Ciprofloxacin Ophthalmic Solution Description

Each mL of Ciprofloxacin ophthalmic solution 0.3% 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 water for injection. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm.

Ciprofloxacin Ophthalmic Solution - Clinical Pharmacology

Microbiology: Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.

Aerobic gram-Positive microorganisms:

Staphylococcus aureus (methicillin-susceptible strains)

Staphylococcus epidermidis (methicillin-susceptible strains)

Streptococcus pneumoniae

Streptococcus (Viridans Group)

Aerobic gram-negative microorganisms:

Haemophilus influenzae

Pseudomonas aeruginosa

Serratia marcescens

Ciprofloxacin has been shown to be active in vitro against most strains of the following organisms, however, the clinical significance of these data is unknown:

Gram-Positive:

Enterococcus faecalis (Many strains are only moderately susceptible)

Staphylococcus haemolyticus

Staphylococcus hominis

Staphylococcus saprophyticus

Streptococcus pyogenes

Gram-Negative

Acinetobacter calcoaceticus subsp. anitratus

Aeromonas caviae

Aeromonas hydrophila

Brucella melitensis

Campylobacter coli

Campylobacter jejuni

Citrobacter diversus

Citrobacter freundii

Edwardsiella tarda

Enterobacter aerogenes

Enterobacter cloacae

Escherichia coli

Haemophilus ducreyi

Haemophilus parainfluenzae

Kiebsiella pneumoniae

Klebsiella oxytoca

Legionella pneumophila

Moraxella (Branhamella) catarrhalis

Morganella morganii

Neisseria gonorrhoeae

Neisseria meningitides

Pasteurella multocida

Proteus mirabilis

Proteus vulgaris

Providencia rettgeri

Providencia stuartii

Salmonella enteritidis

Salmonella typhi

Shigella sonneii

Shigella flexneri

Vibrio cholera

Vibrio parahaemolyticus

Vibrio vulnificus

Yersinia enterocolitica

Chlamydia trachomatis (only moderately susceptible) and Mycobacterium tuberculosis (only moderately susceptible).

Most strains of Pseudomonas cepacia and some strains of Pseudomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile.

The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2. Resistance to ciprofloxacin in vitro usually develops slowly (multiple-step mutation).

Ciprofloxacin does not cross-react with other antimicrobial agents such as beta-lactams or aminoglycosides; therefore, organisms resistant to these drugs may be susceptible to ciprofloxacin.

Indications and Usage for Ciprofloxacin Ophthalmic Solution

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.

Contraindications

Warnings and Precautions

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

Adverse Reactions/Side Effects

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

Overdosage

Ciprofloxacin Ophthalmic Solution Dosage and Administration

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.

How is Ciprofloxacin Ophthalmic Solution supplied

2.5 mL - NDC 69315-308-02

5 mL – NDC 69315-308-05

10 mL – NDC 69315-308-10

STORAGE:

Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature]. Retain in carton until contents are used and protect from light.

ANIMAL PHARMACOLOGY:

Ciprofloxacin and related drugs have been shown to cause arthropathy in immature animals of most species tested following oral administration. However, a one month topical ocular study using immature Beagle dogs did not demonstrate any articular lesions.

CLINICAL STUDIES:

Following therapy with Ciprofloxacin ophthalmic solution 0.3%, 76% of the patients with corneal ulcers and positive bacterial cultures were clinically cured and complete re-epithelialisation occurred in about 92% of the ulcers.

In 3 and 7 day multicenter clinical trials, 52% of the patients with conjunctivitis and positive conjunctival cultures were clinically cured and 70-80% had all causative pathogens eradicated by the end of treatment.

In a randomized, double-masked, multicenter, parallel-group clinical trial of pediatric patients with bacterial conjunctivitis, between birth and 31 days of age, patients were dosed with Ciprofloxacin ophthalmic solution or another anti-infective agent. Clinical outcomes for the trial demonstrated a clinical cure rate of 80% at Day 9 and a microbiological eradication success rate of 85% at Day 9.

Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

Rx Only

Distributed by:

Leading Pharma, LLC.

Fairfield, NJ07004

Manufactured By:

FDC Limited,

B-8, MIDC Industrial Area,

Waluj, Aurangabad - 431 136,

Maharashtra, India

Revision: 10/2019

STERILE OPHTHALMIC SOLUTION

CIPROFLOXACIN OPHTHALMIC SOLUTION USP 0.3%

INSTRUCTIONS FOR USE

Read this Instruction for Use before you start using Ciprofloxacin ophthalmic solution and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

Use Ciprofloxacin ophthalmic solution as prescribed by your doctor. Ask your doctor if you have questions about how to use Ciprofloxacin ophthalmic solution.

Important information:

• Ciprofloxacin ophthalmic solution is for use in the eye only. Ciprofloxacin ophthalmic solution should not be injected into the eye.
• If you use other medicines in your eye, wait at least 10 minutes between using Ciprofloxacin ophthalmic solution and your other eye medicines.
• If you wear contact lenses, remove them before using Ciprofloxacin ophthalmic solution. Wait at least 15 minutes after using Ciprofloxacin ophthalmic solution before placing your contact lenses back in your eyes.
• Do not touch your eye, fingers, or other surfaces with the tip of the Ciprofloxacin ophthalmic solution bottle. You may get bacteria on the tip of the bottle that can cause you to get an eye infection. This eye infection can lead to serious eye damage or vision loss. If you think you have gotten bacteria on the tip of the bottle or you have an eye infection, call your doctor right away.
• Wash your hands before each use.

• Check the expiration date on the bottle before use. Do not use Ciprofloxacin ophthalmic solution if the expiration date has passed.
• Check that the seal on the dust cover is not broken or missing. Do not use the medicine if the seal is broken or missing. Call your doctor or pharmacist.

Step 1: Turn the dust cover clockwise to break the seal.

• If your doctor has told you to use drops in both eyes, repeat Step 5 for your other eye.
• The Ciprofloxacin ophthalmic solution bottle tip is made to give a certain amount of medicine in 1 drop. Do not make the opening of the bottle tip bigger or you may get too much Ciprofloxacin ophthalmic solution.
• After you use all of the doses of Ciprofloxacin ophthalmic solution that your doctor has prescribed, there will be some medicine left in the bottle. Do not use the extra medicine in the bottle. Throw the bottle away.

• Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].
• Retain in carton until contents are used and protect from light

This Instruction for Use has been approved by the U.S. Food and Drug Administration.

Distributed by:

Leading Pharma, LLC.

Fairfield, NJ07004

Manufactured By:

FDC Limited,

B-8, MIDC Industrial Area,

Waluj, Aurangabad - 431 136,

Maharashtra, India

Revision: 10/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69315-308-05

Ciprofloxacin Ophthalmic Solution USP 0.3% as base

Rx Only

5 mL Sterile

PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.

USUAL DOSAGE: Read enclosed insert.

FOR TOPICAL OPHTHALMIC USE ONLY.

EACH mL CONTAINS:

Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg ciprofloxacin base.

Preservative: benzalkonium chloride 0.006%.

Inactives: sodium acetate, acetic acid, mannitol, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH) and water for injection.

STORAGE: Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].Protect from light.