Tobi Podhaler

What is Tobi Podhaler?

• Tobi Podhaler is an aminoglycoside antibacterial used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa.

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What are the uses of this medicine?

• This medicine is used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa. TOBI Podhaler contains an antibacterial medicine called tobramycin (an aminoglycoside).

Limitations of use: It is not known if TOBI Podhaler is safe and effective:

• in children under 6 years of age
• in people who have an FEV1 less than 25% or greater than 80% predicted
• in people who are colonized with a bacterium called Burkholderia cepacia

How does this medicine work?

• Tobramycin (toe" bra mye' sin) is a semisynthetic aminoglycoside, similar in spectrum of activity to gentamicin, that is widely used for severe bacterial infections caused by sensitive agents, primarily aerobic gram negative bacteria.
• Like other aminoglycosides, tobramycin is thought to act by binding to bacterial ribosomes and inhibiting protein synthesis.
• Nevertheless, tobramycin is considered bacteriocidal as well as bacteriostatic.
• Tobramycin and other aminoglycosides are typically used in combination with a penicillin or cephalosporin for treatment of severe infections with E.Coli, Staphylococcus aureus, Enterobacter, Klebsiella, Serratia, Pseudomonas aeruginosa, and other gram negative bacteria resistant to less toxic antibiotic.

Who Should Not Use this medicine ?

This medicine cannot be used:

• with a known hypersensitivity to any aminoglycoside.

What drug interactions can this medicine cause?

• No clinical drug interaction studies have been performed with TOBI Podhaler.
• TOBI Podhaler should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol.
• Concurrent and/or sequential use of TOBI Podhaler with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

Recommended Dosage:

• The recommended dosage of TOBI Podhaler for both adults and pediatric patients 6 years of age and older is the inhalation of the contents of four 28 mg TOBI Podhaler capsules twice-daily for 28 days using the Podhaler device.
• Each dose of four capsules should be taken as close to 12 hours apart as possible; each dose should not be taken less than 6 hours apart.
• TOBI Podhaler is administered twice-daily in alternating periods of 28 days. After 28 days of therapy, patients should stop TOBI Podhaler therapy for the next 28 days, and then resume therapy for the next 28-day on and 28-day off cycle.

Administration

• Use TOBI Podhaler exactly as your healthcare provider tells you to use it. Ask your healthcare provider or pharmacist if you are not sure.
• The usual dose for adults and children over 6 years of age is:
• The contents of 4 TOBI Podhaler capsules inhaled by mouth in the morning using your Podhaler device and the contents of 4 TOBI Podhaler capsules inhaled by mouth in the evening using your Podhaler device.
• Check to see that each capsule is empty after inhaling. If powder remains in the capsule, repeat inhalation until the capsule is empty.
• Each dose of 4 TOBI Podhaler capsules should be taken as close to 12 hours apart as possible.
• You should not take your dose of 4 TOBI Podhaler capsules less than 6 hours apart.
• After using TOBI Podhaler for 28 days, you should stop using it and wait 28 days. After you have stopped using TOBI Podhaler for 28 days, you should start using TOBI Podhaler 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 have been prescribed a 7-day pack of TOBI Podhaler either immediately before or during a 28-day treatment with TOBI Podhaler, then you must count each day of use toward the 28-day on-treatment part of the cycle. You should only take a total of 28 consecutive days of treatment during a cycle.
• If you have been prescribed a 1-day pack of TOBI Podhaler either immediately before or during a 28-day treatment with TOBI Podhaler, then you must count each day of use toward the 28-day on-treatment part of the cycle. You should only take a total of 28 consecutive days of treatment during a cycle.
• If you are taking other medicines inhaled through your mouth, your healthcare provider will tell you how to take your medicines the right way.
• If you are doing therapies for cystic fibrosis (chest physiotherapy), you should use TOBI Podhaler after your other therapies are done.
• If you inhale too much TOBI Podhaler, tell your healthcare provider right away.
• If you accidentally swallow TOBI Podhaler capsules, tell your healthcare provider right away.
• Use a new TOBI Podhaler device every 7 days.
• Caregivers should help children who are 10 years of age and younger use TOBI Podhaler, and keep watching them use their TOBI Podhaler until they are able to use it the right way without help.
• Tell your doctor if your symptoms worsen while using your TOBI Podhaler.

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

This medicine is available in fallowing doasage form:

• As Inhalation powder: 28 mg in a capsule

This medicine is available in fallowing brand namesː

• TOBI Podhaler

What side effects can this medication cause?

The most common side effects of this medicine include:

• cough
• worsening of lung problems or cystic fibrosis
• productive cough
• shortness of breath
• fever
• sore throat
• changes in your voice (hoarseness)
• coughing up blood
• headache

TOBI Podhaler can cause serious side effects, including:

• severe breathing problems (bronchospasm)
• hearing loss or ringing in the ears (ototoxicity)
• worsening kidney problems (nephrotoxicity)
• worsening muscle weakness

What special precautions should I follow?

• Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction.
• Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported in clinical trials.
• Bronchospasm has been reported with inhalation of TOBI Podhaler . Bronchospasm should be treated as medically appropriate.
• Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.
• Nephrotoxicity was not observed during TOBI Podhaler clinical studies. Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected renal dysfunction.
• Aminoglycosides can cause fetal harm when administered to a pregnant woman.
• Audiograms, serum concentrations, and renal function should be monitored as appropriate.

What to do in case of emergency/overdose?

Management for overdosage:

• Overdosage should be treated with immediate withdrawal of TOBI Podhaler, and baseline tests of renal function should be undertaken.
• Hemodialysis may be helpful in removing tobramycin from the body.
• 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.

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?

• It is not known if TOBI Podhaler is safe and effective in children under 6 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tobramycin
• Inactive ingredients: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride, and sulfuric acid (for pH adjustment)

Who manufactures and distributes this medicine?

Packager: Mylan Specialty L.P.

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

• Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)
• Protect TOBI Podhaler from moisture.
• TOBI Podhaler capsules should be used with the Podhaler device only. The Podhaler device should not be used with any other capsules.
• Capsules should always be stored in the blister and each capsule should only be removed immediately before use.
• Always use the new Podhaler device provided with each weekly pack.
• Keep this and all drugs out of the reach of children.

• Dailymed label info on Tobi Podhaler
• FDA Tobi Podhaler

Tobi Podhaler Resources
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