Ciprofloxacin Hydrochloride Ophthalmic Solution, 0.3% as base, Sterile

/Ciprofloxacin Hydrochloride Ophthalmic Solution, 0.3% as base, Sterile
Ciprofloxacin Hydrochloride Ophthalmic Solution, 0.3% as base, Sterile2018-09-06T09:12:40+00:00

Prescription Drug Name:

Ciprofloxacin Hydrochloride Ophthalmic Solution, 0.3% as base, Sterile

ID:

2dedb271-e605-4fa7-913d-09f28f38522f

Code:

34391-3

DESCRIPTION


id: 53bbcbee-5c3f-44ef-bbcf-5310fb56bb61
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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: 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%, 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.

CLINICAL PHARMACOLOGY


id: f6f11202-7eb8-4be8-a764-22eb4746ee99
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Systemic Absorption: A systemic absorption study was performed in which Ciprofloxacin Hydrochloride Ophthalmic Solution was administered in each eye every two hours while awake for two days followed by every four hours while awake for an additional 5 days. The maximum reported plasma concentration of ciprofloxacin was less than 5 ng/mL. The mean concentration was usually less than 2.5 ng/mL. 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. Ciprofloxacin has been shown to be active against most strains of the following organisms both in vitro and in clinical infections. (See INDICATIONS AND USAGE section). Gram-Positive: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group) Gram-Negative: 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 Klebsiella pneumoniae Klebsiella oxytoca Legionella pneumophila Moraxella (Branhamella) catarrhalis Morganella morganii Neisseria gonorrhoeae Neisseria meningitidis Pasteurella multocida Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Salmonella enteritidis Salmonella typhi Shigella sonneii Shigella flexneri Vibrio cholerae Vibrio parahaemolyticus Vibrio vulnificus Yersinia enterocolitica Other Organisms:
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. Clinical Studies: Following therapy with Ciprofloxacin Hydrochloride Ophthalmic Solution, 76% of the patients with corneal ulcers and positive bacterial cultures were clinically cured and complete re-epithelialization 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.

INDICATIONS AND USAGE


id: 41ed0f66-c7c1-4b4d-b3a1-f1433297063b
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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.

CONTRAINDICATIONS


id: e841012c-6a7b-4d48-8505-4c900d579b36
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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


id: 3ce81018-4e50-44ef-a114-e7dc13b27516
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

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.

Nursing Mothers


id: 85c66017-6e74-4078-b170-196fc340b99d
displayName: NURSING MOTHERS SECTION
FDA Article Code: 34080-2

It is not known whether topically applied ciprofloxacin is excreted in human milk; however, it is known that orally administered ciprofloxacin is excreted in the milk of lactating rats and oral ciprofloxacin has been reported in human breast milk after a single 500 mg dose. Caution should be exercised when Ciprofloxacin Hydrochloride Ophthalmic Solution is administered to a nursing mother.

Pediatric Use


id: 7c1ee255-767c-4d9e-8d3b-274daa5bb203
displayName: PEDIATRIC USE SECTION
FDA Article Code: 34081-0

Safety and effectiveness in pediatric patients below the age of 1 year have not been established. 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


id: a4886ca0-5301-452a-82db-989cfc570518
displayName: GERIATRIC USE SECTION
FDA Article Code: 34082-8

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS


id: ea9e3733-cb6a-47cf-aa0b-a3f4cd937f36
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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.

OVERDOSAGE


id: 789eca0e-106f-4070-85ad-97d4856c71a0
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

A topical overdose of Ciprofloxacin Hydrochloride Ophthalmic Solution may be flushed from the eye(s) with warm tap water.

DOSAGE AND ADMINISTRATION


id: 36a8905a-d5cd-47c6-94b0-aa5b80b9e4ab
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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.

HOW SUPPLIED


id: eee43510-a13a-4d87-a90f-290e42ad6f11
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

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. 5 mL – NDC 68788-7100-5 STORAGE: Store at 2° to 25°C (36° to 77°F). Protect from light.

ANIMAL PHARMACOLOGY


id: 63dac4d2-44a7-4bf8-9af3-410401b6af89
displayName: ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION
FDA Article Code: 34091-9

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. 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. Rx Only Rev. May 2012 **DROP-TAINER is a registered trademark of Alcon Research, Ltd. 9007230-1011 SANDOZ

Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc.
Princeton, NJ 08540
Printed in USA Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL


id: 12894298-bb50-41cd-9326-b0650a03ee98
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 68788-7100-5

Ciprofloxacin Hydrochloride Ophthalmic Solution, 0.3% as base

0.3%

Rx only

STERILE

5 ml

SANDOZ

FOR TOPICAL OPHTHALMIC USE ONLY.

INGREDIENTS: Each mL contains:

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

Preservative: benzalkonium chloride 0.006%.

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

USUAL DOSAGE: Read insert.

STORAGE: Store at 2º to 25ºC (36º to 77ºF).
Protect from light.

Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc.
Princeton, NJ 08540

Rev. 05/2012 Relabeled By: Preferred Pharmaceuticals Inc.