Vancomycin 25mg/ml Oral Soln 150ml

Manufacturer ASCEND LABORATORIES Active Ingredient Vancomycin Oral Solution(van koe MYE sin) Pronunciation van koe MYE sin
It is used to treat certain types of bowel infections. This includes an infection called C diff.
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Drug Class
Antibiotic
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Pharmacologic Class
Glycopeptide antibiotic
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Pregnancy Category
Category B
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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 oral solution is an antibiotic used to treat a severe type of diarrhea caused by a specific germ called Clostridioides difficile (C. diff). It works by killing the C. diff bacteria in your intestines, helping to stop the diarrhea and other symptoms. It is not absorbed into your body like other antibiotics, so it mainly works where the infection is, in your gut.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most out of your medication, follow these steps:

Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Before you receive your medication, your pharmacist will need to mix it. Once you have it, shake the bottle well before each use.
When measuring liquid doses, use the measuring device that comes with your medication. If one is not provided, ask your pharmacist for a suitable device to measure your doses accurately.
Continue taking your medication as instructed by your doctor or healthcare provider, even if you start feeling better.

Important: Checking Your Medication

Before using your medication, check the solution for any signs of haziness or particles. If you notice either of these, do not use the medication. Instead, contact your doctor or pharmacist for guidance on what to do next.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

Store it in the refrigerator at all times. Do not freeze your medication.
Protect it from light to preserve its potency.
* Keep the lid tightly closed when not in use.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Remember, you should not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take the medication exactly as prescribed by your doctor, even if you start feeling better.
  • Do not skip doses or stop taking the medication early, as this can lead to the infection coming back.
  • Stay well-hydrated, especially if you are experiencing significant diarrhea.
  • Practice good hand hygiene (frequent hand washing with soap and water) to prevent the spread of C. diff.
  • Avoid taking anti-diarrhea medications (like loperamide) unless specifically instructed by your doctor, as they can worsen C. diff infection by trapping the toxins in the gut.

Dosing & Administration

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Adult Dosing

Standard Dose: For initial episode of Clostridioides difficile infection (CDI): 125 mg orally 4 times daily for 10 days.
Dose Range: 125 - 500 mg

Condition-Specific Dosing:

Severe/Fulminant CDI: 500 mg orally 4 times daily for 10 days.
Recurrent CDI (first recurrence): 125 mg orally 4 times daily for 10 days (after standard course of metronidazole or vancomycin).
Recurrent CDI (second or subsequent recurrence): Tapered and pulsed regimens may be used, e.g., 125 mg 4 times daily for 10-14 days, then 125 mg twice daily for 7 days, then 125 mg once daily for 7 days, then 125 mg every 2-3 days for 2-8 weeks.
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Pediatric Dosing

Neonatal: Not established for oral use in CDI. Consult specialist.
Infant: 10 mg/kg orally 3-4 times daily (maximum 125 mg/dose or 500 mg/day) for 10 days for CDI.
Child: 10 mg/kg orally 3-4 times daily (maximum 125 mg/dose or 500 mg/day) for 10 days for CDI.
Adolescent: 10 mg/kg orally 3-4 times daily (maximum 125 mg/dose or 500 mg/day) for 10 days for CDI, or adult dose if weight allows.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for oral vancomycin for CDI due to minimal systemic absorption.
Moderate: No adjustment needed for oral vancomycin for CDI due to minimal systemic absorption.
Severe: No adjustment needed for oral vancomycin for CDI due to minimal systemic absorption.
Dialysis: No adjustment needed for oral vancomycin for CDI due to minimal systemic absorption. Vancomycin is not significantly removed by dialysis when administered orally.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No 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 the peptidoglycan precursor. This binding prevents the transglycosylation and transpeptidation steps necessary for peptidoglycan elongation and cross-linking, leading to cell wall damage and bacterial cell death. For Clostridioides difficile, its action is primarily local within the gastrointestinal lumen.
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Pharmacokinetics

Absorption:

Bioavailability: <5% (systemic absorption from oral administration)
Tmax: Not applicable for systemic effect (oral vancomycin acts locally in the gut)
FoodEffect: Minimal effect on local action in the gut.

Distribution:

Vd: Not applicable (minimal systemic distribution from oral administration)
ProteinBinding: Not applicable (minimal systemic distribution from oral administration)
CnssPenetration: No (minimal systemic absorption)

Elimination:

HalfLife: Not applicable for systemic effect (primarily eliminated via feces)
Clearance: Not applicable for systemic effect (primarily eliminated via feces)
ExcretionRoute: Primarily fecal (unchanged drug)
Unchanged: >95% (excreted unchanged in feces after oral administration)
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Pharmacodynamics

OnsetOfAction: Clinical improvement typically seen within 2-4 days for CDI.
PeakEffect: Not applicable for systemic effect (local action in gut).
DurationOfAction: Maintains therapeutic concentrations in the gut lumen for the duration of dosing.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Swelling in the arms or legs.
Hearing loss or changes in hearing, which may be permanent and more likely with long-term use. Do not take this medication for longer than prescribed by your doctor.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening and may also affect internal organs. Seek immediate medical help if you experience: red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

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 or seek medical help:

Diarrhea, stomach pain, upset stomach, or vomiting.
Gas.
Feeling tired or weak.
Back pain.
Headache.

