Vancomycin 1gm/200m Inj 12x200ml

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
Not available
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FDA Approved
Aug 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. It works by stopping bacteria from building their cell walls. It is usually given into a vein (IV) for serious infections.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the instructions closely. This medication is typically administered as an infusion into a vein over a period of time. In some cases, your doctor may prescribe this medication to be taken orally or through a feeding tube instead of as an injection.

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 immediately to receive guidance on what to do next.
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Lifestyle & Tips

  • Report any changes in hearing (ringing in ears, hearing loss) or dizziness immediately.
  • Report any signs of kidney problems (less urine, swelling in legs/feet, unusual tiredness).
  • Report any rash, flushing, or itching 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, infused over at least 60 minutes. Max single dose typically 2g.
Dose Range: 15 - 20 mg

Condition-Specific Dosing:

severeInfections: Consider initial loading dose of 25-30 mg/kg, followed by 15-20 mg/kg every 8-12 hours. Target trough 15-20 mcg/mL.
meningitis: 20 mg/kg IV every 8 hours (max 2g/dose), target trough 15-20 mcg/mL.
endocarditis: 15-20 mg/kg IV every 8-12 hours, target trough 15-20 mcg/mL.
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Pediatric Dosing

Neonatal: Initial dose 15 mg/kg IV, then 10 mg/kg IV every 12-24 hours depending on post-natal age and gestational age. Adjust based on TDM.
Infant: 15 mg/kg IV every 6 hours. Adjust based on TDM.
Child: 15 mg/kg IV every 6 hours. Adjust based on TDM.
Adolescent: 15 mg/kg IV every 6-8 hours. Adjust based on TDM.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Consider extending dosing interval to 12-24 hours or reducing dose. Monitor trough levels.
Moderate: CrCl 20-49 mL/min: Administer 15 mg/kg every 24-48 hours. Monitor trough levels closely.
Severe: CrCl <20 mL/min: Initial dose 15 mg/kg, then subsequent doses based on trough levels (e.g., 15 mg/kg every 48-96 hours or more).
Dialysis: Hemodialysis: Initial dose 15 mg/kg, then 5-10 mg/kg after each dialysis session or 15 mg/kg every 7 days. Peritoneal Dialysis: 15 mg/kg IV every 7 days or 30 mg/L in dialysate. Monitor trough levels.

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 nascent peptidoglycan precursors. This binding prevents the transglycosylation and transpeptidation steps, 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: End of infusion (IV)
FoodEffect: Not applicable (IV administration)

Distribution:

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

Elimination:

HalfLife: 4-6 hours (normal renal function); significantly prolonged in renal impairment (up to 7.5 days in anuric patients)
Clearance: 0.9-1.3 mL/min/kg (normal renal function)
ExcretionRoute: Primarily renal (glomerular filtration)
Unchanged: >80-90% (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 maintains therapeutic levels for 6-12 hours with appropriate dosing.

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 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. 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
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Sudden decrease in urine output
  • Swelling in the ankles or feet
  • Unusual tiredness or weakness
  • Ringing in the ears (tinnitus)
  • Hearing loss
  • Dizziness or vertigo
  • Severe diarrhea (especially if bloody or watery) and stomach cramps (may indicate C. difficile 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, any of 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 information 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.

Kidney problems, such as kidney failure, have been associated with this drug. If you have a history of kidney problems, notify your doctor promptly.

Regular blood work and other laboratory tests, as directed by your doctor, are crucial to monitor your health while taking this medication.

Long-term use of this drug may increase the risk of permanent hearing loss. Do not exceed the prescribed duration of treatment. Immediately report any changes in your hearing or symptoms of hearing loss to your doctor. Your doctor may recommend regular hearing tests during treatment.

Do not use this medication for an extended period, as this may lead to a secondary infection.

Antibiotics, including this drug, can cause diarrhea. Although rare, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur, potentially leading to life-threatening bowel problems. CDAD can develop during or several months after antibiotic treatment. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately. Before treating diarrhea, consult your doctor.

This medication is not approved for injection into the eye, as it may cause 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 benefits and risks of this medication 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 (acute kidney injury, anuria)
  • Ototoxicity (hearing loss, tinnitus, vertigo)
  • Hypotension
  • Red Man Syndrome (severe flushing, rash, pruritus)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is supportive. Hemodialysis may be useful in removing vancomycin from the blood in cases of severe overdose or renal failure.

