Drugs Details

Drugs Info of Garamycin Ophthalmic, Gentak, Gentasol, Ocu-Mycin
Drugs Details
  • Drugs Type  : Multum
  • Date : 27th Jan 2015 04:28 am
  • Brand Name : Garamycin Ophthalmic, Gentak, Gentasol, Ocu-Mycin
  • Generic Name : gentamicin ophthalmic (Pronunciation: JEN ta MYE sin off THAL mik)
Descriptions

GENTAK® Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group.

Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains 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 of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, and C1A. All three components appear to have similar antimicrobial activities. 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

What are the possible side effects of gentamicin ophthalmic (Garamycin Ophthalmic, Gentak, Gentasol, Ocu-Mycin)?

Serious side effects are not expected to occur during treatment with this medication.

Commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Gentak »

What are the precautions when taking gentamican sulfate ophthalmic ointment (Gentak)?

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...

Read All Potential Precautions of Gentak »


This monograph has been modified to include the generic and brand name in many instances.

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 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.
(NDC 17478-284-35)

Storage

Store at 2° to 30°C (36° to 86°F).

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


This monograph has been modified to include the generic and brand name in many instances.

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, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.

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

Read the Gentak (gentamican sulfate ophthalmic ointment) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.

Read the Gentak Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

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 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.

Ophthalmic ointments may retard corneal healing.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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 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.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

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


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

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


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

GENTAMICIN OINTMENT - OPHTHALMIC

 

(jen-ta-MYE-sin)

 

USES: This medication is used to treat bacterial infections (such as blepharitis, conjunctivitis) of the eye and the skin around the eyes (such as eyelids). It is also used to prevent infection after eye injury or surgery. It belongs to a class of drugs known as aminoglycoside antibiotics. Gentamicin works by killing the bacteria.

This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

 

HOW TO USE: To apply eye ointment, wash your hands first. To avoid contamination, be careful not to touch the tip of the tube or let it touch your eye, eyelid, or any other surface. Apply to the eyes only. Do not swallow or inject.

Do not wear contact lenses while you are using this medication. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again.

To apply eye ointments, tilt your head back, look up, and gently pull down the lower eyelid to make a pouch. Place a half-inch (1.3 centimeters) strip of ointment into the pouch as directed by your doctor. Gently close the eye and roll the eyeball in all directions to spread the medication. Try not to blink and do not rub the eye. Repeat these steps for your other eye if so directed. Wipe the tip of the ointment tube with a clean tissue to remove extra medication before recapping it. Wait several minutes for your vision to clear before driving or operating machinery.

The dosage is based on your medical condition and response to treatment. Your doctor may direct you to use this medication more often at first, then use it less frequently as the infection improves. Do not increase your dose or use it more often than directed. Your doctor may prescribe gentamicin drops for use during the day and gentamicin ointment at bedtime.

If you are using another kind of eye medication (such as drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed. Stopping the medication too soon may allow the bacteria to continue to grow, which may result in a return of the infection.

Tell your doctor if your condition persists or worsens.

Consumer Overview Side Effect

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.

 

Read the Gentak (gentamican sulfate ophthalmic ointment) Side Effects Center for a complete guide to possible side effects

Learn More »

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.

Consumer Overview Missed Dose

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection. unless your doctor directs you to do so. A different medication may be necessary in that case.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 - 86 degrees F (15 - 30 degrees C) is permitted. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Garamycin Ophthalmic, Gentak, Gentasol, Ocu-Mycin

Generic Name: gentamicin ophthalmic (Pronunciation: JEN ta MYE sin off THAL mik)

  • What is gentamicin ophthalmic (Gentak)?
  • What are the possible side effects of gentamicin ophthalmic (Gentak)?
  • What is the most important information I should know about gentamicin ophthalmic (Gentak)?
  • Who should not use gentamicin ophthalmic (Gentak)?
  • How should I use gentamicin ophthalmic (Gentak)?
  • What happens if I miss a dose (Gentak)?
  • What happens if I overdose (Gentak)?
  • What should I avoid while using gentamicin ophthalmic (Gentak)?
  • What other drugs will affect gentamicin ophthalmic (Gentak)?
  • Where can I get more information?

What is gentamicin ophthalmic (Gentak)?

Gentamicin ophthalmic is an antibiotic.

Gentamicin ophthalmic is used to treat bacterial infections of the eyes.

Gentamicin ophthalmic may also be used for purposes other than those listed in this medication guide.

Gentamicin 0.3% Ophth-AKO

What are the possible side effects of gentamicin ophthalmic (Gentak)?

Serious side effects are not expected to occur during treatment with this medication.

Commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Gentak (gentamican sulfate ophthalmic ointment) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about gentamicin ophthalmic (Gentak)?

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.

Side Effects Centers
  • Gentak

Patient Detailed How Take

Who should not use gentamicin ophthalmic (Gentak)?

Do not use gentamicin ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only.

It is not known whether gentamicin ophthalmic will harm an unborn baby. Do not use gentamicin ophthalmic without first talking to your doctor if you are pregnant.

It is also not known whether gentamicin ophthalmic passes into breast milk. Do not use gentamicin ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use gentamicin ophthalmic (Gentak)?

Use gentamicin ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using the eyedrops or ointment.

To apply the eyedrops:

  • Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

To apply the ointment:

  • Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before the next application.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Do not use any eyedrop that is discolored or has particles in it.

Store gentamicin ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.

Side Effects Centers
  • Gentak

Patient Detailed Avoid Taking

What happens if I miss a dose (Gentak)?

Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.

What happens if I overdose (Gentak)?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using gentamicin ophthalmic (Gentak)?

Use caution when driving, operating machinery, or performing other hazardous activities. Gentamicin ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment. After applying this medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with gentamicin ophthalmic unless otherwise directed by your doctor.

What other drugs will affect gentamicin ophthalmic (Gentak)?

Do not use other eye drops or medications during treatment with gentamicin ophthalmic unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with gentamicin ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about gentamicin ophthalmic written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 5.03. Revision date: 12/15/2010.

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Side Effects Centers
  • Gentak

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