Genoptic

What is Genoptic and how is it used?

Genoptic is a prescription medicine used to treat the symptoms of Conjunctivitis and as a postoperative prophylaxis. Genoptic may be used alone or with other medications.

Genoptic belongs to a class of drugs called Aminoglycosides, Ophthalmic.

What are possible side effects of Genoptic?

Side effects of Genoptic include:

• eye infections,
• fungal eye finections,
• pain in the eye,
• swelling of the eye,
• thick discharge or pus from the eye,
• easy bruising or bleading,
• mood changes,
• hallucinations,
• rash,
• itching,
• swelling of the face, tongue or throat,
• severe dizziness, and
• trouble breathing

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Genoptic include:

• eye stinging or burning,
• redness of the eye,
• temporary blurred vision

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Genoptic. For more information, ask your doctor or pharmacist.

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

DESCRIPTION

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.

INDICATIONS

Gentamicin Sterile Ophthalmic Solution is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms:

Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

DOSAGE AND ADMINISTRATION

Gentamicin Sterile Ophthalmic Solution: Instill one or two drops into the affected eye every 4 hours. In severe infections, dosage may be increased to as much as two drops once every hour.

HOW SUPPLIED

GENOPTIC® (gentamicin sulfate ophthalmic solution, USP) 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with white high impact polystyrene (HIPS) caps as follows:

1 mL in 5 mL bottle--NDC 11980-117-01

Note: Store at or below 25°C (77°F). Avoid exposure to excessive heat (104°F/40°C or above).

Store Genoptic (gentamicin sulfate ophthalmic) Sterile Ophthalmic Solution between 2° and 30° C (36° and 86° F).

SIDE EFFECTS

Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.

The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, nonspecific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia.

Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura, and hallucinations.

DRUG INTERACTIONS

No information provided.

WARNINGS

NOT FOR INJECTION INTO THE EYE. Gentamicin Sulfate Ophthalmic Solution is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

PRECAUTIONS

General

Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation, or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation, and appropriate therapy should be instituted.

Information for Patients

To avoid contamination, do not touch tip of container to the eye, eyelid, or any surface.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be nonmutagenic.

Pregnancy

Pregnancy Category C: Gentamicin has been shown to depress body weights, kidney weights, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use

Safety and effectiveness in neonates have not been established.

OVERDOSE

No information provided.

CONTRAINDICATIONS

GARAMYCIN Sterile Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.

CLINICAL PHARMACOLOGY

Microbiology

Gentamicin sulfate is active in vitro against many strains of the following microorganisms:

Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

PATIENT INFORMATION

To avoid contamination, do not touch tip of container to the eye, eyelid, or any surface.