Gentamicin sulfate ointment usp 0 1

Contents

Gentamicin

Generic Name: gentamicin (GEN ta MYE sin)
Brand Name: Garamycin, Cidomycin, Septopal (obsolete)

Medically reviewed by Drugs.com on Feb 28, 2019 – Written by Cerner Multum

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is gentamicin?

Gentamicin is an antibiotic that fights bacteria.

Gentamicin is used to treat severe or serious bacterial infections.

Gentamicin may also be used for purposes not listed in this medication guide.

Important Information

Gentamicin can harm your kidneys, and may also cause nerve damage or hearing loss, especially if you have kidney disease or use certain other medicines.

Tell your doctor about all your medical conditions and all the medicines you are using. If you need surgery, tell the surgeon ahead of time that you are using gentamicin.

Before taking this medicine

You should not use gentamicin if you are allergic to gentamicin or similar antibiotics such as amikacin, kanamycin, neomycin, paromomycin, streptomycin, or tobramycin.

To make sure gentamicin is safe for you, tell your doctor if you have:

  • kidney disease;

  • asthma or sulfite allergy;

  • myasthenia gravis;

  • a nerve-muscle disorder;

  • a nervous system disorder such as Parkinson’s disease;

  • an electrolyte imbalance (low levels of calcium, potassium, or magnesium in your blood); or

  • if you are dehydrated.

Do not use gentamicin if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy during treatment.

It is not known whether gentamicin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take gentamicin?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Gentamicin is usually given for 7 to 10 days.

Gentamicin is injected into a muscle, or into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Do not use gentamicin if it has changed colors or has particles in it. Call your pharmacist for new medication.

Do not mix gentamicin with other medicines in a syringe or IV bag.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Gentamicin will not treat a viral infection such as the flu or a common cold.

Drink plenty of liquids while you are taking gentamicin. This will help keep your kidneys working properly.

While using gentamicin, you may need frequent blood or urine tests. Your hearing, kidney function, and nerve function may also need to be checked.

If you need surgery, tell the surgeon ahead of time that you are using gentamicin.

Store this medicine at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of gentamicin.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking gentamicin?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Gentamicin side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • hearing loss, or a roaring sound in your ears;

  • severe or ongoing dizziness;

  • weak or shallow breathing;

  • numbness or tingly feeling;

  • twitching, muscle tightness or contraction;

  • seizure (convulsions);

  • severe stomach pain, diarrhea that is watery or bloody;

  • fever, blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

  • kidney problems–little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;

  • signs of an electrolyte imbalance–confusion, weakness, bone pain, increased urination; or

  • increased pressure inside the skull–severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Side effects may be more likely in older adults.

Common side effects may include:

  • vision problems;

  • nausea, vomiting, loss of appetite, weight loss;

  • a light-headed feeling, like you might pass out;

  • itching or rash;

  • pain where the medicine was injected;

  • headache, mood changes; or

  • joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect gentamicin?

Gentamicin can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • a diuretic or “water pill”; or

  • any other antibiotic.

This list is not complete. Other drugs may interact with gentamicin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 2.01.

Medical Disclaimer

More about gentamicin

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Interactions
  • Compare Alternatives
  • Support Group
  • Pricing & Coupons
  • En Español
  • Drug class: aminoglycosides
  • FDA Alerts (1)

Consumer resources

  • Gentamicin (Systemic)
  • Gentamicin Injection (Advanced Reading)

Other brands: Garamycin

Professional resources

  • Gentamicin Sulfate (AHFS Monograph)
  • … +4 more

Related treatment guides

  • Bone infection
  • Bacteremia
  • Bacterial Endocarditis Prevention
  • Bacterial Infection
  • … +16 more

Tobramycin

Prevention of ototoxicity

Aminoglycoside antibiotics, including neomycin, kanamycin, tobramycin, amikacin, and gentamicin and the chemotherapy anti-cancer agent cisplatin (CDDP) are the most common drugs causing hair cell loss and, consequently, hearing loss (ototoxicity). Although this review will emphasize the cochlear effects of ototoxic agents, we should note that aminoglycosides can also cause vestibular toxicity and loss of balance. ROS increase significantly in inner ear tissues following aminoglycoside treatment both in organ explants and in vivo . Conversely, cellular antioxidant defense system constituents, such as glutathione, decrease after aminoglycoside treatment .

The resulting redox imbalance resulting from increased ROS production and decreased antioxidant function then initiates competing signaling pathways of cell death and survival. involving intracellular organelles such as mitochondria and lysosomes and a network of interfacing signaling systems based on enzymatic actions (e.g., activation of proteases) and changes in gene expression (e.g., via transcription factors or epigenetic modifications). Indicative of this complexity, cell death by aminoglycosides includes both apoptosis and necrosis of hair cells in cochlear and vestibular organs ; and both caspase-dependent and caspase-independent pathways appear to contribute to hair cell pathology. Caspase-3 has also been implicated in hair cell death, primarily in in vitro models of explant cultures and isolated cells or in the vestibular system (e.g., reference ). The pro-apoptotic mediator c-Jun NH2-terminal kinase (JNK) apoptotic pathway is often involved, since pharmacological inhibitors (e.g., CEP-1347) can offer some protection in vitro from aminoglycosides . Like the caspase pathway, involvement of the JNK pathway is reported mostly in cultured explants but may contribute to the overall pattern of cell death in vivo. A dominance of caspase-independent cell death emerges in a chronic drug treatment model, where the onset of cochlear deficit is delayed and continues to develop after the cessation of treatment, akin to the clinical situation. In this model, activated calpain and cathepsins are the major mediators of cell death . Most recently, inhibitors of histone deacetylation have emerged as promising candidates for clinical application. Two histone deacetylase inhibitors, trichostatin and butyrate, can reduce gentamicin ototoxicity in experimental models by inhibiting the epigenetic histone modifications induced by aminoglycoside treatment.

