Vancomycin 1000mg Inj

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
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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 caused by bacteria resistant to other common antibiotics, like MRSA. It works by stopping bacteria from building their cell walls. It is usually given through 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 for guidance on proper storage.

Missing a Dose

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

  • Report any changes in hearing (ringing in ears, muffled sounds) or kidney function (less urine, swelling) immediately.
  • 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, not to exceed 2g per dose. For serious infections (e.g., MRSA bacteremia, endocarditis), target trough levels of 15-20 mcg/mL. For less severe infections, target trough levels of 10-15 mcg/mL.
Dose Range: 1000 - 4000 mg

Condition-Specific Dosing:

initial_loading_dose: 25-30 mg/kg IV (actual body weight) for critically ill patients or those with severe infections, followed by maintenance dosing.
c_difficile_oral: 125-500 mg orally 4 times daily for 10-14 days (Note: This is for oral formulation, not IV).
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Pediatric Dosing

Neonatal: 15 mg/kg IV loading dose, then 10 mg/kg IV every 12-24 hours (adjust based on post-natal age and gestational age).
Infant: 15 mg/kg IV every 6 hours (for infants >1 month of age).
Child: 15 mg/kg IV every 6 hours (for children >1 month of age).
Adolescent: 15-20 mg/kg IV every 8-12 hours (similar to adult dosing, target trough levels).
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Consider extending dosing interval to every 12-24 hours or reducing dose. Monitor trough levels closely.
Moderate: CrCl 20-49 mL/min: Administer 15 mg/kg IV every 24-48 hours. Monitor trough levels closely.
Severe: CrCl <20 mL/min: Administer 15 mg/kg IV as a single dose, then monitor trough levels and redose when level falls below target (e.g., <10 mcg/mL).
Dialysis: Hemodialysis: Administer 15 mg/kg IV as a loading dose, then 500-1000 mg after each dialysis session or 10-15 mg/kg IV 3 times weekly, post-dialysis. Peritoneal Dialysis: 15-30 mg/kg IV every 5-7 days or 20 mg/L in each dialysate exchange. Monitor trough levels closely.

Hepatic Impairment:

Mild: No specific dose adjustment generally required as vancomycin is minimally metabolized by the liver.
Moderate: No specific dose adjustment generally required.
Severe: No specific dose adjustment generally 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 cell wall weakening and bacterial lysis. It also alters bacterial cell membrane permeability and RNA synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: Poor (<5% orally for systemic effect)
Tmax: IV: End of infusion (peak concentration)
FoodEffect: Not applicable for IV administration.

Distribution:

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

Elimination:

HalfLife: 4-6 hours (normal renal function); significantly prolonged in renal impairment (up to 7.5 days in anuric patients)
Clearance: Primarily renal (glomerular filtration)
ExcretionRoute: Renal (urine)
Unchanged: >80-90%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV infusion)
PeakEffect: End of infusion (for peak concentration); clinical effect depends on achieving target trough levels over time.
DurationOfAction: Dependent on renal function and dosing interval; typically maintains therapeutic levels for 8-24 hours based on dosing.

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):
+ Fever
+ Chills
+ Sore throat
+ Pain when passing urine
+ Change in balance
+ Flushing
+ Rash on the face, neck, trunk, and arms during infusion
Rapid infusion of this medication can cause:
+ 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. If you are concerned about 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, 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:

  • Red Man Syndrome (flushing, rash, itching, hives, rapid heartbeat, low blood pressure during or shortly after infusion)
  • Signs of kidney problems (decreased urination, swelling in legs/feet, unusual tiredness)
  • Signs of hearing problems (ringing in ears, dizziness, hearing loss)
  • Severe allergic reaction (difficulty breathing, swelling of face/throat, severe rash)
  • Fever, chills, sore throat (may indicate neutropenia, a rare side effect)
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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 or exacerbate underlying health issues.

To ensure your safety, it is crucial to verify that it is safe to take this medication in conjunction 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 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 your 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 guidance.