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:

  • Worsening diarrhea or no improvement after a few days of treatment.
  • New or worsening abdominal pain or cramping.
  • Fever that does not go away.
  • Signs of dehydration (e.g., extreme thirst, decreased urination, dizziness).
  • Any signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing) - seek immediate medical attention.
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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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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.

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

You may require periodic hearing tests during treatment with this medication; consult with your doctor regarding the necessity of these tests.

Do not exceed the prescribed duration of treatment, as prolonged use can lead to a secondary infection.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Due to minimal systemic absorption, systemic toxicity from oral overdose is unlikely.
  • Possible gastrointestinal upset (nausea, vomiting, increased diarrhea).

What to Do:

Contact a poison control center (1-800-222-1222) or seek emergency medical attention. Management is primarily supportive, as significant systemic absorption is not expected.

Drug Interactions

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Moderate Interactions

  • Cholestyramine
  • Colestipol

Monitoring

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Baseline Monitoring

Baseline renal function (SCr, BUN)

Rationale: Although systemic absorption is minimal, monitoring renal function is prudent, especially in patients with inflammatory bowel disease or impaired renal function where some systemic absorption could theoretically occur.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Resolution of diarrhea and other CDI symptoms

Frequency: Daily

Target: Complete resolution or significant improvement

Action Threshold: Lack of improvement or worsening symptoms after 3-5 days may indicate treatment failure or need for re-evaluation.

Fluid and electrolyte balance

Frequency: As clinically indicated, especially in severe diarrhea

Target: Normal hydration and electrolyte levels

Action Threshold: Signs of dehydration or electrolyte imbalance require intervention.

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Symptom Monitoring

  • Resolution of watery diarrhea
  • Decrease in abdominal pain/cramping
  • Absence of fever
  • Improvement in appetite
  • Signs of dehydration (e.g., dry mouth, decreased urination, lethargy)
  • New onset of rash or itching (rare, but possible allergic reaction)

Special Patient Groups

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Pregnancy

Vancomycin oral solution is generally considered safe for use during pregnancy for the treatment of C. difficile infection due to its minimal systemic absorption. Animal studies have not shown evidence of fetal harm. Clinical data are limited but reassuring.

Trimester-Specific Risks:

First Trimester: Low risk due to minimal systemic absorption.
Second Trimester: Low risk due to minimal systemic absorption.
Third Trimester: Low risk due to minimal systemic absorption.
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Lactation

Vancomycin is poorly absorbed orally, leading to minimal systemic exposure in the mother and negligible transfer into breast milk. It is generally considered compatible with breastfeeding for the treatment of C. difficile infection.

Infant Risk: Low risk. Monitor breastfed infant for changes in bowel habits (e.g., diarrhea) or rash, though these are unlikely.
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Pediatric Use

Oral vancomycin is effective and generally well-tolerated in pediatric patients for the treatment of C. difficile infection. Dosing is typically weight-based. Close monitoring for clinical response is important.

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Geriatric Use

No specific dose adjustment is required for elderly patients for oral vancomycin for CDI due to minimal systemic absorption. However, elderly patients may be more susceptible to dehydration from severe diarrhea and should be monitored closely for fluid and electrolyte balance.

Clinical Information

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Clinical Pearls

  • Oral vancomycin is specifically used for Clostridioides difficile infection (CDI) because it acts locally in the gut lumen with minimal systemic absorption. It is NOT used for systemic infections.
  • Do not confuse oral vancomycin with intravenous (IV) vancomycin. IV vancomycin is used for systemic infections and requires therapeutic drug monitoring (TDM) due to its nephrotoxic and ototoxic potential; oral vancomycin does not typically require TDM.
  • The 25mg/ml concentration is a common strength for compounding or commercially available oral solutions. Ensure correct measurement, especially in pediatric patients.
  • For severe or fulminant CDI, higher doses (500 mg QID) are recommended.
  • For recurrent CDI, tapered and pulsed regimens are often employed to reduce recurrence rates.
  • Patients should complete the full course of therapy, even if symptoms improve, to prevent recurrence.
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Alternative Therapies

  • Fidaxomicin (for C. difficile infection)
  • Metronidazole (for initial, non-severe C. difficile infection)
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Cost & Coverage

Average Cost: Price varies widely by pharmacy and formulation (generic vs. brand) per 150ml bottle
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often covered for C. difficile infection)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.