Uses

This medication is used to treat people with cystic fibrosis who have an ongoing lung infection with a certain bacteria (Pseudomonas aeruginosa). People with cystic fibrosis produce thick, sticky mucus that can plug up the tubes, ducts and passageways in the lungs. This can result in serious breathing problems and infections in the lungs.

Tobramycin belongs to a class of drugs known as aminoglycoside antibiotics. Tobramycin works by stopping the growth of bacteria, including Pseudomonas aeruginosa, that commonly infect the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, and helps to improve breathing.

How To Use

Read the Patient Information Leaflet and instruction sheet if available from your pharmacist before you start using tobramycin and each time you get a refill. Learn how to use the inhaler properly. Children may need help from an adult to use this medication properly. If you have any questions, ask your doctor or pharmacist.

Do not swallow these capsules by mouth. Use the special inhaler to inhale the powder in the capsules. Inhale this medication by mouth as directed by your doctor, usually twice daily (12 hours apart). Each dose is usually 4 of the 28-milligram capsules. Inhale 2 times per capsule to make sure you inhale all of the drug. Do not breathe out into the mouthpiece at any time. Each dose takes approximately 2 to 6 minutes.

Inhaled tobramycin is usually given for 28 days, followed by a 28-day break when you do not inhale any tobramycin. Then if directed by your doctor, you may start another 28-day course of inhaled tobramycin. Do not use this medication for more than 28 days at a time. Keep track of the days that you use this medication.

After each dose, wipe the mouthpiece with a clean, dry cloth. The inhaler should never be washed with water. Keep it dry and store it in its case. Use a new inhaler every week.

Do not inhale any other medications at the same time you inhale tobramycin. If you are taking other inhaled medications or doing chest physiotherapy, your doctor will let you know which order you should receive your treatments. Inhaled tobramycin should always be the last treatment.

If you are using a quick-relief inhaler (such as salbutamol, albuterol), you should inhale it 15 to 90 minutes before inhaling tobramycin. This will help you inhale and absorb the tobramycin.

For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time(s) every day.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Hoarseness, cough, dry mouth, difficulty speaking, change in taste, and changes in voice may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

Tell your doctor right away if you have any serious side effects, including:

• signs of hearing damage (such as ringing/roaring sounds in the ears, hearing loss, dizziness)
• signs of kidney problems (such as change in the amount of urine)
• coughing up blood
• chest tightness/wheezing

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using tobramycin, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (such as gentamicin); 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:

• hearing problems (including deafness, decreased hearing)
• kidney problems
• coughing up blood
• myasthenia gravis
• Parkinson's disease

Tobramycin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using tobramycin before having any immunizations/vaccinations.

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. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if inhaled tobramycin passes into breast milk. Consult your doctor before breastfeeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• botulinum toxin
• neostigmine
• pyridostigmine

Other medications that may affect hearing or cause kidney damage may increase the risk of hearing loss or kidney problems if taken with tobramycin. Some affected drugs include: amikacin, gentamicin, mannitol, tacrolimus, platinum compounds such as carboplatin/cisplatin, among others.

Overdose

This medication will not work and may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as breathing tests, hearing tests, kidney function, tobramycin levels) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is less than 6 hours before your next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store this medication at room temperature away from moisture. Keep the capsules stored in the blister package until right before use. Do not store in the bathroom. Keep the inhaler in a tightly closed case when not in use. 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.