The establishment of the mechanisms underlying both apoptotic and necrotic cell death in ototoxicity provides a basis for a rational approach to prevention. For example, small synthetic molecules designed to inhibit one of the many steps in the apoptotic cascade can potentially stave off cell death. For a clinical application, however, a systemic application of such powerful signaling molecules may have far-ranging physiological consequences, particularly when applied to drug treatment, which may last for weeks. Local gene therapy, the process of virally introducing a gene into a tissue may be more suitable in such a situation . However, given the complexity of cell death mechanisms, targeting a single pathway may not be sufficient as the inhibition of one might be bypassed by the activity of others.

The currently most applicable method of prevention is antioxidant therapy, which has become a successful clinical approach to many pathologies that involve free radicals. This type of intervention would also act directly on the ROS upstream of the ensuing cell death pathways and therefore suppress toxic mechanisms at the very onset. A wide variety of antioxidant molecules have been shown to attenuate ototoxicity in vivo constituting the most compelling support for ROS as major mediators of aminoglycoside induced hearing loss . The attenuation achieved in animal models can be dramatic. For example, a gentamicin-induced hearing loss of 60–80 dB could be reduced to a negligible loss of 10 dB or less . Since neither the serum levels of the drugs nor their antibacterial efficacy are compromised, antioxidant therapy provides a promising approach for a clinical application.

A clinically feasible prophylactic therapy requires drugs that by themselves are non-toxic and easily administered to the patients. One such example that emerged from laboratory studies is salicylate, the active ingredient of aspirin . The efficacy of aspirin was tested in a randomized double-blind and placebo-controlled study in patients receiving gentamicin for acute infections . Fourteen of 106 patients (13%) met the criteria of hearing loss in the placebo group, while only three out of 89 (3%) sustained a hearing loss in the aspirin group, for a 75% reduction in the incidence of ototoxicity. Aspirin did not influence gentamicin serum levels or the course of therapy. The protection against gentamicin-induced hearing loss with aspirin was confirmed by a second clinical trial . Although aspirin is widely used in the United States as a daily prophylaxis against myocardial infarction, as well as for treatment of inflammation, fever, and pain, aspirin carries with it a small risk of gastrointestinal side effects. Other antioxidants utilized in clinical trials to date include vitamin E and N-acetylcysteine (NAC). NAC reduced hearing losses in a small study of patients receiving gentamicin for bacteremia and in a study of peritonitis patients receiving aminoglycosides for peritoneal dialysis . In contrast and despite success in animal studies, vitamin E did not reduce hearing loss in a clinical study, underscoring the complexity of aminoglycoside responses in humans and the potential pitfalls of translation of animal studies to clinical medicine . Cisplatin (CDDP) also generates ROS as well as reactive nitrogen species in the cochlea and several antioxidants have been shown to provide protection from CDDD induced ototoxicity including L-methionine, NAC, glutathione and ebselen . Susceptibility to ototoxicity can be influenced by factors such as diet (e.g., , ) as well as genetic influences such as the mitochondrial mutations that can render people hyper-sensitive to aminoglycosides .

Gentamicin

Gentamicin and Tobramycin are both part of a class of powerful and affordable antibiotics, aminoglycosides. These drugs are delivered intravenously to patients with severe infections, and are very effective when the proper dose is administered and patients are monitored by a medical professional. It has been found that high dosages and extended use of these powerful antibiotics can result in serious injury in patients.

Gentamicin has been in commercial production for over fifty years. While it was the first and only antibiotic available to treat infections, negative side effects were noticed almost immediately. Because of the low cost and effectiveness in proper dosages, doctors and healthcare providers continue to frequently prescribe gentamicin and tobramycin to patients across the United States.

Symptoms and Side Effects

Problems can arise when a patient receives too high of a dosage of gentamicin and tobramycin, resulting in poisoning of the patient. Because some patients are very sick (in many cases they are bed-bound) at the time of their dosage, their overdose symptoms are often misdiagnosed or mistaken for normal ailments associated with their illnesses.

Bouncing Vision (Oscillopsia)

Serious side effects, including bouncing vision, can occur in patients who have received the wrong dosage of gentamicin or tobramycin. Bouncing vision, or oscillopsia, occurs when the vestibular system is damaged. The patient’s visual field is interrupted by bouncing, jerky movements. This side effect can permanently limit a person’s ability to drive, read, and/or focus.

Impaired Concentration and Memory

Along with damage to the vestibular system, patients who have been poisoned by gentamicin or tobramycin often experience difficultly concentrating, as well as memory loss. This can result in a feeling of “brain fog” that can seriously affect a person’s life. What were once easy tasks suddenly become difficult and confusing.

