tobi podhaler
Pharmaranks rates Tobi Podhaler 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Tobi Podhaler (Tobramycin) is an aminoglycoside antibacterial used to treat Infectious Bone Diseases, Central Nervous System Infections, Pseudomonas Infections, Respiratory Tract Infections.
Tobramycin · by Viatris
Available as a generic: Tobrex
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Tobramycin
- Drug class
- Aminoglycoside Antibacterial
- Form
- Capsule
- Strength
- Tobramycin 28MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Viatris
- What the pharmacy pays
- ~$1.08 per ml — not your price
- FDA application
- NDA201688
What is Tobi Podhaler?
From the FDA label:TOBI Podhaler consists of a dry powder formulation of tobramycin for oral inhalation only with the Podhaler device. The inhalation powder is filled into clear, colorless hypromellose capsules. Each clear, colorless hypromellose capsule contains a spray dried powder of 28 mg of tobramycin active ingredient with 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride, and sulfuric acid (for pH adjustment). The active component of TOBI Podhaler is tobramycin. Tobramycin is an aminoglycoside antibiotic. Its chemical name is O -3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O -[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine; its structural formula is: Tobramycin has a molecular weight of 467.52, and its empirical formula is C 18 H 37 N 5 O 9 . Tobramycin is a white to almost white powder; visually free from any foreign contaminants. Tobramycin is freely soluble in water, very slightly soluble in ethanol, and practically insoluble in chloroform and ether. The Podhaler device is a plastic device used to inhale the dry powder contained in the TOBI Podhaler capsule. Under standardized in vitro testing at a fixed flow rate of 60 L/min and volume of 2 L for 2 seconds, the Podhaler device has a target delivered dose of 102 mg of tobramycin from the mouthpiece (4 capsules per dose). Peak inspiratory flow rate and inhaled volumes were explored in 96…
How to use
Podhaler capsules must not be swallowed as the intended effects in the lungs will not be obtained. The contents of TOBI Podhaler capsules are only for oral inhalation and should only be used with the Podhaler device. 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. Refer to the Instructions For Use (IFU) for full administration information. Dosage is not adjusted by weight. 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. TOBI Podhaler capsules should always be stored in the blister and each capsule should only be removed IMMEDIATELY BEFORE USE. For patients taking several different inhaled medications and/or performing chest physiotherapy, the order of therapies should follow the physician’s recommendation. It is recommended that TOBI Podhaler is taken last. • DO NOT swallow TOBI Podhaler capsules ( 2 ) • For use with the Podhaler device only ( 2 ) • For oral inhalation only ( 2 ) •…
Side effects
The most common adverse reactions (≥10 % of TOBI Podhaler and TOBI patients in primary safety population) are cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. TOBI Podhaler has been evaluated for safety in 425 cystic fibrosis patients exposed to at least one dose of TOBI Podhaler, including 273 patients who were exposed across three cycles (6 months) of treatment. Each cycle consisted of 28 days on-treatment (with 112 mg administered twice-daily) and 28 days off-treatment. Patients with serum creatinine ≥2 mg/dL and blood urea nitrogen (BUN) ≥40 mg/dL were excluded from clinical studies. There were 218 males and 207 females in this population, and reflecting the cystic fibrosis population in the U.S., the vast majority of patients were Caucasian. There were 221 patients ≥20 years old, 121 patients ≥13 to <20 years old, and 83 patients ≥6 to <13 years old. There were 239…
Warnings
Important safety information
Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction ( 5.2 , 5.3 , 5.4 ) • Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported in clinical trials ( 5.2 ) • Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function ( 5.6 ) • Bronchospasm can occur with inhalation of TOBI Podhaler ( 5.1 ) • Audiograms, serum concentrations, and renal function should be monitored as appropriate ( 5.3 , 5.5 , 5.6 ) • Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm Apprise women of the potential hazard to the fetus ( 5.6 , 8.1 ) 5.1 Bronchospasm Bronchospasm has been reported with inhalation of TOBI Podhaler [see Adverse Reactions (6.1) ] . Bronchospasm should be treated as medically appropriate. 5.2 Ototoxicity Ototoxicity with use of TOBI Podhaler Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected auditory or vestibular dysfunction. Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the TOBI Podhaler clinical studies [see Adverse Reactions (6.1) ] . Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. Ototoxicity, manifested as both auditory (hearing loss) and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness. Risk of Ototoxicity Due to Mitochondrial DNA Variants Cases of ototoxicity with aminoglycosides have been observed in patients with certain variants in the mitochondrially encoded 12S rRNA gene (MT-RNR1) , particularly the m.1555A>G variant. Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range. Mitochondrial DNA variants are present in less than 1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as the severity of ototoxicity is unknown. In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies. 5.3 Nephrotoxicity Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected renal dysfunction. Nephrotoxicity was not observed during TOBI Podhaler clinical studies but has been associated with aminoglycosides as a class. 5.4 Neuromuscular Disorders Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected neuromuscular dysfunction. TOBI Podhaler should be used cautiously in patients with neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, since aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. 5.5 Embryo-Fetal Toxicity Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. However, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3) ] . Patients who use TOBI Podhaler during pregnancy, or become pregnant while taking TOBI Podhaler should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1) ] . 5.6 Concomitant Use of Systemic Aminoglycosides Patients receiving concomitant TOBI and parenteral aminoglycoside therapy should be monitored as clinically appropriate for toxicities associated with aminoglycosides as a class. Serum tobramycin levels should be monitored.
