Gentamicin Pf Ped 10mg/ml Inj, 2ml
WARNING: This drug may cause kidney, nerve, and hearing problems (like long-lasting hearing loss), even at normal doses. The risk may be higher if you already have kidney or hearing problems, you take higher doses, or you use this drug for a long time. The risk may be higher in older people, infants, or with dehydration. Hearing loss can happen even after this drug is stopped. If you already have kidney problems or hearing problems, tell your doctor. You may need to have hearing and kidney tests.Do not use this drug if you are taking or have recently taken any drugs that can cause nerve, kidney, or hearing problems. This may be drugs like amphotericin B, bacitracin, cephaloridine, cisplatin, colistin, cyclosporine, ethacrynic acid, furosemide, paromomycin, polymyxin B, vancomycin, viomycin, or other drugs like this one. There are many other drugs that can do this. Ask your doctor or pharmacist if you are not sure.Muscle problems (muscle weakness) and severe breathing problems have happened with drugs like this one. The risk is higher in people who already have nerve or muscle problems like myasthenia gravis. The risk is also higher in people who are getting other drugs like those that are used to put you to sleep or to relax muscles. If you have questions, talk with the doctor.This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat bacterial infections.
Drug Class
Aminoglycoside Antibiotic
Pharmacologic Class
Bactericidal protein synthesis inhibitor (30S ribosomal subunit)
Pregnancy Category
Category D
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gentamicin is an antibiotic medication given by injection to treat serious bacterial infections. It works by stopping the growth of bacteria. It's very important to take this medicine exactly as prescribed and to have regular blood tests to ensure it's working safely and effectively.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Your doctor will administer this medication as an injection into a muscle or as an infusion into a vein over a period of time. It is essential to drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Your doctor will administer this medication as an injection into a muscle or as an infusion into a vein over a period of time. It is essential to drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Stay well-hydrated by drinking plenty of fluids, unless otherwise instructed by your doctor.
- Report any changes in hearing, balance, or urination immediately to your healthcare provider.
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:
Conventional dosing: 3-5 mg/kg/day IV/IM divided every 8 hours. Extended-interval dosing: 5-7 mg/kg IV/IM once daily.
Dose Range:
3 - 7 mg
Condition-Specific Dosing:
seriousInfections:
3-5 mg/kg/day IV/IM in 3 divided doses
urinaryTractInfections:
1-2 mg/kg/day IV/IM in 2-3 divided doses
endocarditisProphylaxis:
1.5 mg/kg IV/IM 30-60 minutes before procedure (max 120 mg)
Pediatric Dosing
Neonatal:
Premature or full-term <1 week: 2.5 mg/kg/dose IV/IM every 12-24 hours (adjust based on post-natal age and weight). Full-term 1 week to 4 weeks: 2.5 mg/kg/dose IV/IM every 8-12 hours.
Infant:
1 month to <1 year: 2.5 mg/kg/dose IV/IM every 8 hours.
Child:
1 year to 12 years: 2.5 mg/kg/dose IV/IM every 8 hours. (Total daily dose 7.5 mg/kg/day).
Adolescent:
12 years to 18 years: 2.5 mg/kg/dose IV/IM every 8 hours or 5-7 mg/kg IV/IM once daily (extended-interval dosing).
Dose Adjustments
Renal Impairment:
Mild:
CrCl 60-90 mL/min: Administer usual dose every 8-12 hours or extend interval for once-daily dosing.
Moderate:
CrCl 30-59 mL/min: Administer usual dose every 12-24 hours or extend interval for once-daily dosing.
Severe:
CrCl <30 mL/min: Administer usual dose every 24-48 hours or reduce dose and extend interval. Requires careful therapeutic drug monitoring.
Dialysis:
Hemodialysis: Administer 1-1.7 mg/kg post-dialysis. Peritoneal Dialysis: 0.5-1 mg/kg every 24 hours or 4-8 mg/L in dialysate. Requires therapeutic drug monitoring.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Gentamicin is a bactericidal aminoglycoside antibiotic. It irreversibly binds to the 30S ribosomal subunit of susceptible bacteria, inhibiting protein synthesis. This leads to misreading of the mRNA code, resulting in the production of non-functional proteins and disruption of bacterial cell membrane integrity.