Kidney Damage

Another severe side effect of long term and high-dose gentamicin use is damage to the kidneys, which help the body filter out toxins. Patients receiving gentamicin can experience progressive failure, and eventual complete failure of the kidneys.

Your Legal Options

To minimize damage caused by gentamicin overdose or tobramycin overdose, use of the antibiotic should be monitored by a medical professional. If you or a loved one’s gentamicin or tobramycin dosage has not been properly administered or monitored, you may begin to experience the severe side effects detailed above and more. If this happens, you should report symptoms immediately to your physician, nurse, or pharmacist.

Our attorneys are currently evaluating cases related to Gentamicin. If you took the drug Gentamicin, please contact us through this simple form or our toll-free number, 800-598-0314. You might be entitled to compensation for medical bills associated with your condition, pain and suffering, and more.

Gentamicin is the generic form of the brand-name drug Garamycin, an antibiotic used to treat many types of bacterial infections.

The injection or intravenous (IV) form of gentamicin is very effective, but can be toxic, so it’s generally used only for serious infections with careful monitoring, or in short-term doses to prevent infections.

The solution and cream are used for eye and skin infections.

Gentamicin belongs to a class of antibiotics called aminoglycosides, which directly kill bacteria.

Like all antibiotics, gentamicin only treats bacterial infections. It doesn’t work for viruses or fungal infections.

The IV form of gentamicin is particularly effective for severe infections of the blood, central nervous system (such as meningitis), urinary tract, lungs, bones, joints, and the abdomen, such as the stomach, intestines, and other abdominal conditions including peritonitis.

It’s sometimes used short-term to prevent infection, such as before abdominal surgery or a colonoscopy.

Gentamicin was approved by the Food and Drug Administration (FDA) in 1966.

Gentamicin Warnings

There is a black-box warning for gentamicin. The drug can be toxic to your kidneys and ears, causing severe and often permanent hearing or balance problems.

These effects are mainly caused by injectable or IV gentamicin, which is given in the hospital. Usually the effects happen with longer treatments, but they can happen near the beginning of your treatment as well.

You should tell the doctor immediately if you experience any of the following symptoms while taking gentamicin:

  • Dizziness
  • Vertigo (sense of the room spinning or loss of balance)
  • Hearing loss
  • Ringing in the ears
  • Numbness
  • Muscle twitching or weakness
  • Breathing difficulties
  • Decreased urination
  • Rash
  • Itching
  • Sore throat

Your doctor should order blood tests during your treatment with gentamicin to monitor your kidney function.

Effects on hearing and balance may occur while you are on the drug, although sometimes they are not noticed until after the treatment is completed.

Before taking gentamicin, tell your doctor if you have a family history of ear problems, or if someone in your family has developed hearing or balance problems from any drug.

Some people are genetically vulnerable to these effects (known as “ototoxic”) of gentamicin, according to the American Hearing Research Foundation.

If you are receiving gentamicin by an IV or injection through a catheter, you should know the signs of a developing infection:

  • Irritation
  • Warmth
  • Tenderness
  • Drainage
  • Swelling
  • Redness
  • Pain

You should tell your doctor if you have or have ever had the following conditions before taking gentamicin:

  • Parkinson’s disease
  • Myasthenia gravis (a neuromuscular disorder)
  • Kidney disease
  • Vertigo
  • Hearing loss
  • Ringing in the ears (tinnuitis)
  • A history of ear infections

It’s important to stay hydrated while taking gentamicin. Your doctor may administer intravenous fluids during your treatment.

Gentamicin for Dogs and Cats

Gentamicin can be used to treat a variety of infections in dogs and cats, including respiratory infections, wounds, surgical infections, skin infections, ear infections, eye infections, and pneumonia.

Your veterinarian will determine the appropriate dosage. You should watch for any effects on your animal’s hearing and balance.

Pregnancy and Gentamicin

Gentamicin is a very potent drug that can harm an unborn baby.

Don’t use gentamicin without first talking with your doctor if you’re pregnant or may become pregnant during treatment.

Don’t use gentamicin without first talking to your doctor if you are breastfeeding a baby.

Gentamicin Ophthalmic Topical Spray is a topical medication prescribed to help treat superficial lesions caused by bacteria. It works to help heal hot spots, rashes and skin infections. It’s also effective in the treatment of sensitive skin and allergies. Customers may receive this drug under the names Gentocin, Genoptic, Gentak, GenOne or GentaCalm.

Uses

This topical spray is for the treatment of infected superficial lesions caused by bacteria. It contains gentamicin, an antibiotic, and betamethasone, an anti-inflammatory.

Possible Side Effects

Serious side effects have not been frequently reported. Prolonged use of this medication may allow the overgrowth of non-susceptible organisms such as fungi and yeasts. Weight loss increased thirst, and urination, vomiting, and diarrhea have been reported in animals following the use of synthetic corticosteroids. Continue the medication and talk to your veterinarian about any side effect that seems unusual or bothersome to your pet.

Drug & Food Interactions

Do not administer other corticosteroids during treatment with this medication. Do not use in combination with other aminoglycosides, such as neomycin. Notify your veterinarian of any other medications, including vitamins and supplements, your pet is taking while your pet is receiving gentamicin.

