Tobramycin inhalation

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Tobramycin is inhaled into the lungs with the use of a nebulizer or an inhaler device. Do not swallow the medicine by mouth.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Tobramycin is given in a treatment cycle of 28 days on the medicine followed by 28 days off the medicine. Follow your doctor's dosing instructions very carefully. Your doctor will determine how long to treat you with tobramycin.

During your 28 days on the medicine, use your doses at regular intervals of 12 hours apart but not less than 6 hours apart.

If you use other inhaled medicines, or if you perform chest physiotherapy to remove mucus from the lungs, use these other treatments first before using your tobramycin dose.

Do not use tobramycin inhalation solution if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

Tobi Podhaler is a powder form of tobramycin that comes with a special inhaler device and blister packs containing capsules of the medicine. You will load one capsule into the inhaler device each time you use the medicine. Pushing the buttons on the end of the Podhaler device will pierce the capsule and release the medicine into the inhaler chamber. Use only the capsules provided with the Tobi Podhaler device.

Store tobramycin ampules in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius).

If refrigeration is not available, store the ampules at cool room temperature for up to 28 days. Protect from light. The solution may become darker in color at room temperature, but this should not affect the quality of the medicine. Throw away any ampules not used before the expiration date on the label.

Store tobramycin capsules in their blister pack at room temperature away, from moisture and heat. Remove only one capsule at a time and only when you are ready to use it.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or worsening breathing problems, such as wheezing, cough, chest tightness, or trouble breathing;

• hearing problems, ringing in your ears;

• muscle weakness; or

• severe dizziness, spinning sensation, balance problems.

Common side effects may include:

• cough, sore throat, hoarse voice;

• noisy breathing;

• worsening of lung problems or cystic fibrosis;

• coughing up mucus or blood;

• altered sense of taste;

• fever;

• headache; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In the U.S.

• Bethkis
• Kitabis Pak
• Tobi
• Tobi Podhaler

Available Dosage Forms:

• Solution
• Capsule

Therapeutic Class: Antibiotic

Chemical Class: Aminoglycoside

Tobramycin inhalation is used to treat lung infections in patients with cystic fibrosis. The medicine is breathed into the lungs through the mouth to treat infections caused by the Pseudomonas aeruginosa bacteria.

Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by killing bacteria or preventing their growth. However, tobramycin will not work for colds, flu, or other virus infections.

tobramycin is available only with your doctor's prescription.

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 tobramycin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tobramycin 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 inhalation in children younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of Bethkis® have not been performed in the geriatric population.

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

Although appropriate studies on the relationship of age to the effects of Tobi® Podhaler™ have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving tobramycin.

Pregnancy

Breast Feeding

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.

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

Using tobramycin 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

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.

Other Medical Problems

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

• Allergy to aminoglycoside antibiotics (eg, amikacin, gentamicin, streptomycin, Garamycin®)—Should not be used in patients with this condition.

• Breathing problems (eg, bronchospasm) or
• Kidney problems or
• Myasthenia gravis (severe muscle weakness) or
• Parkinson's disease or
• Problems with hearing or balance—Use with caution. May make these conditions worse.

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

Remember that your doctor has prescribed this medication because he or she 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.

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 as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during pregnancy. Although there have been reports of harm in babies born to women using similar drugs, the risk for harm may not be the same with this drug. Discuss the risks and benefits with your doctor.

It is unknown if inhaled tobramycin passes into breast milk. However, other forms of this drug pass into breast milk in very small amounts, and many doctors consider breastfeeding safe while using this drug. Consult your doctor before breastfeeding.

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.