Details for: VIGAMOX
Company: NOVARTIS PHARMACEUTICALS CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02252260 | VIGAMOX | MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) | 0.5 % | SOLUTION | OPHTHALMIC |
Summary Reports
Summary Safety Review - Oral FLUOROQUINOLONES - Assessing the Potential Risk of Retinal Detachment
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
VIGAMOX is an antibiotic used to treat bacterial infection of the eye (pink eye).
What it does
VIGAMOX is an antibiotic that stops the growth of bacteria. This kills the bacteria and reduces eye infections.
When it should not be used
- Allergic to moxifloxacin or any of the ingredients in VIGAMOX (see What are the ingredients in VIGAMOX?)
- Allergic to other quinolones.
What the medicinal ingredient is
Moxifloxacin 0.5% w/v (as moxifloxacin hydrochloride)
What the non-medicinal ingredients are
Boric acid, purified water and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
What dosage form it comes in
VIGAMOX is a clear greenish-yellow solution and comes in a 3 mL oval plastic bottle.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VIGAMOX. Talk about any health conditions or problems you may have, including if you:
- Develop an allergic reaction (see Serious side effects and what to do about them). Stop taking VIGAMOX and get immediate medical help.
- Notice your infection gets worse. Stop taking VIGAMOX and get immediate medical help. As with any antibiotic, use of VIGAMOX for a long time may lead to other infections. Do NOT use VIGAMOX longer than your doctor tells you to.
- Develop pain or swelling in your tendons. Stop taking VIGAMOX and get immediate medical help. This is more likely to happen if you are elderly or taking corticosteroids at the same time as VIGAMOX.
Other warnings you should know about:
- VIGAMOX can be used in children as young as 1 year of age. VIGAMOX should not be used in children younger than 1 year of age.
- Do NOT wear contact lenses if you have an eye infection.
- Your vision may be temporarily blurry after using VIGAMOX. Wait until your vision clears before driving or using machinery.
- If you are pregnant or planning to become pregnant or are breast-feeding or planning to breastfeed, talk to your doctor or pharmacist before using VIGAMOX.
- Antibacterial drugs like VIGAMOX treat only bacterial infections. They do not treat viral infections, such as the common cold. Although you may feel better early in treatment, VIGAMOX should be taken exactly as directed. Misuse or overuse of VIGAMOX could lead to the growth of bacteria that will not be killed by VIGAMOX (resistance). This means that VIGAMOX may not work for you in the future. Do not share your medicine.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- Tell your doctor or pharmacist if you are:
- taking or have recently taken any prescription or non-prescription medicines,
- using any other eye products,
- taking corticosteroids as this may increase your chance of developing pain or swelling of your tendons.
Proper use of this medication
- Get the bottle of VIGAMOX* and a mirror.
- Wash your hands.
- Twist off the cap. After cap is removed: if security snap collar is loose, remove before using VIGAMOX.
- Hold the bottle, pointing down, between your thumb and fingers.
- Tilt your head back.
- Pull down your eyelid with a clean finger, until there is a “pocket” between your eyelid and eye. The drop will go in there.
- Bring the bottle close to the eye. Use the mirror if it helps.
- Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could contaminate the drops.
- Gently squeeze the bottle to release one drop of VIGAMOX* solution.
- If the drop misses you eye, wipe it up and try again.
- If you need drops in both eyes, repeat the steps for your other eye.
- Keep the bottle tightly closed when not in use.
Usual dose
Apply one drop in the affected eye(s) three times a day (morning, afternoon and at night) unless
your doctor tells you otherwise.
Use VIGAMOX for seven days or as long as your doctor tells you to.
Overdose
If you use too much VIGAMOX, rinse it out of your eyes with warm water. Do not put any more
drops of VIGAMOX in until it’s time for your next dose.
If you accidentally swallow VIGAMOX, talk to your doctor or pharmacist.
Missed Dose
If you miss a dose, apply the missed dose as soon as possible and then go back to your regular dosing schedule. If the drop misses your eye, try again.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking VIGAMOX. If you
experience any side effects not listed here, contact your healthcare professional.
Common eye side effects while using VIGAMOX include:
- mild temporary burning or stinging,
- itching or redness.
Other less common eye side effects include:
- dryness,
- sensation of pressure, discomfort, corneal inflammation, broken blood vessels in the white part of the eye, swelling of the eye or eyelid,
- blurry vision,
- temporary reduction of vision,
- pain, inflammation of the eye surface or eyelid, tired eyes, redness of the eyelid,
- watery eyes, sensitivity to light, eye discharge.
You may also experience reactions in other areas of your body, including:
- bad taste,
- headache,
- throat pain,
- abnormal liver blood tests,
- abnormal skin sensation,
- vomiting,
- nose discomfort,
- dizziness,
- irregular heart rhythm,
- shortness of breath,
- nausea,
- allergic reaction,
- skin redness or itching,
- rash or hives.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Unknown | |||
Severe allergic reaction:
|
✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store between 4°C and 25°C. Keep out of the reach and sight of children.
Do not use VIGAMOX after the expiry date (shown as EXP on the package). Discard 28 days
after opening.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:>
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.novartis.ca, or by calling 1-800-363-8883.
This leaflet was prepared by Novartis Pharmaceuticals Canada Inc.
Last Revised: December 1, 2017
VIGAMOX is a registered trademark.
Moxifloxacin ingredient is in-licensed from Bayer, used with permission.