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.
  • Neuromuscular blockers (e.g., succinylcholine, rocuronium): May potentiate and prolong neuromuscular blockade.
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Moderate Interactions

  • NSAIDs (e.g., ibuprofen, naproxen): May increase risk of nephrotoxicity.
  • Amphotericin B: Increased risk of nephrotoxicity.
  • Radiographic contrast media: Increased risk of nephrotoxicity.

Monitoring

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Baseline Monitoring

Renal function (Serum Creatinine, BUN)

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

Timing: Prior to initiation of therapy

Complete Blood Count (CBC)

Rationale: To establish baseline and monitor for potential hematologic adverse effects (e.g., neutropenia, thrombocytopenia), though rare.

Timing: Prior to initiation of therapy

Audiometric testing (if pre-existing hearing impairment or high risk)

Rationale: To establish baseline and monitor for ototoxicity, especially in patients at high risk or receiving concomitant ototoxic drugs.

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), then at least weekly or more frequently if dose changes, renal function changes, or clinical concern.

Target: 10-15 mcg/mL for most infections; 15-20 mcg/mL for serious infections (e.g., endocarditis, osteomyelitis, meningitis, HAP/VAP, bacteremia, severe MRSA infections).

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

Renal function (Serum Creatinine, BUN)

Frequency: Daily or every 2-3 days during therapy, especially in patients with unstable renal function, concomitant nephrotoxins, or critical illness.

Target: Within patient's baseline range or acceptable increase.

Action Threshold: Increase in SCr by â‰Ĩ0.5 mg/dL or â‰Ĩ50% from baseline (whichever is smaller) on two consecutive measurements, or significant decrease in urine output, warrants dose adjustment or discontinuation.

Fluid balance and urine output

Frequency: Daily

Target: Adequate urine output for hydration status.

Action Threshold: Oliguria or anuria may indicate acute kidney injury.

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Symptom Monitoring

  • Rash (especially 'Red Man Syndrome' - flushing, pruritus, erythema of upper body, neck, face, arms, back)
  • Hearing changes (tinnitus, hearing loss)
  • Dizziness or vertigo
  • Signs of kidney dysfunction (decreased urine output, swelling, fatigue)
  • Fever, chills, sore throat (signs of neutropenia, though rare)
  • Pain or phlebitis at infusion site

Special Patient Groups

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Pregnancy

Vancomycin is generally considered acceptable for use in pregnancy when clearly indicated for serious infections, as the benefits outweigh the potential risks. Limited human data suggest no increased risk of major birth defects or miscarriage. However, potential for ototoxicity and nephrotoxicity in the fetus/neonate cannot be entirely excluded, especially with high maternal concentrations.

Trimester-Specific Risks:

First Trimester: Limited data, but no clear evidence of teratogenicity.
Second Trimester: Generally considered safe when indicated.
Third Trimester: Potential for fetal ototoxicity or nephrotoxicity, especially if maternal levels are high or prolonged. Monitor fetal renal function and hearing if exposure occurs.
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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 minimal. Risk of adverse effects in breastfed infants is generally considered low. Monitor infant for changes in bowel habits (diarrhea), rash, or thrush.

Infant Risk: Low (L3)
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Pediatric Use

Dosing is weight-based and often requires therapeutic drug monitoring (TDM) to achieve target trough levels, especially in neonates and infants due to variable renal maturation. Close monitoring of renal function is essential.

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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 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 infuse vancomycin slowly over at least 60 minutes (or longer for doses >1g) to prevent Red Man Syndrome.
  • Therapeutic drug monitoring (TDM) with trough levels is critical for optimizing efficacy and minimizing toxicity, especially for serious infections or in patients with unstable renal function.
  • Target trough levels vary based on the severity and type of infection (10-15 mcg/mL for less severe, 15-20 mcg/mL for serious 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 alternative agents if a patient develops significant nephrotoxicity or ototoxicity, or if they have a history of severe hypersensitivity reactions.
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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)
  • Clindamycin (for some Gram-positive infections, but resistance is common)
  • Trimethoprim/Sulfamethoxazole (for some MRSA infections)
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Cost & Coverage

Average Cost: $10 - $50 per 1g vial (generic)
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 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 a healthcare professional. 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. Some medications may have additional patient information leaflets, 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.