Vancomycin 500mg/100ml Inj, 100ml

Manufacturer XELLIA PHARMACEUTICALS USA 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
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Pregnancy Category
Category C
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FDA Approved
Jun 1958
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Vancomycin is an antibiotic given through a vein (IV) to treat serious bacterial infections, especially those caused by bacteria resistant to other antibiotics, like MRSA. It works by stopping bacteria from building their cell walls, which kills them.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. This drug is typically administered as an infusion into a vein over a specified period of time. In some cases, your doctor may prescribe this medication to be taken orally or through a feeding tube as an alternative to injection.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage procedures.

If you miss a dose, contact your doctor immediately to determine the best course of action.
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Lifestyle & Tips

  • Report any changes in hearing or ringing in the ears immediately.
  • Report any signs of kidney problems, such as decreased urination or swelling.
  • Inform healthcare providers about all medications, supplements, and herbal products being taken.
  • Stay well-hydrated unless otherwise instructed by a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 15-20 mg/kg IV every 8-12 hours (initial dose), adjusted based on therapeutic drug monitoring (TDM)
Dose Range: 1000 - 2000 mg

Condition-Specific Dosing:

severeInfections: Initial dose up to 25-30 mg/kg IV, followed by 15-20 mg/kg IV every 8-12 hours, adjusted by TDM.
meningitis: 20 mg/kg IV every 8 hours (max 2g/dose), adjusted by TDM.
C.difficile_oral: Not applicable for IV formulation. Oral vancomycin is used for C. difficile.
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Pediatric Dosing

Neonatal: 15 mg/kg IV loading dose, then 10 mg/kg IV every 12-24 hours (postnatal age/gestational age dependent), adjusted by TDM.
Infant: 15 mg/kg IV loading dose, then 10 mg/kg IV every 8-12 hours, adjusted by TDM.
Child: 15 mg/kg IV loading dose, then 10 mg/kg IV every 6 hours (or 60 mg/kg/day divided every 6 hours), adjusted by TDM.
Adolescent: Same as adult dosing (15-20 mg/kg IV every 8-12 hours), adjusted by TDM.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Consider extending dosing interval or reducing dose. Monitor TDM closely.
Moderate: CrCl 20-49 mL/min: 15 mg/kg IV every 24-48 hours. Monitor TDM closely.
Severe: CrCl <20 mL/min: Initial dose 15 mg/kg IV, then subsequent doses based on TDM (e.g., 15 mg/kg every 3-7 days or as needed).
Dialysis: Hemodialysis: Initial dose 15 mg/kg IV, then 500-1000 mg after each dialysis session or based on TDM. Peritoneal Dialysis: 15 mg/kg IV loading dose, then 15 mg/kg IV every 5-7 days or 30 mg/L in dialysate. Monitor TDM closely.

Hepatic Impairment:

Mild: No specific dose adjustment required, as vancomycin is minimally metabolized by the liver.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required.

Pharmacology

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Mechanism of Action

Vancomycin is a tricyclic glycopeptide antibiotic that inhibits bacterial cell wall synthesis by binding to the D-Ala-D-Ala terminus of the peptidoglycan precursor. This binding prevents the transglycosylation and transpeptidation steps, leading to cell lysis and bacterial death. It is bactericidal against susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (IV administration for systemic effect); Oral bioavailability is <10% for systemic absorption.
Tmax: End of infusion (for IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: 0.4-1 L/kg (adults)
ProteinBinding: 30-55%
CnssPenetration: Limited (increased in inflamed meninges)

Elimination:

HalfLife: 4-6 hours (normal renal function); significantly prolonged in renal impairment (up to 7-9 days in anuric patients)
Clearance: Primarily renal clearance (glomerular filtration)
ExcretionRoute: Renal (glomerular filtration)
Unchanged: >80-90%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV infusion)
PeakEffect: End of infusion
DurationOfAction: Dose-dependent, typically 8-12 hours for therapeutic levels with normal renal function, but prolonged in renal impairment.

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. Many people may not experience any side effects or only minor ones. However, if you are bothered by any of the following side effects or if they persist, 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 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.
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Seek Immediate Medical Attention If You Experience:

  • Redness, itching, or rash on the face, neck, or upper body (Red Man Syndrome) during or shortly after infusion.
  • Dizziness, ringing in the ears (tinnitus), or hearing loss.
  • Decreased urine output, swelling in legs or feet.
  • Fever, chills, sore throat, or unusual tiredness (signs of low white blood cell count).
  • Unusual bleeding or bruising.
  • Severe diarrhea (could indicate C. difficile infection, though less common with IV vancomycin).
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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 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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Do not initiate, discontinue, or modify the dose of any medication without first consulting your doctor.
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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, such as kidney failure, notify your doctor, as this medication can cause kidney issues. Your doctor will likely recommend regular blood tests and other laboratory evaluations 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 your hearing or hearing loss to your doctor. Your doctor may recommend regular hearing tests during treatment.

To minimize the risk of a secondary 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 Clostridioides difficile-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 with your doctor.

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 potential benefits and risks with your doctor. For women of childbearing age, your doctor may require a pregnancy test before initiating treatment to confirm that you are not pregnant.
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Overdose Information

Overdose Symptoms:

  • Severe kidney damage (renal failure)
  • Hearing loss (ototoxicity)
  • Hypotension
  • Red Man Syndrome

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including maintaining hydration, monitoring renal function, and potentially hemodialysis to remove vancomycin from the blood in severe cases.

