moxifloxacin 0.5 % Ophthalmic Solution

Details

Generic Name: MOXIFLOXACIN HYDROCHLORIDE

Brand Name: VIGAMOX

Substance Name(s):
MOXIFLOXACIN HYDROCHLORIDE

DRUG INTERACTIONS

7 Drug-drug interaction studies have not been conducted with VIGAMOX® solution. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.

DESCRIPTION

11 VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b]pyridin-6-yl]-4-oxo-3-quinoline carboxylic acid, monohydrochloride. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of VIGAMOX® solution contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base. Contains: Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and purified water. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. VIGAMOX® solution is an isotonic solution with an osmolality of approximately 290 mOsm/kg. chemical

CLINICAL STUDIES

14 In two randomized, double-masked, multicenter, controlled clinical trials in which patients were dosed 3 times a day for 4 days, VIGAMOX® solution produced clinical cures on day 5-6 in 66% to 69% of patients treated for bacterial conjunctivitis. Microbiological success rates for the eradication of baseline pathogens ranged from 84% to 94%. Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

HOW SUPPLIED

Product: 50090-0859 NDC: 50090-0859-0 3 mL in a BOTTLE, PLASTIC

GERIATRIC USE

8.5 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.

DOSAGE FORMS AND STRENGTHS

3 4 mL bottle filled with 3 mL sterile ophthalmic solution of moxifloxacin hydrochloride, 0.5% as base. 4 mL bottle filled with 3 mL sterile ophthalmic solution of moxifloxacin hydrochloride, 0.5% as base. (3)

MECHANISM OF ACTION

12.1 Mechanism of Action Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs (See 12.4 Microbiology).

INDICATIONS AND USAGE

1 VIGAMOX® solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae* Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. VIGAMOX® solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. (1)

PEDIATRIC USE

8.4 Pediatric Use The safety and effectiveness of VIGAMOX® solution in infants below 1 year of age have not been established. There is no evidence that the ophthalmic administration of VIGAMOX® solution has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.

PREGNANCY

8.1 Pregnancy Pregnancy Category C. Teratogenic Effects: Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose); however, decreased fetal body weights and slightly delayed fetal skeletal development were observed. There was no evidence of teratogenicity when pregnant Cynomolgus monkeys were given oral doses as high as 100 mg/kg/day (approximately 4,300 times the highest recommended total daily human ophthalmic dose). An increased incidence of smaller fetuses was observed at 100 mg/kg/day. Since there are no adequate and well-controlled studies in pregnant women, VIGAMOX® solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

NUSRING MOTHERS

8.3 Nursing Mothers Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when VIGAMOX® solution is administered to a nursing mother.

WARNING AND CAUTIONS

5 WARNINGS AND PRECAUTIONS Topical ophthalmic use only. (5.1) Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin. (5.2) Prolonged use may result in overgrowth of non-susceptible organisms, including fungi. (5.3) Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. (5.4) 5.1 Topical Ophthalmic Use Only NOT FOR INJECTION. VIGAMOX® solution is for topical ophthalmic use only and should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. 5.2 Hypersensitivity Reaction In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated. 5.3 Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining. 5.4 Avoidance of Contact Lens Wear Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

INFORMATION FOR PATIENTS

17 PATIENT COUNSELING INFORMATION Patients should be advised not to touch the dropper tip to any surface to avoid contaminating the contents. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis. Systemically administered quinolones including moxifloxacin have been associated with hypersensitivity reactions, even following a single dose. Patients should be told to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction. Rx Only Licensed to Alcon by Bayer Pharma AG. U.S. PAT. NO. 5,607,942; 6,716,830; 7,671,070 © 2003-2011 Novartis Manufactured by Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 9007343-1011

DOSAGE AND ADMINISTRATION

2 Instill one drop in the affected eye 3 times a day for 7 days. Instill one drop in the affected eye 3 times a day for 7 days. (2)