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Tobramycin 300 mg/4mL Solution — NDC 70756-617-56 (Billing 70756-0617-56)

by Lifestar Pharma LLC · 14 POUCH in 1 CARTON / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE

This is a package of Tobramycin 300 mg/4mL Solution from Lifestar Pharma LLC, marketed since Sep 2022 and currently FDA-listed. It is this product's only package size.

NDC 70756-0617-56
🏷️ FDA NDC (as labeled) 70756-617-56 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70756-617-56
Product NDC 70756-617
11-digit billing NDC 70756061756
NCPDP billing unit ML — per mL (volume)
RxCUI 1314763
UNII VZ8RRZ51VK
UPC 0370756617563, 0370756617440
Application # ANDA216725
SPL Set ID 96517b44-55df-4d2c-8fe8-110ed51dfafe
Established class (EPC) Aminoglycoside Antibacterial
Chemical class Aminoglycosides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-23
Route RESPIRATORY (INHALATION)
Dosage form SOLUTION
Substance TOBRAMYCIN
TE code (Orange Book) AN · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 07000070002530
GCN Seq No 064682
GCN 16122
HICL code 017765
Ingredient (HICL) Tobramycin
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1F
Therapeutic class — specific (HIC3) Aminoglycoside Antibiotics
AHFS code 08:12.02.00
AHFS class Aminoglycoside Antibiotics
FDB label name TOBRAMYCIN 300 MG/4 ML AMPULE
FDB brand name Tobramycin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064682
  • GCN: 16122
  • GPI-14 (Medi-Span): 07000070002530
  • HICL (First Databank): 017765
  • AHFS class code: 08:12.02.00
  • RxCUI (RxNorm): 1314763
Why two NDCs? The FDA registers this code as 70756-617-56 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70756-0617-56. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Aminoglycoside Antibacterial class.

Pharmacologic class Aminoglycoside Antibacterial
Drug family (ATC) Other aminoglycosides, Antibiotics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name TOBRAMYCIN 300 MG/4 ML AMPULE Ingredient Tobramycin
📗 Our plain-language guide HelloPharmacist
  • It depends on the form. Inhaled tobramycin treats Pseudomonas aeruginosa lung infection in cystic fibrosis. Eye drops and ointment treat external eye infections. The injection trea...
  • You breathe it in by mouth, usually twice a day about 12 hours apart, for 28 days. Then you take 28 days off. TOBI Podhaler capsules must never be swallowed; they are used only wit...
  • Cough, shortness of breath, fever, sore throat, hoarseness and headache are common with the inhaled form. Mention them to your care team if they bother you.
  • Call about ringing in the ears, hearing loss, dizziness or balance trouble, new muscle weakness, or wheezing after a dose. These can be signs of serious effects.
📖 Read our full Tobramycin guide →
8
Nutrient depletion considerations

Tobramycin may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Tobramycin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $8.89 $1,991.14 / 224 ml
Medicare drug plans payPart D · Q2 2026 $16.66 $3,731.03 / 224 ml
Medicare Part B allowsASP · J7682 $12.305 / J7682 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)70756-617-56
11-digit billing NDC70756-0617-56
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7682
DescriptorTOBRAMYCIN, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, UNIT DOSE FORM, ADMINISTERED THROUGH DME, PER 300 MILLIGRAMS
Billing units / pkg0.25 units
How the units are derivedThis package is 4 ML; the HCPCS unit is 300 MG, so one package = 0.25 billing units.
Medicare Part B spend (2026 (Q1))$1,576,434 · 2,369 claims · $665.44 per claim (all NDCs under J7682)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70756-0617-56 You're viewing this Main listing 14 POUCH in 1 CARTON / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE 2022-09-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tobramycin 300 mg/4mL 00093-3750-28 Teva 7 pouches — — Discontinued —
Bethkis 300 mg/4mL 10122-0820-28 Chiesi 7 pouches — AN FDA listed —
Tobramycin Inhalation 300 mg/4mL 66993-0195-94 Prasco, 14 pouches — AN FDA listed —
Tobramycin 300 mg/4mLthis 70756-0617-56 Lifestar 14 pouches — AN FDA listed —
Tobramycin 300 mg/4mL 72603-0630-56 NorthStar 14 pouches — AN FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Sep 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLifestar Pharma LLC
Application holderMANKIND PHARMA LTD
FDA applicationANDA216725 (ANDA)
Labeler code70756
First marketedSep 2022
Product typeHuman Prescription Drug
Portfolio155 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 125 words ▾

