Tobramycin Inhalation (Page 5 of 7)

15 REFERENCES

  1. Neu HC. Tobramycin: an overview. [Review]. J Infect Dis. 1976; Suppl 134:S3-19.
  2. Weber A, Smith A, Williams-Warren J, et al. Nebulizer delivery of tobramycin to the lower respiratory tract. Pediatr Pulmonol. 1994; 17(5):331-9.
  3. Clinical and laboratory Standards Institute (CLSI) Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically: Approved Standard -9th edition. CLSI document M07-A9. CLSI 940 West Valley Rd. Suite 1400, Wayne PA 19087-1898. 2012
  4. CLSI Performance Standards for Antimicrobial Susceptibility Testing: 22nd Informational supplement CLSI document M100-S22. CLSI 2012.
  5. CLSI Performance standards for Antimicrobial Disk Susceptibility Tests: Approved standard -11th ed. CLSI document M02-A11. CLSI 2012.
  6. PARI Vios Aerosol Delivery System with LC Plus Nebulizer: Instructions for Use. PARI Respiratory Equipment, Inc. 2010; 310D0028 Rev A 6-10.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tobramycin Inhalation Solution 300 mg/4 mL is supplied as a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution and is available as follows:

  • NDC 66993-195-94: 4 mL single-use ampule (carton of 14 foil pouches each containing four ampules)

16.2 Storage and Handling

Tobramycin Inhalation Solution should be stored under refrigeration at 2°C ‑ 8°C (36°F ‑ 46°F). Upon removal from the refrigerator, or if refrigeration is unavailable, Tobramycin Inhalation Solution pouches (opened or unopened) may be stored at room temperature [up to 25°C (77°F)] for up to 28 days. Tobramycin Inhalation Solution should not be used beyond the expiration date stamped on the ampule when stored under refrigeration 2°C ‑ 8°C (36°F ‑ 46°F) or beyond 28 days when stored at room temperature [up to 25°C (77°F)].

Tobramycin Inhalation Solution ampules should not be exposed to intense light. Tobramycin Inhalation Solution is light sensitive; unopened ampules should be returned to the foil pouch. The solution in the ampule is colorless to pale yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Information for Patients

Information on the long term efficacy and safety of Tobramycin Inhalation Solution is limited. There is no information in patients with severe cystic fibrosis (FEV1 < 40% predicted).

Patients should be advised to complete a full 28-day course of Tobramycin Inhalation Solution, even if they are feeling better. After 28 days of therapy, patients should stop Tobramycin Inhalation Solution therapy for the next 28 days, and then resume therapy for the next 28 day on and 28 day off cycle.

For patients taking several different inhaled medications and/or performing chest physiotherapy, advise the patient regarding the order they should take the therapies. It is recommended that Tobramycin Inhalation Solution be taken last.

Tobramycin Inhalation Solution is to be used with the PARI LC PLUS reusable nebulizer and the PARI VIOS air compressor. Refer to the manufacturer’s instructions for care and use of the nebulizer and compressor.

17.1 Ototoxicity

Inform patients that ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients treated with tobramycin. Physicians should consider an audiogram at baseline, particularly for patients at increased risk of auditory dysfunction.

If a patient reports tinnitus or hearing loss during Tobramycin Inhalation Solution therapy, the physician should refer that patient for audiological assessment.

Patients should be reminded that vestibular toxicity may manifest as vertigo, ataxia, or dizzines.

17.2 Bronchospasm

Inform patients that bronchospasm can occur with inhalation of tobramycin.

17.3 Risks Associated with Aminoglycosides

Inform patients of adverse reactions associated with aminoglycosides such as nephrotoxicity and neuromuscular disorders.

17.4 Laboratory Tests

Inform patients of the need to monitor hearing, serum concentrations of tobramycin, or renal function as necessary during treatment with Tobramycin Inhalation Solution.

17.5 Embryo-Fetal Toxicity

Inform patients that aminoglycosides can cause fetal harm when administered to a pregnant woman. Advise them to inform their doctor if they are pregnant, become pregnant, or plan to become pregnant.

