Zymaxid

DRUG DESCRIPTION

ZYMAXID™ (gatifloxacin ophthalmic solution) sterile ophthalmic solution is an 8-methoxyfluoroquinolone anti-infective for the treatment of bacterial conjunctivitis. Its chemical name is (±)-1-Cyclopropyl-6fluoro-1,4-dihydro-8-methoxy-7-(3-methyl1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid, sesquihydrate. Its molecular formula is C19H22FN3O4 • 1?H2O, and its molecular weight is 402.42. Its chemical structure is:

ZYMAXID™(gatifloxacin) Structural Formula Illustration

ZYMAXID™ (gatifloxacin ophthalmic solution) is a clear, pale yellow, sterile, preserved aqueous solution with an osmolality of 260-330 mOsm/kg and a pH of 5.1-5.7.

ZYMAXID™ contains Active: gatifloxacin 0.5% (5 mg/mL); Inactives: benzalkonium chloride 0.005%; edetate disodium; purified water; and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

What are the precautions when taking gatifloxacin ophthalmic solution (Zymaxid )?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to quinolone antibiotics (such as ciprofloxacin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

Your vision may be temporarily blurred or unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Use of this medication for prolonged or repeated periods may result in a secondary infection.

This drug should be used...

Read All Potential Precautions of Zymaxid »


Zymaxid Consumer (continued)

SIDE EFFECTS: Blurred vision, watery eyes, headache, eye irritation/pain/dryness/redness, bad taste in mouth may occur. If any of these effects persist or worsen, inform your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: persistent eye redness, swelling of the eye or eyelid.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to quinolone antibiotics (such as ciprofloxacin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

Your vision may be temporarily blurred or unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Use of this medication for prolonged or repeated periods may result in a secondary infection.

This drug should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this medication is passes into breast milk. Consult your doctor before breast-feeding.



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