Vancomycin 500mg Inj, 1 Vial

Manufacturer HOSPIRA Active Ingredient Vancomycin Injection(van koe MYE sin) Pronunciation van koe MYE sin
WARNING: Some products are not for use during the first and second trimesters of pregnancy. These products contain other things that may cause harm to the unborn baby. If you are pregnant, talk with your doctor. @ COMMON USES: It is used to treat or prevent bacterial infections.If taken by mouth, some products can be used to treat certain types of bowel infections. This includes C diff.
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Drug Class
Antibiotic
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Pharmacologic Class
Glycopeptide Antibiotic; Cell Wall Synthesis Inhibitor
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Pregnancy Category
C
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FDA Approved
Mar 1958
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Vancomycin is a strong antibiotic used to treat serious bacterial infections, especially those resistant to other common antibiotics. It works by stopping bacteria from building their cell walls, which kills them. It is usually given through a vein (IV) in a hospital setting.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the instructions closely. This medication is typically administered as an intravenous infusion, which means it is given through a vein over a period of time. In some cases, your doctor may prescribe an oral form of this medication, which can be taken by mouth or administered through a feeding tube as an alternative to injection.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

Missing a Dose

If you miss a dose, contact your doctor immediately to receive guidance on what to do next.
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Lifestyle & Tips

  • Report any side effects immediately, especially ringing in the ears, hearing changes, dizziness, or decreased urination.
  • Stay well-hydrated unless otherwise instructed by your doctor.
  • Inform healthcare providers about all medications you are taking, including over-the-counter drugs and supplements.

Dosing & Administration

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Adult Dosing

Standard Dose: 15-20 mg/kg IV every 8-12 hours (initial dose), not to exceed 2 g per dose
Dose Range: 1000 - 4000 mg

Condition-Specific Dosing:

severeInfections: 15-20 mg/kg IV every 8-12 hours, targeting trough levels of 15-20 mcg/mL
moderateInfections: 15 mg/kg IV every 12 hours, targeting trough levels of 10-15 mcg/mL
surgicalProphylaxis: 15 mg/kg IV administered 2 hours prior to incision
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Pediatric Dosing

Neonatal: 15 mg/kg IV loading dose, then 10 mg/kg IV every 12-24 hours (frequency depends on postmenstrual age and postnatal age), targeting trough levels of 10-15 mcg/mL
Infant: 15 mg/kg IV loading dose, then 10 mg/kg IV every 6-12 hours, targeting trough levels of 10-15 mcg/mL
Child: 15 mg/kg IV loading dose, then 10 mg/kg IV every 6-8 hours, targeting trough levels of 10-15 mcg/mL (or 15-20 mcg/mL for severe infections)
Adolescent: 15 mg/kg IV every 8-12 hours, targeting trough levels of 10-15 mcg/mL (or 15-20 mcg/mL for severe infections)
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: 15 mg/kg IV every 12-24 hours or adjust dose based on trough levels
Moderate: CrCl 30-49 mL/min: 15 mg/kg IV every 24-48 hours or adjust dose based on trough levels
Severe: CrCl <30 mL/min: Initial dose 15 mg/kg IV, then subsequent doses based on trough levels (e.g., 15 mg/kg IV every 48-96 hours or less frequently)
Dialysis: Hemodialysis: Initial dose 15 mg/kg IV, then 500-1000 mg IV after each dialysis session or based on trough levels. Peritoneal Dialysis: 15-20 mg/kg IV loading dose, then 15 mg/kg IV every 7 days or based on trough levels.

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: No specific adjustment needed

Pharmacology

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Mechanism of Action

Vancomycin inhibits bacterial cell wall synthesis by binding with high affinity to the D-Ala-D-Ala terminus of the peptidoglycan precursor units. This binding prevents the transpeptidation (cross-linking) and transglycosylation (elongation) steps, leading to weakened cell walls and bacterial lysis. It is bactericidal against most susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Approximately 1 hour (after end of IV infusion)
FoodEffect: Not applicable for IV administration

Distribution:

Vd: 0.4-1 L/kg (adults), higher in neonates and infants
ProteinBinding: 10-50%
CnssPenetration: Limited (unless meninges are inflamed)

Elimination:

HalfLife: 4-6 hours (normal renal function), significantly prolonged in renal impairment
Clearance: Primarily renal clearance, proportional to creatinine clearance
ExcretionRoute: Renal (glomerular filtration)
Unchanged: Approximately 80-90% excreted unchanged in urine
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV infusion)
PeakEffect: Within 1 hour of IV infusion completion
DurationOfAction: Dose-dependent, typically 8-24 hours based on renal function and target trough levels

