Vancomycin 1.25gm Inj 1 Vial

Manufacturer MYLAN INSTITUTIONAL 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
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 an antibiotic used to treat serious bacterial infections, especially those caused by bacteria resistant to other antibiotics, like MRSA. It works by stopping bacteria from building their cell walls, which kills them. It is usually given into a vein (IV) slowly.
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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, your doctor may prescribe an oral form of this medication, which can be taken by mouth or through a feeding tube as an alternative to injection.

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 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 unless otherwise instructed by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 15-20 mg/kg IV every 8-12 hours, infused over at least 60 minutes. Target trough concentration 10-20 mcg/mL (15-20 mcg/mL for serious infections like endocarditis, osteomyelitis, meningitis, hospital-acquired pneumonia).
Dose Range: 1000 - 2000 mg

Condition-Specific Dosing:

severeInfections: 20 mg/kg IV loading dose may be considered, followed by maintenance dosing.
C.difficile(oral): 125 mg to 500 mg orally 4 times daily for 10-14 days (Note: This request is for IV formulation, but oral is a common use for C. diff).
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Pediatric Dosing

Neonatal: Initial dose 15 mg/kg IV, then 10 mg/kg IV every 12-24 hours (frequency depends on post-menstrual age and postnatal age). Target trough 10-15 mcg/mL.
Infant: 15 mg/kg IV every 6 hours. Target trough 10-20 mcg/mL.
Child: 15 mg/kg IV every 6 hours. Target trough 10-20 mcg/mL.
Adolescent: 15 mg/kg IV every 6-8 hours. Target trough 10-20 mcg/mL.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Consider extending interval to every 12-24 hours or reducing dose.
Moderate: CrCl 20-49 mL/min: Extend interval to every 24-48 hours or reduce dose significantly. Dosing should be guided by therapeutic drug monitoring.
Severe: CrCl <20 mL/min: Extend interval to every 48-96 hours or administer a single dose and monitor levels. Dosing should be guided by therapeutic drug monitoring.
Dialysis: Hemodialysis: Administer dose after dialysis session. Peritoneal Dialysis: Dosing varies, often 15-20 mg/kg IV once, then monitor levels. Continuous Renal Replacement Therapy (CRRT): Dosing highly variable, requires frequent monitoring and adjustment.

Hepatic Impairment:

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

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 assembly. This leads to osmotic instability and cell lysis. It also alters bacterial cell membrane permeability and RNA synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (IV is 100% for systemic effect; oral bioavailability is <10% for systemic effect)
Tmax: End of infusion (IV)
FoodEffect: Not applicable for IV formulation

Distribution:

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

Elimination:

HalfLife: 4-6 hours (normal renal function); significantly prolonged in renal impairment
Clearance: Primarily renal clearance (glomerular filtration)
ExcretionRoute: Renal (unchanged drug)
Unchanged: Approximately 80-90% (in patients with normal renal function)
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV infusion)
PeakEffect: End of infusion (IV)
DurationOfAction: Dose-dependent, typically 8-12 hours based on half-life and target trough levels

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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

Additional Side Effects to Watch for When Receiving This Medication by Injection:

Fever
Chills
Sore throat
Pain when passing urine
Changes in balance
Flushing
Rash on the face, neck, trunk, and arms during infusion

Potential Complications of Rapid Infusion:

Shortness of breath or wheezing
Itching
Muscle pain
Chest pain
Signs of low blood pressure, such as dizziness or fainting

If you experience any of these symptoms, inform your doctor immediately.

Tissue Damage:

If the medication leaks from the vein, it can cause tissue damage. Notify your nurse if you experience:
Redness
Burning
Pain
Swelling
Blisters
Skin sores
Leaking of fluid at the injection site

Other Possible Side Effects:

Most people do not experience severe side effects, but some may occur. If you have any of the following side effects or any other concerns, contact your doctor:
Diarrhea
Stomach pain
Upset stomach
Vomiting

Reporting Side Effects:

If you have questions or concerns about side effects, 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
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Dizziness or lightheadedness
  • Rapid heartbeat
  • Flushing or redness of the upper body (Red Man Syndrome)
  • Ringing in the ears (tinnitus) or hearing loss
  • Decreased urination or swelling in the legs/feet
  • Fever, chills, or sore throat (signs of 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 symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor assess potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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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, be sure to discuss this with 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 promptly report any changes in your hearing or symptoms of hearing loss to your doctor. Your doctor may also recommend regular 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 C. diff-associated diarrhea (CDAD) can occur, which may lead to life-threatening bowel problems. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately. Before treating diarrhea, consult with your doctor to determine the best course of action.

