Gentak

Last updated on RxList:11/7/2022

Drug Summary

What Is Gentak?

Gentak (gentamicin sulfate) Ophthalmic Ointment is anantibioticused to treat bacterial infections of the eyes. Gentak Ophthalmic Ointment is available in generic form.

What Are Side Effects of Gentak?

Gentak may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • severe burning, stinging, or irritation after using the medicine,
  • signs of eye infection (pain, swelling, severe discomfort, crusting or drainage), and
  • increased sensitivity to light

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

Common side effects of Gentak Ophthalmic Ointment include:

  • eye burning,
  • stinging,
  • irritation,
  • itching,
  • redness,
  • blurred vision,
  • eyeliditching,
  • eyelid swelling, or
  • sensitivity to light.

Use of Gentak for prolonged or repeated periods may result in other types of eye infections, including fungal infections. Tell your doctor if you notice new or worsening eye symptoms (such as pain, swelling, thickdischargeorpus).

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Gentak

The recommended dose of Gentak is a small amount (approximately 1/2 inch ribbon) of ointment applied to the affected eye(s) two or three times a day. Do not use other eye drops or medications during treatment with Gentak ophthalmic unless directed by your doctor.

What Drugs, Substances, or Supplements Interact with Gentak?

Other drugs may interact with Gentak ophthalmic. Tell your doctor all medications and supplements you use.

Gentak During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Gentak ophthalmic; it is unknown if it will harm a fetus. It is unknown if Gentak ophthalmic passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Gentak (gentamicin sulfate) Ophthalmic Ointment Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Drug Description

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DESCRIPTION

GENTAK®硫酸庆大霉素是一种水溶性antibioticof the aminoglycoside group.

Gentamicin sulfateophthalmicointmentis a sterile ointment for ophthalmic use. Eachgramcontains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives.

Gentamicin is obtained from cultures ofMicromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, and C1A. All three components appear to have similarantimicrobialactivities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:

GENTAK® (Gentamicin Sulfate) Structural Formula Illustration

Indications & Dosage

INDICATIONS

Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis, 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

Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.

HOW SUPPLIED

GENTAK® Gentamicin sulfate ophthalmic ointment USP, 0.3% is supplied in 3.5 g tube, box of one.
(NDC17478-284-35)

Storage

Store at 2° to 30°C (36° to 86°F).

Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Rev. 09/08.

Side Effects & Drug Interactions

SIDE EFFECTS

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

The most frequently reported adverse reactions areocularburning and irritation upon drug instillation, non-specificconjunctivitis,conjunctivalepithelialdefects and conjunctival hyperemia.

Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenicpurpuraand hallucinations.

DRUG INTERACTIONS

No information provided.

Warnings & Precautions

警告INGS

NOT FOR INJECTION INTO THE EYE.

Gentamicin sulfate ophthalmic ointment is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into theanterior chamberof 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. Ifpurulentdischarge, 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.

Ophthalmic ointments may retard corneal healing.

致癌作用、诱变、Fertili的障碍ty

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

Pregnancy

Pregnancy Category C.Gentamicin has been shown to depress body weights, kidney weights and medianglomerularcounts 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 & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

Gentamicin sulfate ophthalmic ointment is contraindicated in patients with known hypersensitivity to any of the components.

Clinical Pharmacology

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.

Medication Guide

PATIENT INFORMATION

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

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