Ciprofloxacin Hydrochloride Solution

Ciprofloxacin Hydrochloride Solution

Ciprofloxacin Hydrochloride Solution Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Ciprofloxacin Hydrochloride 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.

History

There is currently no drug history available for this drug.

Other Information

Ciprofloxacin Hydrochloride 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 C17H18FN3O3•HCl•H2O and its chemical structure is as follows:

Chemical Structure

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 Hydrochloride Ophthalmic Solution contains: Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactive: sodium acetate, acetic acid, mannitol 4.6%, edentate 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.

Ciprofloxacin Hydrochloride Solution Manufacturers


  • Rebel Distributors Corp
    Ciprofloxacin Hydrochloride Solution [Rebel Distributors Corp]
  • Falcon Pharmaceuticals, Ltd.
    Ciprofloxacin Hydrochloride Solution [Falcon Pharmaceuticals, Ltd.]
  • Stat Rx Usa Llc
    Ciprofloxacin Hydrochloride Solution [Stat Rx Usa Llc]

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