Apo-Tobramycin: Uses, Side Effects and Dosage

What is APO-TOBRAMYCIN used for?

APO-TOBRAMYCIN is used in adults and children above the age of 1 year to treat bacterial infections of the external part of the eye, such as conjunctivitis.

Antibacterial drugs like APO-TOBRAMYCIN treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, APO-TOBRAMYCIN should be used exactly as directed. Misuse or overuse of APO-TOBRAMYCIN could lead to the growth of bacteria that will not be killed by APO-TOBRAMYCIN (resistance). This means that APO-TOBRAMYCIN may not work for you in the future. Do not share your medicine.

How does APO-TOBRAMYCIN work?

APO-TOBRAMYCIN contains a medicine called tobramycin. Tobramycin belongs to the aminoglycoside class of antibiotic. Tobramycin works by killing bacteria that cause infections.

The signs of your eye infections [eye redness, increased tearing, discharge (pus or mucus) etc.] may start to improve within 3 days after starting APO-TOBRAMYCIN.

What are the ingredients in APO-TOBRAMYCIN?

Medicinal ingredients: tobramycin 0.3% w/v (3 mg/mL)

Non-medicinal ingredients:

Preservative: benzalkonium chloride 0.01% w/v

Other ingredients: boric acid, sodium chloride, sodium hydroxide and/or sulfuric acid (to adjust pH) , sodium sulfate anhydrous, tyloxapol and water for injection.

APO-TOBRAMYCIN comes in the following dosage forms:

APO-TOBRAMYCIN (Tobramycin Ophthalmic Solution USP) 0.3% w/v, is supplied as a sterile ophthalmic solution in white opaque LDPE bottles of 5 mL.

Do not use APO-TOBRAMYCIN if you are allergic to:

• tobramycin,
• any of the other ingredients in APO-TOBRAMYCIN (see What are the ingredients in APO-TOBRAMYCIN?),
• other aminoglycoside antibiotics such as amikacin, gentamycin, kanamycin, paromomycin, streptomycin.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-TOBRAMYCIN. Talk about any health conditions or problems you may have, including if you:

• are pregnant, you think you may be pregnant or are planning to have a baby. You will need to talk to your healthcare professional about the benefits and risks of using APO-TOBRAMYCIN while you are pregnant.

• are breast-feeding. APO-TOBRAMYCIN is not recommended during breastfeeding. It is unknown whether APO-TOBRAMYCIN will get into your milk.
• have or if you have ever had conditions such as myasthenia gravis or Parkinson’s disease. Antibiotics of this kind may worsen muscle weakness.

Other warnings you should know about:

While you are using APO-TOBRAMYCIN

• Driving and using machines: your vision may be blurred for a time just after you apply APO-TOBRAMYCIN. Do not drive or use machines until this has worn off.

• If you wear contact lenses:

  • APO-TOBRAMYCIN Eye Drops contains the preservative benzalkonium chloride. This can cause eye inflammation, including inflammation and damage to the cornea. Benzalkonium chloride discolours soft contact lenses. It is best not to wear contact lenses while you are using APO-TOBRAMYCIN.
  • You should not wear contact lenses if you have an eye infection. If you are allowed to wear contact lenses, remove them before using APO-TOBRAMYCIN. Wait at least 15 minutes after using APO-TOBRAMYCIN to put your lenses back into your eyes.
• If the signs of your eye infection do not improve within 3 days or if they become worse, tell your healthcare professional.

Tell your healthcare professional about all the medicines you are using, have recently used or might use, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The use of APO-TOBRAMYCIN with other medicines has not been studied.

Tell your healthcare professional if you are using:

• Other antibiotics of the same family (aminoglycosides) such as amikacin, gentamycin, kanamycin, paromomycin, streptomycin

Always keep a list of your medicines and show it to your healthcare professional when you get a new medicine. It is important that your healthcare professional reviews all medications and supplements you are taking before prescribing APO-TOBRAMYCIN.

How to take APO-TOBRAMYCIN

Usual dose (adults and children 1 year and older):

The usual dose will depend on the type and severity of your infection

• In mild to moderate eyes infections your healthcare professional may recommend one drop or two drops into the affected eye(s), every four hours.
• In severe eyes infections this may be increased to two drops every hour.

Your healthcare professional will tell you how much you need to use each day. Ask your healthcare professional if you have any questions about the drug.

How to use:

1 2

1. 1. Wash your hands.
2. 2. Get the APO-TOBRAMYCIN bottle and a mirror.
3. 3. Shake well before use.
4. 4. After removing the cap: if the security snap collar is loose, remove it before using APO-TOBRAMYCIN.
5. 5. Hold the bottle, pointing down, between your thumb and fingers.
6. 6. Tilt your head back.
7. 7. Pull down your lower eyelid with a clean finger until there is a “v” pocket between your eyelid and your eye. The drop will go in here (picture 1).
8. 8. Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
9. 9. Do not touch your eye, eyelid, surrounding areas or other surfaces with the dropper, to avoid contaminating the suspension.
10. 10. Gently press on the base of the bottle to release one drop at a time. Do not squeeze the bottle. It is designed so that a gentle press on the bottom is all that it needs (picture 2).
11. 11. If you miss, wipe up and try again.
12. 12. Close the bottle immediately after use.

If your doctor has prescribed other eye drop or ointment medicines to be used along with APO-TOBRAMYCIN, apply each medicine at least 5 minutes apart. Eye ointments should be administered last.

Overdose:

Missed Dose:

If you forget to use APO-TOBRAMYCIN, continue with the next dose as planned. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use a double dose to make up for forgotten individual doses.

What are possible side effects from using APO-TOBRAMYCIN?

These are not all the possible side effects you may feel when taking APO-TOBRAMYCIN. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

The following side effects are common and about 3 in 100 people experienced them:

• itchy and swollen eyelid
• eye redness
• watery eye(s).

Other side effects include:

• eye problems such as:

  • eye discharge
  • dry, itchy or swollen eyes
  • increased tearing
  • corneal damage (the corneal is the clear surface of your eye)
  • blurred vision
  • eye allergy
  • loss of eyelashes
• headache
• skin problems such as swollen skin, hives, itchy or dry skin, white patches on the skin.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store at room temperature 15ºC to 30ºC. Use within 28 days after opening container.

Keep out of the reach and sight of children.

If you want more information about APO-TOBRAMYCIN:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this patient medication information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Patient Medication Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last revised: June 10, 2020