Gentamicin 0.1% Oint 15gm (topical)
It is used to treat skin infections.
Drug Class
Antibiotic, Topical
Pharmacologic Class
Aminoglycoside
Pregnancy Category
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 certain bacterial skin infections. It works by killing the bacteria causing the infection.
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 necessary, the treated area may be covered 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 necessary, the treated area may be covered 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 before and after applying the ointment.
- Clean the affected skin area thoroughly before applying the ointment.
- Apply a thin layer of ointment to cover the entire affected area.
- Do not cover the treated area with a bandage or dressing unless directed by your doctor.
- Avoid getting the ointment in your eyes, nose, mouth, or other mucous membranes.
- Do not use for longer than prescribed, as this can lead to resistance or superinfection.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
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 film to the affected skin area 3 to 4 times daily.
Condition-Specific Dosing:
duration:
Treatment duration typically 7-10 days, or as directed by physician.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to potential for increased systemic absorption through immature skin or large surface areas).
Infant:
Not established (use with caution, similar to neonatal considerations).
Child:
Apply a thin film to the affected skin area 3 to 4 times daily. Use with caution, especially on large surface areas or broken skin.
Adolescent:
Apply a thin film to the affected skin area 3 to 4 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed for topical application due to minimal systemic absorption.
Moderate:
No adjustment typically needed for topical application due to minimal systemic absorption.
Severe:
No adjustment typically needed for topical application due to minimal systemic absorption. However, caution if applied to large, denuded areas where systemic absorption may occur.
Dialysis:
No adjustment typically needed for topical application.
Hepatic Impairment:
Mild:
No adjustment typically needed for topical application.
Moderate:
No adjustment typically needed for topical application.
Severe:
No adjustment typically needed for topical application.
Pharmacology
Mechanism of Action
Gentamicin is an aminoglycoside antibiotic that inhibits bacterial protein synthesis by binding 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 ultimately bacterial cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal (<1%) through intact skin; significantly increased with denuded skin, burns, or large surface area application.
Tmax:
Not well-defined for topical application; systemic absorption is generally negligible.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically relevant for topical application due to minimal systemic absorption.
ProteinBinding:
Not clinically relevant for topical application.
CnssPenetration:
No
Elimination:
HalfLife:
Not clinically relevant for topical application; if absorbed systemically, renal elimination half-life is approximately 2-3 hours.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
Primarily renal (unchanged) if systemically absorbed.
Unchanged:
Nearly 100% if systemically absorbed.
Pharmacodynamics
OnsetOfAction:
Local antibacterial effect begins shortly after application.
PeakEffect:
Not precisely defined for topical application; clinical improvement typically seen within a few days.
DurationOfAction:
Local effect persists until washed off or metabolized locally; reapplication is needed 3-4 times daily.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following severe side effects, contact your doctor or seek medical attention immediately. Although rare, some individuals may be at risk of life-threatening reactions when taking this medication. Be aware of the following signs and symptoms that may indicate a serious side effect:
- Allergic reaction symptoms, such as rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever)
- Respiratory issues, including wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking
- Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
As with any medication, side effects can occur. While many people may not experience any side effects or only minor ones, it's essential to monitor your response to the drug. If you notice any of the following side effects or any other unusual effects, consult your doctor or seek medical help:
- Irritation at the site where the medication was applied
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. For medical advice on side effects, contact your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following severe side effects, contact your doctor or seek medical attention immediately. Although rare, some individuals may be at risk of life-threatening reactions when taking this medication. Be aware of the following signs and symptoms that may indicate a serious side effect:
- Allergic reaction symptoms, such as rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever)
- Respiratory issues, including wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking
- Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
As with any medication, side effects can occur. While many people may not experience any side effects or only minor ones, it's essential to monitor your response to the drug. If you notice any of the following side effects or any other unusual effects, consult your doctor or seek medical help:
- Irritation at the site where the medication was applied
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. For medical advice on side effects, contact your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of worsening infection (e.g., increased redness, swelling, pain, pus)
- New or worsening skin irritation (e.g., severe itching, rash, burning, blistering)
- Signs of an allergic reaction (e.g., swelling of face/tongue, severe rash, difficulty breathing)
- Signs of systemic absorption (very rare with topical use, but seek medical attention if dizziness, ringing in ears, or decreased urination occur, especially if applied to large, broken skin areas).