Precautions

Do not use for more than 7 days unless otherwise indicated by your veterinarian. Do not use if your pet has a viral or fungal infection. Consult your veterinarian if your pet is pregnant or lactating.

NOTE: For Generic Medications, picture displayed may not depict actual product. Generic medications may vary from one order to the next by size, color and shape depending on manufacturer. Customers may receive the same drug under the name Gentocin, Genoptic, Gentak, GenOne or GentaCalm.

Also available in ear drops.

  1. Prescribing Information

See all items by Gentamicin

Gentamicin Topical Spray RX

Each mL contains: gentamicin sulfate, USP equivalent to 0.57 mg gentamicin base, betamethasone valerate, USP equivalent to 0.284 mg betamethasone, 163 mg isopropyl alcohol, propylene glycol, methylparaben and propylparaben as preservatives, purified water q.s. Hydrochloric acid may be added to adjust pH.
Prior to treatment, remove excessive hair and clean the lesion and adjacent area. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer 2 to 4 times daily for 7 days. Each depression of the sprayer head delivers 0.7 mL of Gentamicin Sulfate Topical Spray.
Warning

Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have produced cleft palate. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy.

Gentamicin skin cream or ointment

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    Dosage forms

    Form Route Strength
    Cream Topical
    Ointment Topical
    Liquid Intramuscular; Intravenous
    Liquid Auricular (otic); Ophthalmic
    Cream Topical
    Solution Ophthalmic 3 mg/1mL
    Ointment Topical
    Solution Auricular (otic); Ophthalmic
    Solution / drops Auricular (otic)
    Solution / drops Ophthalmic
    Injection, solution Intramuscular; Intravenous 10 mg/1mL
    Injection, solution Intramuscular; Intravenous 40 mg/1mL
    Ointment Ophthalmic 0.3 %
    Solution Ophthalmic .3 %
    Solution Ophthalmic 0.3 %
    Solution Intramuscular; Intravenous
    Cream Topical 1 mg/1g
    Injection, solution Intravenous 120 mg/50mL
    Injection, solution Intravenous 40 mg/100mL
    Injection, solution Intravenous 60 mg/100mL
    Injection, solution, concentrate Intramuscular; Intravenous 40 mg/1mL
    Injection, solution, concentrate Intravenous 10 mg/1mL
    Ointment Ophthalmic 3 mg/1g
    Ointment Topical 1 mg/1g
    Powder Not applicable 1 g/1g
    Powder Not applicable 1 kg/1kg
    Solution Ophthalmic 3.0 mg/1mL
    Solution / drops Ophthalmic 3 mg/1mL
    Solution Intravenous
    Injection, solution Intravenous 0.6 mg/1mL
    Injection, solution Intravenous 0.8 mg/1mL
    Injection, solution Intravenous 0.9 mg/1mL
    Injection, solution Intravenous 1 mg/1mL
    Injection, solution Intravenous 1.2 mg/1mL
    Injection, solution Intravenous 1.4 mg/1mL
    Injection, solution Intravenous 1.6 mg/1mL
    Injection, solution Intravenous 100 mg/50mL
    Injection, solution Intravenous 100 mg/100mL
    Injection, solution Intravenous 60 mg/50mL
    Injection, solution Intravenous 80 mg/50mL
    Injection, solution Intravenous 80 mg/100mL
    Solution Intravenous
    Ointment Ophthalmic
    Solution / drops Ophthalmic; Topical
    Liquid Ophthalmic; Topical
    Ointment Ophthalmic; Topical
    Solution Ophthalmic
    Ointment Ophthalmic
    Suspension / drops Ophthalmic
    Liquid Ophthalmic
    Solution Auricular (otic)
    Implant Parenteral

    Prices

    Unit description Cost Unit
    Gentak 0.3% Ointment 3.5 gm Tube 19.99USD tube
    Gentamicin Sulfate 0.1% Cream 15 gm Tube 12.99USD tube
    Gentamicin Sulfate 0.1% Ointment 15 gm Tube 11.99USD tube
    Gentamicin Sulfate 0.3% Solution 5ml Bottle 11.99USD bottle
    Gentamicin sulfate powder 5.05USD g
    Gentamicin Sulfate 10 mg/ml Solution 2ml Vial 5.0USD vial
    Gentamicin 40 mg/ml 2.82USD ml
    Gentamicin ped 10 mg/ml vial 2.4USD ml
    Gentak 3 mg/ml eye drops 1.91USD ml
    Gentamicin 3 mg/ml eye drops 1.89USD ml
    Gentamicin 10 mg/ml vial 1.29USD ml
    Garamycin 0.3 % Ointment 1.2USD g
    Sandoz Gentamicin Sulfate 0.3 % Ointment 1.2USD g
    Garamycin 0.3 % Solution 0.75USD ml
    Sandoz Gentamicin Sulfate 0.3 % Solution 0.75USD ml
    Gentamicin 40 mg/ml vial 0.45USD ml
    Ratio-Gentamicin Sulfate 0.1 % Cream 0.43USD g
    Ratio-Gentamicin Sulfate 0.1 % Ointment 0.37USD g
    Gentamicin 0.1% cream 0.16USD g
    Iso gentamicin 120 mg/100 ml 0.09USD ml
    Gentamicin 90 mg/ns 100 ml pb 0.05USD ml
    Isoton gentamicin 40 mg/100 ml 0.05USD ml
    Gentamicin 60 mg/ns 100 ml pb 0.04USD ml
    Gentamicin 100 mg/ns 100 ml 0.03USD ml
    Gentamicin 80 mg/ns 100 ml pb 0.03USD ml

    DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only. Patents Not Available

    Properties

    State Solid Experimental Properties

    Property Value Source
    melting point (°C) 105 °C PhysProp
    water solubility 100 mg/mL Not Available
    logP -3.1 Not Available

    Predicted Properties

    Property Value Source
    Water Solubility 12.6 mg/mL ALOGPS
    logP -1.6 ALOGPS
    logP -3.1 ChemAxon
    logS -1.6 ALOGPS
    pKa (Strongest Acidic) 12.55 ChemAxon
    pKa (Strongest Basic) 10.18 ChemAxon
    Physiological Charge 5 ChemAxon
    Hydrogen Acceptor Count 12 ChemAxon
    Hydrogen Donor Count 8 ChemAxon
    Polar Surface Area 199.73 Å2 ChemAxon
    Rotatable Bond Count 7 ChemAxon
    Refractivity 118.02 m3·mol-1 ChemAxon
    Polarizability 51.92 Å3 ChemAxon
    Number of Rings 3 ChemAxon
    Bioavailability 0 ChemAxon
    Rule of Five No ChemAxon
    Ghose Filter No ChemAxon
    Veber’s Rule No ChemAxon
    MDDR-like Rule Yes ChemAxon

    Predicted ADMET features

    Property Value Probability
    Human Intestinal Absorption 0.944
    Blood Brain Barrier 0.9826
    Caco-2 permeable 0.6987
    P-glycoprotein substrate Substrate 0.6882
    P-glycoprotein inhibitor I Non-inhibitor 0.6808
    P-glycoprotein inhibitor II Non-inhibitor 0.9586
    Renal organic cation transporter Non-inhibitor 0.8738
    CYP450 2C9 substrate Non-substrate 0.8001
    CYP450 2D6 substrate Non-substrate 0.8314
    CYP450 3A4 substrate Substrate 0.5917
    CYP450 1A2 substrate Non-inhibitor 0.9034
    CYP450 2C9 inhibitor Non-inhibitor 0.891
    CYP450 2D6 inhibitor Non-inhibitor 0.9331
    CYP450 2C19 inhibitor Non-inhibitor 0.9043
    CYP450 3A4 inhibitor Non-inhibitor 0.9517
    CYP450 inhibitory promiscuity Low CYP Inhibitory Promiscuity 0.9294
    Ames test Non AMES toxic 0.7338
    Carcinogenicity Non-carcinogens 0.9696
    Biodegradation Not ready biodegradable 0.9588
    Rat acute toxicity 2.0383 LD50, mol/kg Not applicable
    hERG inhibition (predictor I) Weak inhibitor 0.9954
    hERG inhibition (predictor II) Non-inhibitor 0.8784

    ADMET data is predicted using admetSAR, a free tool for evaluating chemical ADMET properties. (23092397)

    Spectra

    Mass Spec (NIST) Not Available Spectra

    Spectrum Spectrum Type Splash Key
    Predicted GC-MS Spectrum – GC-MS Predicted GC-MS Not Available
    Predicted MS/MS Spectrum – 10V, Positive (Annotated) Predicted LC-MS/MS splash10-0i29-1319700000-e55d2931137c5abc8493
    Predicted MS/MS Spectrum – 20V, Positive (Annotated) Predicted LC-MS/MS splash10-03di-0904000000-de986ac47725d8f3a72a
    Predicted MS/MS Spectrum – 40V, Positive (Annotated) Predicted LC-MS/MS splash10-0592-9602000000-c7fd77457525743faeba
    Predicted MS/MS Spectrum – 10V, Negative (Annotated) Predicted LC-MS/MS splash10-014i-2911100000-93e47b752e7992b12263
    Predicted MS/MS Spectrum – 20V, Negative (Annotated) Predicted LC-MS/MS splash10-014i-2958400000-7303bf3ebe16dd1c1d60
    Predicted MS/MS Spectrum – 40V, Negative (Annotated) Predicted LC-MS/MS splash10-0udi-2692000000-a8234ed8e0131019f62b

    Taxonomy

    Description This compound belongs to the class of organic compounds known as aminocyclitol glycosides. These are organic compounds containing an amicocyclitol moiety glycosidically linked to a carbohydrate moiety. There are two major classes of aminoglycosides containing a 2-streptamine core. They are called 4,5- and 4,6-disubstituted 2-deoxystreptamines. Kingdom Organic compounds Super Class Organic oxygen compounds Class Organooxygen compounds Sub Class Carbohydrates and carbohydrate conjugates Direct Parent Aminocyclitol glycosides Alternative Parents 2-deoxystreptamine aminoglycosides / O-glycosyl compounds / Aminocyclitols and derivatives / Cyclohexylamines / Cyclohexanols / Oxanes / Monosaccharides / Tertiary alcohols / 1,2-aminoalcohols / Oxacyclic compoundsDialkylamines / Acetals / Organopnictogen compounds / Monoalkylamines / Hydrocarbon derivatives show 5 more Substituents Amino cyclitol glycoside / 2-deoxystreptamine aminoglycoside / Glycosyl compound / O-glycosyl compound / Aminocyclitol or derivatives / Cyclohexanol / Cyclohexylamine / Cyclitol or derivatives / Monosaccharide / OxaneTertiary alcohol / Cyclic alcohol / Secondary alcohol / 1,2-aminoalcohol / Secondary amine / Acetal / Organoheterocyclic compound / Secondary aliphatic amine / Oxacycle / Alcohol / Hydrocarbon derivative / Primary aliphatic amine / Organopnictogen compound / Organic nitrogen compound / Amine / Primary amine / Organonitrogen compound / Aliphatic heteromonocyclic compound show 18 more Molecular Framework Aliphatic heteromonocyclic compounds External Descriptors Not Available