17.6 Administration

Patients should be informed about what to do in the event they miss a dose of Tobramycin Inhalation Solution:

  • In case a dose of Tobramycin Inhalation Solution is missed and there are at least 6 hours until the next dose, patients should be instructed to take the prescribed dose of Tobramycin Inhalation Solution as soon as possible. Otherwise, the missed dose should not be taken and the patient should resume the usual dosing schedule.

  • Patients should be advised to contact their healthcare provider if they have questions.

17.7 Storage Instructions

You should store Tobramycin Inhalation Solution ampules in a refrigerator (36-46 °F or 2-8 °C). However, when you don’t have a refrigerator available (e.g., transporting your Tobramycin Inhalation Solution), you may store the foil pouches (opened or unopened) at room temperature (up to 77 °F/25 °C) for up to 28 days.

Tobramycin Inhalation Solution is light sensitive; unopened ampules should be returned to the foil pouch. Avoid exposing Tobramycin Inhalation Solution ampules to intense light. Unrefrigerated Tobramycin Inhalation Solution, which is normally colorless to pale yellow, may darken with age; however, the color change does not indicate any change in the quality of the product.

You should not use Tobramycin Inhalation Solution if it is cloudy, if there are particles in the solution, or if it has been stored at room temperature for more than 28 days. You should not use Tobramycin Inhalation Solution beyond the expiration date stamped on the ampule.

Nebulizers and Compressors: 1-800-327-8632

Tobramycin Inhalation Solution: 1-866-525-0688

U.S. Patent 6,987,094.

Manufactured for Prasco Laboratories

Mason, Ohio 45040 USA

by Woodstock Sterile Solutions, Inc.

Woodstock, Illinois 60098

Printed in USA

CTB-013-0521-01-SPL

FDA-Approved Patient Labeling

Patient Information

Tobramycin Inhalation Solution

(toh-bruh-mahy -sin)

for oral inhalation use

What is Tobramycin Inhalation Solution?

Tobramycin Inhalation Solution is a prescription medicine that is used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa. Tobramycin Inhalation Solution contains an antibacterial medicine called tobramycin (an aminoglycoside).

It is not known if Tobramycin Inhalation Solution is safe and effective:

  • in children under 6 years of age
  • in people who have decreased lung volume or a forced expiratory volume in one second (FEV1 ) less than 40% or greater than 80% predicted
  • in people who are colonized with a bacterium called Burkholderia cepacian

Do not take Tobramycin Inhalation Solution if you are allergic to tobramycin, any of the ingredients in Tobramycin Inhalation Solution, or to any other aminoglycoside antibacterial.

See the end of this Patient Information for a complete list of ingredients in Tobramycin Inhalation Solution.

Before you take Tobramycin Inhalation Solution, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had hearing problems (including noises in your ears such as ringing or hissing)

  • have dizziness

  • have or have had kidney problems

  • have or have had problems with muscle weakness such as myasthenia gravis or Parkinson’s disease

  • have or have had breathing problems such as wheezing, coughing, or chest tightness

  • are pregnant or plan to become pregnant. Tobramycin Inhalation Solution is in a class of medicines that can harm your unborn baby and may be connected with complete deafness in babies at birth. The deafness affects both ears and cannot be changed.

  • are breastfeeding or plan to breastfeed. It is not known if Tobramycin Inhalation Solution passes into your breast milk. Tobramycin, the medicine in Tobramycin Inhalation Solution may cause the following symptoms in your breastfed baby:

    • loose or bloody stools

    • yeast infection in the mouth or throat (thrush)

    • diaper rash

Call your baby’s healthcare provider if your breastfed baby has any of these problems. Talk to your healthcare provider about the best way to feed your baby during treatment with Tobramycin Inhalation Solution.

  • are receiving aminoglycoside therapy by injection or through a vein (intravenous) while taking Tobramycin Inhalation Solution. Your blood levels of tobramycin will be checked.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

How should I take Tobramycin Inhalation Solution?

  • See the step-by-step Instructions for Use at the end of this Patient Information leaflet about the right way to take your Tobramycin Inhalation Solution.

  • Take Tobramycin Inhalation Solution exactly as your healthcare provider tells you to. Do not change your dose or stop taking Tobramycin Inhalation Solution unless your healthcare provider tells you to.

  • The usual dose of Tobramycin Inhalation Solution for adults and children over 6 years of age is:

    • 1 single-use ampule of Tobramycin Inhalation Solution inhaled 2 times each day using your hand-held PARI LC PLUS Reusable Nebulizer with a PARI Vios air compressor.