1 INDICATIONS AND USAGE Tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV 1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ]. Tobramycin inhalation solution is an inhaled aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

( 1 ) Safety and efficacy have not been demonstrated in patients under the age of six years, patients with a forced expiratory volume in one second (FEV 1 ) less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia . ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION For oral inhalation only ( 2.1 ) Administer the entire contents of one ampule twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug. ( 2.1 )

2.1Dosage Tobramycin inhalation solution is for oral inhalation only [see Dosage and Administration (2.2) ] . The recommended dosage of tobramycin inhalation solution for patients six years of age and older is to administer one single-dose ampule (300 mg/4 mL) twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug. The doses should be taken as close to 12 hours apart as possible and not less than 6 hours apart.

The 300 mg/4 mL dose of tobramycin inhalation solution is the same for patients regardless of age or weight. Tobramycin inhalation solution has not been studied in patients less than six years old. If patients miss a dose, they should take it as soon as possible anytime up to 6 hours prior to their next scheduled dose.

If less than 6 hours remain before the next dose, wait until their next scheduled dose.

2.2Administration Instructions Tobramycin inhalation solution is administered by oral inhalation using a hand-held PARI LC PLUS Reusable Nebulizer with a PARI Vios Air compressor over an approximately 15 minute period and until sputtering from the output of the nebulizer has occurred for at least one minute. 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.

Further patient instructions on how to administer tobramycin inhalation solution are provided in the Patient's Instructions for Use [see Patient Counseling Information (17) ]. Tobramycin inhalation solution should not be used 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.

💊 Dosage Forms and Strengths 57 words ▾

3 DOSAGE FORMS AND STRENGTHS Tobramycin inhalation solution, USP is supplied as a sterile, a clear, colorless or slight yellow to pale yellow color, non-pyrogenic, aqueous inhalational solution for nebulization in single-dose 4 mL ampule containing 300 mg of tobramycin, USP. Inhalation Solution: 300 mg tobramycin per 4 mL solution in a single-dose ampule. ( 16 )

⛔ Contraindications 33 words ▾

4 CONTRAINDICATIONS Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Caution should be exercised when prescribing tobramycin inhalation solution to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. ( 5.1 , 5.2 , 5.3 and 5.5 ) Aminoglycoside may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function. ( 5.3 ) Bronchospasm can occur with inhalation of tobramycin inhalation solution.

( 5.4 ) Audiograms, serum concentration, and renal function should be monitored as appropriate. ( 5.2 and 5.5 ) Fetal harm can occur when aminoglycosides are administered to a pregnant woman. Apprise women of the potential hazard to the fetus.

( 5.6 )

5.1Ototoxicity Ototoxicity with use of tobramycin inhalation solution Caution should be exercised when prescribing tobramycin inhalation solution to patients with known or suspected auditory or vestibular dysfunction. Findings related to ototoxicity as measured by audiometric evaluations and auditory adverse event reports were similar between tobramycin inhalation solution and placebo in controlled clinical trials. Hearing loss was reported in two (1.1%) tobramycin inhalation solution-treated patients and in one (0.9%) placebo-treated patient during clinical studies.

Additionally, dizziness and vertigo, both of which may be manifestations of vestibular forms of ototoxicity, were observed in similar numbers of tobramycin inhalation solution- and placebo-treated patients. Dizziness occurred in two (1.1%) tobramycin inhalation solution-treated patients and one (0.9%) placebo-treated patient and vertigo occurred in two (1.1%) tobramycin inhalation solution-treated patients versus no placebo patients in clinical studies. None of the tobramycin inhalation solution patients discontinued their therapy due to hearing loss, dizziness or vertigo.

Tinnitus may be a sentinel symptom of ototoxicity. No reports of tinnitus occurred in patients during clinical studies with tobramycin inhalation solution, but because it has been observed with inhaled tobramycin solutions [see Adverse Reactions (6.2) ] , onset of this symptom warrants caution. Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides.

