Vancomycin 1gm Inj, 1 Vial

Manufacturer MYLAN 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 a strong antibiotic given through a vein (IV) 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's very important to take this medicine exactly as prescribed and to have blood tests done regularly to make sure the dose is right and to check for side effects.
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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 precisely. This medication 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 instead of an 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

  • Stay well-hydrated unless otherwise instructed by your doctor.
  • Report any new or worsening symptoms immediately.
  • Do not stop the medication early, even if you feel better, to prevent antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: 15-20 mg/kg IV every 8-12 hours
Dose Range: 1000 - 2000 mg

Condition-Specific Dosing:

severe_infections: Target trough 15-20 mcg/mL (e.g., endocarditis, osteomyelitis, meningitis, hospital-acquired pneumonia)
less_severe_infections: Target trough 10-15 mcg/mL
max_single_dose: Typically not exceeding 2g per single dose
max_daily_dose: Typically not exceeding 3-4g per day
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Pediatric Dosing

Neonatal: 10-15 mg/kg IV loading dose, then 10 mg/kg IV every 8-12 hours (adjust based on post-natal age and renal function)
Infant: 15 mg/kg IV every 6 hours or 10-15 mg/kg IV every 6-8 hours
Child: 15 mg/kg IV every 6 hours or 10-15 mg/kg IV every 6-8 hours
Adolescent: 15-20 mg/kg IV every 8-12 hours (similar to adult dosing, target trough 10-20 mcg/mL)
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Dose Adjustments

Renal Impairment:

Mild: Adjust dose or interval based on CrCl (e.g., CrCl 50-79 mL/min: 15 mg/kg q12-24h)
Moderate: Adjust dose or interval based on CrCl (e.g., CrCl 20-49 mL/min: 15 mg/kg q24-48h)
Severe: Significant dose reduction or extended interval (e.g., CrCl <20 mL/min: 15 mg/kg q48-72h or single dose then monitor levels)
Dialysis: Hemodialysis: Administer 15 mg/kg IV after each dialysis session, or 500-1000 mg after each session, or maintain trough levels. Peritoneal Dialysis: 15-30 mg/kg IV once weekly or 20 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. It binds with high affinity to the D-Ala-D-Ala terminus of peptidoglycan precursors, preventing the transglycosylation and transpeptidation steps necessary for cell wall elongation and cross-linking. This leads to increased cell wall permeability and inhibition of RNA synthesis, ultimately resulting in bacterial cell death. It is bactericidal against susceptible Gram-positive organisms.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration); <5% (oral administration for systemic effect)
Tmax: End of infusion (IV)
FoodEffect: Not applicable for IV formulation; oral absorption is poor regardless of food.

Distribution:

Vd: 0.4-1 L/kg (adults)
ProteinBinding: 10-50%
CnssPenetration: Limited (increased with meningeal inflammation)

Elimination:

HalfLife: 4-6 hours (normal renal function); significantly prolonged in renal impairment (up to 7.5 days in anuric patients)
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 (IV)
DurationOfAction: Dose-dependent, typically 8-12 hours for therapeutic levels with normal renal function

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 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 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:

  • Decreased urination or swelling (signs of kidney problems)
  • Ringing in the ears, dizziness, or hearing changes (signs of ear problems)
  • Flushing, rash, itching, or dizziness during or shortly after the infusion (Red Man Syndrome)
  • Severe diarrhea (especially if watery or bloody, could be C. difficile infection)
  • Fever, chills, or new signs of infection
  • Unusual bruising or bleeding
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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, any of 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 identify potential interactions between this medication and other substances.
* 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 other 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.

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 symptoms of hearing loss to your doctor. Your doctor may also recommend periodic 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 nephrotoxicity (acute kidney injury, anuria)
  • Ototoxicity (permanent hearing loss, tinnitus, vertigo)
  • Hypotension
  • Red Man Syndrome (severe form)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is supportive. Hemodialysis is not effective for removing vancomycin due to its large molecular size and protein binding, but hemoperfusion with resin or charcoal may be considered in severe cases. Maintain hydration and monitor vital signs and renal function closely.

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.
  • Other nephrotoxic drugs (e.g., amphotericin B, cyclosporine, tacrolimus, NSAIDs, cisplatin): Increased risk of nephrotoxicity.
  • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium): May prolong neuromuscular blockade.
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Moderate Interactions

  • Metformin: Vancomycin may increase metformin concentrations by inhibiting OCT1/2 transporters, though clinical significance is often low.
  • Cholestyramine/Colestipol (oral vancomycin): May bind to oral vancomycin, reducing its efficacy for C. difficile infection.

