TOBRAMYCIN POWDER IN CAPSULE - ORAL INHALATION

TOBRAMYCIN POWDER IN CAPSULE - ORAL INHALATION

PHONETIC PRONUNCIATION: (TOE-bra-MYE-sin)

COMMON BRAND NAME(S): Tobi Podhaler

GENERIC NAME(S): tobramycin

Uses

USES: This medication is used to treat people with cystic fibrosis who have a persistent 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 TOBRAMYCIN POWDER IN CAPSULE - ORAL INHALATION

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

SIDE EFFECTS: 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.

Precautions

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 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.

Interactions

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

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. Canada residents can call a provincial poison control center.

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Faq for TOBRAMYCIN POWDER IN CAPSULE - ORAL INHALATION

Tobramycin powder in capsule-oral inhalation is used to treat certain lung infections caused by bacteria in patients with cystic fibrosis.

You should empty the contents of one capsule into the nebulizer device and inhale the medication using the nebulizer machine or other suitable device as directed by your healthcare provider. Do not swallow the capsule.

Common side effects may include voice changes, cough, shortness of breath, chest discomfort, throat irritation, and headaches. Contact your doctor if you experience severe side effects such as wheezing, rash, or difficulty breathing.

Yes, Tobramycin powder in capsule-oral inhalation can be used in children aged 6 years and older for the treatment of lung infections associated with cystic fibrosis.

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

No, it is important to complete the full course of treatment as prescribed by your healthcare provider, even if your symptoms improve. Stopping the medication prematurely may lead to a recurrence of the infection.

You should discuss the potential risks and benefits of using Tobramycin powder in capsule-oral inhalation during pregnancy or breastfeeding with your healthcare provider. They will determine if the medication is suitable for you.

Inform your doctor about all other medications you are taking, including prescription, over-the-counter drugs, and herbal supplements. Tobramycin may interact with certain medications, so it is important to disclose your complete medication history.

Store Tobramycin capsules at room temperature away from moisture and heat. Keep them in the original blister pack until ready to use. Do not use capsules that are damaged or have expired.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.