Vancomycin 1.75gm/350ml Inj, 350ml

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
Mar 1986
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Vancomycin is an antibiotic given through a vein (IV) to treat serious bacterial infections, especially those resistant to other antibiotics. It works by stopping bacteria from building their cell walls, which kills them. It's very important to take this medication 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

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

  • Stay well-hydrated to help your kidneys function properly.
  • Report any new or worsening symptoms to your healthcare provider immediately.
  • Avoid alcohol if it causes stomach upset or other issues, though no direct interaction is known.
  • Complete the full course of treatment, even if you start feeling better, to prevent antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: 15 to 20 mg/kg IV every 8 to 12 hours (not to exceed 2 g per dose) for most serious infections. For less severe infections, 15 mg/kg IV every 12 hours.
Dose Range: 15 - 20 mg

Condition-Specific Dosing:

severeInfections: 15-20 mg/kg IV q8-12h (max 2g/dose)
lessSevereInfections: 15 mg/kg IV q12h
endocarditis: 15-20 mg/kg IV q8-12h (target trough 15-20 mcg/mL)
osteomyelitis: 15-20 mg/kg IV q8-12h (target trough 15-20 mcg/mL)
meningitis: 15-20 mg/kg IV q8-12h (target trough 15-20 mcg/mL)
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Pediatric Dosing

Neonatal: 15 mg/kg IV loading dose, then 10 mg/kg IV every 12-24 hours depending on post-natal age and gestational age. Trough monitoring essential.
Infant: 15 mg/kg IV loading dose, then 10 mg/kg IV every 8-12 hours. Trough monitoring essential.
Child: 15 mg/kg IV every 6 hours or 20 mg/kg IV every 8 hours (max 2g/dose). Target trough 10-15 mcg/mL for most infections, 15-20 mcg/mL for serious infections.
Adolescent: 15 mg/kg IV every 8-12 hours (max 2g/dose). Target trough 10-15 mcg/mL for most infections, 15-20 mcg/mL for serious infections.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Consider extending dosing interval or reducing dose. Monitor troughs.
Moderate: CrCl 30-49 mL/min: Administer 15 mg/kg IV every 24-48 hours. Monitor troughs closely.
Severe: CrCl <30 mL/min: Administer 15 mg/kg IV every 48-96 hours or as a single dose followed by monitoring. Often requires individualized dosing based on trough levels.
Dialysis: Hemodialysis: Administer 15 mg/kg IV after each dialysis session or 10 mg/kg IV after each session. Peritoneal Dialysis: 15-20 mg/kg IV once weekly or 30 mg/kg IV every 2 weeks. Continuous Renal Replacement Therapy (CRRT): Dosing highly variable, often 7.5-10 mg/kg IV every 12-24 hours, requiring frequent monitoring.

Hepatic Impairment:

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

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 transglycosylation and transpeptidation steps necessary for peptidoglycan elongation and cross-linking, leading to cell lysis and bacterial death. 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 <5% for systemic absorption.
Tmax: Not applicable (IV administration); Peak serum concentrations are typically achieved at the end of the infusion.
FoodEffect: Not applicable (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 200 hours).
Clearance: Primarily renal clearance (glomerular filtration).
ExcretionRoute: Renal (approximately 80-90% of an IV dose is excreted unchanged in the urine within 24 hours).
Unchanged: 80-90%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV infusion completion)
PeakEffect: At the end of infusion
DurationOfAction: Dependent on half-life and renal function, typically maintains therapeutic levels for 8-24 hours depending on dosing interval.
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 (intravenous):
+ Fever
+ Chills
+ Sore throat
+ Pain when passing urine
+ Change 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. 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, 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:

  • Redness, itching, or rash, especially on the upper body, during or shortly after infusion (Red Man Syndrome)
  • Hearing changes, ringing in the ears (tinnitus), or dizziness (vertigo)
  • Decreased urine output, swelling in legs/feet, unusual tiredness (signs of kidney problems)
  • Fever, chills, sore throat (signs of new infection or blood disorder)
  • Unusual bleeding or bruising
  • Severe diarrhea (could be C. difficile infection, even after stopping vancomycin)
  • 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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.

To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any existing health problems

Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. 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 recommend regular hearing tests during treatment.

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 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 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 advice.