This medication is not approved for injection into the eye, as it can cause serious 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 (kidney damage)
  • Ototoxicity (hearing loss, tinnitus)
  • Hypotension
  • Red Man Syndrome

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is supportive, including maintaining hydration, monitoring renal function, and potentially hemodialysis to remove the drug 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): Increased risk of ototoxicity.
  • Other nephrotoxic drugs (e.g., amphotericin B, cyclosporine, tacrolimus, NSAIDs): 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: May bind oral vancomycin, reducing its efficacy for C. difficile (not relevant for IV).

Monitoring

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Baseline Monitoring

Renal function (serum creatinine, BUN, estimated 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 high-dose therapy anticipated)

Rationale: To establish baseline for potential ototoxicity.

Timing: Prior to initiation of therapy

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Routine Monitoring

Vancomycin trough concentration

Frequency: Prior to 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)

Action Threshold: Levels outside target range require dose adjustment; levels >20 mcg/mL increase risk of toxicity.

Renal function (serum creatinine, 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

Action Threshold: Significant increase (e.g., 0.5 mg/dL or 50% increase from baseline) may indicate nephrotoxicity and requires dose adjustment or discontinuation.

Complete Blood Count (CBC)

Frequency: Periodically, especially with prolonged therapy.

Target: Within normal limits

Action Threshold: Leukopenia, neutropenia, or thrombocytopenia may occur rarely.

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Symptom Monitoring

  • Red Man Syndrome (flushing, rash, pruritus, urticaria, tachycardia, hypotension on upper body/face during or shortly after infusion)
  • Ototoxicity (tinnitus, dizziness, vertigo, hearing loss)
  • Nephrotoxicity (decreased urine output, edema, fatigue, nausea)
  • Hypersensitivity reactions (rash, fever, chills, anaphylaxis)
  • Injection site reactions (pain, tenderness, phlebitis)

Special Patient Groups

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Pregnancy

Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks. Vancomycin crosses the placenta. Monitor maternal vancomycin levels and consider monitoring fetal hearing and renal function if prolonged high-dose therapy is required.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations.
Second Trimester: No specific increased risks identified.
Third Trimester: No specific increased risks identified. Potential for ototoxicity or nephrotoxicity in the neonate, though rare.
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Lactation

Vancomycin is excreted in breast milk in low concentrations. Generally considered compatible with breastfeeding, but monitor the infant for potential adverse effects such as disruption of gut flora (diarrhea, candidiasis) or allergic reactions (rash).

Infant Risk: Low
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Pediatric Use

Dosing is weight-based and requires careful monitoring of serum concentrations (troughs) due to variability in pharmacokinetics, especially in neonates and young infants. 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 close monitoring of vancomycin levels and renal function to prevent accumulation and toxicity.

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,' a histamine-mediated reaction.
  • Therapeutic drug monitoring (trough levels) is crucial for optimizing efficacy and minimizing toxicity, especially in patients with renal impairment, obesity, or severe infections.
  • Vancomycin is ineffective against Gram-negative bacteria.
  • 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 if a patient develops significant nephrotoxicity or ototoxicity while on vancomycin.
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Alternative Therapies

  • Linezolid (for MRSA, VRE)
  • Daptomycin (for MRSA, VRE)
  • Ceftaroline (for MRSA)
  • Telavancin (for MRSA)
  • Dalbavancin (for MRSA)
  • Oritavancin (for MRSA)
  • Quinupristin/Dalfopristin (for VRE, some MRSA)
  • Metronidazole (for C. difficile)
  • Fidaxomicin (for C. difficile)
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Cost & Coverage

Average Cost: Not available per 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 evaluation and guidance. To ensure safe use, never share your prescription medications with others, and do not take medications that have been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best disposal method, as some communities have designated drug take-back programs.

Additionally, some medications may have a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, it is crucial 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, including the dosage, time of ingestion, and any other relevant details to ensure prompt and effective treatment.