Vancomycin Hcl 2gm Sdv 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
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 that are resistant to other antibiotics, like MRSA. It works by stopping the bacteria from building their cell walls, which kills them. It is usually given through a vein (IV) for severe 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 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, swelling, or unusual tiredness.
  • Report any rash, itching, or flushing during or after the infusion.
  • 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, not to exceed 2g per dose or 4g per day for normal renal function.
Dose Range: 1000 - 4000 mg

Condition-Specific Dosing:

serious_infections: Target trough 15-20 mcg/mL (e.g., endocarditis, osteomyelitis, meningitis, hospital-acquired pneumonia)
less_serious_infections: Target trough 10-15 mcg/mL (e.g., skin and soft tissue infections)
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Pediatric Dosing

Neonatal: 10-15 mg/kg IV loading dose, then 10 mg/kg IV every 12-24 hours (adjust based on post-natal age and renal function).
Infant: 15 mg/kg IV every 6 hours.
Child: 15 mg/kg IV every 6 hours.
Adolescent: 15 mg/kg IV every 6 hours or adult dosing (15-20 mg/kg IV every 8-12 hours) if weight > 40 kg.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Consider 15-20 mg/kg IV every 12-24 hours or adjust dose/frequency to achieve target trough.
Moderate: CrCl 20-49 mL/min: Consider 15-20 mg/kg IV every 24-48 hours or adjust dose/frequency to achieve target trough.
Severe: CrCl < 20 mL/min: Consider 15 mg/kg IV loading dose, then subsequent doses based on trough levels (e.g., 500-1000 mg every 2-7 days).
Dialysis: Hemodialysis: 15-20 mg/kg IV loading dose, then 500-1000 mg after each dialysis session or 10-15 mg/kg IV 3 times weekly post-dialysis. Peritoneal Dialysis: 15-30 mg/kg IV every 5-7 days or 20-30 mg/L in dialysate.

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 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: 100% (IV)
Tmax: Not applicable for IV administration (peak concentration achieved at end of infusion)
FoodEffect: Not applicable for IV administration

Distribution:

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

Elimination:

HalfLife: 4-8 hours (normal renal function); significantly prolonged in renal impairment
Clearance: Primarily renal clearance (glomerular filtration)
ExcretionRoute: Renal (urine)
Unchanged: Approximately 80-90% of IV dose excreted unchanged in urine
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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 6-12 hours for therapeutic levels)
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 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 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. Many people may not experience any side effects or only minor ones. However, if you are bothered by any of the following side effects or if they persist, 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 about side effects, consult 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
  • Difficulty breathing or swallowing
  • Swelling of the face, throat, or tongue
  • Sudden decrease in urine output
  • Unusual tiredness or weakness
  • Ringing in the ears (tinnitus)
  • Hearing loss
  • Dizziness or vertigo
  • Fever or chills (could indicate neutropenia)
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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 interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
A complete list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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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.

Prolonged 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 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 Clostridioides difficile-associated diarrhea (CDAD) can occur, potentially leading to life-threatening bowel problems. CDAD may develop during or after antibiotic treatment. 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, 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 (nephrotoxicity)
  • Hearing loss (ototoxicity)
  • Red Man Syndrome (severe flushing, rash, hypotension)
  • Hypotension
  • Dizziness

What to Do:

Call 911 or Poison Control (1-800-222-1222). Treatment is supportive, including maintaining renal function, fluid and electrolyte balance, 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): May increase risk of ototoxicity.
  • Cisplatin: Increased risk of nephrotoxicity and ototoxicity.
  • Cyclosporine, Tacrolimus: Increased risk of nephrotoxicity.
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Moderate Interactions

  • NSAIDs (e.g., ibuprofen, naproxen): May increase risk of nephrotoxicity.
  • Amphotericin B: Increased risk of nephrotoxicity.
  • Polymyxin B: Increased risk of nephrotoxicity.
  • Neuromuscular blockers (e.g., succinylcholine, rocuronium): Vancomycin may potentiate or prolong neuromuscular blockade.

Monitoring

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Baseline Monitoring

Renal function (SCr, BUN)

Rationale: Vancomycin is primarily renally eliminated; renal impairment necessitates dose adjustment and increases risk of nephrotoxicity.

Timing: Prior to initiation of therapy

Weight

Rationale: Dosing is weight-based.

Timing: Prior to initiation of therapy

Hearing assessment (if pre-existing hearing loss or risk factors)

Rationale: To establish baseline for potential ototoxicity.

Timing: Prior to initiation of therapy

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Routine Monitoring

Vancomycin trough level

Frequency: Prior to the 4th or 5th dose (at steady state), then at least weekly or more frequently if renal function changes or target not met.

Target: 10-15 mcg/mL (most infections); 15-20 mcg/mL (serious infections)

Action Threshold: Levels outside target range; adjust dose/frequency.

Renal function (SCr, BUN)

Frequency: At least 2-3 times per week, or daily if unstable renal function or concomitant nephrotoxic agents.

Target: Stable or improving

Action Threshold: Increase in SCr by â‰Ĩ0.5 mg/dL or â‰Ĩ50% from baseline, or significant decrease in urine output.

Fluid balance and urine output

Frequency: Daily

Target: Adequate

Action Threshold: Oliguria or anuria.

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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, hypotension during infusion)
  • Signs of hypersensitivity reactions (rash, fever, chills)
  • Signs of neutropenia (fever, sore throat, signs of infection)

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. Limited data suggest it crosses the placenta. Fetal ototoxicity and nephrotoxicity have been reported in animal studies but not definitively in humans.

Trimester-Specific Risks:

First Trimester: Limited human data; animal studies show some risk. Use only if clearly needed.
Second Trimester: Limited human data; use with caution, monitor maternal levels and fetal well-being.
Third Trimester: Limited human data; use with caution, monitor maternal levels and fetal well-being.
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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 potential for disruption of infant gut flora, allergic sensitization, or direct effects on the infant's kidneys/ears cannot be completely ruled out. Monitor infant for diarrhea, candidiasis, or rash. Generally considered L3 (moderately safe).

Infant Risk: Low risk of adverse effects, but monitor for GI upset, candidiasis, or rash. Theoretical risk of ototoxicity/nephrotoxicity, but systemic absorption by infant is minimal.
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Pediatric Use

Dosing is weight-based and adjusted for age, especially in neonates and infants due to immature renal function. Close monitoring of serum concentrations (troughs) and renal function is crucial to optimize efficacy and minimize toxicity.

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Geriatric Use

Elderly patients are more likely to have decreased renal function, which necessitates dose adjustment and careful monitoring of vancomycin levels and renal function. They may also be more susceptible to nephrotoxicity and ototoxicity.

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 prevent Red Man Syndrome.
  • Therapeutic drug monitoring (TDM) with trough levels is essential for optimizing efficacy and minimizing toxicity, especially in patients with unstable renal function, obesity, or serious infections.
  • Hydration is important to reduce the risk of nephrotoxicity.
  • 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 more stable drug levels and potentially reduce nephrotoxicity.
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Alternative Therapies

  • Linezolid (for MRSA, VRE)
  • Daptomycin (for MRSA, VRE)
  • Ceftaroline (for MRSA)
  • Teicoplanin (not available in US, similar to vancomycin)
  • Tigecycline (for MRSA, VRE, broad spectrum)
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Cost & Coverage

Average Cost: Varies widely by manufacturer and quantity 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 persist or worsen, it is essential to contact your doctor for further guidance. 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 reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Additionally, some medications may have a separate patient information leaflet, which your pharmacist can provide. 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion to ensure prompt and effective treatment.