Vigamox

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.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients.

Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.

Read the entire FDA prescribing information for Vigamox (Moxifloxacin)

Common side effects of Vigamox eye drops include eye irritation, fever, and eye inflammation.

This is not a complete list of Vigamox side effects. Ask your doctor or pharmacist for more information.

No drug interactions have been conducted by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

This section provides information on the proper use of a number of products that contain moxifloxacin. It may not be specific to Vigamox. Please read with care.

Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

To use the eye drops:

• First, wash your hands. Tilt the head back and pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.
• If you think you did not get the drop of medicine into your eye properly, repeat the directions with another drop.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To help clear up your eye infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared and even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For bacterial conjunctivitis:
    • Adults and children—Put one drop in the affected eye(s) 3 times a day for 7 days.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• If you have an allergy to moxifloxacin or any other part of Vigamox (moxifloxacin (ophthalmic)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.

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.

Pediatric Use

The safety and effectiveness of Vigamox® (moxifloxacin ophthalmic solution) 0.5% have been established in all ages. Use of Vigamox® is supported by evidence from adequate and well controlled studies of Vigamox® in adults, children, and neonates [see Clinical Studies (14)].

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.

Geriatric Use

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

Vigamox® (moxifloxacin 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[3,4b]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.

Vigamox® solution is 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.

3 mL in a 4 mL bottle - NDC 0065-4013-03

Storage: Store at 2°C-25°C (36°F-77°F).

NDC 0065-4013-03       STERILE

Vigamox®
(moxifloxacin hydrochloride ophthalmic solution) 0.5% as base

3 mL

Alcon®

Rx Only

FOR TOPICAL OPHTHALMIC USE ONLY

Usual Dosage: Instill one drop in affected eye three-times a day for 7 days.

Storage: Store at 2°-25°C (36°-77°F).

U.S. Patents Nos. 4,990,517; 5,607,942; 6,716,830; 7,671,070.

Licensed to Alcon, Inc. by Bayer Schering Pharma AG.

351119-0410

Each mL Contains:

Active: moxifloxacin hydrochloride 5.45 mg, equivalent to moxifloxacin 5 mg.

Inactives: boric acid, sodium chloride and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Alcon®

ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134 USA
1-800-757-9195
MedInfo@AlconLabs.com
Printed in USA
© 2003-2004, 2006, 2010 Alcon, Inc.

LOT:

EXP.:

NDC 0065-4013-03

Vigamox®

(moxifloxacin hydrochloride ophthalmic solution) 0.5% as base

3 mL

FOR TOPICAL OPHTHALMIC USE ONLY

Each mL contains: moxifloxacin hydrochloride 5.45 mg

Storage: Store at 2°-25°C (36°-77°F).

Usual Dosage: Read enclosed insert.

Rx Only   STERILE

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

Licensed to Alcon, Inc. by Bayer AG.

© 2003, 2005 Alcon, Inc.

LOT:

EXP.:

H13631-0714

Applies to moxifloxacin ophthalmic: ophthalmic solution

General

The most common side effects were eye irritation and eye pain.

Ocular

Common (1% to 10%): Conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, tearing, eye irritation, eye pain
Uncommon (0.1% to 1%): Punctuate keratitis, eye pruritus, conjunctival hemorrhage, eyelid edema
Rare (less than 0.1%): Corneal epithelium defect, corneal disorder, blepharitis, eye swelling, conjunctival edema, blurred vision, asthenopia, erythema of eyelid
Frequency not reported: Endophthalmitis, ulcerative keratitis, corneal erosion, corneal abrasion, intraocular pressure increased, corneal opacity, corneal infiltrates, corneal deposits, eye allergy, corneal edema, photophobia, lacrimation increased, eye discharge, foreign body sensation in eyes, corneal staining, eyelid disorder, abnormal sensation in eye[Ref]

Respiratory

Common (1% to 10%): Increased cough, pharyngitis, rhinitis
Rare (less than 0.1%): Nasal discomfort, pharyngolaryngeal pain, sensation of foreign body (throat)
Frequency not reported: Dyspnea[Ref]

Dermatologic

Common (1% to 10%): Rash
Frequency not reported: Erythema, pruritus, urticaria[Ref]

Other

Common (1% to 10%): Otitis media, fever/pyrexia, infection[Ref]

Nervous system

Uncommon (0.1% to 1%): Dysgeusia, headache
Rare (less than 0.1%): Paresthesia
Frequency not reported: Dizziness[Ref]

Gastrointestinal

Rare (less than 0.1%): Vomiting
Frequency not reported: Nausea[Ref]

Hematologic

Rare (less than 0.1%): Decreased hemoglobin[Ref]

Hepatic

Rare (less than 0.1%): Increased ALT, increased GGT[Ref]

Hypersensitivity

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions (some after first dose) have been reported with systemic quinolones.[Ref]

Frequency not reported: Hypersensitivity

Systemic quinolones:
-Frequency not reported: Hypersensitivity (anaphylactic) reactions[Ref]

Cardiovascular

Frequency not reported: Palpitations[Ref]

Musculoskeletal

Systemic fluoroquinolones:
-Frequency not reported: Tendon ruptures[Ref]

Ruptures of the shoulder, hand, Achilles, or other tendons (requiring surgical repair or resulting in prolonged disability) have been reported with systemic fluoroquinolones. Risk of such ruptures may be increased in patients using concomitant corticosteroids, especially geriatric patients and in tendons under high stress (including the Achilles tendon).[Ref]

Some side effects of Vigamox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.