Vancomycin 750mg/150ml Inj, 150ml

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 1986
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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 caused by bacteria that are resistant to other common 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

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 into 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 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 best way to store it.

What to Do If You Miss a Dose

If you miss a dose, contact your doctor immediately to find out what steps to take next.
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Lifestyle & Tips

  • Report any changes in hearing or ringing in the ears immediately.
  • Report any decrease in urine output or swelling.
  • Inform healthcare providers about all medications, supplements, and herbal products being taken.
  • Stay well-hydrated during treatment unless otherwise advised by your doctor.

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 - 2000 mg

Condition-Specific Dosing:

Severe Infections (e.g., endocarditis, osteomyelitis): 15-20 mg/kg IV every 8-12 hours, targeting trough levels of 15-20 mcg/mL.
Moderate Infections: 15 mg/kg IV every 12 hours, targeting trough levels of 10-15 mcg/mL.
Surgical Prophylaxis: 15 mg/kg IV administered 2 hours prior to incision.
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Pediatric Dosing

Neonatal: 10-15 mg/kg IV every 12-24 hours, adjusted based on post-natal age and renal function. Trough levels 10-15 mcg/mL.
Infant: 15 mg/kg IV every 6 hours (or 10-15 mg/kg every 8-12 hours for younger infants), targeting trough levels 10-15 mcg/mL.
Child: 15 mg/kg IV every 6 hours, targeting trough levels 10-15 mcg/mL (or 15-20 mcg/mL for severe infections).
Adolescent: 15 mg/kg IV every 6-8 hours, targeting trough levels 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: Consider extending dosing interval to every 12-24 hours or reducing dose. Monitor trough levels.
Moderate: CrCl 20-49 mL/min: Initial dose 15 mg/kg, then subsequent doses and intervals guided by trough levels (e.g., every 24-48 hours).
Severe: CrCl <20 mL/min: Initial dose 15 mg/kg, then subsequent doses and intervals guided by trough levels (e.g., every 48-96 hours or longer). May require single doses every few days.
Dialysis: Hemodialysis: Administer 15 mg/kg IV after each dialysis session (intermittent HD) or 500-1000 mg every 5-7 days. Peritoneal Dialysis: 15-20 mg/kg IV every 5-7 days or 30 mg/L in each dialysate exchange. Monitor trough levels 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 with high affinity to the D-Ala-D-Ala terminus of the peptidoglycan precursor units. This binding prevents the transglycosylation and transpeptidation steps, leading to defective cell wall formation and increased bacterial cell membrane permeability, ultimately resulting in bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (IV administration for systemic effect); Oral bioavailability is <5% for systemic absorption.
Tmax: End of infusion (IV)
FoodEffect: Not applicable (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 7-9 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 (for peak concentration); clinical effect depends on infection type and site.
DurationOfAction: Dependent on renal function and dosing interval; typically maintains therapeutic levels for 8-12 hours with appropriate 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, including:
+ 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, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Severe skin reactions, including:
+ 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 or hives
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Dizziness or lightheadedness
  • Sudden flushing, itching, or rash (Red Man Syndrome)
  • Ringing in the ears (tinnitus)
  • Hearing loss
  • Decreased urination
  • Unusual tiredness or weakness
  • Fever or chills (could indicate neutropenia or new 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 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 allergic reaction you experienced, including any symptoms that occurred.
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 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 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 recommend regular hearing tests during treatment.

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

Antibiotics, including this medication, can cause diarrhea, which is usually mild. 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 several months after antibiotic treatment. 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. 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 (kidney failure)
  • Ototoxicity (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 hemofiltration/hemoperfusion may be considered in severe cases. Maintain hydration and monitor renal function.