Vestibular toxicity may be manifested by vertigo, ataxia or dizziness. Patients with known or suspected auditory or vestibular dysfunction should be closely monitored when taking tobramycin inhalation solution. Monitoring may include obtaining audiometric evaluations and serum tobramycin levels.

If ototoxicity is noted, the patient should be managed as medically appropriate, including potentially discontinuing tobramycin inhalation solution. 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.

5.2Nephrotoxicity Caution should be exercised when prescribing tobramycin inhalation solution to patients with known or suspected renal dysfunction. Nephrotoxicity was not seen during tobramycin inhalation solution clinical studies but has been associated with aminoglycosides as a class. Patients with known or suspected renal dysfunction or taking concomitant nephrotoxic drugs along with tobramycin inhala… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Common adverse reactions (more than 5%) occurring more frequently in tobramycin inhalation solution patients are forced expiratory volume decreased, rales, red blood cell sedimentation rate increased, and dysphonia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to tobramycin inhalation solution in two placebo-controlled studies in 305 cystic fibrosis patients. Patients receiving tobramycin inhalation solution ranged in age from 6 to 31 years.

In Study 1, an eight week study, 29 patients received tobramycin inhalation solution versus 30 patients who received placebo for a total of four weeks on drug and four weeks off drug. All patients were ≤ 30 years of age (mean age 12.6 years) and 46% were females. 52.5% of patients were 6 to 12 years of age while 30.5% of patients were 13-17 years old.

Only 16.5% of patients were adults (> 17 years old). Eighty percent (80%) of patients were chronically colonized with Pseudomonas aeruginosa while 20.3% of patients were initially or intermittently colonized with Pseudomonas aeruginosa during the study. More patients in the placebo group discontinued/dropped out of Study 1 than in the tobramycin inhalation solution group (23% [7/30] vs 3.4% [1/29], respectively).

Five patients in the placebo group compared to none in the tobramycin inhalation solution group discontinued/dropped out because of treatment-emergent adverse events (TEAEs) such as pulmonary exacerbations and respiratory disorders. In Study 2, a 24 week study, 161 patients received tobramycin inhalation solution versus 85 patients who received placebo in alternating four week on-off cycles for three cycles. All patients were ≤ 46 years of age (mean age 14.8 years) and 45% were females.

41% of patients were 6-12 years old while 29% of patients were 13-17 years old. Only 30% were adults (>17 years). Eighty-seven percent (87%) of patients were chronically colonized with P. aeruginosa .

Only 13% were either initially or intermittently colonized with P. aeruginosa during the study. More patients in the placebo group discontinued/dropped out of Study 2 than in the tobramycin inhalation solution group (9.4% [8/85] vs 4.3% [7/161], respectively). Of these, 3 patients in the tobramycin inhalation solution group (1.9%) compared to 2 patients in the placebo group (2.4%) withdrew due to a TEAE.

The most common TEAEs causing patients to discontinue from the study drug are respiratory, thoracic, and mediastinal disorders. The most common adverse experiences reported were respiratory disorders, consistent with the underlying disease in the patient population being evaluated and these were similarly distributed between both tobramycin inhalation solution- and placebo-treated patients. The following adverse reactions were reported in at least 5% of tobramycin inhalation solution -treated patients and at rates ≥ 2% more common compared to the placebo-treated patients: decreased forced expiratory volume, rales, red blood cell sedimentation rate increased, and dysphonia (Table 1).

Table 1: Patients with Selected Treatment-Emergent Adverse Reactions Occurring in ≥ 2% of Tobramycin Inhalation Solution Patients Adverse Reactions Tobramycin Inhalation Solution N=190 (%) Placebo N=115 (%) Forced expiratory volume decreased 59 (31%) 33 (29%) Rales 36 (19%) 18 (16%) Red blood cell sedimentation rate increased 16 (8%) 6 (5%) Dysphonia 11 (6%) 2 (2%) Wheezing 10 (5%) 4 (4%) Epistaxis 6 (3%) 0 Pharyngolaryngeal pain 5 (3%) 2 (2%) Bronchitis 5 (3%) 1 (1%) Tonsillitis 4 (2%) 0 Diarrhea 3 (2%) 1 (1%) Eosinophilia 3 (2%) 0 I… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 119 words ▾

7 DRUG INTERACTIONS Concurrent and/or sequential use of tobramycin inhalation solution with other drugs with neurotoxic, nephrotoxic or ototoxic potential should be avoided. ( 7.1 ) Tobramycin inhalation solution should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. ( 7.2 )

7.1Drugs with Neurotoxic, Nephrotoxic, or Ototoxic Potential Concurrent and/or sequential use of tobramycin inhalation solution with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided.

