Gentamicin 0.1% Cream 30gm
It is used to treat skin infections.
Drug Class
Topical antibiotic
Pharmacologic Class
Aminoglycoside antibiotic
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gentamicin cream is an antibiotic medicine applied to the skin to treat certain bacterial skin infections. It works by stopping the growth of bacteria.
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 before and after applying the cream.
- Apply a thin layer of cream only to the affected skin area.
- Do not cover the treated area with bandages or dressings unless your doctor tells you to.
- Avoid getting the cream in your eyes, nose, mouth, or other mucous membranes. If it gets into your eyes, rinse thoroughly with water.
- Do not use for longer than prescribed, typically no more than 7 days, to prevent resistance and side effects.
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 affected skin areas 3 to 4 times daily.
Dose Range:
3 - 4 mg
Condition-Specific Dosing:
duration:
Treatment should not exceed 7 days unless directed by a physician.
Pediatric Dosing
Neonatal:
Not established. Use with caution due to increased systemic absorption risk through immature skin barrier.
Infant:
Not established. Use with caution due to increased systemic absorption risk through immature skin barrier.
Child:
Apply a thin film to affected skin areas 3 to 4 times daily. Use with caution on large surface areas or broken skin.
Adolescent:
Apply a thin film to affected skin areas 3 to 4 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required for topical use on intact skin.
Moderate:
No adjustment typically required for topical use on intact skin.
Severe:
No adjustment typically required for topical use on intact skin. Use with caution if applied to large areas of compromised skin due to potential for systemic absorption.
Dialysis:
No adjustment typically required for topical use on intact skin. Use with caution if applied to large areas of compromised skin due to potential for systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically required for topical use.
Moderate:
No adjustment typically required for topical use.
Severe:
No adjustment typically required for topical use.
Pharmacology
Mechanism of Action
Gentamicin is an aminoglycoside antibiotic that inhibits bacterial protein synthesis by irreversibly 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. Increased absorption can occur with denuded skin, burns, large surface areas, or occlusive dressings.
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically significant for topical application due to minimal systemic absorption.
ProteinBinding:
Not clinically significant for topical application due to minimal systemic absorption.
CnssPenetration:
Limited (not clinically relevant for topical use).
Elimination:
HalfLife:
Not clinically significant for topical application due to minimal systemic absorption.
Clearance:
Not clinically significant for topical application due to minimal systemic absorption.
ExcretionRoute:
Primarily local action; minimal systemic excretion via kidneys if absorbed.
Unchanged:
Not applicable for topical formulation.
Pharmacodynamics
OnsetOfAction:
Within hours to days (local antibacterial effect).
PeakEffect:
Within days of consistent application.
DurationOfAction:
Maintained with regular application.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as:
- 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
- Irritation at the site where the medication was applied
- Any other side effects that bother you or do not go away
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. For medical advice 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as:
- 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
- Irritation at the site where the medication was applied
- Any other side effects that bother you or do not go away
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. For medical advice 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.
Seek Immediate Medical Attention If You Experience:
- Increased redness, itching, burning, or swelling at the application site (may indicate irritation or allergic reaction).
- Signs that the infection is getting worse (e.g., increased pus, fever, spreading redness).
- Development of a new infection (e.g., fungal infection, different type of rash) in the treated area.
- Though rare with topical use, report any changes in hearing, dizziness, or changes in urination (signs of potential systemic absorption).
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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Do not initiate, discontinue, or modify 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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all 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. 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 to help you make an informed decision.
Overdose Information
Overdose Symptoms:
- Overdose with topical gentamicin is highly unlikely due to minimal systemic absorption. However, excessive application to large areas of broken skin could theoretically lead to systemic effects similar to injectable gentamicin, such as kidney problems (decreased urination) or hearing problems (ringing in ears, hearing loss), though this is extremely rare.
What to Do:
If accidental ingestion or excessive application to compromised skin occurs, contact a poison control center immediately (Call 1-800-222-1222 in the US) or seek emergency medical attention. Treatment would be supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of skin infection
Rationale: To confirm bacterial infection and suitability for gentamicin cream.
Timing: Prior to initiation of therapy.
Routine Monitoring
Resolution of infection signs (redness, swelling, pus)
Frequency: Daily
Target: Improvement or resolution of symptoms
Action Threshold: Lack of improvement or worsening symptoms after 3-5 days; discontinue and re-evaluate.
Local skin reactions (irritation, itching, rash)
Frequency: Daily
Target: Absence or minimal reaction
Action Threshold: Significant irritation, itching, or rash; discontinue use.
Symptom Monitoring
- Signs of worsening infection (increased pain, redness, swelling, fever)
- Signs of allergic reaction (severe rash, hives, swelling, difficulty breathing)
- Signs of superinfection (new fungal or non-susceptible bacterial infection)
- Signs of systemic absorption (rare, but consider if applied to large areas of compromised skin: hearing changes, dizziness, kidney function changes)
Special Patient Groups
Pregnancy
Category C. While systemic absorption from topical application is minimal, gentamicin is an aminoglycoside, which can cause fetal harm (e.g., ototoxicity) when administered systemically. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for risk, but minimal systemic absorption reduces concern.
Second Trimester:
Potential for risk, but minimal systemic absorption reduces concern.
Third Trimester:
Potential for risk, but minimal systemic absorption reduces concern. Aminoglycosides are known to cross the placenta.
Lactation
L3 (Moderate risk). It is not known whether topical gentamicin is excreted in human milk. Due to minimal systemic absorption, significant exposure to the infant is unlikely. However, caution should be exercised. Avoid applying to the breast area to prevent direct infant ingestion.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption by the mother.
Pediatric Use
Use with caution in neonates and infants due to their immature skin barrier, which can lead to increased systemic absorption and potential for systemic toxicity (e.g., ototoxicity, nephrotoxicity) at higher doses or with prolonged use on large surface areas or broken skin. Close monitoring is recommended.
Geriatric Use
No specific dosage adjustments are typically required for topical use in geriatric patients. However, older adults may have thinner skin, which could theoretically increase absorption, though this is generally not clinically significant for topical gentamicin on intact skin.
Clinical Information
Clinical Pearls
- Gentamicin cream is for external use only. Do not ingest.
- Systemic absorption is minimal through intact skin, but can increase significantly if applied to large areas of denuded skin, burns, or with occlusive dressings.
- Prolonged use or use on large areas of compromised skin, especially in patients with renal impairment, can rarely lead to systemic aminoglycoside toxicity (ototoxicity, nephrotoxicity).
- Discontinue use if irritation or sensitization occurs.
- Not effective against fungal or viral infections.
- Risk of bacterial resistance development with prolonged or inappropriate use.
Alternative Therapies
- Mupirocin cream/ointment (for impetigo, other skin infections)
- Retapamulin ointment
- Bacitracin ointment
- Neomycin/Polymyxin B/Bacitracin (Triple antibiotic ointment)
- Fusidic acid cream/ointment (where available)
Cost & Coverage
Average Cost:
$15 - $40 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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 details. If you have any questions or concerns about this 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 reporting the incident, be prepared to provide information about the medication taken, the amount, and the time it occurred.