    Targets

    Kind Protein Organism Escherichia coli (strain K12) Pharmacological action Yes Actions Adduct General Function Trna binding Specific Function With S4 and S5 plays an important role in translational accuracy.Interacts with and stabilizes bases of the 16S rRNA that are involved in tRNA selection in the A site and with the mRNA backbone. Lo… Gene Name rpsL Uniprot ID P0A7S3 Uniprot Name 30S ribosomal protein S12 Molecular Weight 13736.995 Da Kind Nucleotide Organism Enteric bacteria and other eubacteria Pharmacological action Yes Actions AdductIn prokaryotes, the 16S rRNA is essential for recognizing the 5′ end of mRNA and hence positioning it correctly on the ribosome. The 16S rRNA has a characteristic secondary structure in which half of the nucleotides are base-paired. The 16S rRNA sequence has been highly conserved and is often used for evolutionary and species comparative analysis.

    1. Doi Y, de Oliveira Garcia D, Adams J, Paterson DL: Coproduction of novel 16S rRNA methylase RmtD and metallo-beta-lactamase SPM-1 in a panresistant Pseudomonas aeruginosa isolate from Brazil. Antimicrob Agents Chemother. 2007 Mar;51(3):852-6. Epub 2006 Dec 11.
    2. Bogaerts P, Galimand M, Bauraing C, Deplano A, Vanhoof R, De Mendonca R, Rodriguez-Villalobos H, Struelens M, Glupczynski Y: Emergence of ArmA and RmtB aminoglycoside resistance 16S rRNA methylases in Belgium. J Antimicrob Chemother. 2007 Mar;59(3):459-64. Epub 2007 Jan 15.
    3. Aslangul E, Massias L, Meulemans A, Chau F, Andremont A, Courvalin P, Fantin B, Ruimy R: Acquired gentamicin resistance by permeability impairment in Enterococcus faecalis. Antimicrob Agents Chemother. 2006 Nov;50(11):3615-21.
    4. Schroeder R, Waldsich C, Wank H: Modulation of RNA function by aminoglycoside antibiotics. EMBO J. 2000 Jan 4;19(1):1-9.

    Kind Protein Organism Humans Pharmacological action No Actions Other/unknown General Function Calcium ion binding Specific Function Acts together with cubilin to mediate HDL endocytosis (By similarity). May participate in regulation of parathyroid-hormone and para-thyroid-hormone-related protein release. Gene Name LRP2 Uniprot ID P98164 Uniprot Name Low-density lipoprotein receptor-related protein 2 Molecular Weight 521952.77 Da

    1. Watanabe A, Nagai J, Adachi Y, Katsube T, Kitahara Y, Murakami T, Takano M: Targeted prevention of renal accumulation and toxicity of gentamicin by aminoglycoside binding receptor antagonists. J Control Release. 2004 Mar 24;95(3):423-33.
    2. Takamoto K, Kawada M, Ikeda D, Yoshida M: Apolipoprotein E3 (apoE3) safeguards pig proximal tubular LLC-PK1 cells against reduction in SGLT1 activity induced by gentamicin C. Biochim Biophys Acta. 2005 Apr 15;1722(3):247-53.
    3. Nagai J, Saito M, Adachi Y, Yumoto R, Takano M: Inhibition of gentamicin binding to rat renal brush-border membrane by megalin ligands and basic peptides. J Control Release. 2006 May 1;112(1):43-50. Epub 2006 Feb 20.

    Kind Protein Organism Bacillus subtilis (strain 168) Pharmacological action Unknown General Function Nad+ synthase activity Specific Function Catalyzes a key step in NAD biosynthesis, transforming deamido-NAD into NAD by a two-step reaction. Gene Name nadE Uniprot ID P08164 Uniprot Name NH(3)-dependent NAD(+) synthetase Molecular Weight 30394.995 Da Kind Protein Organism Humans Pharmacological action Unknown General Function Nadph binding Specific Function Key enzyme in folate metabolism. Contributes to the de novo mitochondrial thymidylate biosynthesis pathway. Catalyzes an essential reaction for de novo glycine and purine synthesis, and for DNA pre… Gene Name DHFR Uniprot ID P00374 Uniprot Name Dihydrofolate reductase Molecular Weight 21452.61 Da

    Transporters

    Kind Protein Organism Humans Pharmacological action Unknown Actions Inhibitor General Function Sodium-independent organic anion transmembrane transporter activity Specific Function Involved in the renal elimination of endogenous and exogenous organic anions. Functions as organic anion exchanger when the uptake of one molecule of organic anion is coupled with an efflux of one … Gene Name SLC22A6 Uniprot ID Q4U2R8 Uniprot Name Solute carrier family 22 member 6 Molecular Weight 61815.78 Da

    1. Jariyawat S, Sekine T, Takeda M, Apiwattanakul N, Kanai Y, Sophasan S, Endou H: The interaction and transport of beta-lactam antibiotics with the cloned rat renal organic anion transporter 1. J Pharmacol Exp Ther. 1999 Aug;290(2):672-7.

