative results:
• Rat Hepatocyte DNA Repair Assay
• Micronucleus Test (Mice)
• Dominant Lethal Test (Mice) Long term carcinogenicity studies in mice and rats have been completed. After daily oral dosing for up to two years, there is no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. Pregnancy Reproduction studies have been performed in rats and mice at doses up to six times the usual daily human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to ciprofloxacin. In rabbits, as with most antimicrobial agents, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion. No teratogenicity was observed at either dose. After intravenous administration, at doses up to 20 mg/kg, no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed. There are no adequate and well controlled studies in pregnant women. Ciprofloxacin ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Side effects
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 Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
Pregnancy
Pregnancy Reproduction studies have been performed in rats and mice at doses up to six times the usual daily human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to ciprofloxacin. In rabbits, as with most antimicrobial agents, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion. No teratogenicity was observed at either dose. After intravenous administration, at doses up to 20 mg/kg, no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed. There are no adequate and well controlled studies in pregnant women. Ciprofloxacin ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric use
Pediatric Use The safety and effectiveness of ciprofloxacin ophthalmic solution 0.3% have been established in all ages. Use of ciprofloxacin ophthalmic solution is supported by evidence from adequate and well controlled studies of ciprofloxacin ophthalmic solution in adults, children and neonates [see Clinical Studies ]. Although ciprofloxacin and other quinolones cause arthropathy in immature animals after oral administration, topical ocular administration of ciprofloxacin to immature animals did not cause any arthropathy and there is no evidence that the ophthalmic dosage form has any effect on the weight bearing joints.
Geriatric use
Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Overdosage
OVERDOSAGE A topical overdose of ciprofloxacin ophthalmic solution may be flushed from the eye(s) with warm tap water.
Description
Ciprofloxacin ophthalmic solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1- piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C 17 H 18 FN 3 O 3 ∙HCl∙H 2 O and its chemical structure is as follows: Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of ciprofloxacin ophthalmic solution contains: Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactives: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm. chemical
How supplied
As a sterile ophthalmic solution in Alcon’s DROP-TAINER ® dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package. 2.5 mL in 8mL bottle NDC 61314-656-25 5 mL in 8mL bottle NDC 61314-656-05 10 mL in 10mL bottle NDC 61314-656-10 STORAGE Store at 2° to 25°C (36° to 77°F). Protect from light.
Patient information
Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution.
Label text from the FDA structured product label by Sandoz Inc (revised Jul 18, 2019). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ciprofloxacin Hydrochloride in 25 products
Ciprofloxacin Hydrochloride NDC products (25)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7843 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7848 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 72888-102 | Ciprofloxacin Hydrochloride 3 mg/mL Solution | Advagen Pharma Limited | ANDA |
| 80425-0493 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Advanced Rx of Tennessee, LLC | ANDA |
| 67046-1692 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 72789-577 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-4177 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc | ANDA |
| 82804-260 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 67296-2208 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Redpharm Drug | ANDA |
| 60760-847 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 83939-0002 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | VERITYRX, LLC | ANDA |
| 69367-387 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | Westminster Pharmaceuticals, LLC | ANDA |
| 69367-386 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Westminster Pharmaceuticals, LLC | ANDA |
| 69367-385 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Westminster Pharmaceuticals, LLC | ANDA |
| 50090-1754 | Ciprofloxacin Hydrochloride 3 mg/mL Solution/ Drops | A-S Medication Solutions | NDA AUTHORIZED GENERIC |
| 50090-0882 | Ciprofloxacin Hydrochloride 3 mg/mL Solution/ Drops | A-S Medication Solutions | NDA AUTHORIZED GENERIC |
| 76420-942 | Ciprofloxacin Hydrochloride 3 mg/mL Solution/ Drops | Asclemed USA, Inc. | NDA AUTHORIZED GENERIC |
| 68071-4235 | Ciprofloxacin Hydrochloride 3 mg/mL Solution/ Drops | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC |
| 68071-4139 | Ciprofloxacin Hydrochloride 3 mg/mL Solution/ Drops | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC |
| 68071-3351 | Ciprofloxacin Hydrochloride 3 mg/mL Solution/ Drops | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC |
| 68788-8198 | Ciprofloxacin Hydrochloride 3 mg/mL Solution/ Drops | Preferred Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
| 63187-985 | Ciprofloxacin Hydrochloride 3 mg/mL Solution/ Drops | Proficient Rx LP | NDA AUTHORIZED GENERIC |
| 67296-0142 | Ciprofloxacin Hydrochloride 3 mg/mL Solution/ Drops | Redpharm Drug | NDA AUTHORIZED GENERIC |
| 70518-1170 | Ciprofloxacin Hydrochloride 3 mg/mL Solution/ Drops | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC |
| 61314-656 | Ciprofloxacin Hydrochloride 3 mg/mL Solution/ Drops | Sandoz Inc | NDA AUTHORIZED GENERIC |
Ciprofloxacin Hydrochloride recalls
- D-1044-2022 Jun 15, 2022 · Class II · Terminated
cGMP deviations: Temperature abuse
Frequently asked questions
What is Ciprofloxacin Hydrochloride used for?
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…
What are the side effects of Ciprofloxacin Hydrochloride?
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,… See the full label for the complete list.
Who makes Ciprofloxacin Hydrochloride?
Ciprofloxacin Hydrochloride is listed by 16 labelers in the FDA NDC directory, including A-S Medication Solutions, Advagen Pharma Limited, Advanced Rx of Tennessee, LLC, Coupler LLC.
Has Ciprofloxacin Hydrochloride been recalled?
The FDA enforcement database lists 1 recall for Ciprofloxacin Hydrochloride, most recently D-1044-2022 (class ii): cGMP deviations: Temperature abuse