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Tobramycin (Inhalation Route)

US Brand Names

Description

Tobramycin is used to treat Pseudomonas infections in patients with cystic fibrosis. It belongs to the family of medicines called antibiotics.

This medicine is available only with your doctor's prescription.

Before Using

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

Appropriate studies have not been performed on the relationship of age to the effects of tobramycin in children below 6 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of tobramycin in geriatric patients.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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 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.

• Alcuronium
• Atracurium
• Cidofovir
• Cisatracurium
• Colistimethate Sodium
• Decamethonium
• Doxacurium
• Ethacrynic Acid
• Fazadinium
• Furosemide
• Gallamine
• Hexafluorenium
• Lysine
• Metocurine
• Mivacurium
• Pancuronium
• Pipecuronium
• Rapacuronium
• Rocuronium
• Succinylcholine
• Tacrolimus
• 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.

• Cisplatin
• Cyclosporine

Other Interactions

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing problems or
• Kidney problems or
• Problems with hearing or balance—Use with caution. May make these conditions worse.

• Myasthenia gravis or
• Parkinson's disease—Use with caution. May worsen muscle weakness in patients with these conditions.

Proper Use

Tobramycin usually comes with patient instructions. Read them carefully before using this medicine.

Tobramycin is packaged in small plastic containers called ampules. Each ampule contains one full dose of tobramycin. Do not use an ampule that has already been opened. Also, do not use an ampule of this medicine after the expiration date printed on the package.

Tobramycin is especially formulated to be used with a PARI LC PLUS™ nebulizer and a DeVilbiss® Pulmo-Aide® compressor. An air compressor is used with a nebulizer to turn the medicine into a fine spray. You will breathe the spray in through your mouth and to your lungs.

You will need to use the nebulizer for about 10 to 15 minutes, or until the medicine in the nebulizer cup is gone. You may hear a sputtering sound when the cup is empty.

Clean all the parts of the nebulizer after each use.

You may want to rinse your mouth or suck on hard candy if the medicine leaves a bad taste in your mouth.

If you are taking any other medicines for cystic fibrosis, keep taking them as you did before you started using tobramycin, unless otherwise directed by your doctor. However, do not put any other inhaled medicine in the nebulizer at the same time that you use tobramycin. Other inhaled medicines may be used in a clean nebulizer before or after your treatment with tobramycin.

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 inhalation dosage form (inhalation solution):
  • For Pseudomonas infection:
    • Adults and children 6 years of age and above—300 milligrams (mg) (one ampule) two times a day (12 hours apart) for 28 days. Stop using this medicine for the next 28 days, and then repeat the cycle.
    • Children below 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take 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. Do not double doses.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

If you can't keep the medicine in the refrigerator, store the medicine in the foil pouch at room temperature away from heat or direct light. You should not use the unrefrigerated medicine after 28 days.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause hearing loss. Call your doctor right away if you notice any changes in your hearing or if you have ringing in your ears, headaches, nausea, vomiting, or dizziness.

Your doctor may want to test your hearing while you are being treated with tobramycin. Tell your doctor if you already have hearing problems before you are given this medicine.

Side Effects

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:

• Bloody nose
• Difficulty in breathing
• Discoloration of sputum
• Runny nose
• Sneezing
• Stuffy nose
• Voice alteration

• Continuing ringing or buzzing or other unexplained noise in the ears
• Hearing loss

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blue lips, fingernails, or skin
• Dizziness or lightheadedness
• Drowsiness
• Feeling of constant movement of self or surroundings
• Irregular, fast or slow, or shallow breathing
• Sensation of spinning
• Shortness of breath
• Unusual tiredness or weakness

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:

• Back pain
• General feeling of discomfort or illness
• Unusual tiredness or weakness

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.

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