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    Drug created on June 13, 2005 07:24 / Updated on February 02, 2020 04:09

    Gentamicin Pediatric

    SIDE EFFECTS

    Nephrotoxicity

    Adverse renal effects, as demonstrated by the presence of casts, cells, or protein in the urine or by rising BUN, NPN, serum creatinine or oliguria, have been reported. They occur more frequently in patients treated for longer periods or with larger dosages than recommended.

    Neurotoxicity

    Serious adverse effects on both vestibular and auditory branches of the eighth nerve have been reported, primarily in patients with renal impairment (especially if dialysis is required), and in patients on high doses and/or prolonged therapy. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears and hearing loss, which, as with other aminoglycosides, maybeirreversible. Hearing loss is usually manifested initially by diminution of high-tone acuity. Other factors which may increase the risk of toxicity include excessive dosage, dehydration and previous exposure to other ototoxic drugs.

    Peripheral neuropathy or encephalopathy, including numbness, skintingling, muscletwitching, convulsions and a myasthenia gravis-like syndrome, have been reported.

    Note: The risk of toxic reactions is low in neo-nates,infantsandchildrenwithnormalrenalfunc-tion who do not receive Gentamicin (gentamicin injection pediatric) Injection at higher doses or for longer periods of time than recommended.

    Other reported adverse reactions possibly related to gentamicin (gentamicin injection pediatric) include: respiratory depression, lethargy, confusion, depression, visual disturbances, decreased appetite, weightloss, hypotension and hypertension; rash, itching, urticaria, generalized burning, laryngeal edema, anaphylactoid reactions, fever and headache; nausea, vomiting, increased salivation and stomatitis; purpura, pseudotum or cerebri, acute organic brain syndrome, pulmonary fibrosis, alopecia, joint pain, transient hepatomegaly and splenomegaly.

    Laboratory abnormalities possibly related to gentamicin (gentamicin injection pediatric) include: increased levels of serum transaminase (SGOT,SGPT), serum LDH and bilirubin, decreased serum calcium, magnesium, sodium and potassium; anemia, leukopenia, granulocytopenia, transient agranulocytosis, eosinophilia, increased and decreased reticulocyte counts and thrombocytopenia. While clinical laboratory test abnormalities may be isolated findings, they may also be associated with clinically related signs and symptoms. For example, tetany and muscle weakness may be associated with hypomagnesemia, hypocalcemia, and hypokalemia.

    While local tolerance of Gentamicin (gentamicin injection pediatric) Injection is generally excellent, there has been an occasional report of pain at the injection site. Subcutaneous atrophy or fat necrosis suggesting local irritation has been reported rarely.

    Read the entire FDA prescribing information for Gentamicin Pediatric (Gentamicin Injection Pediatric)

    gentamicin (Rx)

    Dosage Forms & Strengths

    injectable solution

    • 10mg/mL
    • 40mg/mL

    Intravenous solution

    • 60mg (50mL)
    • 70mg (50mL)
    • 80mg (50mL, 100mL)
    • 90mg (100mL)
    • 100mg (50mL, 100mL)
    • 120mg (100mL)

    Susceptible Infections

    In underweight and nonobese patients, use of total body weight (TBW) instead of ideal body weight for determining initial mg/kg/dose is accepted; ideal body weight (IBW) also may be used to determine doses for patients who are neither underweight nor obese

    Conventional dosing

    • 3-5 mg/kg/day IV/IM divided q8hr

    Extended dosing interval

    • Initial: 5-7 mg/kg/dose IV qDay
    • Not for use in patients with ascites, burns covering >20% of total body surface area, cystic fibrosis, end-stage renal disease, endocarditis, infants, mycobacterial infections, or pregnancy
    • Measure gentamicin level between 6 and 14 hr after initiating gentamicin infusion; use institution-specific nomogram to determine appropriate dosing interval

    Surgical Prophylaxis (Off-label)

    5 mg/kg IV as single dose 1 hr prior to surgical incision; alternativley, 1.5 mg/kg IV as single dose for gynecology procedures

    Dose is based on actual body weight (TBW) unless body weight is >20% above ideal body weight (IBW), in which case the dosing weight can be estimated by IBW + 0.4 (TBW – IBW)

    Infective Endocarditis Treatment

    Enterococcus (native or prosthetic valve); Off-label dose

    • 3 mg/kg/day IV/IM divided q8hr for 4-6 weeks in combination with a beta-lactam and for 6 weeks when administered wiht vancomycin
    • Organism sensitivity testing should determine choice of concomitant antiibotic and treatment duration

    S. aureus (prosthetic valve; methicillin susceptible or resistant); Off-label dose

    • 3 mg/kg/day IV/IM divided q8-12hr for 3-5 days for native valve infections or for 2 weeks for prosthetic valve infections in combination with other antibiotic
    • Organism sensitivity testing should determine choice of concomitant antibiotic

