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{{DrugProjectFormSinglePage
{{Tobramycin}}
|authorTag=
'''''For patient information, click <u>[[Tobramycin Sulfate Injection (patient information)|here]]</u> and <u>[[Tobramycin Ophthalmic (patient information)|here]]</u>'''''.


{{CMG}}


==Overview==
<!--Overview-->


'''Tobramycin''' is an [[aminoglycoside]] [[antibiotic]] derived from [[Streptomyces tenebrarius]] and used to treat various types of [[bacteria]] infections, particularly [[Gram-negative]] infections. It is especially effective against species of [[Pseudomonas]].<ref>{{ cite web | title = Tobramycin | url = http://www.toku-e.com/Upload/Products/PDS/20120515001224.pdf | format = pdf | publisher = Toku-E | date = 2010-01-12 | accessdate = 2012-06-11 }}</ref>
|genericName=


==Category==


Aminoglycoside


==US Brand Names==
|aOrAn=


AKTOB<sup>®</sup>, BETHKIS<sup>®</sup>, NEBCIN<sup>®</sup>, TOBI<sup>®</sup>, TOBRAMYCIN<sup>®</sup>, TOBREX<sup>®</sup>, ZYLET<sup>®</sup>
a


==FDA Package Insert==
|drugClass=


'''  [[Tobramycin description|Description]]'''
'''| [[Tobramycin clinical pharmacology|Clinical Pharmacology]]'''
'''| [[Tobramycin microbiology|Microbiology]]'''
'''| [[Tobramycin indications and usage|Indications and Usage]]'''
'''| [[Tobramycin contraindications|Contraindications]]'''
'''| [[Tobramycin warnings and precautions|Warnings and Precautions]]'''
'''| [[Tobramycin adverse reactions|Adverse Reactions]]'''
'''| [[Tobramycin overdosage|Overdosage]]'''
'''| [[Tobramycin clinical studies|Clinical Studies]]'''
'''| [[Tobramycin dosage and administration|Dosage and Administration]]'''
'''| [[Tobramycin how supplied|How Supplied]]'''
'''| [[Tobramycin labels and packages|Labels and Packages]]'''


==Mechanism of Action==


Tobramycin works by binding to a site on the bacterial [[30S]] and [[50S]] [[ribosome]], preventing formation of the 70S complex.  As a result, [[mRNA]] cannot be [[Translation (biology)|translated]] into protein and cell death ensues.
|indication=


==Administration==


Like all aminoglycosides, tobramycin does not pass the [[gastro-intestinal tract]], so for [[systemic]] use it can only be given [[Intravenous therapy|intravenously]] or [[Intramuscular injection|intramuscularly]]. This formulation for injection is branded Nebcin®. Patients with [[cystic fibrosis]] will often take an [[inhaler|inhalational]] form (Tobi®) for suppression of ''[[Pseudomonas aeruginosa]]'' infections. Tobramycin is also combined with [[dexamethasone]] as an [[TobraDex|ophthalmic solution]] (TobraDex®).


Bausch & Lomb Pharmaceuticals, Inc. makes a sterile Tobramycin [[Ophthalmology|Ophthalmic]] Solution (eye-drops) with a tobramycin concentration of 0.3%, which is available by prescription only in the United States and Canada. (In some countries, such as Italy, it is available over the counter.)  It is mixed with 0.01% [[benzalkonium chloride]] as a preservative.  These concentrations result in 3 mg per ml and 0.1 mg per ml, respectively.
|hasBlackBoxWarning=


==Side effects==
Yes


Like other aminoglycosides, tobramycin can cause [[deafness]] or a loss of [[equilibrioception]] (vertigo) in genetically susceptible individuals. These individuals have a normally harmless mutation in their DNA, that allows the tobramycin to affect their cells. The cells of the [[ear]] are particularly sensitive to this.
|adverseReactions=


Tobramycin can also be highly [[nephrotoxic|toxic]] to the [[kidney]]s, particularly if multiple doses accumulate over a course of treatment.


For these reasons, when tobramycin is given [[parenteral]]ly, it is usually dosed by [[body weight]]. Various formulae exist for calculating tobramycin dosage. Also serum levels of tobramycin are monitored during treatment.


==References==
<!--Black Box Warning-->
{{Reflist|2}}


[[Category:Antibiotics]]
|blackBoxWarningTitle=
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Revision as of 14:28, 3 December 2014

Tobramycin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

Disclaimer

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Tobramycin is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

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

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • 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 (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • 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

{{#ask: Page Name::Tobramycin |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Tobramycin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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