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 attention immediately:

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
Severe skin reactions, such as:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that can affect body organs and be life-threatening
+ Symptoms may include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
If you receive this medication through a vein (intravenous injection):
+ Fever
+ Chills
+ Sore throat
+ Pain when passing urine
+ Changes in balance
+ Flushing
+ Rash on the face, neck, trunk, and arms during infusion
If the medication is given too quickly, you may experience:
+ Shortness of breath or wheezing
+ Itching
+ Muscle pain
+ Chest pain
+ Signs of low blood pressure, such as dizziness or fainting
If the medication leaks from the vein, it can cause tissue damage. Inform your nurse immediately if you experience:
+ Redness
+ Burning
+ Pain
+ Swelling
+ Blisters
+ Skin sores
+ Leaking of fluid at the injection site

Other Possible Side Effects

Like all medications, this drug can cause side effects, although not everyone will experience them. If you have any of the following side effects or any other concerns, contact your doctor:

Diarrhea
Stomach pain
Upset stomach
Vomiting

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe rash, hives, or itching (especially with flushing of the face, neck, and upper body - 'Red Man Syndrome')
  • Difficulty breathing or swallowing
  • Swelling of the face, throat, or tongue
  • Ringing in the ears (tinnitus) or hearing loss
  • Dizziness or vertigo
  • Decreased urination or swelling in the legs/feet (signs of kidney problems)
  • Severe diarrhea (may indicate C. difficile infection)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
Describe the allergic reaction you experienced, including any symptoms that occurred.

This medication may interact with other medications or worsen certain health conditions. To ensure safe use, disclose the following information to your doctor and pharmacist:
- All prescription and over-the-counter (OTC) medications you are taking
- Any natural products or vitamins you are using
- Existing health problems or conditions

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so with your current medications and health conditions.
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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 history of kidney problems or kidney failure, notify your doctor, as this medication can cause kidney issues. Your doctor will likely recommend regular blood work and other laboratory tests to monitor your condition.

Long-term use of this medication may increase the risk of permanent hearing loss. Do not exceed the prescribed duration of treatment, and immediately report any changes in hearing or hearing loss to your doctor. Your doctor may also recommend regular hearing tests during treatment.

To minimize the risk of a second infection, do not use this medication for longer than prescribed.

As with many antibiotics, diarrhea is a common side effect. However, in rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) can occur, potentially leading to life-threatening bowel problems. CDAD may develop during or after treatment, sometimes several months later. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor promptly. Before treating diarrhea, consult your doctor for advice.

This medication is not approved for injection into the eye, as it can cause severe eye problems, including permanent vision loss.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. If you are of childbearing age, your doctor may require a pregnancy test before starting treatment to confirm that you are not pregnant.
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Overdose Information

Overdose Symptoms:

  • Severe nephrotoxicity (kidney damage)
  • Ototoxicity (hearing loss, tinnitus)
  • Hypotension
  • Red Man Syndrome (exaggerated)

What to Do:

There is no specific antidote for vancomycin overdose. Treatment is supportive, including maintaining hydration, monitoring renal function, and potentially hemodialysis to remove the drug from the body. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Aminoglycosides (e.g., gentamicin, tobramycin, amikacin): Increased risk of nephrotoxicity and ototoxicity.
  • Loop diuretics (e.g., furosemide): May increase risk of ototoxicity.
  • Cisplatin: Increased risk of nephrotoxicity and ototoxicity.
  • Polymyxins (e.g., colistin, polymyxin B): Increased risk of nephrotoxicity.
  • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium): May potentiate and prolong neuromuscular blockade.
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Moderate Interactions

  • Amphotericin B: Increased risk of nephrotoxicity.
  • Cyclosporine: Increased risk of nephrotoxicity.
  • Tacrolimus: Increased risk of nephrotoxicity.
  • NSAIDs (e.g., ibuprofen, naproxen): May increase risk of nephrotoxicity.
  • Radiographic contrast media: Increased risk of nephrotoxicity.

Monitoring

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Baseline Monitoring

Renal function (Serum Creatinine, BUN, CrCl)

Rationale: Vancomycin is primarily renally eliminated; baseline function is crucial for dosing and monitoring for nephrotoxicity.

Timing: Prior to initiation of therapy

Audiometric testing (if pre-existing hearing impairment or prolonged therapy anticipated)

Rationale: To establish baseline for potential ototoxicity.

Timing: Prior to initiation of therapy

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Routine Monitoring

Vancomycin Trough Levels

Frequency: Prior to the 4th or 5th dose (at steady state), then at least weekly for prolonged therapy, or more frequently with renal impairment/unstable renal function.