  • Each dose of Tobramycin Inhalation Solution should be taken as close to 12 hours apart as possible.

  • You should not take your dose of Tobramycin Inhalation Solution less than 6 hours apart.

  • Tobramycin Inhalation Solution is taken as a breathing treatment (inhalation) with a hand-held PARI LC Reusable Nebulizer with a PARI Vios air compressor. Do not use any other nebulizer for your Tobramycin Inhalation Solution treatment.

  • Do not mix or dilute Tobramycin Inhalation Solution with dornase alfa or other medicines in your nebulizer system.

  • Each treatment of Tobramycin Inhalation Solution should take about 15 minutes.

  • Tobramycin Inhalation Solution should be inhaled while you are sitting or standing upright and breathing normally through the mouthpiece of the nebulizer. Nose clips may help you to breathe through your mouth.

  • If you forget to take Tobramycin Inhalation Solution and there are at least 6 hours to your next dose, take your dose as soon as you can. Otherwise, wait for your next dose. Do not double the dose to make up for the missed dose.

  • After taking Tobramycin Inhalation Solution for 28 days, you should stop taking it and wait 28 days. After you have stopped taking Tobramycin Inhalation Solution for 28 days, you should start taking Tobramycin Inhalation Solution again for 28 days. Complete the full 28-day course even if you are feeling better. It is important that you keep to the 28-day on, 28-day off cycle.

If you are taking several other medicines or treatments to treat your cystic fibrosis, you should take your medicines or other treatments before inhaling Tobramycin Inhalation Solution or as directed by your healthcare provider.

Taking Tobramycin Inhalation Solution with certain other medicines can cause serious side effects.

If you are taking Tobramycin Inhalation Solution, you should discuss with your healthcare provider if you should take:

  • other medicines that may harm your nervous system, kidneys, or hearing

  • “water pills” (diuretics) such as ethacrynic acid, furosemide, or intravenous mannitol

  • Urea

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

  • If you take too much Tobramycin Inhalation Solution, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Tobramycin Inhalation Solution?

Tobramycin Inhalation Solution can cause serious side effects, including:

  • hearing loss or ringing in the ears (ototoxicity). Some people who were treated with tobramycin, the medicine in Tobramycin Inhalation Solution had hearing loss or ringing in the ears. Tell your healthcare provider right away if you have hearing loss or hear noises in your ears (such as ringing or hissing), or if you develop vertigo, dizziness, or difficulty with balance.
  • worsening kidney problems (nephrotoxicity). Your healthcare provider may do a blood test and urine test to check how your kidneys are working while you are taking Tobramycin Inhalation Solution.

  • worsening muscle weakness (neuromuscular disorder). Tobramycin Inhalation Solution can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis or Parkinson’s disease).

  • severe breathing problems (bronchospasm). Tell your healthcare provider right away if you get any of these symptoms of bronchospasm while taking Tobramycin Inhalation Solution:

    • shortness of breath with wheezing

    • coughing and chest tightness

The most common side effects of Tobramycin Inhalation Solution include:

  • worsening of lung problems or cystic fibrosis

  • noisy breathing (rales)

  • abnormal red blood cell activity

  • changes in your voice (hoarseness)

These are not all of the possible side effects of Tobramycin Inhalation Solution.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Tobramycin Inhalation Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tobramycin Inhalation Solution for a condition for which it was not prescribed. Do not give Tobramycin Inhalation Solution to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for more information about Tobramycin Inhalation Solution that is written for health professionals.

What are the ingredients in Tobramycin Inhalation Solution?

Active ingredient: tobramycin

Inactive ingredients: sodium chloride, sulfuric acid in water for injection, and sodium hydroxide (for pH adjustment)

What is Psuedomonas aeriguinosa?

It is a very common bacterium that infects the lungs of nearly everyone with cystic fibrosis at some time during their lives. Some people do not get this infection until later in their lives, while others get it very young. It is one of the most damaging bacteria for people with cystic fibrosis. If the infection is not properly managed, it will continue to damage your lungs causing further problems to your breathing.

For more information, go to www.prasco.com or call 1-866-525-0688.

This Patient Information has been approved by the U.S. Food and Drug Administration. 05/2021

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