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.
  • Cyclosporine: Increased risk of nephrotoxicity.
  • Tacrolimus: Increased risk of nephrotoxicity.
  • Neuromuscular Blocking Agents (e.g., succinylcholine, rocuronium): Vancomycin may potentiate and prolong neuromuscular blockade.
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Moderate Interactions

  • Metformin: Vancomycin may increase metformin concentrations by inhibiting OCT1/2, potentially increasing risk of lactic acidosis (rare, but theoretical).
  • Colistin: Increased risk of nephrotoxicity.
  • Polymyxin B: Increased risk of nephrotoxicity.
  • Amphotericin B: Increased risk of nephrotoxicity.

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 nephrotoxicity.

Timing: Prior to initiation of therapy.

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

Rationale: Vancomycin can cause ototoxicity, especially at high concentrations or with concomitant ototoxic drugs.

Timing: Prior to initiation, particularly in high-risk patients.

Complete Blood Count (CBC)

Rationale: To establish baseline and monitor for potential neutropenia or thrombocytopenia (rare adverse effects).

Timing: Prior to initiation.

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Routine Monitoring

Vancomycin Trough Levels

Frequency: Prior to the 4th or 5th dose (at steady state) and then at least weekly for stable patients, or more frequently (e.g., every 2-3 days) in unstable patients, those with changing renal function, or those on continuous renal replacement therapy.

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

Action Threshold: Levels outside target range warrant dose or interval adjustment. Levels >20 mcg/mL increase risk of toxicity.

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 greater) suggests acute kidney injury and requires dose adjustment or discontinuation.

Fluid Balance and Urine Output

Frequency: Daily in hospitalized patients.

Target: Adequate hydration and urine output.

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

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Symptom Monitoring

  • Signs of nephrotoxicity (decreased urine output, swelling, fatigue)
  • Signs of ototoxicity (tinnitus, hearing loss, vertigo)
  • Signs of Red Man Syndrome (flushing, rash, pruritus, urticaria, hypotension, tachycardia during or shortly after infusion)
  • Signs of hypersensitivity reactions (rash, fever, chills)
  • Signs of neutropenia (fever, sore throat, signs of infection)
  • Signs of thrombophlebitis (pain, redness, swelling 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. Vancomycin crosses the placenta. Cases of fetal ototoxicity and nephrotoxicity have been reported, but a causal relationship has not been established.

Trimester-Specific Risks:

First Trimester: Potential for fetal exposure; use only if clearly needed.
Second Trimester: Potential for fetal exposure; monitor maternal trough levels and renal function closely.
Third Trimester: Potential for fetal exposure; monitor maternal trough levels and renal function closely. Consider potential for neonatal effects if administered close to delivery.
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Lactation

Vancomycin is excreted into breast milk in small amounts. The risk of adverse effects in a breastfed infant appears to be low, but theoretical concerns include disruption of infant gut flora, allergic sensitization, and direct effects. Monitor the infant for diarrhea, candidiasis (thrush, diaper rash), or rash. Use with caution, especially in preterm or neonates.

Infant Risk: Low risk (L3)
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Pediatric Use

Dosing is weight-based and adjusted for age and renal function. Neonates and infants have immature renal function, requiring careful monitoring and individualized dosing. Trough level monitoring is crucial to ensure efficacy and minimize toxicity. Higher clearance rates may be observed in older children compared to adults, potentially requiring more frequent dosing.

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Geriatric Use

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

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. For doses >1g, extend infusion time (e.g., 90-120 minutes for 1.5g, 120-180 minutes for 2g).
  • Therapeutic drug monitoring (TDM) with trough levels is essential for optimizing efficacy and minimizing toxicity, especially for severe infections, unstable renal function, or prolonged therapy.
  • Maintain adequate hydration to reduce the risk of nephrotoxicity.
  • Avoid concomitant use with other nephrotoxic or ototoxic drugs whenever possible. If co-administration is necessary, monitor renal function and hearing even more closely.
  • 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 or those with fluctuating renal function to maintain stable drug levels and potentially reduce toxicity.
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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)
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Cost & Coverage

Average Cost: Not available per 750mg/150ml 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 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. 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 for advice. Additionally, you may want to inquire about potential drug take-back programs in your area. Some medications may come with a separate patient information leaflet, so be sure to check with your pharmacist. 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 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.