Vancomycin Hcl 1.75gm 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
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Pregnancy Category
Not available
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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 a strong 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.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is typically administered as an infusion into a vein over a specified period of time. In some cases, it may be given orally or through a feeding tube as an alternative to injection, if deemed necessary by your healthcare provider.

For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.

If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Report any changes in hearing or ringing in the ears immediately.
  • Report any signs of kidney problems, such as decreased urination or swelling.
  • Inform healthcare providers if you experience flushing, rash, or itching during the infusion, as this might be 'Red Man Syndrome' and the infusion rate may need to be slowed.
  • Complete the full course of treatment as prescribed, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: 15 to 20 mg/kg IV every 8 to 12 hours (initial dose), adjusted to achieve target trough concentrations.
Dose Range: 1000 - 2000 mg

Condition-Specific Dosing:

severe_infections: 20 mg/kg IV every 8 hours (initial dose), up to 2000 mg per dose.
meningitis: 15 to 20 mg/kg IV every 8 to 12 hours, adjusted to achieve target trough concentrations.
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Pediatric Dosing

Neonatal: 10 to 15 mg/kg IV every 12 to 24 hours, adjusted based on post-natal age, gestational age, and renal function.
Infant: 15 mg/kg IV every 6 hours (initial dose), adjusted to achieve target trough concentrations.
Child: 15 mg/kg IV every 6 hours (initial dose), adjusted to achieve target trough concentrations.
Adolescent: 15 mg/kg IV every 6 to 8 hours (initial dose), adjusted to achieve target trough concentrations.
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Dose Adjustments

Renal Impairment:

Mild: Dose adjustment required; extend dosing interval or reduce dose based on creatinine clearance (CrCl) and therapeutic drug monitoring (TDM).
Moderate: Significant dose adjustment required; extend dosing interval or reduce dose based on CrCl and TDM.
Severe: Significant dose adjustment required; often 15 mg/kg IV once, then subsequent doses based on TDM (e.g., every 2-7 days).
Dialysis: Hemodialysis: Administer 15 mg/kg IV once, then subsequent doses based on TDM (e.g., 500-1000 mg after each dialysis session or 10-15 mg/kg every 3-7 days). Peritoneal Dialysis: 15 mg/kg IV once, then 15 mg/kg every 5-7 days or 30 mg/L in dialysate.

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 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. It also alters bacterial cell membrane permeability and RNA synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV); <10% (oral for systemic effect)
Tmax: End of infusion (IV)
FoodEffect: Not applicable for IV formulation; oral absorption is poor regardless of food.

Distribution:

Vd: 0.4-1 L/kg (adults); higher in children
ProteinBinding: 10-50%
CnssPenetration: Limited (unless meninges are inflamed)

Elimination:

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

OnsetOfAction: Rapid (IV)
PeakEffect: End of infusion (IV)
DurationOfAction: Dose-dependent, typically 8-12 hours for therapeutic levels with normal renal function.

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
+ Changes in balance
+ Flushing
+ Rash on the face, neck, trunk, and arms during infusion
If this medication is administered too quickly, it 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical attention if you experience:

Diarrhea
Stomach pain
Upset stomach
Vomiting
* Any other side effects that bother you or do not go away

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 skin rash or hives
  • Difficulty breathing or swallowing
  • Swelling of the face, throat, tongue, lips, or eyes
  • Hoarseness
  • Dizziness or lightheadedness
  • Ringing in the ears (tinnitus)
  • Hearing loss
  • Decreased urine output
  • Unusual tiredness or weakness
  • Fever or chills (unrelated to infection)
  • 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 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 is crucial to avoid potential interactions between this medication and other substances.
Any existing health problems you have, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is vital to:

Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor. This will help prevent any potential interactions or adverse effects.
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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 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 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 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 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 kidney damage (renal failure)
  • Hearing loss or deafness
  • Severe hypotension
  • Red Man Syndrome (exaggerated flushing, rash, pruritus, hypotension)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including maintaining hydration, monitoring renal function, and potentially hemodialysis to remove vancomycin from the blood.

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.
  • 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 levels by inhibiting renal tubular secretion (theoretical, clinical significance unclear).
  • Cholestyramine: May bind oral vancomycin, reducing its efficacy for C. difficile infection (not relevant for IV vancomycin).

Monitoring

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Baseline Monitoring

Renal function (Serum Creatinine, BUN)

Rationale: Vancomycin is primarily renally eliminated, and nephrotoxicity is a major adverse effect. Baseline assessment is crucial for dosing.

