Tobramycin Inhalation Solution 300 mg/5mL
Tobramycin Inhalation Solution · INHALANT · Dr. Reddy's Laboratories Inc.
Tobramycin Inhalation Solution is a inhalant containing tobramycin inhalation solution at 300 mg/5mL, taken respiratory (inhalation). Manufactured by Dr. Reddy's Laboratories Inc..
Key Facts
- Brand Name
- Tobramycin Inhalation Solution
- Generic Name
- Tobramycin Inhalation Solution
- NDC Code (Product)
43598-605- Manufacturer
- Dr. Reddy's Laboratories Inc.
- Strength
- 300 mg/5mL
- Dosage Form
- INHALANT
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- ANDA207080
- Drug Class
- Aminoglycoside Antibacterial [EPC]
- Marketing Start
- 05/14/2019
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TOBRAMYCIN INHALATION SOLUTION PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV 1 < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies ( 14 )]. TOBRAMYCIN INHALATION SOLUTION PAK contains tobramycin, an aminoglycoside antibacterial drug indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION TOBRAMYCIN INHALATION SOLUTION PAK is a co-packaging of tobramycin inhalation solution with a PARI LC PLUS ® Reusable Nebulizer ( 2.1 ). Administer tobramycin inhalation solution as one single–use ampule (300 mg/5 mL) twice a day by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug ( 2.1 ). Dosage is not adjusted by weight ( 2.1 ). Take doses as close to 12 hours apart as possible; but not less than 6 hours apart ( 2.1 ). Administer each 300 mg dose using the PARI LC PLUS Reusable Nebulizer and DeVilbiss ® Pulmo-Aide ® compressor ( 2.2 ). 2.1 Dosing Information TOBRAMYCIN INHALATION SOLUTION PAK is a co-packaging of tobramycin inhalation solution ampules with a PARI LC PLUS Reusable Nebulizer. Administer as follows: One single-use ampule (300 mg/5 mL) of tobramycin inhalation solution twice a day by oral inhalation in alternating periods of 28 days on drug, followed by 28 days off drug. The 300 mg/5 mL dose of tobramycin inhalation solution is the same for all patients regardless of age or weight. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart. 2.2 A…
Contraindications
4 CONTRAINDICATIONS Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Known hypersensitivity to any aminoglycoside ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS Concurrent and/or sequential use with other drugs with neurotoxic, nephrotoxic or ototoxic potential should be avoided ( 7.1 ). Concomitant administration with ethacrynic acid, furosemide, urea, or intravenous mannitol is not recommended due to possible enhancement of aminoglycoside toxicity ( 7.2 ). 7.1 Drugs 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 if possible. 7.2 Diuretics Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Tobramycin inhalation solution should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Bronchospasm [ see Warnings and Precautions ( 5.1 )] Ototoxicity [ see Warnings and Precautions ( 5.2 )] The most common adverse reactions (> 5%) in patients treated with tobramycin inhalation solution were increased cough, pharyngitis, increased sputum, dyspnea, hemoptysis, decreased lung function, voice alteration, taste perversion and rash ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact 1-844-548-2247 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. Tobramycin inhalation solution was studied in two clinical studies in 258 cystic fibrosis patients ranging in age from 6 to 48 years. Patients received tobramycin inhalation solution in alternating periods of 28 days on and 28 days off drug in addition to their standard cystic fibrosis therapy for a total of 24 weeks. Adverse r…
Frequently Asked Questions
What is Tobramycin Inhalation Solution used for?
Tobramycin Inhalation Solution contains Tobramycin Inhalation Solution. It is a inhalant taken respiratory (inhalation). Consult your doctor for specific uses.
Is Tobramycin Inhalation Solution a controlled substance?
Tobramycin Inhalation Solution is not classified as a controlled substance by the DEA.
What is the generic name for Tobramycin Inhalation Solution?
The generic name for Tobramycin Inhalation Solution is Tobramycin Inhalation Solution. There are no other listed brand versions of Tobramycin Inhalation Solution.
What is the NDC code for Tobramycin Inhalation Solution 300 mg/5mL?
The NDC (National Drug Code) for Tobramycin Inhalation Solution 300 mg/5mL is 43598-605, listed by Dr. Reddy's Laboratories Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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