Vancomycin 1.5gm/300ml Inj, 300ml

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; Cell wall synthesis inhibitor
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Pregnancy Category
Category C
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FDA Approved
Mar 1986
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Vancomycin is an antibiotic used to treat serious bacterial infections, especially those caused by bacteria resistant to other antibiotics, like MRSA (Methicillin-resistant Staphylococcus aureus). It works by stopping bacteria from building their cell walls, which kills them. 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 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 (ringing in ears, dizziness, hearing loss) or kidney function (decreased urination, 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 herbal supplements.

Dosing & Administration

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Adult Dosing

Standard Dose: 15 to 20 mg/kg IV every 8 to 12 hours (initial dose), adjusted based on renal function and therapeutic drug monitoring (TDM). Max single dose typically 2g.
Dose Range: 1000 - 2000 mg

Condition-Specific Dosing:

Severe infections (e.g., endocarditis, osteomyelitis): Higher initial doses (e.g., 25-30 mg/kg loading dose) may be considered, followed by 15-20 mg/kg every 8-12 hours, targeting AUC/MIC or higher trough levels.
Obesity: Dosing should be based on total body weight, but careful monitoring is crucial due to altered pharmacokinetics.
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Pediatric Dosing

Neonatal: 15 mg/kg IV loading dose, then 10 mg/kg IV every 12-24 hours (frequency depends on postmenstrual age and postnatal age). TDM is essential.
Infant: 15 mg/kg IV loading dose, then 10 mg/kg IV every 8-12 hours. TDM is essential.
Child: 15 mg/kg IV loading dose, then 10 mg/kg IV every 6-8 hours. TDM is essential.
Adolescent: Similar to adult dosing: 15 mg/kg IV every 8-12 hours, adjusted based on renal function and TDM.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Consider 15 mg/kg every 12-24 hours or standard dose with extended interval. Monitor levels.
Moderate: CrCl 20-49 mL/min: 15 mg/kg every 24-48 hours or reduced dose with extended interval. Monitor levels closely.
Severe: CrCl <20 mL/min: Initial dose 15 mg/kg, then subsequent doses based on TDM (e.g., 500-1000 mg every several days or as needed).
Dialysis: Hemodialysis: 15 mg/kg loading dose, then 500-1000 mg after each dialysis session or 10-15 mg/kg 3 times weekly, adjusted to maintain target levels. Peritoneal Dialysis: 15-30 mg/L in each dialysate exchange or 15 mg/kg IV every 5-7 days. TDM is critical.

Hepatic Impairment:

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

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 defective cell wall formation and increased bacterial cell membrane permeability, ultimately resulting in bacterial cell lysis and death. It is bactericidal against susceptible organisms.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: 0.4-1 L/kg (adults); higher in children and neonates.
ProteinBinding: 10-50%
CnssPenetration: Limited (poor penetration into uninflamed meninges; increased penetration with inflamed meninges).

Elimination:

HalfLife: 4-11 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 (glomerular filtration)
Unchanged: >80-90%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV infusion)
PeakEffect: End of infusion
DurationOfAction: Dependent on renal function and dosing interval; typically maintains therapeutic levels for 8-24 hours with appropriate dosing.
Confidence: High

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 (intravenously):
+ 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 of the following symptoms at the injection site, inform your nurse immediately:
+ Redness
+ Burning
+ Pain
+ Swelling
+ Blisters
+ Skin sores
+ Leaking of fluid

Other Possible Side Effects

As with any medication, you may experience side effects. While many people have no 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, contact your doctor or seek medical attention if they bother you or persist:

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, hives, or itching (especially with flushing of the face, neck, and upper body - 'Red Man Syndrome')
  • Difficulty breathing or wheezing
  • Swelling of the face, lips, tongue, or throat
  • Ringing in the ears (tinnitus)
  • Hearing loss
  • Dizziness or vertigo
  • Decreased urination
  • Unusual tiredness or weakness
  • Fever or chills (if new or worsening)
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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 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 it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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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 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. You may need to undergo hearing tests during treatment, so be sure to discuss this with your doctor.

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

Antibiotics, including this medication, can cause diarrhea, which may be mild or severe. 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 intended 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, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to you and your baby. If you are 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 kidney damage (decreased urine output, swelling)
  • Hearing loss or deafness
  • Dizziness
  • Tinnitus
  • Hypotension
  • Red Man Syndrome (severe flushing, rash, itching, hypotension)

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and may include hemodialysis to remove the drug from the body, especially in patients with renal impairment.

