Vancomycin 10gm Inj, 1 Vial

Manufacturer HIKMA 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
FDA Approved
Mar 1958
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Vancomycin is a strong antibiotic used to treat serious bacterial infections, especially those caused by bacteria that are resistant to other antibiotics, like MRSA. It works by stopping bacteria from building their cell walls. It is usually given through a vein (IV) in the hospital.
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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 procedures.

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 urination or swelling.
  • Inform healthcare providers about all other medications, including over-the-counter drugs and supplements.
  • 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 3-4g per day. Dosing should be individualized based on therapeutic drug monitoring (TDM) to achieve target trough concentrations.
Dose Range: 15 - 20 mg

Condition-Specific Dosing:

severeInfections: Initial dose up to 25-30 mg/kg IV (loading dose) followed by 15-20 mg/kg IV every 8-12 hours.
meningitis: 20 mg/kg IV every 8 hours (max 2g/dose).
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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. TDM is crucial.
Infant: 15 mg/kg IV every 6 hours. TDM is crucial.
Child: 15 mg/kg IV every 6 hours. TDM is crucial.
Adolescent: 15 mg/kg IV every 6-8 hours or adult dosing (15-20 mg/kg every 8-12 hours) depending on weight and renal function. TDM is crucial.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-80 mL/min: Consider extending dosing interval to every 12-24 hours or reducing dose. TDM is essential.
Moderate: CrCl 20-49 mL/min: Extend dosing interval to every 24-72 hours or significantly reduce dose. TDM is essential.
Severe: CrCl <20 mL/min: Administer initial loading dose (e.g., 15 mg/kg) then subsequent doses based on TDM, often every 4-7 days or after dialysis. TDM is essential.
Dialysis: Hemodialysis: Administer dose after each dialysis session. Peritoneal Dialysis: Dosing varies, often 15-20 mg/kg IV every 5-7 days or 20-30 mg/L in dialysate. TDM is essential.

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. It binds with high affinity to the D-Ala-D-Ala terminus of peptidoglycan precursors, preventing the transpeptidation (cross-linking) and transglycosylation (elongation) steps necessary for cell wall formation. This leads to increased cell wall permeability and bacterial cell lysis. It is bactericidal against susceptible Gram-positive organisms.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (IV administration for systemic effect); <10% (oral for systemic effect)
Tmax: Not applicable (IV administration); 1-2 hours (oral for C. difficile)
FoodEffect: Not applicable (IV administration); minimal effect on oral absorption for C. difficile

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
Clearance: Primarily renal clearance via glomerular filtration
ExcretionRoute: Renal (urine)
Unchanged: >80-90%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV infusion)
PeakEffect: End of infusion (for peak concentration); clinical effect depends on infection type and severity
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 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 you notice any signs of tissue damage at the injection site, such as:
+ Redness
+ Burning
+ Pain
+ Swelling
+ Blisters
+ Skin sores
+ Leaking of fluid

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 do not go away:

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:

  • Redness, flushing, itching, or rash on the upper body (Red Man Syndrome)
  • Dizziness, ringing in the ears (tinnitus), or hearing loss
  • Decreased urination, swelling in legs or feet (signs of kidney problems)
  • Fever, chills, sore throat (signs of low white blood cell count)
  • 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, any of 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 ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.

To guarantee your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in combination with your other medications and health conditions. Your doctor and pharmacist will work together to ensure that all your medications, including this one, are safe and appropriate for you to take.
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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 symptoms of hearing loss to your doctor. You may need to undergo hearing tests during treatment, so be sure to discuss this with your doctor.

Use this medication only for the recommended duration, as prolonged use can lead to a second infection.

Antibiotics, including this medication, can cause diarrhea, which may be mild or severe. 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 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, inform your doctor, as they will need to discuss the potential benefits and risks to you and your baby. If you are 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 kidney damage (nephrotoxicity)
  • Hearing loss (ototoxicity)
  • Hypotension
  • Dizziness
  • Tinnitus

What to Do:

Treatment is supportive. Hemodialysis may be useful in removing vancomycin from the blood in cases of severe overdose or renal failure. Contact a poison control center immediately (e.g., 1-800-222-1222 in the US).