7.2Diuretics Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. Therefore, tobramycin inhalation solution should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and tobramycin inhalation solution has not been evaluated.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Aminoglycosides can cause fetal harm when administered to a pregnant woman. ( 8.1 ) Nursing mothers: discontinue drug or nursing, taking into consideration the importance of the drug to a mother. ( 8.2 )

8.1Pregnancy Risk Summary Aminoglycosides can cause fetal harm. Published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [ Warnings and Precautions (5.6) ]. Although there are no available data on use of tobramycin inhalation solution in pregnant women to be able to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3) ].

There are risks to the mother associated with cystic fibrosis in pregnancy (see Clinical Considerations) . In animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis there were no adverse developmental outcomes; however, ototoxicity was not evaluated in the offspring from these studies (see Data) . Advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Cystic fibrosis may increase the risk for preterm delivery. Data Animal Data No reproduction toxicology studies have been conducted with inhaled tobramycin. However, subcutaneous administration of tobramycin at doses of up to 100 (rat) or 20 (rabbit) mg/kg/day during organogenesis was not associated with adverse developmental outcomes.

Subcutaneous doses of tobramycin ≥ 40mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. Ototoxicity was not evaluated in offspring during nonclinical reproductive toxicity studies with tobramycin.

8.2Lactation Risk Summary There are no data on the presence of tobramycin in either human or animal milk, the effects on the breastfed infant, or the effects on milk production following oral inhalation of tobramycin inhalation solution. Limited published data on other formulations of tobramycin in lactating women indicate that tobramycin is present in human milk. However, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3) ] .

Tobramycin may cause alteration in the intestinal flora of the breastfeeding infant (see Clinical Considerations) . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tobramycin inhalation solution and any potential adverse effects on the breastfed child from tobramycin inhalation solution or from the underlying maternal condition. Clinical Considerations Tobramycin may cause intestinal flora alteration.

Advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash).

8.4Pediatric Use The safety and efficacy of tobramycin inhalation solution have not been studied in pediatric cystic fibrosis patients under six years of age.

8.5Geriatric Use Clinical studies of tobramycin inhalation solution did not include patients aged 65 years and over. Tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function [see… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Aminoglycosides can cause fetal harm. Published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [ Warnings and Precautions (5.6) ]. Although there are no available data on use of tobramycin inhalation solution in pregnant women to be able to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3) ].

There are risks to the mother associated with cystic fibrosis in pregnancy (see Clinical Considerations) . In animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis there were no adverse developmental outcomes; however, ototoxicity was not evaluated in the offspring from these studies (see Data) . Advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Cystic fibrosis may increase the risk for preterm delivery. Data Animal Data No reproduction toxicology studies have been conducted with inhaled tobramycin. However, subcutaneous administration of tobramycin at doses of up to 100 (rat) or 20 (rabbit) mg/kg/day during organogenesis was not associated with adverse developmental outcomes.

Subcutaneous doses of tobramycin ≥ 40mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. Ototoxicity was not evaluated in offspring during nonclinical reproductive toxicity studies with tobramycin.

🧒 Pediatric Use 25 words ▾

8.4Pediatric Use The safety and efficacy of tobramycin inhalation solution have not been studied in pediatric cystic fibrosis patients under six years of age.

🧓 Geriatric Use 73 words ▾

8.5Geriatric Use Clinical studies of tobramycin inhalation solution did not include patients aged 65 years and over. Tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function [see Warnings and Precautions (5.2 , 5.5 )].

🆘 Overdosage 107 words ▾

10 OVERDOSAGE No overdoses have been reported with tobramycin inhalation solution in clinical trials. Signs and symptoms of acute toxicity from overdosage of intravenous tobramycin might include dizziness, tinnitus, vertigo, loss of high-tone hearing acuity, respiratory failure, neuromuscular blockade, and renal impairment. Administration by inhalation results in low systemic bioavailability of tobramycin.