Timing: Prior to initiation of therapy.

Audiometric testing (if pre-existing hearing loss or risk factors)

Rationale: Ototoxicity is a rare but serious adverse effect, especially with high concentrations or prolonged therapy.

Timing: Prior to initiation of therapy in high-risk patients.

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Routine Monitoring

Vancomycin trough concentration

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

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

Action Threshold: Adjust dose or interval if trough is outside target range; investigate potential causes (e.g., renal function changes, adherence).

Renal function (Serum Creatinine, BUN)

Frequency: Daily or every other day during initial therapy, then at least 2-3 times per week, or more frequently in patients with unstable renal function or concomitant nephrotoxic agents.

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 greater) suggests acute kidney injury; consider dose adjustment or discontinuation.

Complete Blood Count (CBC)

Frequency: Weekly or as clinically indicated.

Target: Normal ranges.

Action Threshold: Significant leukopenia, neutropenia, or thrombocytopenia may warrant discontinuation or investigation.

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Symptom Monitoring

  • Signs of nephrotoxicity (decreased urine output, swelling, fatigue)
  • Signs of ototoxicity (hearing loss, tinnitus, vertigo)
  • Signs of Red Man Syndrome (flushing, rash, pruritus, hypotension during infusion)
  • Signs of hypersensitivity reactions (rash, fever, chills)
  • Signs of phlebitis at infusion site (pain, redness, swelling)

Special Patient Groups

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Pregnancy

Vancomycin is generally considered for use in pregnancy when clearly needed and benefits outweigh potential risks. It crosses the placenta. Limited data suggest no increased risk of major birth defects or miscarriage. Fetal auditory and renal function should be monitored if prolonged high-dose therapy is used.

Trimester-Specific Risks:

First Trimester: Limited human data, no clear evidence of increased risk of major birth defects.
Second Trimester: No clear evidence of increased risk.
Third Trimester: No clear evidence of increased risk. Fetal auditory and renal function should be monitored if prolonged high-dose therapy is used.
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Lactation

Vancomycin is excreted into breast milk in small amounts. Oral absorption by the infant is poor, so systemic exposure to the infant is expected to be low. Monitor breastfed infants for changes in bowel flora (e.g., diarrhea, candidiasis) and potential allergic reactions. Generally considered compatible with breastfeeding when indicated.

Infant Risk: Low
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Pediatric Use

Dosing is weight-based and adjusted based on age, renal function, and therapeutic drug monitoring (trough levels). Neonates and infants require careful monitoring due to immature renal function. Higher doses per kg may be needed in older children due to faster clearance.

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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 vancomycin trough levels and renal function to prevent accumulation and toxicity. 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 10 mg/minute) to prevent Red Man Syndrome.
  • Therapeutic drug monitoring (TDM) with trough levels is crucial for optimizing efficacy and minimizing toxicity, especially in patients with unstable renal function, severe infections, or those receiving concomitant nephrotoxic agents.
  • Target trough levels vary based on the severity and type of infection (10-15 mcg/mL for less severe, 15-20 mcg/mL for severe infections).
  • Vancomycin is not absorbed orally for systemic infections; oral vancomycin is used only for Clostridioides difficile infection.
  • Hydration is important to minimize the risk of nephrotoxicity.
  • Consider continuous infusion vancomycin in critically ill patients to maintain stable concentrations and potentially reduce nephrotoxicity, especially when targeting higher troughs.
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Alternative Therapies

  • Linezolid (for MRSA, VRE)
  • Daptomycin (for MRSA, VRE)
  • Ceftaroline (for MRSA)
  • Teicoplanin (glycopeptide, not available in US)
  • Tigecycline (for MRSA, VRE, broad spectrum)
  • Quinupristin/dalfopristin (for MRSA, VRE)
  • Ceftobiprole (for MRSA, not available in US)
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Cost & Coverage

Average Cost: Varies widely by manufacturer and quantity (e.g., $10-$50 per 1.75g vial) per 1.75g 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, do not share your medication with others, and never 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 flush medications down the toilet or pour them down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. If you are unsure about the best method for disposing of medications, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet. If you have questions or concerns about your medication, it is recommended that you consult with your pharmacist, who can provide further information and clarification.

In the event of a suspected overdose, it is critical to seek immediate medical attention or contact your local poison control center. Be prepared to provide detailed information about the medication, including the amount taken and the time of ingestion, to ensure prompt and effective treatment.