Gentamicin (ophthalmic): Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{AJ}}
|authorTag={{AJ}}
|genericName=Gentamicin sulfate
|aOrAn=a
|drugClass=antibacterial and aminoglycoside
|indicationType=treatment
|indicationType=treatment
|indication=ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
|adverseReactions=ocular burning, irritation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult=* Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
====Dosing Information====
* Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Gentamicin (ophthalmic) in adult patients.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Gentamicin (ophthalmic) in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Gentamicin (ophthalmic) in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Gentamicin (ophthalmic) in adult patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Gentamicin (ophthalmic) in pediatric patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Gentamicin (ophthalmic) in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Gentamicin (ophthalmic) in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Gentamicin (ophthalmic) in pediatric patients.
|contraindications=* Gentamicin sulfate ophthalmic solution, USP is contraindicated in patients with known hypersensitivity to any of its components.
|warnings=* NOT FOR INJECTION INTO THE EYE.
* Gentamicin sulfate ophthalmic solution, USP is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.
====PRECAUTIONS====
=====General=====
* Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible microorganisms, including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.
* If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted.
|clinicalTrials=* Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.
* The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.
* Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.
|FDAPregCat=C
|useInPregnancyFDA=* Gentamicin has been shown to depress body weights, kidney weights and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
|administration=* Ophthalmic solution
|drugBox={{Drugbox2
| Verifiedfields = changed
| verifiedrevid = 443833957
| IUPAC_name = (3''R'',4''R'',5''R'')-2-{[(1''S'',2''S'',3''R'',4''S'',6''R'')-4,6-<br />diamino-3-{[(2''R'',3''R'',6''S'')-<br />3-amino-6-[(1''R'')-<br />1-(methylamino)ethyl]oxan-2-yl]oxy}-<br />2-hydroxycyclohexyl]oxy}-5-methyl-<br />4-(methylamino)oxane-3,5-diol
| image = Gentamicin C2.png
| width = 350
| image2 = Gentamicin.png
<!--Clinical data-->
| Drugs.com = {{drugs.com|monograph|gentamicin-sulfate}}
| MedlinePlus = a682275
| pregnancy_category = D
| legal_UK = POM
| routes_of_administration = [[Intravenous therapy|IV]], [[Eye drop|Ophthalmic]], [[Intramuscular injection|IM]], [[topical]]
<!--Pharmacokinetic data-->
| bioavailability = limited oral bioavailability
| protein_bound = 0-10%
| elimination_half-life = 2 hrs
| excretion = renal
<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 1403-66-3
| ATC_prefix = D06
| ATC_suffix = AX07
| ATC_supplemental =  {{ATC|J01|GB03}} {{ATC|S01|AA11}} {{ATC|S02|AA14}} {{ATC|S03|AA06}} {{ATCvet|A07|AA91}} {{ATCvet|G01|AA91}} {{ATCvet|G51|AA04}} {{ATCvet|J51|GB03}}
| PubChem = 3467
| IUPHAR_ligand = 2427
| DrugBank_Ref = {{drugbankcite|changed|drugbank}}
| DrugBank = DB00798
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 390067
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = T6Z9V48IKG
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D08013
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI = 27412
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 195892
<!--Chemical data-->
| C=21 | H=43 | N=5 | O=7
| molecular_weight = 477.596 g/mol
| smiles = O[C@]3(C)[C@H](NC)[C@@H](O)[C@@H](O[C@H]2[C@H](N)C[C@H](N)[C@@H](O[C@H]1O[C@H](C(NC)C)CC[C@H]1N)[C@@H]2O)OC3
| InChI = 1/C21H43N5O7/c1-9(25-3)13-6-5-10(22)19(31-13)32-16-11(23)7-12(24)17(14(16)27)33-20-15(28)18(26-4)21(2,29)8-30-20/h9-20,25-29H,5-8,22-24H2,1-4H3/t9?,10-,11+,12-,13+,14+,15-,16-,17+,18-,19-,20-,21+/m1/s1
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/C21H43N5O7/c1-9(25-3)13-6-5-10(22)19(31-13)32-16-11(23)7-12(24)17(14(16)27)33-20-15(28)18(26-4)21(2,29)8-30-20/h9-20,25-29H,5-8,22-24H2,1-4H3/t9?,10-,11+,12-,13+,14+,15-,16-,17+,18-,19-,20-,21+/m1/s1
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = CEAZRRDELHUEMR-URQXQFDESA-N
}}
|mechAction=* Gentamicin is an aminoglycoside antibiotic, inhibiting microbial protein synthesis in susceptible pathogens
|structure=* Gentamicin sulfate ophthalmic solution, USP is a sterile, topical anti-infective agent for ophthalmic use.
* Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, and C1A. All three components appear to have similar antimicrobial activity. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:
[[File:Gentamicin ophthalmic structure.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|PD======Microbiology=====
* Gentamicin sulfate is active in vitro against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
|nonClinToxic======Carcinogenesis, Mutagenesis, Impairment of Fertility=====
* There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.
|packLabel=PACIFIC
PHARMA®
NDC 60758-188-05
GENTAMICIN
SULFATE
ophthalmic
solution, USP
0.3%
5 mL
sterile
Rx only
[[File:Gentamicin ophthalmic drug label.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:Gentamicin ophthalmic ingredients.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|fdaPatientInfo=* To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.
|alcohol=Alcohol-Gentamicin (ophthalmic) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=Alcohol-Gentamicin (ophthalmic) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|brandNames=* Ocu-Mycin
* Genoptic
* Genoptic S.O.P.
}}
}}

