Gentamicin 0.1% Oint 30gm (topical)
It is used to treat skin infections.
Drug Class
Topical Antibiotic
Pharmacologic Class
Aminoglycoside Antibiotic
Pregnancy Category
C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gentamicin ointment is an antibiotic medicine applied to the skin to treat bacterial infections. It works by stopping the growth of certain bacteria that cause skin infections.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
If recommended by your doctor, you may cover the treated area with a dressing.
Storage and Disposal
Store this medication at room temperature, away from heat and moisture.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications. You may also want to explore drug take-back programs in your area.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
If recommended by your doctor, you may cover the treated area with a dressing.
Storage and Disposal
Store this medication at room temperature, away from heat and moisture.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications. You may also want to explore drug take-back programs in your area.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash your hands thoroughly before and after applying the ointment.
- Clean the affected skin area gently before applying the medicine.
- Apply a thin layer of ointment to cover the entire infected area.
- Do not cover the treated area with bandages or dressings unless your doctor tells you to, as this can increase absorption.
- Avoid getting the ointment in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
- Do not use this medicine for longer than prescribed, as it can lead to resistant bacteria or side effects.
- Do not share this medicine with others.
Available Forms & Alternatives
Available Strengths:
- Gentamicin 0.3% Ophth Soln 5ml
- Gentamicin 0.3% Ophth Solution
- Gentamicin 40mg/ml Inj, 2ml
- Gentamicin 0.1% Cream 15gm
- Gentamicin 40mg/ml Inj, 20ml
- Gentamicin 0.1% Cream 30gm
- Gentamicin Pf Ped 10mg/ml Inj, 2ml
- Gentamicin 0.1% Oint 15gm (topical)
- Gentamicin 0.1% Oint 30gm (topical)
- Gentamicin 80mg/ml Inj, 2ml
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected area 3-4 times daily.
Pediatric Dosing
Neonatal:
Use with caution; Not established for routine use due to potential for increased systemic absorption through immature skin barrier.
Infant:
Use with caution; Not established for routine use due to potential for increased systemic absorption through immature skin barrier.
Child:
Apply a thin layer to the affected area 3-4 times daily, under medical supervision.
Adolescent:
Apply a thin layer to the affected area 3-4 times daily.
Dose Adjustments
Renal Impairment:
Mild:
Not applicable for topical use due to minimal systemic absorption.
Moderate:
Not applicable for topical use due to minimal systemic absorption.
Severe:
Not applicable for topical use due to minimal systemic absorption.
Dialysis:
Not applicable for topical use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
Not applicable for topical use due to minimal systemic absorption.
Moderate:
Not applicable for topical use due to minimal systemic absorption.
Severe:
Not applicable for topical use due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Gentamicin is an aminoglycoside antibiotic that inhibits bacterial protein synthesis by binding irreversibly to the 30S ribosomal subunit, leading to misreading of the mRNA code and premature termination of protein synthesis. This results in the production of non-functional proteins and disruption of bacterial cell membrane integrity.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption through intact skin. Absorption may be increased with denuded skin, burns, or occlusive dressings.
Tmax:
Not applicable for topical administration (systemic absorption is minimal).
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not applicable for topical administration (minimal systemic distribution).
ProteinBinding:
Not applicable for topical administration (minimal systemic distribution).
CnssPenetration:
No (for topical administration, minimal systemic absorption).
Elimination:
HalfLife:
Not applicable for topical administration (minimal systemic absorption).
Clearance:
Not applicable for topical administration (minimal systemic absorption).
ExcretionRoute:
Primarily renal if absorbed systemically, but minimal for topical use.
Unchanged:
Not applicable for topical administration (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within hours to days of initiation.
PeakEffect:
Peak therapeutic effect usually seen within several days of consistent application.
DurationOfAction:
Continuous with regular application as directed.
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Seek immediate medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:
Rash
Hives
Itching
Red, swollen, blistered, or peeling skin with or without fever
Wheezing
Tightness in the chest or throat
Trouble breathing, swallowing, or talking
Unusual hoarseness
Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
Irritation at the site where the medication was applied
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is available to provide medical advice about side effects.
