Label: TOBRAMYCIN solution

  • NDC Code(s): 72603-630-04, 72603-630-56
  • Packager: NorthStar RxLLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 24, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TOBRAMYCIN INHALATION SOLUTION safely and effectively. See full prescribing information for TOBRAMYCIN INHALATION ...
  • Table of Contents
    Table of Contents
  • 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosage - 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 ...
  • 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 ...
  • 4 CONTRAINDICATIONS
    Tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Ototoxicity - Ototoxicity with use of tobramycin inhalation solution - Caution should be exercised when prescribing tobramycin inhalation solution to patients with known or suspected ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drugs cannot be directly compared ...
  • 7 DRUG INTERACTIONS
    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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Aminoglycosides can cause fetal harm. Published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral ...
  • 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 ...
  • 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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Tobramycin inhalation solution is an aminoglycoside antibacterial [see Clinical Pharmacology (12.4)]. 12.3 Pharmacokinetics - Tobramycin inhalation solution ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - A two-year rat inhalation toxicology study to assess carcinogenic potential of an inhaled solution of tobramycin has been completed ...
  • 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 ...
  • 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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How 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 ...
  • 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 ...
  • 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 ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 72603-630-04 - 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 ...
  • INGREDIENTS AND APPEARANCE
    Product Information