Who should not take Tobi Podhaler
TOBI Podhaler is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Known hypersensitivity to any aminoglycoside ( 4 )
Overdose — what happens if you take too much
The maximum tolerated daily dose of TOBI Podhaler has not been established. In the event of accidental oral ingestion of TOBI Podhaler capsules, systemic toxicity is unlikely as tobramycin is poorly absorbed. Tobramycin serum concentrations may be helpful in monitoring overdosage. Acute toxicity 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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No clinical drug interaction studies have been performed with TOBI Podhaler. In clinical studies, patients receiving TOBI Podhaler continued to take dornase alfa, bronchodilators, inhaled corticosteroids, and macrolides. No clinical signs of drug interactions with these medicines were identified. Concurrent and/or sequential use of TOBI Podhaler with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI Podhaler should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and TOBI Podhaler has not been evaluated. Concurrent and/or sequential use of TOBI Podhaler with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided ( 7 )
Drug class
How this class works, per Aminoglycosides - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- infectious bone diseases
- central nervous system infections
- pseudomonas infections
- respiratory tract infections
- infectious skin diseases
- staphylococcal infections
See how Tobi Podhaler ranks — best-rated aminoglycoside antibacterial for:
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Tobi Podhaler treat?
- Tobi Podhaler (Tobramycin) may be used to treat infectious bone diseases, central nervous system infections, pseudomonas infections, respiratory tract infections, infectious skin diseases, staphylococcal infections, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Tobi Podhaler work?
- Tobi Podhaler is a aminoglycoside antibacterial. Aminoglycosides kill bacteria by latching onto the germ's protein-making machinery (the 30S ribosomal subunit). This jams and misreads the bacterial genetic code so the microbe builds faulty proteins it can't survive on, which is why these drugs destroy the bacteria rather than just stopping their growth.
- How is Tobi Podhaler rated?
- pharmaranks gives Tobi Podhaler a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Tobi Podhaler cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.08 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Tobi Podhaler?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tobi Podhaler. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Tobi Podhaler?
- Tobi Podhaler is marketed by Viatris. You can see Viatris's full profile, rating, and other products on pharmaranks.
- Is Tobi Podhaler a brand-name or generic drug?
- Tobi Podhaler is a brand-name product with the active ingredient Tobramycin. Lower-cost generic equivalents containing Tobramycin are available — ask your pharmacist.
- Is Tobi Podhaler available over the counter?
- No. Tobi Podhaler is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Tobi Podhaler come in?
- Tobi Podhaler is currently marketed as capsule, per the FDA's National Drug Code Directory.
- What class of drug is Tobi Podhaler?
- Tobi Podhaler is classified as aminoglycoside antibacterial, per the FDA's Established Pharmacologic Class.
- Is Tobi Podhaler FDA-registered?
- Tobi Podhaler is on record with the U.S. FDA under application number NDA201688. You can verify this on its official FDA label.
- Has Tobi Podhaler been recalled by the FDA?
- Tobi Podhaler has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Tobi Podhaler safe?
- There's no single safe-or-not verdict. pharmaranks gives Tobi Podhaler a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Tobi Podhaler?
- Tobi Podhaler's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (≥10 % of TOBI Podhaler and TOBI patients in primary safety population) are cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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