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

If you are 65 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 starting treatment to confirm that you are not pregnant.
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Overdose Information

Overdose Symptoms:

  • Severe nephrotoxicity (acute kidney failure)
  • Ototoxicity (permanent hearing loss, tinnitus)
  • Hypotension
  • Red Man Syndrome (severe form)

What to Do:

Call 911 or Poison Control (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, bumetanide): Increased risk of ototoxicity.
  • Amphotericin B: Increased risk of nephrotoxicity.
  • Cyclosporine, Tacrolimus: Increased risk of nephrotoxicity.
  • Cisplatin: Increased risk of nephrotoxicity and ototoxicity.
  • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium): Vancomycin may enhance or prolong the neuromuscular blockade.
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Moderate Interactions

  • Metformin: Vancomycin may increase metformin levels by inhibiting renal tubular secretion (theoretical, clinical significance unclear).
  • Cholestyramine (oral vancomycin): May bind to oral vancomycin, reducing its efficacy for C. difficile infection.
  • Radiocontrast agents: Increased risk of acute kidney injury when co-administered with other nephrotoxic agents including vancomycin.

Monitoring

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Baseline Monitoring

Renal function (SCr, BUN, CrCl)

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 risk factors)

Rationale: Vancomycin can cause ototoxicity, though rare with current dosing and monitoring.

Timing: Prior to initiation in high-risk patients.

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Routine Monitoring

Vancomycin trough concentration

Frequency: Prior to the 4th or 5th dose (at steady state) and then at least weekly, or more frequently in unstable patients, those with changing renal function, or those on high doses.

Target: 10-15 mcg/mL (for most infections); 15-20 mcg/mL (for serious infections like bacteremia, endocarditis, osteomyelitis, meningitis, hospital-acquired pneumonia).

Action Threshold: Levels outside target range require dose adjustment; levels >20 mcg/mL increase risk of toxicity and warrant immediate re-evaluation.

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 baseline values.

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

Complete Blood Count (CBC)

Frequency: Periodically (e.g., weekly)

Target: Normal ranges.

Action Threshold: Significant leukopenia or neutropenia (rare) may necessitate discontinuation.

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Symptom Monitoring

  • Signs of nephrotoxicity (decreased urine output, edema, fatigue)
  • Signs of ototoxicity (tinnitus, hearing loss, vertigo)
  • Signs of Red Man Syndrome (flushing, rash, pruritus, hypotension, tachycardia during or shortly after infusion)
  • Signs of hypersensitivity reactions (rash, fever, chills)
  • Signs of neutropenia (fever, signs of infection)

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 human data suggest low risk, but animal studies are lacking or show some risk. Therapeutic drug monitoring is crucial.

Trimester-Specific Risks:

First Trimester: Limited data, theoretical risk of organogenesis disruption, but generally considered low risk.
Second Trimester: Generally considered safe if clinically indicated, with careful monitoring.
Third Trimester: Generally considered safe if clinically indicated, with careful monitoring. Vancomycin crosses the placenta.
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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 for alteration of infant gut flora, allergic sensitization, or direct effects on the infant (e.g., ototoxicity, nephrotoxicity) exists, though unlikely. Monitor infant for diarrhea, candidiasis, or rash. Use with caution.

Infant Risk: Low risk (L3)
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Pediatric Use

Dosing is weight-based and adjusted for age, especially in neonates and infants due to differences in renal function and volume of distribution. Therapeutic drug monitoring (trough levels) is essential to ensure efficacy and minimize toxicity. Neonates and young infants have immature renal function, requiring longer dosing intervals.

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Geriatric Use

Elderly patients are more likely to have age-related decreases in renal function, which can lead to reduced vancomycin clearance and increased risk of toxicity. Dose adjustments based on renal function are frequently necessary. Close monitoring of renal function and vancomycin trough levels is critical.

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 in patients with unstable renal function, severe infections, or those receiving prolonged therapy.
  • Hydration is important to minimize the risk of nephrotoxicity.
  • Vancomycin is NOT absorbed orally for systemic infections; oral vancomycin is used only for Clostridioides difficile infection.
  • Consider continuous infusion vancomycin in critically ill patients to maintain stable drug levels and potentially reduce nephrotoxicity, especially when targeting higher trough levels (15-20 mcg/mL).
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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 VRE, MRSA)
  • Clindamycin (for some Gram-positive infections, but resistance is common)
  • Trimethoprim/Sulfamethoxazole (for some MRSA infections)
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Cost & Coverage

Average Cost: Varies widely by manufacturer, dosage, and pharmacy. Typically $10-$50 per 1000mg vial. per 1000mg vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic) for most commercial and government insurance plans.
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. 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: 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, 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 it was taken to ensure prompt and effective treatment.