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): Increased risk of ototoxicity.
  • Cisplatin: Increased risk of nephrotoxicity and ototoxicity.
  • Cyclosporine: Increased risk of nephrotoxicity.
  • Tacrolimus: Increased risk of nephrotoxicity.
  • Polymyxin B: Increased risk of nephrotoxicity.
  • Amphotericin B: Increased risk of nephrotoxicity.
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Moderate Interactions

  • Neuromuscular blockers (e.g., succinylcholine, rocuronium): May potentiate or prolong neuromuscular blockade.
  • Metformin: Vancomycin may increase metformin levels (though less common with IV vancomycin).
  • Radiographic contrast agents: Increased risk of nephrotoxicity, especially in patients with pre-existing renal impairment.

Monitoring

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Baseline Monitoring

Renal function (SCr, BUN)

Rationale: Vancomycin is primarily renally eliminated; renal impairment necessitates dose adjustment and increases risk of toxicity.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC)

Rationale: To establish baseline and monitor for potential neutropenia or thrombocytopenia.

Timing: Prior to initiation of therapy.

Audiology assessment (if pre-existing hearing impairment or high risk)

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 or more frequently if renal function changes or dose adjustments are made.

Target: 10-15 mcg/mL for most infections; 15-20 mcg/mL for serious infections (e.g., endocarditis, osteomyelitis, meningitis, HAP/VAP, bacteremia).

Action Threshold: Levels outside target range; adjust dose to achieve target.

Renal function (SCr, BUN)

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

Target: Stable or improving renal function.

Action Threshold: Increase in SCr by â‰Ĩ0.5 mg/dL or â‰Ĩ50% from baseline; consider dose adjustment or alternative therapy.

Complete Blood Count (CBC)

Frequency: Weekly, especially with prolonged therapy.

Target: Normal ranges for WBC, platelets.

Action Threshold: Significant decrease in WBC (especially neutrophils) or platelets; consider discontinuation or alternative therapy.

Signs/symptoms of ototoxicity

Frequency: Daily patient assessment; formal audiology if symptoms develop.

Target: No new hearing loss, tinnitus, or vertigo.

Action Threshold: New onset of hearing loss, tinnitus, or vertigo; consider discontinuation or alternative therapy.

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Symptom Monitoring

  • Red man syndrome (flushing, rash, pruritus, urticaria, tachycardia, hypotension) during infusion
  • Hearing loss, tinnitus, vertigo
  • Signs of kidney injury (decreased urine output, swelling)
  • Fever, chills, sore throat (signs of neutropenia)
  • Unusual bleeding or bruising (signs of thrombocytopenia)
  • Injection site reactions (pain, phlebitis)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if clearly needed and potential benefits outweigh potential risks to the fetus. Vancomycin crosses the placenta.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations. Use with caution.
Second Trimester: Generally considered safe if clinically indicated, with careful monitoring of maternal levels and renal function.
Third Trimester: Generally considered safe if clinically indicated, with careful monitoring of maternal levels and renal function. Potential for ototoxicity or nephrotoxicity in the fetus/neonate, though rare.
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Lactation

L3 (Moderately Safe). Vancomycin is excreted into breast milk in small amounts. Monitor breastfed infant for changes in bowel habits (diarrhea), thrush, or rash. Risk of affecting infant gut flora or sensitization is theoretical.

Infant Risk: Low to moderate. Potential for disruption of infant gut flora, but systemic absorption by infant is minimal. Monitor for adverse effects.
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Pediatric Use

Dosing is weight-based and requires careful therapeutic drug monitoring (TDM) due to variable pharmacokinetics in different age groups, especially neonates and infants. Renal function must be closely monitored.

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Geriatric Use

Increased risk of renal impairment, which necessitates careful dose adjustment and close monitoring of renal function and vancomycin trough levels. Elderly patients may also be more susceptible to ototoxicity.

Clinical Information

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Clinical Pearls

  • Always administer vancomycin IV infusions slowly over at least 60 minutes (or longer for doses >1g) to minimize the risk of Red Man Syndrome.
  • Therapeutic drug monitoring (TDM) with trough levels is crucial for optimizing efficacy and minimizing toxicity, especially for serious infections or in patients with unstable renal function.
  • Target trough levels vary based on the severity and type of infection (10-15 mcg/mL for less severe, 15-20 mcg/mL for severe infections).
  • Hydration is important to reduce the risk of nephrotoxicity.
  • Avoid concomitant use with other nephrotoxic or ototoxic drugs whenever possible, or monitor patients extremely closely if co-administration is necessary.
  • Vancomycin is not effective against Gram-negative bacteria.
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Alternative Therapies

  • Linezolid (for MRSA, VRE)
  • Daptomycin (for MRSA, VRE)
  • Ceftaroline (for MRSA)
  • Tedizolid (for MRSA)
  • Dalbavancin (for MRSA)
  • Oritavancin (for MRSA)
  • Tigecycline (for MRSA, VRE)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 500mg vial/bag per 500mg/100ml Inj
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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 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. 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 have additional patient information leaflets, so it is a good idea to check with your pharmacist. 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.