Target: 10-15 mcg/mL (for most infections), 15-20 mcg/mL (for severe infections like MRSA bacteremia, endocarditis, osteomyelitis, meningitis)

Action Threshold: Levels outside target range require dose adjustment; levels >20 mcg/mL increase risk of toxicity.

Renal function (Serum Creatinine, BUN)

Frequency: At least 2-3 times per week, or daily in critically ill patients or those with unstable renal function.

Target: Within patient's baseline range

Action Threshold: Increase in serum creatinine by â‰Ĩ0.5 mg/dL or â‰Ĩ50% from baseline (whichever is greater) suggests acute kidney injury and requires dose adjustment or discontinuation.

Fluid balance and urine output

Frequency: Daily

Target: Adequate hydration and urine output

Action Threshold: Oliguria or significant fluid retention may indicate renal impairment.

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Symptom Monitoring

  • Red man syndrome (flushing, rash, pruritus, urticaria, tachycardia, hypotension) - usually with rapid infusion
  • Ototoxicity (tinnitus, vertigo, hearing loss)
  • Nephrotoxicity (decreased urine output, swelling, fatigue)
  • Hypersensitivity reactions (rash, fever, chills)
  • Neutropenia (rare, usually with prolonged therapy)
  • Thrombophlebitis (at infusion site)

Special Patient Groups

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Pregnancy

Vancomycin is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited data suggest it crosses the placenta. Close monitoring of maternal vancomycin levels and fetal auditory function may be considered.

Trimester-Specific Risks:

First Trimester: Limited human data; animal studies show no evidence of teratogenicity.
Second Trimester: Crosses placenta; potential for fetal exposure. Risk of ototoxicity and nephrotoxicity in fetus is theoretical but not well-established in humans.
Third Trimester: Crosses placenta; potential for fetal exposure. Risk of ototoxicity and nephrotoxicity in fetus is theoretical but not well-established in humans.
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Lactation

Vancomycin is excreted into breast milk in small amounts. The amount ingested by the infant is generally considered low. Risk of adverse effects in the infant (e.g., disruption of gut flora, allergic sensitization) is theoretical but generally considered low. Monitor breastfed infants for diarrhea, candidiasis, or rash. Use with caution, especially in preterm infants or those with impaired renal function.

Infant Risk: L3 (Moderate risk) - Monitor infant for GI upset, candidiasis, or rash. Consider alternative if infant is premature or has renal impairment.
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Pediatric Use

Dosing is weight-based and often requires therapeutic drug monitoring (trough levels) to ensure efficacy and minimize toxicity. Renal function is highly variable in neonates and infants, requiring careful dose adjustment and frequent monitoring. Higher doses per kg may be needed in children due to faster clearance.

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Geriatric Use

Elderly patients are more likely to have age-related decline in renal function, which can significantly prolong vancomycin half-life and increase the risk of accumulation and toxicity (nephrotoxicity, ototoxicity). Dosing should be carefully adjusted based on estimated creatinine clearance and therapeutic drug monitoring. Start with lower doses and monitor closely.

Clinical Information

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Clinical Pearls

  • Always administer vancomycin IV infusions slowly over at least 60 minutes (or 10 mg/min) to prevent 'Red Man Syndrome'.
  • Therapeutic drug monitoring (trough levels) is essential for optimizing efficacy and minimizing toxicity, especially for severe infections or in patients with unstable renal function.
  • Target trough levels for severe infections (e.g., MRSA bacteremia, endocarditis) are 15-20 mcg/mL, while for less severe infections, 10-15 mcg/mL may be sufficient.
  • Hydration is important to minimize the risk of nephrotoxicity.
  • Avoid concomitant use with other nephrotoxic or ototoxic drugs whenever possible, or monitor renal function and hearing even more closely if co-administration is necessary.
  • Oral vancomycin is used ONLY for Clostridioides difficile infection and is not absorbed systemically; IV vancomycin is ineffective for C. difficile.
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Alternative Therapies

  • Linezolid (for MRSA, VRE)
  • Daptomycin (for MRSA, VRE)
  • Ceftaroline (for MRSA)
  • Telavancin (for MRSA)
  • Dalbavancin (for MRSA)
  • Oritavancin (for MRSA)
  • Tigecycline (for MRSA, VRE)
  • Clindamycin (for susceptible MRSA, but resistance is common)
  • Trimethoprim-sulfamethoxazole (for susceptible MRSA)
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Cost & Coverage

Average Cost: $10 - $50 per 500mg vial (generic)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred brand/non-preferred generic)
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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, and do not take medication prescribed for someone else. 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. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.