Vancomycin 1.5mg Inj, 1 Vial

Manufacturer HIKMA 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 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. For infections in the blood or other body parts, it's given through a vein (IV). For a specific gut infection called C. difficile, it's taken by mouth.
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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 precisely. This medication is typically administered as an intravenous infusion, which means it is given 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 administered 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 to determine the best storage method.

What to Do If You Miss a Dose

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

  • Stay well-hydrated while taking this medication, especially if receiving it intravenously.
  • Report any changes in hearing or ringing in the ears immediately.
  • Report any significant decrease in urine output or swelling.
  • If receiving IV, report any flushing, rash, or itching during or after the infusion.

Dosing & Administration

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Adult Dosing

Standard Dose: IV: 15-20 mg/kg (based on actual body weight) every 8-12 hours, not to exceed 2 g per dose. Oral: 125 mg to 500 mg four times daily for C. difficile infection.
Dose Range: 15 - 20 mg

Condition-Specific Dosing:

Severe Infections (e.g., endocarditis, osteomyelitis): IV: Initial dose up to 25-30 mg/kg, followed by 15-20 mg/kg every 8-12 hours, targeting higher trough levels (15-20 mcg/mL).
Surgical Prophylaxis: IV: 15 mg/kg administered within 120 minutes prior to surgical incision.
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Pediatric Dosing

Neonatal: IV: Initial dose 15 mg/kg, then 10 mg/kg every 12-24 hours depending on post-natal age and gestational age. Trough-guided dosing is essential.
Infant: IV: 15 mg/kg initial dose, then 10 mg/kg every 6-12 hours. Trough-guided dosing is essential.
Child: IV: 15 mg/kg initial dose, then 10 mg/kg every 6-8 hours. Max 60-80 mg/kg/day. Trough-guided dosing is essential. Oral: 10 mg/kg/dose up to 125 mg/dose, 4 times daily for C. difficile.
Adolescent: IV: 15-20 mg/kg every 8-12 hours, similar to adult dosing. Trough-guided dosing is essential.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Consider extending dosing interval or reducing dose. Monitor levels closely.
Moderate: CrCl 30-49 mL/min: Administer 15 mg/kg every 24-48 hours. Monitor levels closely.
Severe: CrCl <30 mL/min: Administer 15 mg/kg once, then subsequent doses based on serum concentrations (e.g., 15 mg/kg every 48-96 hours or more).
Dialysis: Hemodialysis: Administer 15 mg/kg once, then 5-10 mg/kg after each dialysis session or based on levels. Peritoneal Dialysis: 15 mg/kg once, then 15 mg/kg every 7 days or based on levels. Continuous Renal Replacement Therapy (CRRT): Dosing highly variable, often 15-20 mg/kg loading dose, then 7.5-10 mg/kg every 12-24 hours, or continuous infusion, guided by levels.

Hepatic Impairment:

Mild: No specific dose adjustment required, as vancomycin is minimally metabolized by the liver. However, monitor for potential accumulation if renal function is also impaired.
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 to the D-Ala-D-Ala terminus of the peptidoglycan precursor. This binding prevents the transpeptidation (cross-linking) and transglycosylation (elongation) steps, leading to cell lysis and bacterial death. It is bactericidal against susceptible Gram-positive organisms.
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Pharmacokinetics

Absorption:

Bioavailability: IV: 100% (systemic). Oral: <5% (systemic, primarily acts locally in GI tract for C. difficile).
Tmax: IV: End of infusion (typically 1-2 hours after start of infusion). Oral: Not applicable for systemic effect.
FoodEffect: Oral absorption is not significantly affected by food, but it is poorly absorbed regardless.

Distribution:

Vd: 0.4-1 L/kg (adults), higher in children and critically ill patients.
ProteinBinding: 10-50% (variable, typically 30-55%).
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 7.5 days in anuric patients).
Clearance: Primarily renal clearance (glomerular filtration).
ExcretionRoute: Renal (glomerular filtration) for IV administration; Fecal for oral administration (unabsorbed drug).
Unchanged: >80-90% (IV administration).
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV infusion).
PeakEffect: At the end of infusion (for IV administration).
DurationOfAction: Dependent on renal function and dosing interval; typically maintains therapeutic levels for 8-24 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 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, although not everyone will experience them. If you have any of the following side effects or any other concerns, 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, 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
  • Ringing in the ears (tinnitus)
  • Hearing loss
  • Decreased urine output
  • Unusual tiredness or weakness
  • Fever or chills (unrelated to infection being treated)
  • Unusual bleeding or bruising
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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, 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 dosage of any medication without first consulting your doctor. This will help prevent 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 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 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.