    Viridans group streptococcus and S bovis (native or prosthetic valve); Off-label use

    • 3 mg/kg/day IV/IM qDay (preferred) or divided q8hr for 2 weeks for native or prosthetic valve infections or for 6 weeks for prosthetic valve infections with relatively or fully resistant strains in combination with other antibiotic
    • Organism sensitivity testing and source of infection should determine choice of concomitant antibiotic

    Cystic Fibrosis (Off-label)

    7.5-10.5 mg/kg/day IV/IM divided q8hr

    Pelvic Inflammatory Disease (Off-label)

    Loading dose: 2 mg/kg IV or IM

    Maintenance dose: 1.5 mg/kg IV/IM q8hr plus clindamycin IV or 3-5 mg/kg IV qDay

    May initiate transition from parenteral to oral therapy of either oral doxycycline or oral clindamycin within 24-48 hr of clinical improvement for total treatment duration of 14 days

    Plague (Yersinia pestis) Treatment (Off-label)

    5 mg/kg IV/IM qDay for 10 days or 2 mg/kg IV/IM loading dose; then 1.7 mg/kg/dose IV/IM q8hr for 10-14 days or until 2 days after patient is afebrile; doxycycline, ciprofloxacin, or chloramphenicol could be used as third-line alternatives

    Dosage Modifications

    Renal impairment

      • Renally adjusted dose recomendations are based on doses of 1.7 mg/kg/dose q8hr or 5-7 mg/kg/dose once daily
      • CrCl>50 mL/min: No dosage adjustment necessary
      • CrCl 10-50 mL/min: Administer q12-48 hr
      • CrCl
    • Once daily (interval adjustment of extended interval dosing)
      • Adjust doses based on serum concentrations and organism MIC
      • CrCl≥60mL/min: No dosage adjustment necessary
      • CrCl 40-59 mL/min: 5-7 mg/kg IV q36hr
      • CrCl 20-39 mL/min: 5-7 mg/kg IV q48hr
      • CrCl
    • Intermittent hemodialysis
      • Administer after hemodialysis on dialysis days
      • Dependent on patients size, site of injection, filter, duration and type of intermittent hemodialysis, it is ~30-50% dialyzable
      • 1-1.7 mg/kg IV/IM after initial hemodialysis session; serum gentamicin concentrations should guide subsequent dosing
      • Dosing dependent on assumption of 3 times/wk complete intermittent hemodialysis sessions
    • Peritoneal dialysis
      • Intermittent dosing: 0.6 mg/kg per exchange once daily for anuric patients; 0.75 mg/kg/dose IP for non-anuric patients qDay during long dwell periods; depending on infecting organism and patient’s clinical status, may treat for 2-3 weeks
      • Continuous dosing: 8 mg/L loading dose; followed by 4 mg/L maintenance dose
    • Continuous renal replacement therapy
      • Drug clearance is highly dependent on method of renal replacement, filter type, and flow rate; close monitoring of pharmacologic response, sign of adverse reactions due to accumulation, and target drug concentration necessary for appropriate dosing
      • 3 mg/kg/day IV/IM divided q8hr; may administer up to 5 mg/kg/day IV/IM divided q6-8hr in life-threatening infections; peak; adjust dose based on serum concentration monitoring; peak concentration >12 mcg/mL should be avoided

    Dosing Considerations

    Gentamicin may be administered IV/IM

    Infuse over 30-120 min when administering IV

    Dosing regimens are numerous and are adjusted based on CrCl and changes in volume of distribution, as well as on the body space where distribution of the agent will occur

    Monitor peak (4-12 mg/L) and trough (1-2 mg/L)

    Monitor nephrotoxicity, neurotoxicity, and ototoxicity; assess at beginning of therapy and throughout

    Each regimen must be followed by at least trough level drawn on third or fourth dose, 30 min before dosing unless renal toxicity suspected

    May draw peak level 30 min after 30-min infusion has been completed or 1 hr after IM injection

    Use ideal body weight for mg/kg/dose; more accurate than total body weight

    Gentamicin is usually a first-line aminoglycoside against infections with gram-negative organisms such as Pseudomonas aeruginosa, Proteus, Escherichia coli, Klebsiella, Enterobacter, Serratia, and Citrobacter, as well as against Staphylococcus (gram- positive)

    Bacterial organisms causing susceptible infections

    • Susceptible infections include the following:
    • Pseudomonas aeruginosa
    • Proteus species (indole-positive and indole-negative)
    • Escherichia coli
    • Klebsiella-Enterobacter-Serratia species
    • Citrobacter species
    • Staphylococcus species (coagulase-positive and coagulase-negative)
    • Pseudomonas aeruginosa
    • Proteus species (indole-positive and indole-negative)
    • Escherichia coli
    • Klebsiella-Enterobacter-Serratia species
    • Citrobacter species
    • Staphylococcus species (coagulase-positive and coagulase-negative)

    Mycobacterium Infection (Orphan)

    Gentamicin liposome injection: For disseminated Mycobacterium avium-intracellulare infection

    Orphan indication sponsor

    • Liposome Company, Inc; One Research Way; Princeton, NJ 08540

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