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.
  • Other nephrotoxic drugs (e.g., amphotericin B, cisplatin, cyclosporine, NSAIDs, tacrolimus): Increased risk of nephrotoxicity.
  • Other ototoxic drugs (e.g., aspirin, cisplatin, erythromycin, quinine): Increased risk of ototoxicity.
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Moderate Interactions

  • Neuromuscular blockers (e.g., succinylcholine, rocuronium): Vancomycin may enhance or prolong the neuromuscular blockade.
  • Metformin: Vancomycin may increase metformin plasma 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 (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 prolonged therapy)

Rationale: To establish baseline for potential ototoxicity.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC)

Rationale: To assess for potential hematologic adverse effects (e.g., neutropenia, 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) and then at least weekly, or more frequently in patients with unstable renal function, severe infections, or obesity.

Target: 10-20 mcg/mL for most infections; 15-20 mcg/mL for complicated infections (e.g., endocarditis, osteomyelitis, pneumonia, bacteremia). AUC/MIC ratio of 400-600 is increasingly preferred.

Action Threshold: Levels outside target range necessitate dose adjustment. Troughs >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.

Signs and symptoms of ototoxicity (e.g., tinnitus, vertigo, hearing loss)

Frequency: Daily, patient interview.

Target: Absence of symptoms.

Action Threshold: New or worsening symptoms require immediate evaluation and consideration of drug discontinuation or alternative therapy.

Signs and symptoms of Red Man Syndrome (e.g., flushing, rash, pruritus, hypotension)

Frequency: During and immediately after infusion.

Target: Absence of symptoms.

Action Threshold: Occurrence requires slowing infusion rate, antihistamine administration, and potentially discontinuation.

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Symptom Monitoring

  • Tinnitus
  • Hearing loss
  • Vertigo
  • Dizziness
  • Flushing (especially upper body)
  • Rash
  • Pruritus
  • Hypotension
  • Fever
  • Chills
  • Nausea
  • Vomiting
  • Diarrhea
  • Injection site pain/phlebitis

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks to the fetus. Vancomycin crosses the placenta. Fetal auditory and renal function should be monitored if used during pregnancy.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations based on available human data.
Second Trimester: Potential for fetal ototoxicity and nephrotoxicity, especially with high maternal doses or prolonged exposure. Fetal monitoring recommended.
Third Trimester: Potential for fetal ototoxicity and nephrotoxicity. Fetal monitoring recommended.
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Lactation

L3 (Moderate risk). Vancomycin is excreted into breast milk in small amounts. While systemic absorption by the infant is poor, potential risks include alteration of bowel flora, direct effects on the infant (e.g., ototoxicity, nephrotoxicity), and interference with culture results if fever workup is needed. Use with caution; monitor infant for adverse effects.

Infant Risk: Low systemic absorption, but theoretical risks of gut flora disruption, ototoxicity, and nephrotoxicity. Monitor for diarrhea, thrush, or rash.
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Pediatric Use

Dosing is weight-based and requires careful monitoring of serum concentrations (trough or AUC) due to variable pharmacokinetics and higher clearance rates compared to adults. Neonates and infants are particularly vulnerable to toxicity due to immature renal function. Close monitoring of renal function and hearing is essential.

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Geriatric Use

Elderly patients are more likely to have decreased renal function, which necessitates dose adjustment and increases the risk of vancomycin accumulation and toxicity (nephrotoxicity, ototoxicity). Close monitoring of renal function and vancomycin levels is crucial.

Clinical Information

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Clinical Pearls

  • Vancomycin is a time-dependent killer; maintaining adequate drug exposure (AUC/MIC) is more critical than high peak levels.
  • Therapeutic drug monitoring (TDM) with trough levels (or increasingly, AUC-guided dosing) is essential for safe and effective use, especially in critically ill patients, those with unstable renal function, or those receiving prolonged therapy.
  • Infuse vancomycin slowly over at least 60 minutes (or longer for doses >1g) to prevent Red Man Syndrome.
  • Red Man Syndrome is a pseudoallergic reaction, not a true IgE-mediated allergy. It can be managed by slowing the infusion rate and administering antihistamines.
  • Oral vancomycin is used ONLY for Clostridioides difficile infection (CDI) due to its poor systemic absorption; it is not effective for systemic infections when given orally.
  • Consider alternative agents or dose reduction if concomitant nephrotoxic or ototoxic drugs are unavoidable.
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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)
  • Quinupristin/Dalfopristin (for VRE, MRSA)
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Cost & Coverage

Average Cost: Not available per 30 tablets
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 the reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring 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 offer 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 contact 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 ingested, to ensure prompt and effective treatment.