Latest revision as of 19:41, 7 May 2015

Gentamicin (ophthalmic)
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]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

Disclaimer

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Overview

Gentamicin (ophthalmic) is a antibacterial and aminoglycoside that is FDA approved for the treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.. Common adverse reactions include ocular burning, irritation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

Dosing Information

  • Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Gentamicin (ophthalmic) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Gentamicin (ophthalmic) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Gentamicin (ophthalmic) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Gentamicin (ophthalmic) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Gentamicin (ophthalmic) in pediatric patients.

Contraindications

  • Gentamicin sulfate ophthalmic solution, USP is contraindicated in patients with known hypersensitivity to any of its components.

Warnings

  • NOT FOR INJECTION INTO THE EYE.
  • Gentamicin sulfate ophthalmic solution, USP is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

PRECAUTIONS

General
  • Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible microorganisms, including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.
  • If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted.

Adverse Reactions

Clinical Trials Experience

  • Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.
  • The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.
  • Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.

Postmarketing Experience

There is limited information regarding Gentamicin (ophthalmic) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Gentamicin (ophthalmic) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • Gentamicin has been shown to depress body weights, kidney weights and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Gentamicin (ophthalmic) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Gentamicin (ophthalmic) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Gentamicin (ophthalmic) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Gentamicin (ophthalmic) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Gentamicin (ophthalmic) in geriatric settings.

Gender

There is no FDA guidance on the use of Gentamicin (ophthalmic) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Gentamicin (ophthalmic) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Gentamicin (ophthalmic) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Gentamicin (ophthalmic) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Gentamicin (ophthalmic) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Gentamicin (ophthalmic) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Ophthalmic solution

Monitoring

There is limited information regarding Gentamicin (ophthalmic) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Gentamicin (ophthalmic) and IV administrations.

Overdosage

There is limited information regarding Gentamicin (ophthalmic) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Template:Px
Template:Px
Gentamicin (ophthalmic)
Systematic (IUPAC) name
(3R,4R,5R)-2-{[(1S,2S,3R,4S,6R)-4,6-
diamino-3-{[(2R,3R,6S)-
3-amino-6-[(1R)-
1-(methylamino)ethyl]oxan-2-yl]oxy}-
2-hydroxycyclohexyl]oxy}-5-methyl-
4-(methylamino)oxane-3,5-diol
Identifiers
CAS number 1403-66-3
ATC code D06AX07 J01GB03 (WHO) S01AA11 (WHO) S02AA14 (WHO) S03AA06 (WHO) Template:ATCvet Template:ATCvet Template:ATCvet Template:ATCvet
PubChem 3467
DrugBank DB00798
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 477.596 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability limited oral bioavailability
Protein binding 0-10%
Metabolism ?
Half life 2 hrs
Excretion renal
Therapeutic considerations
Pregnancy cat.

D

Legal status

POM(UK)

Routes IV, Ophthalmic, IM, topical

Mechanism of Action

  • Gentamicin is an aminoglycoside antibiotic, inhibiting microbial protein synthesis in susceptible pathogens

Structure

  • Gentamicin sulfate ophthalmic solution, USP is a sterile, topical anti-infective agent for ophthalmic use.
  • Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, and C1A. All three components appear to have similar antimicrobial activity. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:
This image is provided by the National Library of Medicine.

Pharmacodynamics

Microbiology
  • Gentamicin sulfate is active in vitro against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

Pharmacokinetics

There is limited information regarding Gentamicin (ophthalmic) Pharmacokinetics in the drug label.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility
  • There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.

Clinical Studies

There is limited information regarding Gentamicin (ophthalmic) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Gentamicin (ophthalmic) How Supplied in the drug label.

Storage

There is limited information regarding Gentamicin (ophthalmic) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Gentamicin (ophthalmic) |?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

PACIFIC PHARMA®

NDC 60758-188-05

GENTAMICIN SULFATE ophthalmic solution, USP 0.3%

5 mL

sterile

Rx only

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

{{#ask: Label Page::Gentamicin (ophthalmic) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

  • To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.

Precautions with Alcohol

Alcohol-Gentamicin (ophthalmic) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Ocu-Mycin
  • Genoptic
  • Genoptic S.O.P.

Look-Alike Drug Names

There is limited information regarding Gentamicin (ophthalmic) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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

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