Pharmacokinetics
Absorption:
Bioavailability:
Poor (oral), >90% (IM/IV)
Tmax:
0.5-1 hour (IM), End of infusion (IV)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
0.2-0.3 L/kg (increases in neonates, ascites, edema; decreases in dehydration)
ProteinBinding:
<30%
CnssPenetration:
Limited (poor penetration into CSF, even with inflamed meninges; higher in neonates)
Elimination:
HalfLife:
2-4 hours (adults with normal renal function); significantly prolonged in renal impairment and neonates
Clearance:
Primarily renal (glomerular filtration)
ExcretionRoute:
Renal (unchanged drug)
Unchanged:
>90%
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of IV administration)
PeakEffect:
Within 30-60 minutes post-infusion (IV) or 1 hour post-IM injection
DurationOfAction:
Concentration-dependent killing with a significant post-antibiotic effect (PAE) allowing for extended-interval dosing
Safety & Warnings
BLACK BOX WARNING
NEPHROTOXICITY: Aminoglycosides can cause nephrotoxicity. The risk is greater in patients with impaired renal function, those receiving prolonged therapy, or those receiving higher doses. OTOTOXICITY: Aminoglycosides can cause ototoxicity (vestibular and auditory). Vestibular toxicity is characterized by dizziness, vertigo, and ataxia. Auditory toxicity is characterized by tinnitus and hearing loss. The risk is greater in patients with impaired renal function, those receiving prolonged therapy, or those receiving higher doses. Concurrent use with other neurotoxic or nephrotoxic drugs should be avoided. NEUROMUSCULAR BLOCKADE: Aminoglycosides can cause neuromuscular blockade and respiratory paralysis, especially when given rapidly or to patients with pre-existing neuromuscular disorders (e.g., myasthenia gravis) or those receiving neuromuscular blocking agents.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention 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
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or loss of consciousness
+ Changes in vision
Dizziness or fainting
Balance problems
Ringing in the ears, hearing loss, or other changes in hearing
Muscle weakness
New or worsening breathing difficulties
Abnormal burning, numbness, or tingling sensations
Twitching
Seizures
Confusion
Extreme fatigue or weakness
Depression
Changes in vision
Fever
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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
Decreased appetite
Weight loss
Headache
Upset stomach or vomiting
Excessive saliva production
Mouth irritation or sores
Hair loss
Joint pain
This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention 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
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or loss of consciousness
+ Changes in vision
Dizziness or fainting
Balance problems
Ringing in the ears, hearing loss, or other changes in hearing
Muscle weakness
New or worsening breathing difficulties
Abnormal burning, numbness, or tingling sensations
Twitching
Seizures
Confusion
Extreme fatigue or weakness
Depression
Changes in vision
Fever
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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
Decreased appetite
Weight loss
Headache
Upset stomach or vomiting
Excessive saliva production
Mouth irritation or sores
Hair loss
Joint pain
This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
Seek Immediate Medical Attention If You Experience:
- Ringing in the ears (tinnitus)
- Hearing loss
- Dizziness or spinning sensation (vertigo)
- Difficulty with balance or walking
- Decreased amount of urine
- Swelling in the hands, ankles, or feet
- Unusual muscle weakness or difficulty breathing
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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe use, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems
Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to:
Start taking this medication
Stop taking this medication
Change the dosage of this medication or any other medication you are taking
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions.
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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe use, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems
Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to:
Start taking this medication
Stop taking this medication
Change the dosage of this medication or any other medication you are taking
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a known allergy to sulfites, consult with your doctor, as some formulations of this drug may contain sulfites.
Regular monitoring of your blood work, hearing, and other laboratory tests is crucial, as directed by your doctor. Do not exceed the recommended duration of treatment, as this may increase the risk of developing a secondary infection.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to experiencing side effects. Additionally, if you are breastfeeding, consult with your doctor to discuss potential risks to your baby and determine the best course of action.
Regular monitoring of your blood work, hearing, and other laboratory tests is crucial, as directed by your doctor. Do not exceed the recommended duration of treatment, as this may increase the risk of developing a secondary infection.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to experiencing side effects. Additionally, if you are breastfeeding, consult with your doctor to discuss potential risks to your baby and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Severe dizziness or vertigo
- Profound hearing loss
- Kidney failure (decreased urine output, swelling)
- Respiratory depression or paralysis
- Muscle weakness
What to Do:
Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment may involve hemodialysis to remove the drug from the body, supportive care, and administration of calcium salts for neuromuscular blockade.
Drug Interactions
Major Interactions
- Nephrotoxic drugs (e.g., amphotericin B, cisplatin, cyclosporine, NSAIDs, vancomycin, loop diuretics): Increased risk of nephrotoxicity.
- Ototoxic drugs (e.g., loop diuretics, vancomycin, cisplatin): Increased risk of ototoxicity.
- Neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium): Potentiation of neuromuscular blockade, leading to respiratory depression/paralysis.
- Botulinum toxin: Increased risk of neuromuscular blockade.
Moderate Interactions
- Cephalosporins (especially cephalothin): May increase risk of nephrotoxicity.
- Penicillins (e.g., piperacillin, ticarcillin): Inactivation of gentamicin in vitro when mixed directly; administer separately. May also reduce gentamicin levels in vivo in patients with severe renal impairment.
- Oral anticoagulants (e.g., warfarin): Potential for increased anticoagulant effect due to altered gut flora.
Minor Interactions
- Indomethacin (in neonates): May decrease renal clearance of gentamicin, leading to increased gentamicin levels.
Monitoring
Baseline Monitoring
Renal function (Serum Creatinine, BUN, CrCl)
Rationale: Gentamicin is renally eliminated; baseline function is crucial for dosing and to assess risk of nephrotoxicity.