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Seek immediate medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:
Rash
Hives
Itching
Red, swollen, blistered, or peeling skin with or without fever
Wheezing
Tightness in the chest or throat
Trouble breathing, swallowing, or talking
Unusual hoarseness
Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
Irritation at the site where the medication was applied
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is available to provide medical advice about side effects.
Seek Immediate Medical Attention If You Experience:
- Signs of worsening infection (e.g., increased redness, swelling, pain, pus)
- Signs of an allergic reaction (e.g., rash, itching, hives, severe dizziness, trouble breathing)
- New or unusual skin irritation at the application site
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, it is vital to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, it is vital to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To minimize the risk of a second infection, do not use this drug for a longer duration than prescribed. If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor immediately. Your doctor will discuss the potential benefits and risks of this medication with you, considering both your health and the health of your baby, to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to local irritation.
- If ingested, symptoms may include nausea, vomiting, diarrhea. Systemic toxicity (kidney damage, hearing loss) is rare but possible with large ingestions.
What to Do:
For local irritation, wash off excess ointment. If ingested, seek immediate medical attention or call a poison control center (1-800-222-1222). Management is supportive.
Drug Interactions
Contraindicated Interactions
- None known for topical use due to minimal systemic absorption.
Major Interactions
- None known for topical use due to minimal systemic absorption.
Moderate Interactions
- None known for topical use due to minimal systemic absorption.
Minor Interactions
- None known for topical use due to minimal systemic absorption.
Monitoring
Baseline Monitoring
Clinical assessment of infection (e.g., redness, swelling, pain, discharge)
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy.
Skin integrity of affected area
Rationale: To assess for open wounds, burns, or denuded skin which may increase systemic absorption.
Timing: Prior to initiation of therapy.
Routine Monitoring
Resolution of infection symptoms
Frequency: Daily
Target: Decrease in redness, swelling, pain, and discharge.
Action Threshold: Lack of improvement or worsening symptoms after 3-7 days may indicate treatment failure or resistant organism; re-evaluate.
Signs of local irritation or allergic reaction
Frequency: Daily
Target: Absence of increased redness, itching, rash, or swelling at application site.
Action Threshold: Discontinue if signs of irritation or hypersensitivity develop.
Symptom Monitoring
- Increased redness at application site
- Increased swelling at application site
- Increased pain at application site
- Increased pus or discharge
- Itching or rash at application site (signs of allergic reaction)
- Lack of improvement in infection symptoms
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Gentamicin is Pregnancy Category C. While systemic absorption from topical application is minimal, caution is advised.
Trimester-Specific Risks:
First Trimester:
Minimal risk due to low systemic absorption, but caution advised.
Second Trimester:
Minimal risk due to low systemic absorption, but caution advised.
Third Trimester:
Minimal risk due to low systemic absorption, but caution advised. Systemic aminoglycosides can cause fetal ototoxicity, but this is highly unlikely with topical use.
Lactation
Use with caution. Minimal systemic absorption is expected, making infant exposure via breast milk unlikely. However, avoid applying to areas where the infant might ingest the ointment (e.g., breast).
Infant Risk:
Low risk to infant due to minimal maternal systemic absorption.
Pediatric Use
Use with caution, especially in infants and neonates, due to their higher surface area to body weight ratio and potentially immature skin barrier, which may lead to increased systemic absorption. Avoid prolonged use or application to large areas.
Geriatric Use
Generally safe for use in geriatric patients. No specific dose adjustments are typically needed for topical application. Monitor for local skin reactions.
Clinical Information
Clinical Pearls
- For external use only. Do not ingest.
- Avoid prolonged use (typically more than 7-10 days) to prevent the development of bacterial resistance and minimize any potential for systemic absorption.
- Ensure the affected area is clean and dry before application.
- Not effective against fungal or viral infections.
- Discontinue use if signs of irritation, sensitization, or superinfection occur.
- Systemic absorption is increased if applied to large areas, broken skin, or under occlusive dressings.
Alternative Therapies
- Mupirocin (topical)
- Fusidic acid (topical)
- Retapamulin (topical)
- Oral antibiotics (for more severe or widespread infections, e.g., cephalexin, dicloxacillin)
Cost & Coverage
Average Cost:
$15 - $40 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, including the amount and time of ingestion.