Tobramycin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]
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Overview
Tobramycin is a antibiotic that is FDA approved for the treatment of is an antibacterial aminoglycoside indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Tobramycin is an antibacterial aminoglycoside indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.
Dosing Information
- The recommended dosage for patients six years of age and older is to administer one single-use 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 BETHKIS is the same for patients regardless of age or weight. BETHKIS has not been studied in patients less than six years old.
Administration
- BETHKIS is administered by oral inhalation. Do not use by any other route.
- BETHKIS is administered by 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Tobramycin in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tobramycin in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Tobramycin in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Tobramycin in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tobramycin in pediatric patients.
Contraindications
- Condition1
Warnings
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Tobramycin in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Tobramycin in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tobramycin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tobramycin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Tobramycin with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Tobramycin with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Tobramycin with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Tobramycin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tobramycin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tobramycin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tobramycin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tobramycin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tobramycin in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Tobramycin in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Tobramycin in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Tobramycin in the drug label.
Pharmacology
There is limited information regarding Tobramycin Pharmacology in the drug label.
Mechanism of Action
Structure
This image is provided by the National Library of Medicine.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Tobramycin in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Tobramycin in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Tobramycin in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Tobramycin in the drug label.
How Supplied
Storage
There is limited information regarding Tobramycin Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Tobramycin in the drug label.
Precautions with Alcohol
- Alcohol-Tobramycin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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