Tobramycin is not significantly absorbed following oral administration. Tobramycin serum concentrations may be helpful in monitoring overdosage. 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.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tobramycin inhalation solution is an aminoglycoside antibacterial [see Clinical Pharmacology (12.4) ].

12.3Pharmacokinetics Tobramycin inhalation solution contains tobramycin, a cationic polar molecule that does not readily cross epithelial membranes. 1 The bioavailability of tobramycin inhalation solution may vary because of individual differences in nebulizer performance and airway pathology. 2 Sputum Concentrations Thirty minutes after inhalation of the first 300 mg dose of tobramycin inhalation solution, the maximum geometric mean concentration of tobramycin was 814 mcg/g (ranging from 23 to 2843 mcg/g) in sputum.

High variability of tobramycin concentration in sputum was observed. Three hours after inhalation started, sputum tobramycin concentrations declined to approximately 15% of those observed at 30 minutes. After four weeks of therapy with tobramycin inhalation solution average mean sputum tobramycin concentrations obtained 10 minutes following administration were 717 mcg/g.

Distribution Following administration of tobramycin inhalation solution, tobramycin remains concentrated primarily in the airways. Binding of tobramycin to serum proteins is negligible. Elimination Tobramycin is not metabolized.

The elimination half-life of tobramycin from serum is approximately two hours after intravenous (IV) administration. The elimination half-life following the inhalation of tobramycin inhalation solution is approximately 4.4 hours. Assuming tobramycin absorbed following inhalation behaves similarly to tobramycin following intravenous administration, systemically absorbed tobramycin is eliminated principally by glomerular filtration.

Unabsorbed tobramycin following inhalation is likely eliminated in expectorated sputum.

12.4Microbiology Mechanism of Action Tobramycin, an aminoglycoside antibacterial, acts primarily by disrupting protein synthesis in the bacterial cell which eventually leads to death of the cell. Tobramycin has activity against a wide range of gram-negative bacteria including P. aeruginosa . It is bactericidal at or above the minimal inhibitory concentration (MIC) needed to inhibit growth of bacteria.

Mechanism of Resistance The predominant mechanism of resistance to tobramycin in P. aeruginosa isolated from CF patients is impermeability and to a lesser extent enzymatic modification and other mechanisms which cumulatively lead to decreased susceptibility of P. aeruginosa to tobramycin. Cross Resistance Cross resistance between aminoglycosides exists but the cross resistance is variable. Development of Resistance Treatment for six months with tobramycin inhalation solution in one clinical trial did not affect the susceptibility of the majority of P. aeruginosa isolates tested; however, increases in minimal inhibitory concentrations (MIC) were noted in some patients.

The clinical significance of this information has not been clearly established in the treatment of cystic fibrosis patients. Susceptibility Testing The clinical microbiology laboratory should provide cumulative results of the in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physicians as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial.

Susceptibility Testing Techniques Dilution Techniques Quantitative methods can be used to determine the minimum inhibitory concentration (MIC) of tobramycin that will inhibit the growth of the bacteria being tested. The MIC provides an estimate of the susceptibility of bacteria to tobramycin. The MIC should be determined using a standardized procedure.

3, 5 Standardized procedures are based on a dilution method (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of tobramycin powder. Diffusion Techniques Quantitat… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 16 words ▾

12.1Mechanism of Action Tobramycin inhalation solution is an aminoglycoside antibacterial [see Clinical Pharmacology (12.4) ].

📦 How Supplied / Storage and Handling 220 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Tobramycin inhalation solution, USP 300 mg/4 mL is supplied as a sterile, a clear, colorless or slight yellow to pale yellow color, non-pyrogenic, aqueous solution and is available as follows: NDC 70756-617-56: 4 mL single-dose ampule (carton of 14 foil pouches each containing four ampules)

16.2Storage and Handling Tobramycin inhalation solution, USP should be stored under refrigeration at 2°C to 8°C (36°F 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°C to 8°C (36°F to 46°F) or beyond 28 days when stored at room temperature [up to 25°C (77°F)].

Tobramycin inhalation solution, USP ampules should not be exposed to intense light. Tobramycin inhalation solution, USP 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.

