Gentamicin 0.1% Cream 15gm
It is used to treat skin infections.
Drug Class
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's 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 that 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
If you miss a dose, apply it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's 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 that 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
If you miss a dose, apply it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Wash hands before and after applying the cream.
- Clean the affected area before applying the cream.
- Apply a thin layer of cream to cover the entire affected area.
- Do not cover the treated area with bandages or dressings unless directed by your doctor.
- Use the cream for the full prescribed duration, even if symptoms improve, to prevent the infection from returning.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not use on large areas of skin or for prolonged periods without consulting a doctor.
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 area 3 to 4 times daily
Condition-Specific Dosing:
duration:
Typically 7-10 days, or as directed by physician
Pediatric Dosing
Neonatal:
Not established for routine use; use with caution due to increased systemic absorption risk in premature infants and neonates with immature skin barrier. Consult pediatrician.
Infant:
Apply a thin film to affected skin area 3 to 4 times daily; use with caution due to increased systemic absorption risk. Consult pediatrician.
Child:
Apply a thin film to affected skin area 3 to 4 times daily
Adolescent:
Apply a thin film to affected skin area 3 to 4 times daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption. Use with caution if applied to large areas of compromised skin, as systemic absorption could occur.
Dialysis:
No adjustment typically required due to minimal systemic absorption. Use with caution if applied to large areas of compromised skin.
Hepatic Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption.
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 systemic absorption through intact skin (<1%). Increased absorption can occur with denuded skin, burns, or large surface area application.
Tmax:
Not applicable for topical use (systemic Tmax not clinically relevant for topical application).
FoodEffect:
Not applicable for topical use.
Distribution:
Vd:
Not clinically relevant for topical use.
ProteinBinding:
Not clinically relevant for topical use (systemic: 0-30%).
CnssPenetration:
Limited (not clinically relevant for topical use).
Elimination:
HalfLife:
Not clinically relevant for topical use (systemic: 2-4 hours).
Clearance:
Not clinically relevant for topical use.
ExcretionRoute:
Primarily renal if absorbed systemically, but minimal for topical application.
Unchanged:
Not clinically relevant for topical use.
Pharmacodynamics
OnsetOfAction:
Within hours to days for clinical improvement.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Maintained with regular application.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. Many people have either no side effects or only mild ones. If you encounter any of the following side effects, or if any other side effects bother you or do not go away, contact your doctor for advice:
- Irritation at the site where the drug was applied.
Important Note
This list does not include all possible side effects. If you have concerns about side effects, consult your doctor. For medical advice regarding side effects, contact your doctor. You can also 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 symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. Many people have either no side effects or only mild ones. If you encounter any of the following side effects, or if any other side effects bother you or do not go away, contact your doctor for advice:
- Irritation at the site where the drug was applied.
Important Note
This list does not include all possible side effects. If you have concerns about side effects, consult your doctor. For medical advice regarding side effects, contact 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, swelling, or irritation at the application site (may indicate an allergic reaction or worsening infection).
- Signs of a new infection (e.g., fungal infection, different type of bacterial infection).
- Lack of improvement in symptoms after 3-5 days of use.
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) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other 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 symptoms you experienced as a result of the allergy.
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, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other 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. Do not exceed the recommended duration of use, as this may increase the risk of a second infection occurring. If you are pregnant, planning to become pregnant, or are currently breast-feeding, you must consult with your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Systemic overdose from topical application is highly unlikely due to minimal absorption. However, if large amounts are ingested or absorbed through severely damaged skin, symptoms could include: dizziness, vertigo, hearing loss, ringing in the ears, kidney problems (decreased urination), muscle weakness.
What to Do:
If accidental ingestion or significant systemic absorption is suspected, seek immediate medical attention or call a poison control center (1-800-222-1222).
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of skin infection
Rationale: To determine suitability of treatment and establish baseline for monitoring improvement.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs of infection improvement (e.g., reduced redness, swelling, pus)
Frequency: Daily
Target: Progressive resolution of symptoms
Action Threshold: Lack of improvement or worsening of symptoms after 3-5 days; consider alternative therapy or re-evaluation.
Local skin reactions (e.g., irritation, itching, rash)
Frequency: Daily
Target: Absence or minimal reaction
Action Threshold: Significant irritation, rash, or signs of allergic reaction; discontinue use.
Symptom Monitoring
- Redness
- Swelling
- Pain
- Pus or discharge
- Itching
- Rash
- Signs of superinfection (e.g., fungal infection)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal with topical application, but 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. Aminoglycosides are known to cross the placenta and have caused fetal ototoxicity with systemic use.
Lactation
L3 (Moderately Safe). Minimal systemic absorption is expected, making infant exposure low. Use with caution, especially if applied to large areas or if the infant has compromised skin. Avoid applying to areas where the infant may ingest the cream.
Infant Risk:
Low risk of adverse effects in breastfed infants due to minimal maternal systemic absorption and excretion into breast milk.
Pediatric Use
Use with caution in neonates and infants due to their immature skin barrier and higher surface area to body weight ratio, which can lead to increased systemic absorption and potential for systemic toxicity (ototoxicity, nephrotoxicity). Avoid prolonged use or application to large areas.
Geriatric Use
No specific dosage adjustments are typically required. Use with caution if there is significant skin breakdown or renal impairment, as systemic absorption could theoretically increase the risk of adverse effects, though this is rare with topical use.
Clinical Information
Clinical Pearls
- Gentamicin cream is effective against a wide range of Gram-negative bacteria, including Pseudomonas aeruginosa, and some Gram-positive bacteria.
- Resistance to gentamicin can develop, so it should be used judiciously and for appropriate indications.
- Advise patients to complete the full course of therapy, even if symptoms improve, to prevent recurrence and development of resistance.
- Warn patients about potential for local irritation or sensitization; discontinue if these occur.
- Avoid prolonged use, especially on large areas or broken skin, to minimize the theoretical risk of systemic absorption and associated toxicities (ototoxicity, nephrotoxicity).
Alternative Therapies
- Mupirocin (topical)
- Fusidic acid (topical)
- Retapamulin (topical)
- Bacitracin/Neomycin/Polymyxin B (triple antibiotic ointment)
- Topical clindamycin (for acne, not general skin infections)
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 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 information about the medication taken, the amount, and the time it happened.