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

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

What to Do:

Contact emergency services or poison control immediately (e.g., 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): May increase risk of ototoxicity.
  • Cisplatin: Increased risk of nephrotoxicity and ototoxicity.
  • Cyclosporine: Increased risk of nephrotoxicity.
  • Tacrolimus: Increased risk of nephrotoxicity.
  • Polymyxins (e.g., colistin): Increased risk of nephrotoxicity.
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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 concentrations (theoretical, due to shared renal transporters).
  • Radiocontrast agents: Increased risk of nephrotoxicity when used concurrently or sequentially with vancomycin.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Renal function (SCr, BUN, CrCl)

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

Timing: Prior to initiation of therapy.

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

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), though rare.

Timing: Prior to initiation of therapy.

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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., 2-3 times/week) 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 (e.g., endocarditis, osteomyelitis, meningitis, HAP/VAP, bacteremia, sepsis).

Action Threshold: Levels outside target range require dose 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: Within patient's baseline range; monitor for increases.

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

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

Frequency: Daily patient assessment.

Target: Not applicable

Action Threshold: Report any new or worsening auditory/vestibular symptoms immediately.

Infusion site for phlebitis

Frequency: Daily

Target: Not applicable

Action Threshold: Redness, swelling, pain at infusion site; consider central line for prolonged therapy or high concentrations.

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Symptom Monitoring

  • Red Man Syndrome (flushing, rash, pruritus, urticaria, tachycardia, hypotension, muscle spasms, dyspnea, chest pain, angioedema) - typically during or shortly after infusion
  • Ototoxicity (hearing loss, tinnitus, vertigo)
  • Nephrotoxicity (decreased urine output, swelling, fatigue, nausea, confusion)
  • Hypersensitivity reactions (rash, fever, chills, anaphylaxis)
  • Neutropenia (fever, signs of infection)
  • Thrombocytopenia (unusual bleeding or bruising)
  • Phlebitis/irritation at injection site

Special Patient Groups

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Pregnancy

Vancomycin is generally considered for use in pregnancy only when clearly needed and the benefits outweigh the potential risks. It crosses the placenta. Category C.

Trimester-Specific Risks:

First Trimester: Limited data, but no clear evidence of teratogenicity in humans. Use only if clearly indicated.
Second Trimester: Generally considered safer than in the first trimester, but still used with caution and close monitoring.
Third Trimester: Potential for ototoxicity and nephrotoxicity in the fetus/neonate, especially if maternal levels are high or if used close to delivery. Fetal hearing and renal function should be monitored if exposure occurs.
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Lactation

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

Infant Risk: Low systemic absorption, but potential for gut flora disruption, sensitization, and masking of infection.
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Pediatric Use

Dosing is weight-based and often requires therapeutic drug monitoring (trough levels) due to variable pharmacokinetics, especially in neonates and infants. Renal function must be closely monitored. Higher clearance rates in children may necessitate 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 frequent monitoring of vancomycin trough levels and renal function. They may also be more susceptible to ototoxicity and nephrotoxicity.

Clinical Information

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Clinical Pearls

  • Always administer vancomycin IV infusions slowly over at least 60 minutes (or longer for doses >1g) to minimize the risk of Red Man Syndrome.
  • Therapeutic drug monitoring (trough levels) is essential for optimizing efficacy and minimizing toxicity, especially for serious infections and in patients with unstable renal function.
  • Maintain adequate hydration to reduce the risk of nephrotoxicity.
  • Consider a central venous catheter for prolonged therapy or high concentrations to prevent phlebitis.
  • Vancomycin is NOT absorbed orally for systemic infections; oral vancomycin is used only for Clostridioides difficile infection.
  • The 15-20 mcg/mL trough target is for serious infections (e.g., MRSA bacteremia, endocarditis, meningitis, osteomyelitis, HAP/VAP); for less severe infections, 10-15 mcg/mL may be appropriate.
  • Be vigilant for signs of nephrotoxicity (rising SCr) and ototoxicity (hearing changes, tinnitus).
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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)
  • Tigecycline (for MRSA, VRE, broad spectrum)
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Cost & Coverage

Average Cost: Highly variable, typically $10-$50 per dose depending on concentration and supplier. per 1.75gm/350ml vial
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 guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to 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, do not flush medications down the toilet or drain. If you are unsure about the proper 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, 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.