📦 Storage and Handling 167 words ▾

16.2Storage and Handling Tobramycin inhalation solution, USP should be stored under refrigeration at 2°C to 8°C (36°F 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°C to 8°C (36°F to 46°F) or beyond 28 days when stored at room temperature [up to 25°C (77°F)].

Tobramycin inhalation solution, USP ampules should not be exposed to intense light. Tobramycin inhalation solution, USP 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.

📋 Description 130 words ▾

11 DESCRIPTION Tobramycin inhalation solution, USP is a sterile, a clear, colorless or slight yellow to pale yellow color, non-pyrogenic, aqueous solution with pH and salinity adjusted. Tobramycin inhalation solution, USP is administered by a compressed air driven reusable nebulizer. The chemical formula for tobramycin, USP is C 18 H 37 N 5 O 9 and the molecular weight is 467.52.

Tobramycin, USP 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. The structural formula for tobramycin, USP is: Each single-dose 4 mL ampule of tobramycin inhalation solution, USP contains one 300 mg dose of tobramycin, with sodium chloride and sulfuric acid in water for injection. Sulfuric acid and sodium hydroxide are used, as needed, to adjust the pH to 5.0.

Nitrogen is used for sparging, filling and pouching. The formulation contains no preservatives. Tobramycin structural formula

💬 Information for Patients ~3 min read ▾

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 (FEV 1 < 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.

17.1Ototoxicity 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 dizziness.

17.2Bronchospasm Inform patients that bronchospasm can occur with inhalation of tobramycin.

17.3Risks Associated with Aminoglycosides Inform patients of adverse reactions associated with aminoglycosides such as nephrotoxicity and neuromuscular disorders.

17.4Laboratory Tests Inform patients of the need to monitor hearing, serum concentrations of tobramycin, or renal function as necessary during treatment with tobramycin inhalation solution.

17.5Embryo-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.

17.6Administration 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.

17.7Storage Instructions You should store tobramycin inhalation solution ampules in a refrigerator (36°F to 46°F or 2°C to 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. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Made in India Revised: February 2023, V-04 All tradem… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics 208 words ▾

12.3Pharmacokinetics Tobramycin inhalation solution contains tobramycin, a cationic polar molecule that does not readily cross epithelial membranes. 1 The bioavailability of tobramycin inhalation solution may vary because of individual differences in nebulizer performance and airway pathology. 2 Sputum Concentrations Thirty minutes after inhalation of the first 300 mg dose of tobramycin inhalation solution, the maximum geometric mean concentration of tobramycin was 814 mcg/g (ranging from 23 to 2843 mcg/g) in sputum.

High variability of tobramycin concentration in sputum was observed. Three hours after inhalation started, sputum tobramycin concentrations declined to approximately 15% of those observed at 30 minutes. After four weeks of therapy with tobramycin inhalation solution average mean sputum tobramycin concentrations obtained 10 minutes following administration were 717 mcg/g.

Distribution Following administration of tobramycin inhalation solution, tobramycin remains concentrated primarily in the airways. Binding of tobramycin to serum proteins is negligible. Elimination Tobramycin is not metabolized.

The elimination half-life of tobramycin from serum is approximately two hours after intravenous (IV) administration. The elimination half-life following the inhalation of tobramycin inhalation solution is approximately 4.4 hours. Assuming tobramycin absorbed following inhalation behaves similarly to tobramycin following intravenous administration, systemically absorbed tobramycin is eliminated principally by glomerular filtration.

Unabsorbed tobramycin following inhalation is likely eliminated in expectorated sputum.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Two, double-blind, randomized, placebo-controlled, parallel group clinical studies (Study 1 and Study 2), which randomized and dosed 306 patients, were conducted in cystic fibrosis patients with P. aeruginosa . The osmolality of the drug formulation used in these studies differed from the to-be-marketed product. To rely upon the efficacy and safety established in the placebo-controlled studies, an additional study was conducted as a bridge to the to-be-marketed drug.

The bridging study assessed the efficacy and tolerability of aerosolized Tobramycin Inhalation Solution with osmolality similar to tobramycin inhalation solution over a 4-week treatment in 324 patients with cystic fibrosis. Results of this study showed that the Tobramycin Inhalation Solution in this study had similar efficacy as that seen in the placebo-controlled studies. The compressors in the placebo-controlled studies and the bridging study differed from the PARI VIOS compressor to be used with tobramycin inhalation solution.