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, bumetanide): Increased risk of ototoxicity.
  • Other nephrotoxic drugs (e.g., amphotericin B, cyclosporine, tacrolimus, NSAIDs): Increased risk of nephrotoxicity.
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Moderate Interactions

  • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium): May prolong neuromuscular blockade.
  • Metformin: Vancomycin may increase metformin concentrations by inhibiting renal tubular secretion (theoretical, clinical significance unclear).

Monitoring

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Baseline Monitoring

Renal function (Serum Creatinine, BUN)

Rationale: Vancomycin is primarily renally eliminated; baseline assessment is crucial for dosing and to monitor for nephrotoxicity.

Timing: Prior to initiation of therapy.

Audiometric testing (if pre-existing hearing impairment or prolonged therapy)

Rationale: To establish baseline for potential ototoxicity.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC)

Rationale: To establish baseline and monitor for neutropenia or thrombocytopenia.

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) and then at least weekly, or more frequently if renal function changes or dose adjustments are made.

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

Action Threshold: Levels <10 mcg/mL may indicate subtherapeutic dosing; levels >20 mcg/mL increase risk of toxicity (nephrotoxicity, ototoxicity). Adjust dose or interval accordingly.

Renal function (Serum Creatinine, BUN)

Frequency: At least 2-3 times per week, or daily in critically ill patients or those receiving concomitant nephrotoxic agents.

Target: Within patient's baseline range.

Action Threshold: Increase in SCr by ≥0.5 mg/dL or ≥50% from baseline (whichever is greater) on consecutive measurements, or significant decrease in urine output. Consider dose adjustment or discontinuation.

Complete Blood Count (CBC)

Frequency: Weekly, especially during prolonged therapy.

Target: Within normal limits.

Action Threshold: Neutropenia (ANC <1000 cells/mm³) or thrombocytopenia. Consider discontinuation if severe.

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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, urticaria, hypotension, tachycardia during or shortly after infusion)
  • Signs of hypersensitivity reactions (rash, fever, chills)
  • Signs of phlebitis/thrombophlebitis at infusion site

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 human data suggest no increased risk of major birth defects, but animal studies are lacking or show adverse effects. Therapeutic drug monitoring is essential to maintain appropriate levels and minimize fetal exposure.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations based on available human data.
Second Trimester: No specific increased risks identified beyond general pregnancy considerations.
Third Trimester: No specific increased risks identified beyond general pregnancy considerations. Neonatal ototoxicity and nephrotoxicity have been reported in infants exposed in utero, but causality is not definitively established.
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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 risks include alteration of infant gut flora, direct effects on the infant (e.g., ototoxicity, nephrotoxicity, though unlikely due to poor absorption), and interference with interpretation of culture results if fever workup is needed. Use with caution; monitor infant for adverse effects.

Infant Risk: L3 (Moderate risk)
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Pediatric Use

Dosing is weight-based and often requires more frequent administration than in adults due to higher clearance rates. Therapeutic drug monitoring (TDM) is critical in all pediatric age groups, especially neonates and infants, due to variability in pharmacokinetics and immature renal function. Close monitoring for nephrotoxicity and ototoxicity is essential.

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Geriatric Use

Elderly patients are more likely to have age-related decreases in renal function, which can prolong vancomycin half-life and increase the risk of accumulation and toxicity (nephrotoxicity, ototoxicity). Dosing should be carefully adjusted based on renal function, and therapeutic drug monitoring is highly recommended. Close monitoring for adverse effects is crucial.

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) of trough levels is essential for optimizing efficacy and minimizing toxicity, especially in patients with renal impairment, critical illness, or those receiving prolonged therapy.
  • Hydration is important to help prevent nephrotoxicity.
  • Vancomycin is ineffective against Gram-negative bacteria and atypical organisms.
  • Oral vancomycin is used ONLY for Clostridioides difficile infection (CDI) and is not absorbed systemically; IV vancomycin is NOT effective for CDI.
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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)
  • Quinupristin/dalfopristin (for MRSA, VRE)
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Cost & Coverage

Average Cost: Not available per 10gm 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 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. 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.