GENOPTIC (gentamicin sulfate ophthalmic) ® (gentamicin sulfate ophthalmic solution; USP) is a sterile, topical anti-infective agent for ophthalmic use. The active ingredient, gentamicin sulfate, is a water-soluble antibiotic of the aminoglycoside group. Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C ₁ , C ₂ , and C _1A . All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water but insoluble in alcohol.

GENOPTIC (gentamicin sulfate ophthalmic) ® Solution:

Contains: Each mL contains-- Active: gentamicin sulfate equivalent to 3 mg (0.3%) gentamicin base. Preservative: Benzalkonium chloride. Inactives: edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; and hydrochloric acid and/or sodium hydroxide to adjust the pH. The solution is an aqueous, buffered solution with a pH of 6.5-7.5.

SIDE EFFECTS: Eye stinging/burning/redness or temporary blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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.

Use of this medication for prolonged or repeated periods may result in other types of eye infections, including fungal infections. Stop using this medication and contact your doctor if you notice new or worsening eye symptoms (such as pain, swelling, thick discharge or pus).

Rarely, gentamicin products used in the eye may be absorbed and may cause serious side effects. Tell your doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, mental/mood changes (such as hallucinations).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe 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 gentamicin, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (such as tobramycin); 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.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk. Consult your doctor before breast-feeding.