In vitro cascade impaction studies demonstrated that the various compressors used in the clinical trials delivered equivalent doses and respirable fractions of the to-be-marketed tobramycin inhalation solution and TOBI with the marketed compressor (PARI VIOS) when used with the same nebulizer (PARI LC Plus Reusable nebulizer). All subjects enrolled in both efficacy studies had baseline FEV 1 % predicted ≥ 40% and ≤80% (mean baseline FEV 1 of 60% of predicted normal) and infected with P. aeruginosa . Subjects who were less than 6 years of age, or who had a baseline creatinine of ≥ 1.5 mg/dL, or who had Burkholderia cepacia isolated from sputum were excluded.

A total of 190 patients, 29 in Study 1 and 161 in Study 2, received tobramycin inhalation solution therapy on an outpatient basis. Of these, 55% were males and 45% were females. Eighty-two (43.2%) patients were between 6 and 12 years of age, 54 (28.4%) patients were between 13 and 17 years of age, and the remaining 54 (28.4%) patients were greater than 17 years of age.

Of the patients who received tobramycin inhalation solution, only 89.7% of patients in Study 1 had at least one concomitant medication, while all patients in Study 2 also received at least one concomitant medication. These concomitant medications include mucolytics, steroidal and nonsteroidal anti-inflammatory drugs, bronchodilators, rehabilitative physiotherapies and if necessary, antibiotics for bacterial infections other than P. aeruginosa . Study 1 Study 1 was a double-blind, single cycle study that randomized 59 patients to receive tobramycin inhalation solution (n=29) or placebo (n=30) for one cycle of treatment (28 days on treatment followed by 28 days off treatment).

All patients were ≤ 30 years of age (mean age 12.6 years) and 46% were females. All randomized patients were included in the primary analysis except for one patient who had missing baseline information. Tobramycin inhalation solution significantly improved lung function compared with placebo as measured by the absolute change in FEV 1 % predicted from baseline to the end of Cycle 1 dosing in the primary analysis population.

Treatment with tobramycin inhalation solution and placebo resulted in absolute increases in FEV 1 % predicted of 16% and 5%, respectively (LS mean difference = 11%; 95% CI: 3, 19; p=0.003). This analysis is adjusted for the covariate of baseline FEV 1 % predicted, using multiple imputation for missing data. Figure 1 shows the average change in FEV 1 % predicted over eight weeks.

Study 2 Study 2 was a randomized, double-blind, 3-cycle, placebo-controlled trial. A total of 247 eligible patients were randomized 2:1 to receive three cycles of tobramycin inhalation solution (n=161) or placebo (n=86). As in Study 1, each cycle comprised 28 days on treatment followed by 28 days off treatment.

All patients were ≤46 years of age (mean age 14.8 years) and 44.9% were females. In this study, two randomized patients in the… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 178 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A two-year rat inhalation toxicology study to assess carcinogenic potential of an inhaled solution of tobramycin has been completed. Rats were exposed to tobramycin for up to 1.5 hours per day for 95 weeks. Serum levels of tobramycin up to 35 mcg/mL were measured in rats, 35x the average 1 mcg/mL exposure levels observed in cystic fibrosis patients in clinical trials.

There was no drug-related increase in the incidence of any variety of tumors. Additionally, tobramycin has been evaluated for genotoxicity in a battery of in vitro and in vivo tests. The Ames bacterial reversion test, conducted with five tester strains, failed to show a significant increase in revertants with or without metabolic activation in all strains.

Tobramycin was negative in the mouse lymphoma forward mutation assay, did not induce chromosomal aberrations in Chinese hamster ovary cells, and was negative in the mouse micronucleus test. Subcutaneous administration of up to 100 mg/kg of tobramycin did not affect mating behavior or cause impairment of fertility in male or female rats.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 175 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A two-year rat inhalation toxicology study to assess carcinogenic potential of an inhaled solution of tobramycin has been completed. Rats were exposed to tobramycin for up to 1.5 hours per day for 95 weeks. Serum levels of tobramycin up to 35 mcg/mL were measured in rats, 35x the average 1 mcg/mL exposure levels observed in cystic fibrosis patients in clinical trials.

