Vancomycin 5gm Inj, 1 Vial

Manufacturer FRESENIUS KABI 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
FDA Approved
Jun 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 caused by bacteria resistant to other common antibiotics, like MRSA. It works by stopping bacteria from building their cell walls. It is usually given into a vein (IV) for serious infections.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is typically administered as an infusion into a vein over a period of time. In some cases, it may be given orally or through a feeding tube instead of as an injection, if deemed necessary by your healthcare provider.

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 to receive guidance on what to do next.
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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 if you experience flushing, rash, or itching during or after the infusion (Red Man Syndrome). This can often be managed by slowing down the infusion rate.
  • Stay well-hydrated unless otherwise instructed by your 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) to achieve target trough levels.
Dose Range: 1000 - 2000 mg

Condition-Specific Dosing:

severeInfections: 20-30 mg/kg IV loading dose may be considered for critically ill patients (e.g., sepsis, meningitis) to achieve rapid therapeutic levels, followed by maintenance doses.
endocarditis: 15-20 mg/kg IV every 8-12 hours, targeting trough levels of 15-20 mcg/mL.
osteomyelitis: 15-20 mg/kg IV every 8-12 hours, targeting trough levels of 15-20 mcg/mL.
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Pediatric Dosing

Neonatal: 10-15 mg/kg IV every 12-24 hours, adjusted based on post-natal age, gestational age, and TDM. Initial dose often 15 mg/kg, then 10 mg/kg every 12-24 hours.
Infant: 15 mg/kg IV every 6 hours, adjusted based on TDM.
Child: 15 mg/kg IV every 6 hours, adjusted based on TDM. Max single dose 1.25g.
Adolescent: 15 mg/kg IV every 6-8 hours, adjusted based on TDM. Max single dose 1.25g.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Consider extending dosing interval to 12-24 hours or reducing dose. TDM is crucial.
Moderate: CrCl 30-49 mL/min: 15 mg/kg IV every 24-48 hours. TDM is crucial.
Severe: CrCl <30 mL/min: Initial dose 15 mg/kg IV, then subsequent doses based on TDM (e.g., 15 mg/kg every 48-96 hours or less frequently).
Dialysis: Hemodialysis: Initial dose 15 mg/kg IV, then 500-1000 mg after each dialysis session or based on TDM. Peritoneal Dialysis: 15-20 mg/kg IV every 5-7 days or 30 mg/kg IV every 7 days, or 15 mg/L in each dialysate exchange.

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 with high affinity to the D-Ala-D-Ala terminus of peptidoglycan precursors. This binding prevents the transpeptidation (cross-linking) and transglycosylation (elongation) steps, leading to weakened cell walls and bacterial cell lysis. It also alters bacterial cell membrane permeability and RNA synthesis.
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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 (IV)
FoodEffect: Not applicable (IV administration)

Distribution:

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

Elimination:

HalfLife: 4-6 hours (normal renal function); significantly prolonged in renal impairment (up to 200 hours)
Clearance: Primarily renal clearance (glomerular filtration)
ExcretionRoute: Renal (urine)
Unchanged: >80-90%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV infusion)
PeakEffect: End of infusion
DurationOfAction: Dose-dependent, typically 6-12 hours for therapeutic levels, 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 injection (intravenous administration):
+ 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 administered 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 you notice any signs of tissue damage at the injection site, such as:
+ Redness
+ Burning
+ Pain
+ Swelling
+ Blisters
+ Skin sores
+ Leaking of fluid, inform your nurse immediately

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 symptoms that bother you or do not go away, 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, 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:

  • Severe rash, hives, or itching
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Dizziness or lightheadedness
  • Ringing in the ears (tinnitus) or hearing loss
  • Decreased urination or swelling in the legs/feet
  • Fever, chills, or sore throat (signs of neutropenia)
  • Pain, redness, or swelling at the injection site
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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 existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust the dosage 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.

Kidney problems, such as kidney failure, have been associated with this drug. If you have a history of kidney problems, notify your doctor promptly.

Regular blood work and other laboratory tests, as directed by your doctor, are crucial to monitor your health while taking this medication.

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

Do not use this medication for an extended period, as this may lead to a secondary infection.

Antibiotics, including this drug, can cause diarrhea. Although rare, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur, potentially leading to life-threatening bowel problems. CDAD can develop during or several months after antibiotic treatment. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately. Before treating diarrhea, consult with your doctor.

This medication is not approved for injection into the eye, as it has been associated with eye problems, including permanent vision loss, when administered via this route.

If you are 65 years or older, exercise caution when using this medication, 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. 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 or deafness
  • Severe hypotension
  • Red Man Syndrome (severe flushing, rash, pruritus, tachycardia, hypotension)

What to Do:

Discontinue vancomycin. Provide supportive care, maintain hydration, and monitor renal function. Hemodialysis is not effective for removing vancomycin. Contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention immediately.

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, bumetanide): Increased risk of ototoxicity.
  • Cisplatin: Increased risk of nephrotoxicity and ototoxicity.
  • Cyclosporine, Tacrolimus: Increased risk of nephrotoxicity.
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Moderate Interactions

  • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium): Vancomycin may enhance or prolong the neuromuscular blockade.
  • Anesthetic agents: May increase the risk of histamine release and 'red man syndrome' when co-administered or given immediately after vancomycin infusion.
  • NSAIDs (e.g., ibuprofen, naproxen): May increase risk of nephrotoxicity, especially in patients with pre-existing renal impairment.

