Gentamicin

What is Gentamicin?

• Gentamicin (Garamycin) is a broad spectrum aminoglycoside antibiotic derived from Micromonospora purpurea, an actinomycete.

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Gentamicin Structure

What are the uses of this medicine?

• Gentamicin (Garamycin) is used in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative).
• Gentamicin Injection to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including [[peritonitis), skin, bone and soft tissue (including burns).
• Gentamicin may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing.
• In serious infections when the causative organisms are unknown, gentamicin may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin type drug before obtaining results of susceptibility testing.
• Gentamicin has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa.
• Gentamicin Injection has also been shown to be effective in the treatment of serious staphylococcal infections.

• Topical gentamicin is used in adults and children 1 year of age and older to treat skin infections caused by certain bacteria.

• 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.

How does this medicine work?

• Gentamicin (jen" ta mye' sin) is a aminoglycoside with broad bacteriocidal activity against many aerobic gram negative and some aerobic gram positive organisms.
• gentamicin is the most commonly used aminoglycoside antibiotic and is indicated for moderate-to-severe bacterial infections caused by sensitive agents, primarily gram negative bacteria.
• Like other aminoglycosides, gentamicin is thought to act by binding to bacterial ribosomes and inhibiting protein synthesis. Nevertheless, gentamicin is considered bacteriocidal as well as bacteriostatic.
• Gentamicin and other aminoglycosides are typically used in combination with a penicillin or cephalosporin for treatment of severe infections with E.Coli, Staphylococcus aureus, Enterobacter, Klebsiella, Serratia, Pseudomonas aeruginosa, and other gram negative bacteria resistant to less toxic antibiotics.
• Gentamicin is most commonly used for septicemia, bacterial endocarditis, peritonitis, meningitis, pelvic inflammatory disease and pneumonia.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to gentamicin.
• A history of hypersensitivity or serious toxic reactions to other aminoglycosides.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention the medications listed below:

• acyclovir (Zovirax, Sitavig)
• amphotericin (Abelcet, Ambisome, Amphotec)
• capreomycin (Capastat)
• certain cephalosporin antibiotics such as cefazolin (Ancef, Kefzol), cefixime (Suprax), or cephalexin (Keflex)
• cisplatin
• colistin (Coly-Mycin S)
• cyclosporine (Gengraf, Neoral, Restasis, Sandimmune)
• diuretics ('water pills') such as bumetanide, ethacrynic acid (Edecrin), furosemide (Lasix), or torsemide (Demadex).
• other aminoglycoside antibiotics such as amikacin, kanamycin, neomycin (Neo-Fradin), paromomycin, streptomycin, and tobramycin polymyxin B
• vancomycin (Vanocin)
• other antibiotics such as amoxicillin (Amoxil, Larotid, Moxatag, in Augmentin, in Prevpac), ampicillin, or penicillin
• dimenhydrate (Dramamine)
• meclizine (Bonine)
• nonsteroidal anti-inflammatory drugs such as indomethacin (Indocin, Tivorbex)

Is this medicine FDA approved?

• Gentamicin was first approved for use in the United States in 1970 and remains in wide use.

How should this medicine be used?

Recommended dosage:

• Children: 6 to 7.5 mg/kg/day. (2 to 2.5 mg/kg administered every 8 hours).
• Infants and Neonates: 7.5 mg/kg/day. (2.5 mg/kg administered every 8 hours).
• Premature or Full-term Neonates One Week of Age or Less: 5 mg/kg/day. (2.5 mg/kg administered every 12 hours).

Administration:

• Gentamicin injection comes as a liquid to be injected intravenously (into a vein) or intramuscularly (into a muscle).
• When gentamicin is injected intravenously, it is usually infused (injected slowly) over a period of 30 minutes to 2 hours once every 6 or 8 hours.
• The length of your treatment depends on the type of infection you have.
• You should begin to feel better during the first few days of treatment with gentamicin injection.
• If your symptoms do not improve or get worse, call your doctor.
• Use gentamicin injection until you finish the prescription, even if you feel better.
• If you stop using gentamicin injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Gentamicin sulfate ophthalmic solution:

• 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.