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, any of 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 avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change the dose 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, any of 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 avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change the dose 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 period than prescribed by your healthcare provider. 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 using this medication during pregnancy or breast-feeding, allowing you to make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- If ingested, or if significant systemic absorption occurs (e.g., large amounts on denuded skin), symptoms could include: dizziness, vertigo, tinnitus, hearing loss, kidney impairment (decreased urine output, swelling), muscle weakness.
What to Do:
If accidental ingestion or suspected significant systemic absorption, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive; hemodialysis may be considered in severe systemic toxicity.
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of infection site
Rationale: To determine the extent and type of skin infection and suitability for gentamicin treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (e.g., reduction in redness, swelling, pus)
Frequency: Daily
Target: Improvement of infection signs
Action Threshold: Lack of improvement or worsening of symptoms after 3-5 days; consider alternative therapy or re-evaluation.
Signs of local irritation or hypersensitivity (e.g., itching, rash, burning)
Frequency: Daily
Target: Absence of new or worsening irritation
Action Threshold: Development of significant irritation or allergic reaction; discontinue use.
Signs of superinfection (e.g., fungal overgrowth)
Frequency: Periodically during treatment
Target: Absence of new infections
Action Threshold: Development of new signs of infection (e.g., white patches, unusual odor); consider antifungal or alternative therapy.
Symptom Monitoring
- Worsening redness or inflammation at the application site
- Increased pain or tenderness
- Pus or discharge that does not improve
- Spread of infection
- New rash, itching, or burning at the application site
- Signs of systemic absorption (rare): dizziness, hearing changes, kidney problems (especially if applied to large, broken skin areas)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal with topical use, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Limited data; theoretical risk of ototoxicity/nephrotoxicity if significant systemic absorption occurs, but unlikely with topical use.
Second Trimester:
Limited data; theoretical risk of ototoxicity/nephrotoxicity if significant systemic absorption occurs, but unlikely with topical use.
Third Trimester:
Limited data; theoretical risk of ototoxicity/nephrotoxicity if significant systemic absorption occurs, but unlikely with topical use.
Lactation
L3 (Moderately safe). Minimal systemic absorption is expected, making infant exposure unlikely. Use on breasts should be avoided to prevent direct infant ingestion.
Infant Risk:
Low risk due to minimal maternal systemic absorption and excretion into breast milk. Monitor infant for diarrhea or candidiasis.
Pediatric Use
Use with caution, especially in neonates and infants, or when applied to large surface areas or broken skin, as systemic absorption may be increased, leading to potential for systemic toxicity (e.g., ototoxicity, nephrotoxicity). Dosing should be carefully considered and monitored.
Geriatric Use
No specific dose adjustments are typically needed. However, elderly patients may have thinner skin, which could theoretically increase absorption, though this is generally not clinically significant for topical application. Monitor for skin irritation or signs of superinfection.
Clinical Information
Clinical Pearls
- Topical gentamicin is effective for superficial skin infections caused by susceptible bacteria.
- Avoid prolonged use (typically not more than 7-10 days) to minimize the risk of bacterial resistance and fungal superinfection.
- Not effective against fungal or viral infections.
- Discontinue use if signs of irritation, sensitization, or superinfection develop.
- Systemic absorption is minimal, but caution is warranted when applying to large areas of denuded skin, burns, or in patients with impaired renal function, as systemic effects (ototoxicity, nephrotoxicity) could theoretically occur.
Alternative Therapies
- Mupirocin ointment
- Bacitracin ointment
- Neomycin/Polymyxin B/Bacitracin (Triple Antibiotic Ointment)
- Retapamulin ointment
- Fusidic acid cream/ointment (where available)
Cost & Coverage
Average Cost:
$10 - $30 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred, as this information is crucial for proper treatment.