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.

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.

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.

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.

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing use of this medicine in babies up to one month of age with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of this medicine in the elderly with use in other age groups.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ataluren

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Agalsidase Alfa
• Alcuronium
• Atracurium
• Cholera Vaccine, Live
• Cidofovir
• Cisatracurium
• Colistimethate Sodium
• Decamethonium
• Digoxin
• Doxacurium
• Ethacrynic Acid
• Fazadinium
• Foscarnet
• Furosemide
• Gallamine
• Hexafluorenium
• Lysine
• Metocurine
• Mivacurium
• Pancuronium
• Pipecuronium
• Rapacuronium
• Rocuronium
• Succinylcholine
• Tubocurarine
• Vancomycin
• Vecuronium

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Indomethacin
• Methoxyflurane
• Polygeline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

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

Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution for ophthalmic use.

Each mL contains:
Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin base)
Preservative: Benzalkonium Chloride
Inactives: Disodium Phosphate, Monosodium Phosphate, and Sodium Chloride. The pH range is from 6.8 to 7.3.

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 powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:

Microbiology

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

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.

Applies to gentamicin ophthalmic: ophthalmic ointment, ophthalmic solution

Along with its needed effects, gentamicin ophthalmic (the active ingredient contained in Gentak) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking gentamicin ophthalmic:

• Itching, redness, swelling, or other sign of irritation not present before use of this medicine
• redness of eye, eyelid, or inner lining of eyelid

• Black, tarry stools; blood in urine or stools; or unusual bleeding or swelling
• blurred vision, eye pain, sensitivity to light, and/or tearing
• seeing, hearing, or feeling things that are not there

• hallucinations

Some side effects of gentamicin ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning or stinging

After application, eye ointments usually cause your vision to blur for a few minutes.

Applies to gentamicin ophthalmic: ophthalmic ointment, ophthalmic solution

Ocular

Ocular side effects have included burning and irritation upon administration, nonspecific conjunctivitis, conjunctival hyperemia, and conjunctival epithelial defects.[Ref]

Hematologic

Hematologic side effects have rarely included thrombocytopenic purpura.[Ref]

Psychiatric

Psychiatric side effects have rarely included hallucinations.[Ref]

Hypersensitivity

Hypersensitivity reactions have been reported.[Ref]

Other

Other side effects have included the development of fungal and bacterial corneal ulcers during therapy.[Ref]

Some side effects of Gentak may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.