Topical gentamicin:

• Topical gentamicin comes as a cream and an ointment to apply to the skin.
• It is usually applied to the affected area 3 to 4 times a day.
• Use topical gentamicin at around the same times every day.
• Topical gentamicin is only for use on the skin.
• Be careful not to get the medication in your eyes.
• To use topical gentamicin, apply a small amount of medication to cover the affected area of skin with a thin, even film and rub in gently.
• The area may be covered with a gauze dressing or gelatin packing if your doctor has told you to do so.
• If you are using topical gentamicin to treat impetigo contagiosa (a bacterial skin infection common in young children), gently remove any crusts from the infected skin before applying the medication.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Gentamicin injection
• Gentamicin sulfate ophthalmic solution
• Topical gentamicin

This medicine is available in fallowing brand namesː

• Garamycin I.V; Garamycin

What side effects can this medication cause?

The most common side effects of this medicine include: Topical gentamicin cause side effects:

• skin redness or itching

Gentamicin injection:

• nausea
• vomiting
• diarrhea
• decreased appetite
• pain at the injection site
• headache
• fever
• joint pain
• unusual tiredness

Gentamicin sulfate ophthalmic solution:

• Bacterial and fungal corneal ulcers
• ocular burning and irritation upon drug instillation
• non-specific conjunctivitis
• conjunctival epithelial defects
• conjunctival hyperemia
• allergic reactions
• thrombocytopenic purpura
• hallucinations

What special precautions should I follow?

• Aminoglycosides can cause fetal harm when administered to a pregnant woman. If gentamicin is used during pregnancy or if the patient becomes pregnant while taking gentamicin, she should be apprised of the potential hazard to the fetus.
• Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
• Increased nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporins.
• As with other aminoglycosides, Gentamicin Sulfate Injection, USP is potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high dosage or prolonged therapy.
• Aminoglycosides should be used with caution in patients with neuromuscular disorders, such as myasthenia gravis or parkinsonism, since these drugs may aggravate muscle weakness because of their potential curare-like effects on the neuromuscular junction.
• Elderly patients may have reduced renal function which may not be evident in the results of routine screening tests, such as BUN or serum creatinine. A creatinine clearance determination may be more useful.
• Patients should be well hydrated during treatment.
• Treatment with gentamicin may result in overgrowth of nonsusceptible organisms. If this occurs, appropriate therapy is indicated.
• They do not treat viral infections (e.g., the common cold).
• When gentamicin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may

• (1) decrease the effectiveness of the immediate treatment and
• (2) increase the likelihood that bacteria will develop resistance and will not be treatable by gentamicin or other antibacterial drugs in the future.
• The use of topical antibiotics occasionally allows overgrowth of nonsusceptible organisms, including fungi.

If this condition occurs, or if irritation, sensitization or superinfection develops, treatment with gentamicin sulfate should be discontinued and appropriate therapy instituted.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Aminoglycosides can cause fetal harm when administered to a pregnant woman.
• If gentamicin is used during pregnancy or if the patient becomes pregnant while taking gentamicin, she should be apprised of the potential hazard to the fetus.

Can this medicine be used in children?

• The safety and effectivness of Gentamicin injection have been established in pediatric patients.
• Safety and effectiveness of Gentamicin sulfate ophthalmic solution in neonates have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• GENTAMICIN SULFATE

Inactives ingredients:

• SODIUM METABISULFITE
• EDETATE DISODIUM ANHYDROUS
• METHYLPARABEN
• PROPYLPARABEN
• SULFURIC ACID
• SODIUM HYDROXIDE
• WATER

Who manufactures and distributes this medicine?

Injection:

• Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Topical gentamicin:

• Manufactured By Perrigo
• Bronx, NY

Distributed By Perrigo Allegan, MI

Gentamicin sulfate ophthalmic solution:

• Allergan, Inc.
• Irvine, CA 92612, U.S.A.

What should I know about storage and disposal of this medication?

Topical gentamicin:

• Store at 20-25˚C (68-77˚F).

Gentamicin sulfate ophthalmic solution:

• Store at or below 25°C (77°F).
• Avoid exposure to excessive heat (40°C/104°F or above).

Injection:

• Store at 20°C to 25°C (68°F to 77°F).

List of aminoglycosides

• amikacin
• gentamicin
• neomycin
• streptomycin
• tobramycin

• Dailymed label info on Gentamicin
• FDA Gentamicin

Gentamicin Resources
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