Tobramycin for inhalation

What is Tobramycin for inhalation?

• Tobramycin for inhalation (Bethkis) is an aminoglycoside antibacterial used in the treatment of exacerbations of chronic infection with Pseudomonas aeruginosa in people diagnosed with cystic fibrosis.

Pseudomonas aeruginosa: 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.

Tobramycin

Tobramycin flat

What are the uses of this medicine?

• Tobramycin for inhalation (Bethkis) 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).

Limitations of use:

• It is not known if tobramycin inhalation solution is safe and effective:
• in children under 6 years of age
• in people who have an FEV1 less than 25% or greater than 75% predicted
• in people who are colonized with a bacterium called Burkholderia cepacia

How does this medicine work?

Tobramycin is an aminoglycoside antibacterial. Tobramycin is an aminoglycoside antibacterial produced by Streptomyces tenebrarius. It acts primarily by disrupting protein synthesis, leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to any aminoglycoside.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• drugs with neurotoxic, nephrotoxic, or ototoxic potential
• Diuretics

Is this medicine FDA approved?

• It was patented in 1965, and approved for medical use in 1974.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of tobramycin inhalation solution for both adults and pediatric patients 6 years of age and older is one single-dose ampule (300 mg) administered twice daily for 28 days.
• Dosage is not adjusted by weight.
• All patients should be administered 300 mg twice daily.

Administration:

• Tobramycin inhalation solution is administered by oral inhalation over an approximately 15-minute period,
• Tobramycin inhalation solution should not be diluted or mixed with dornase alfa or other medications in the nebulizer.
• Tobramycin inhalation solution is not for subcutaneous, intravenous or intrathecal administration.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Inhalation Solution: 300 mg per 5 mL solution in a single-dose ampule

This medicine is available in fallowing brand namesː

• Bethkis

What side effects can this medication cause?

The most common side effects of this medicine include:

• increased cough
• coughing up blood
• voice changes
• sore throat
• decreased lung function
• loss or change in taste
• increased sputum
• trouble breathing
• rash

Tobramycin inhalation solution may cause serious side effects, including:

• bronchospasm
• ototoxicity
• nephrotoxicity
• neuromuscular disorder

What special precautions should I follow?

• Bronchospasm can occur with inhalation of tobramycin inhalation solution. Bronchospasm that occurs during the use of tobramycin inhalation solution should be treated as medically appropriate.
• Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. If ototoxicity is noted, the patient should be managed as medically appropriate, including potentially discontinuing tobramycin inhalation solution.
• Nephrotoxicity was not seen during clinical studies with tobramycin inhalation solution but has been associated with aminoglycosides as a class. If nephrotoxicity develops, the patient should be managed as medically appropriate, including potentially discontinuing tobramycin inhalation solution.
• Aminoglycosides, including tobramycin, may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. If neuromuscular blockade occurs, it may be reversed by the administration of calcium salts but mechanical assistance may be necessary.
• Aminoglycosides can cause fetal harm when administered to a pregnant woman. Patients who use tobramycin inhalation solution during pregnancy, or become pregnant while taking tobramycin inhalation solution should be apprised of the potential hazard to the fetus.
• Patients receiving concomitant tobramycin inhalation solution and parenteral aminoglycoside therapy should be monitored as clinically appropriate for toxicities associated with aminoglycosides as a class. Serum tobramycin levels should be monitored.
• Advise a woman to monitor their breastfed infants for diarrhea and/or bloody stools.
• Advise patients to inform their physician if they experience ringing in the ears, dizziness, or any changes in hearing because tobramycin inhalation solution has been associated with hearing loss.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• dizziness
• tinnitus
• vertigo
• loss of high-tone hearing acuity
• respiratory failure
• neuromuscular blockade
• renal impairment

Treatment of overdosage:

• Acute toxicity should be treated with immediate withdrawal of tobramycin inhalation solution, and baseline tests of renal function should be undertaken.
• In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment.
• In the case of any overdosage, the possibility of drug interactions with alterations in drug disposition should be considered.
• Hemodialysis may be helpful in removing tobramycin from the body.

Can this medicine be used in pregnancy?

• Aminoglycosides can cause fetal harm.
• Advise pregnant women of the potential risk to a fetus.

Can this medicine be used in children?

• The safety and efficacy of tobramycin inhalation solution in pediatric patients under 6 years of age has not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tobramycin
• Inactive ingredients: sodium chloride in sterile water for injection, sulfuric acid, sodium hydroxide, and nitrogen

Who manufactures and distributes this medicine?

Manufactured for:

• Akorn, Inc.
• Lake Forest, IL

What should I know about storage and disposal of this medication?

• Tobramycin inhalation solution, USP should be stored under refrigeration at 2° to 8°C/36° to 46°F.
• Upon removal from the refrigerator, or if refrigeration is unavailable, tobramycin inhalation solution, USP pouches (opened or unopened) may be stored at room temperature (up to 25°C/77°F) for up to 28 days.
• Tobramycin inhalation solution, USP should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2° to 8°C/36° to 46°F) or beyond 28 days when stored at room temperature (25°C/77°F).
• Tobramycin inhalation solution, USP ampules should not be exposed to intense light.
• The solution in the ampule is slightly yellow, but may darken with age if not stored in the refrigerator.

• Dailymed label info on Tobramycin for inhalation
• FDA Tobramycin for inhalation

Tobramycin for inhalation Resources
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