Garamycin Ophthalmic

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.

This section provides information on the proper use of a number of products that contain gentamicin. It may not be specific to Garamycin. Please read with care.

For patients using the eye drop form of this medicine:

• The bottle is only partially full to provide proper drop control.
• To use:
  • First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes, to allow the medicine to come into contact with the infection.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• Avoid wearing contact lenses during treatment
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients using the eye ointment form of this medicine:

• First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1-cm (approximately ⅓-inch) strip of ointment is usually enough unless otherwise directed by your doctor. Let go of the eyelid and gently close the eyes and keep them closed for 1 or 2 minutes, to allow the medicine to come into contact with the infection.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using gentamicin eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic ointment dosage form:
  • For eye infections:
    • Adults and children—Use every eight to twelve hours.
• For ophthalmic solution (eye drops) dosage form:
  • For mild to moderate eye infections:
    • Adults and children—One to two drops every four hours.
  • For severe eye infections:
    • Adults and children—One to two drops as often as once every hour as directed by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Along with its needed effects, a medicine 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:

• 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 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.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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.

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.

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.

There are no data on the excretion of gentamicin ophthalmic into human milk. Systemically administered gentamicin is excreted into milk in detectable amounts. Gentamicin is considered compatible with breast-feeding by the American Academy of Pediatrics.