Timing: Prior to first dose
Audiometry/Vestibular function
Rationale: To establish baseline for potential ototoxicity, especially in patients with pre-existing hearing/balance issues or those expected to receive prolonged therapy.
Timing: Prior to first dose (if indicated)
Electrolytes (Magnesium, Potassium, Calcium)
Rationale: Aminoglycosides can cause electrolyte disturbances and hypomagnesemia can exacerbate ototoxicity.
Timing: Prior to first dose
Routine Monitoring
Gentamicin serum concentrations (Peak and Trough)
Frequency: After 3rd or 4th dose (for conventional dosing); 1-2 doses (for extended-interval dosing); then as clinically indicated or with dose changes/renal function changes.
Target: Conventional: Peak 4-10 mcg/mL (depending on infection severity), Trough <2 mcg/mL. Extended-interval: Peak 20-30 mcg/mL, Trough undetectable or <1 mcg/mL.
Action Threshold: Levels outside target range require dose adjustment or interval change to optimize efficacy and minimize toxicity.
Renal function (Serum Creatinine, BUN, Urine Output)
Frequency: Daily or every 2-3 days during therapy, more frequently if renal function changes or risk factors for nephrotoxicity are present.
Target: Stable or improving renal function.
Action Threshold: Significant increase in serum creatinine (>0.5 mg/dL or >50% from baseline) or decrease in urine output warrants dose adjustment or discontinuation.
Electrolytes (Magnesium, Potassium, Calcium)
Frequency: Weekly or as clinically indicated.
Target: Normal ranges.
Action Threshold: Abnormalities require supplementation.
Audiometry/Vestibular function
Frequency: Periodically during prolonged therapy or if symptoms of ototoxicity develop.
Target: Stable hearing and balance.
Action Threshold: New or worsening hearing loss, tinnitus, or vertigo warrants discontinuation or dose reduction.
Symptom Monitoring
- Tinnitus (ringing in ears)
- Hearing loss (high-frequency first)
- Vertigo or dizziness
- Ataxia (loss of coordination)
- Nausea, vomiting (vestibular toxicity)
- Decreased urine output
- Swelling in extremities
- Unusual tiredness or weakness
- Muscle weakness or difficulty breathing (neuromuscular blockade)
Special Patient Groups
Pregnancy
Category D. Gentamicin crosses the placenta and has been associated with bilateral congenital deafness in children whose mothers received aminoglycosides during pregnancy. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, including ototoxicity.
Second Trimester:
Risk of fetal ototoxicity (auditory and vestibular damage).
Third Trimester:
Risk of fetal ototoxicity (auditory and vestibular damage).
Lactation
L3 (Moderately Safe). Gentamicin is excreted into breast milk in small amounts. Oral absorption by the infant is poor. Monitor breastfed infants for diarrhea, candidiasis, and potential effects on gut flora. Risk of ototoxicity or nephrotoxicity in the infant is low but theoretical.
Infant Risk:
Low risk of adverse effects due to poor oral absorption; monitor for gastrointestinal disturbances.
Pediatric Use
Gentamicin is commonly used in pediatric patients, including neonates, for serious infections. Dosing must be carefully calculated based on age, weight, and renal function, and therapeutic drug monitoring is essential due to variable pharmacokinetics and increased susceptibility to toxicity in this population, especially neonates and premature infants who have immature renal function and a larger volume of distribution.
Geriatric Use
Elderly patients are at increased risk for gentamicin-induced nephrotoxicity and ototoxicity due to age-related decline in renal function and pre-existing hearing impairment. Dosing should be carefully adjusted based on renal function, and close monitoring of serum concentrations and renal function is crucial.
Clinical Information
Clinical Pearls
- Therapeutic Drug Monitoring (TDM) is critical for gentamicin to optimize efficacy and minimize toxicity. Peak and trough levels should be measured.
- Extended-interval (once-daily) dosing is often preferred in adults with normal renal function due to its concentration-dependent killing and post-antibiotic effect, potentially reducing nephrotoxicity and simplifying administration.
- Ensure adequate hydration to minimize the risk of nephrotoxicity.
- Avoid concurrent use with other nephrotoxic or ototoxic medications whenever possible.
- Gentamicin is ineffective against anaerobic bacteria and should be used in combination with other agents for polymicrobial infections.
- The 'Pf' in 'Gentamicin Pf Ped' likely indicates 'preservative-free', which is important for neonatal and pediatric use to avoid benzyl alcohol toxicity.
Alternative Therapies
- Other aminoglycosides (e.g., tobramycin, amikacin, streptomycin)
- Beta-lactam antibiotics (e.g., piperacillin/tazobactam, meropenem) for Gram-negative infections
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) for susceptible Gram-negative infections (use with caution in pediatrics)
- Polymyxins (e.g., colistin) for multi-drug resistant Gram-negative infections
Cost & Coverage
Average Cost:
Varies widely, typically low cost for generic per vial
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. 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 a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult your pharmacist, as they may be aware of drug take-back programs in your area. Additionally, some medications may have a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about this medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.