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 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 (decreased urine, swelling)
  • Hearing loss or deafness
  • Severe dizziness or vertigo
  • Hypotension
  • Red Man Syndrome (severe flushing, rash, itching, hypotension)

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). 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): May increase risk of ototoxicity.
  • Cisplatin: Increased risk of nephrotoxicity and ototoxicity.
  • Cyclosporine, Tacrolimus: 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 plasma concentrations by inhibiting OCT1/2, potentially increasing risk of lactic acidosis (rare, theoretical).
  • Cholestyramine, Colestipol (oral vancomycin): May bind to oral vancomycin, reducing its efficacy for C. difficile. Administer vancomycin several hours before or after.
  • Other nephrotoxic or ototoxic drugs: Concurrent use should be carefully monitored.

Monitoring

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Baseline Monitoring

Renal function (SCr, BUN, 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 therapy)

Rationale: To establish baseline for potential ototoxicity.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC)

Rationale: To assess for baseline hematologic abnormalities; vancomycin can rarely cause neutropenia or thrombocytopenia.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Vancomycin trough serum concentrations

Frequency: Prior to the 4th or 5th dose (at steady state), then at least weekly for prolonged therapy, or more frequently in unstable renal function or critical illness.

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

Action Threshold: Levels outside target range necessitate dose adjustment (increase dose/frequency for subtherapeutic, decrease dose/frequency for supratherapeutic) and re-monitoring.

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: Stable or improving renal function.

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

Fluid balance and urine output

Frequency: Daily.

Target: Adequate hydration and urine output.

Action Threshold: Oliguria or signs of dehydration may exacerbate nephrotoxicity.

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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, tachycardia during or shortly after infusion)
  • Signs of hypersensitivity reactions (rash, fever, chills)
  • Signs of neutropenia (fever, sore throat, signs of infection)
  • Signs of thrombocytopenia (unusual bleeding or bruising)

Special Patient Groups

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Pregnancy

Vancomycin is generally considered for use in pregnancy only if clearly needed, as animal studies have shown some evidence of fetal harm (ototoxicity) at high doses, and human data are limited. However, it is often used for serious Gram-positive infections where benefits outweigh risks. Therapeutic drug monitoring is crucial.

Trimester-Specific Risks:

First Trimester: Limited data; potential for fetal exposure. Use only if clearly indicated.
Second Trimester: Generally considered safer than first trimester, but still with caution. Monitor maternal and fetal well-being.
Third Trimester: Risk of ototoxicity to the fetus, especially if maternal levels are high. Close monitoring of maternal levels and fetal auditory function is advised if prolonged exposure.
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Lactation

Vancomycin is excreted into breast milk in small amounts. Oral absorption by the infant is poor, so systemic effects on the infant are unlikely. However, potential for alteration of infant gut flora or allergic sensitization exists. Use with caution, monitor infant for diarrhea or rash. L3 (Moderately Safe).

Infant Risk: Low systemic risk due to poor oral absorption; potential for gut flora disruption or sensitization.
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Pediatric Use

Dosing is weight-based and often requires more frequent administration than adults due to faster clearance. Therapeutic drug monitoring (trough levels) is essential to ensure efficacy and minimize toxicity, especially in neonates and infants due to variable pharmacokinetics and immature renal function. Risk of nephrotoxicity and ototoxicity is present.

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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. They may also be more susceptible to ototoxicity and nephrotoxicity. Lower initial doses and extended dosing intervals are often appropriate.

Clinical Information

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Clinical Pearls

  • Vancomycin 1.5mg Inj is an unusual dose; typical IV doses are in the range of hundreds of milligrams to grams (e.g., 500mg, 1g, 1.5g). This specific dose might be a typo or for a highly specialized, non-systemic use (e.g., ophthalmic, intrathecal, or research). Standard information provided assumes typical systemic IV use.
  • Infuse IV vancomycin slowly over at least 60 minutes (or 10 mg/min) to prevent Red Man Syndrome, an infusion-related reaction.
  • Therapeutic drug monitoring (TDM) with trough levels is critical for optimizing efficacy and minimizing toxicity, especially nephrotoxicity.
  • Vancomycin is the drug of choice for methicillin-resistant Staphylococcus aureus (MRSA) infections.
  • Oral vancomycin is NOT absorbed systemically and is used exclusively for Clostridioides difficile infection (CDI). IV vancomycin is ineffective for CDI.
  • Concurrent use with other nephrotoxic or ototoxic agents should be avoided or closely monitored.
  • Consider continuous infusion vancomycin in critically ill patients or those with unstable renal function to maintain more stable drug levels and potentially reduce toxicity.
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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)
  • Fidaxomicin (for C. difficile, oral)
  • Metronidazole (for C. difficile, oral/IV)
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Cost & Coverage

Average Cost: Varies widely by formulation, strength, and supplier (e.g., $10-$100+ per vial for 500mg-1g). per vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic), Tier 3 (Brand)
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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 or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for the recommended disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call 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 occurred to ensure prompt and effective treatment.