Monitoring

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Baseline Monitoring

Renal function (Serum Creatinine, BUN)

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

Timing: Prior to initiation of therapy.

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

Rationale: To establish baseline for potential ototoxicity.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC)

Rationale: To establish baseline for potential neutropenia or thrombocytopenia.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Vancomycin Trough Levels

Frequency: Before the 4th or 5th dose (at steady state), then at least weekly, or more frequently with dose changes, renal function changes, or clinical instability.

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

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

Renal function (Serum Creatinine, BUN)

Frequency: Daily or every 2-3 days initially, then at least 2-3 times per week, or more frequently if renal function is unstable or co-administered nephrotoxic drugs.

Target: Stable or within patient's baseline.

Action Threshold: Increase in SCr by ≥0.5 mg/dL or ≥50% from baseline (whichever is smaller) suggests acute kidney injury and requires dose adjustment or discontinuation.

Fluid balance and urine output

Frequency: Daily

Target: Adequate urine output.

Action Threshold: Oliguria or anuria may indicate renal impairment.

Complete Blood Count (CBC)

Frequency: Weekly, or more frequently if signs of myelosuppression.

Target: WBC and platelet counts within normal limits.

Action Threshold: Neutropenia (ANC <1000 cells/mm³) or thrombocytopenia may require discontinuation.

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Symptom Monitoring

  • Red man syndrome (flushing, rash, pruritus, urticaria, tachycardia, hypotension) during or shortly after infusion
  • Signs of nephrotoxicity (decreased urine output, edema, fatigue, nausea, confusion)
  • Signs of ototoxicity (tinnitus, hearing loss, vertigo)
  • Signs of hypersensitivity reactions (rash, fever, chills, difficulty breathing)
  • Signs of neutropenia (fever, sore throat, signs of infection)
  • Signs of phlebitis or irritation at injection site

Special Patient Groups

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Pregnancy

Vancomycin crosses the placenta. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus. Monitor maternal vancomycin levels and fetal auditory function.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations. Use only if essential.
Second Trimester: Risk of ototoxicity and nephrotoxicity to the fetus is theoretical but not well-established in humans. Monitor maternal levels.
Third Trimester: Risk of ototoxicity and nephrotoxicity to the fetus is theoretical but not well-established in humans. Monitor maternal levels, especially if given close to delivery.
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Lactation

Vancomycin is excreted in breast milk in low concentrations. Generally considered compatible with breastfeeding, but monitor the infant for potential adverse effects.

Infant Risk: Low risk. Potential for disruption of infant gut flora, diarrhea, or rash. Monitor infant for signs of GI upset (e.g., diarrhea, candidiasis) or rash. Ototoxicity and nephrotoxicity are unlikely due to poor oral absorption by the infant.
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Pediatric Use

Dosing is weight-based and requires careful therapeutic drug monitoring (TDM) due to variable pharmacokinetics and higher clearance rates compared to adults. Neonates and infants require specific dosing regimens based on gestational and postnatal age. Risk of nephrotoxicity and ototoxicity is present, requiring close monitoring.

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Geriatric Use

Elderly patients often have reduced renal function, which significantly prolongs vancomycin half-life and increases the risk of accumulation and toxicity. Dose adjustments based on renal function and therapeutic drug monitoring are essential. Increased susceptibility to ototoxicity and nephrotoxicity.

Clinical Information

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Clinical Pearls

  • Therapeutic Drug Monitoring (TDM) is crucial for vancomycin to ensure efficacy and minimize toxicity. Target trough levels are typically 10-15 mcg/mL for most infections and 15-20 mcg/mL for serious infections (e.g., MRSA bacteremia, endocarditis, osteomyelitis, meningitis).
  • Infuse vancomycin slowly over at least 60 minutes (for doses up to 1g) or 90-120 minutes (for doses >1g) to prevent 'Red Man Syndrome' (histamine-mediated reaction). Rapid infusion is a common cause of this reaction.
  • Vancomycin is NOT absorbed orally for systemic infections; oral vancomycin is used ONLY for Clostridioides difficile infection (CDI).
  • Monitor renal function closely, especially in patients receiving concomitant nephrotoxic agents or those with pre-existing renal impairment.
  • While ototoxicity is a known adverse effect, it is rare with current dosing strategies and TDM, and often associated with very high peak levels or concomitant ototoxic drugs.
  • Consider continuous infusion vancomycin in critically ill patients or those with fluctuating renal function to maintain more stable drug levels and potentially reduce nephrotoxicity.
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Alternative Therapies

  • Linezolid (for MRSA, VRE)
  • Daptomycin (for MRSA, VRE)
  • Ceftaroline (for MRSA)
  • Telavancin (for MRSA)
  • Oritavancin (for MRSA)
  • Dalbavancin (for MRSA)
  • Tigecycline (for MRSA, VRE)
  • Quinupristin/Dalfopristin (for VRE, MRSA)
  • Metronidazole (for C. difficile infection, oral)
  • Fidaxomicin (for C. difficile infection, oral)
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Cost & Coverage

Average Cost: Varies widely by dose and supplier, typically $10-$50 per 5gm vial (generic) per 5gm vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues 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 otherwise, avoid flushing them 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, so it's a good idea to check with your pharmacist. If you have any questions or concerns about your 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 emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time it happened, as this will aid in receiving appropriate care.