There was no drug-related increase in the incidence of any variety of tumors. Additionally, tobramycin has been evaluated for genotoxicity in a battery of in vitro and in vivo tests. The Ames bacterial reversion test, conducted with five tester strains, failed to show a significant increase in revertants with or without metabolic activation in all strains.

Tobramycin was negative in the mouse lymphoma forward mutation assay, did not induce chromosomal aberrations in Chinese hamster ovary cells, and was negative in the mouse micronucleus test. Subcutaneous administration of up to 100 mg/kg of tobramycin did not affect mating behavior or cause impairment of fertility in male or female rats.

📚 References 126 words ▾

15 REFERENCES Neu HC. Tobramycin: an overview. [Review]. J Infect Dis.

1976; Suppl 134:S3-19. 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. Clinical and laboratory Standards Institute (CLSI) Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically: Approved Standard -9 th edition.

CLSI document M07-A9. CLSI 940 West Valley Rd. Suite 1400, Wayne PA 19087-1898.

2012 CLSI Performance Standards for Antimicrobial Susceptibility Testing: 22 nd Informational supplement CLSI document M100-S22. CLSI 2012. CLSI Performance standards for Antimicrobial Disk Susceptibility Tests: Approved standard -11 th ed.

CLSI document M02-A11. CLSI 2012. PARI Vios Aerosol Delivery System with LC Plus Nebulizer: Instructions for Use.

PARI Respiratory Equipment, Inc. 2010; 310D0028 Rev A 6-10.

📄 Patient Package Insert ~3 min read ▾

SPL PATIENT PACKAGE INSERT 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 (FEV 1 ) less than 40% or greater than 80% predicted in people who are colonized with a bacterium called Burkholderia cepacia 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), hearing loss, or your mother has had hearing problems after taking an aminoglycoside. have been told you have certain gene variants (a change in the gene) related to hearing abnormalities inherited from your mother. 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 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-dose 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… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 9 words ▾

RECENT MAJOR CHANGES Warnings and Precautions, Ototoxicity (5.1) 2/2023

📄 Package Label / Principal Display Panel 128 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70756-617-44 Tobramycin Inhalation Solution, USP 300 mg/4 mL For Oral Inhalation Only by Nebulizer Single-Dose Only. Discard Each Ampule After One Use. Each foil pouch contains 4 ampules.

Storage: Store in a Refrigerator at 2°C to 8°C (36°F to 46°F). Protect from Intense Light. Tobramycin inhalation solution is light sensitive; unopened ampules should be returned to the foil pouch.

Rx Only NDC 70756-617-56 Tobramycin Inhalation Solution, USP 300 mg/4 mL For Oral Inhalation Only by Nebulizer Single-Dose Only. Discard Each Ampule After One Use. Storage: Store in a Refrigerator at 2°C to 8°C (36°F to 46°F).

Tobramycin inhalation solution is light sensitive; unopened ampules should be returned to the foil pouch. Each carton contains 56 Single-Dose Ampules (28-Day Supply) Rx Only . .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
288
Units reimbursed last 4 qtrs
60.7K
Gross reimbursed last 4 qtrs
$539.4K
Avg / prescription
$1,872.86
Avg / unit
$8.8890
Latest quarter Q4 2025
65Rx
Fee-for-service vs managed care ⓘ
34% FFS 66% MCO
Fee-for-service · 97 Rx Managed care · 191 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 14,112 units · 181 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 11,136 units · 56.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 2,928 units · 31.5 per 100k residents NJ Massachusetts: no data reported MA California: 7,552 units · 19.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 2,544 units · 29.2 per 100k residents VA Maryland: 2,296 units · 37.2 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 5,408 units · 118 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 14,704 units · 48.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
19.4181
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Washington 181 /100k
2 Louisiana 118 /100k
3 New York 56.9 /100k
4 Texas 48.2 /100k
5 Maryland 37.2 /100k
6 New Jersey 31.5 /100k
7 Virginia 29.2 /100k
8 California 19.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Tobramycin — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Tobramycin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$564.7K
Claims incl. refills
354
Beneficiaries
253
Spend / beneficiary
$2,232.06
Spend / claim
$1,595.23
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lifestar Pharma LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lifestar Pharma LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7682 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70756-0616-05 · Lifestar 70756-0618-05 · Lifestar →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.