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine)

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

Timing: Prior to initiation of therapy

Audiogram (if pre-existing hearing loss 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: Before the 4th or 5th dose (at steady state), then at least weekly for prolonged therapy, or more frequently if renal function changes or dose adjustments are made.

Target: 10-20 mcg/mL (15-20 mcg/mL for serious infections like endocarditis, osteomyelitis, meningitis, HAP)

Action Threshold: Troughs <10 mcg/mL (consider dose increase); Troughs >20 mcg/mL (consider dose decrease or extended interval); Troughs >25-30 mcg/mL (high risk of toxicity, hold dose and reassess)

Renal function (BUN, serum creatinine)

Frequency: Daily or every other day initially, then 2-3 times per week for prolonged therapy.

Target: Stable within patient's baseline

Action Threshold: Increase in serum creatinine by â‰Ĩ0.5 mg/dL or â‰Ĩ50% from baseline (whichever is greater) indicates potential nephrotoxicity; consider dose adjustment or discontinuation.

Complete Blood Count (CBC)

Frequency: Weekly or as clinically indicated

Target: Within normal limits

Action Threshold: Leukopenia, neutropenia, or thrombocytopenia (rare, but possible)

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Symptom Monitoring

  • Signs of nephrotoxicity (decreased urine output, edema, fatigue, elevated BUN/Cr)
  • Signs of ototoxicity (tinnitus, hearing loss, vertigo)
  • Signs of Red Man Syndrome (flushing, rash, pruritus, urticaria, hypotension, tachycardia, muscle spasms, dyspnea, chest pain, angioedema - typically during or shortly after infusion)
  • Hypersensitivity reactions (rash, fever, chills)
  • Gastrointestinal upset (nausea, vomiting, diarrhea)
  • Injection site reactions (pain, phlebitis)

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 no increased risk of major birth defects, but animal studies have shown some adverse effects. Close monitoring of maternal vancomycin levels and fetal auditory function may be considered.

Trimester-Specific Risks:

First Trimester: Limited human data, animal studies show some developmental toxicity at high doses. Use only if clearly needed.
Second Trimester: Limited human data. Close monitoring of maternal levels and fetal well-being is recommended.
Third Trimester: Limited human data. Close monitoring of maternal levels and fetal well-being is recommended. Potential for ototoxicity or nephrotoxicity in the neonate, especially if maternal levels are high.
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Lactation

Vancomycin is excreted into breast milk in small amounts. Due to poor oral absorption by the infant, systemic exposure is expected to be low. However, potential risks to the infant include alteration of bowel flora, diarrhea, and interference with interpretation of cultures if fever workup is needed. Use with caution; monitor the infant for gastrointestinal upset (e.g., diarrhea, thrush) or rash.

Infant Risk: Low to moderate risk (L3)
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Pediatric Use

Dosing is weight-based and requires careful calculation and monitoring, especially in neonates and infants due to immature renal function. Therapeutic drug monitoring (trough levels) is essential to ensure efficacy and minimize toxicity. Renal function should be closely monitored.

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Geriatric Use

Elderly patients are more likely to have age-related decline in renal function, which necessitates careful dose adjustment and more frequent monitoring of vancomycin levels and renal function. They may also be more susceptible to ototoxicity and nephrotoxicity.

Clinical Information

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Clinical Pearls

  • Infuse vancomycin slowly over at least 60 minutes (or at a rate not exceeding 10 mg/min) to prevent Red Man Syndrome.
  • Therapeutic drug monitoring (trough levels) is crucial for optimizing efficacy and minimizing toxicity, especially in patients with changing renal function, severe infections, or prolonged therapy.
  • Hydration is important to help prevent nephrotoxicity.
  • Vancomycin is not effective against Gram-negative bacteria or atypical organisms.
  • Oral vancomycin is used ONLY for Clostridioides difficile infection (CDI) due to its poor systemic absorption; IV vancomycin is NOT effective for CDI.
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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)
  • Quinupristin/Dalfopristin (for MRSA, VRE)
  • Tigecycline (for MRSA, VRE)
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Cost & Coverage

Average Cost: Not available Not available
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not 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 critical information, including the name of the medication, the amount taken, and the time it was taken, to ensure prompt and effective treatment.