Vancomycin 25mg/ml Oral Soln 300ml

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
Jan 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 specific type of severe diarrhea caused by a bacteria called *Clostridioides difficile* (C. diff). Unlike other antibiotics that get absorbed into your body, this medicine stays mostly in your intestines to kill the C. diff bacteria there.
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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 and read all the information provided. Before you receive your medication, your pharmacist will prepare it according to your prescription.

When taking this medication, remember to:

Shake the liquid well before each use.
Measure your dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.
Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling better.

Important: Checking Your Medication

Before using the medication, check the solution for any signs of haziness or particles. If you notice any of these issues, 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 quality and effectiveness of your medication:

Store it in the refrigerator, but do not freeze it.
Protect the medication from light exposure.
Keep the lid tightly closed when not in use.

Missing 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. Avoid taking two doses at the same time or taking extra doses.
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Lifestyle & Tips

  • Take the medicine exactly as prescribed, even if you start feeling better. Do not skip doses or stop early.
  • Shake the bottle well before each use.
  • Use the provided measuring device to ensure accurate dosing.
  • Maintain good hand hygiene to prevent the spread of C. diff.
  • Stay hydrated by drinking plenty of fluids.
  • Avoid anti-diarrhea medications (like loperamide) unless specifically advised by your doctor, as they can worsen C. diff infection.

Dosing & Administration

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Adult Dosing

Standard Dose: 125 mg orally four times daily for 10 days
Dose Range: 125 - 500 mg

Condition-Specific Dosing:

initial_non_severe_CDI: 125 mg orally four times daily for 10 days
severe_CDI: 125 mg orally four times daily for 10 days (IDSA guidelines)
fulminant_CDI: 500 mg orally four times daily for 10 days (often with IV metronidazole)
recurrent_CDI_first_recurrence: 125 mg orally four times daily for 10 days
recurrent_CDI_second_or_more_recurrence: Tapered and pulsed regimens (e.g., 125 mg QID for 10-14 days, then BID for 1 week, then daily for 1 week, then every other day for 2-8 weeks)
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Pediatric Dosing

Neonatal: 10 mg/kg orally every 6 hours for 10 days (max 125 mg/dose)
Infant: 10 mg/kg orally every 6 hours for 10 days (max 125 mg/dose)
Child: 10 mg/kg orally every 6 hours for 10 days (max 125 mg/dose, not to exceed 500 mg/day)
Adolescent: 125 mg orally four times daily for 10 days
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No adjustment needed (minimal systemic absorption; not removed by dialysis)

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Vancomycin inhibits bacterial cell wall synthesis by binding to the D-Ala-D-Ala terminus of the peptidoglycan precursor, thereby preventing transpeptidation and transglycosylation. This leads to cell lysis and death. For *Clostridioides difficile*, its action is primarily local within the gastrointestinal lumen.
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Pharmacokinetics

Absorption:

Bioavailability: <5% (systemic absorption after oral administration)
Tmax: Not clinically relevant for systemic effect (oral use for local gut action)
FoodEffect: Minimal effect on local gut concentration; can be taken with or without food.

Distribution:

Vd: Not clinically relevant for systemic distribution (oral use for local gut action)
ProteinBinding: 10-50% (systemic, but minimal systemic absorption from oral dose)
CnssPenetration: Limited (systemic, but minimal systemic absorption from oral dose)

Elimination:

HalfLife: 4-6 hours (systemic, but minimal systemic absorption from oral dose); primarily eliminated in feces for oral administration
Clearance: Not clinically relevant for systemic clearance (oral use for local gut action)
ExcretionRoute: Primarily fecal (unchanged drug)
Unchanged: >90% (in feces after oral administration)
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Pharmacodynamics

OnsetOfAction: Clinical improvement typically within 2-4 days for CDI
PeakEffect: Not applicable for systemic effect; local concentration in gut lumen is key
DurationOfAction: Maintained as long as dosing continues, due to local action

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 help right away:

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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to pass urine, 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 stomach 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 affect internal organs. Seek medical help immediately 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, 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:

  • Worsening diarrhea or abdominal pain
  • Fever that does not go away or gets worse
  • Signs of dehydration (e.g., decreased urination, dry mouth, dizziness)
  • New or severe allergic reaction symptoms (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
  • Hearing loss or ringing in the ears (rare, but possible with systemic absorption)
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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, it is vital to verify that this medication can be taken with all your current 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. Your doctor will monitor your condition through regular blood work and other laboratory tests, as previously discussed.

During treatment with this medication, you may need to undergo hearing tests. Consult with your doctor to determine the necessity of these tests.

Do not exceed the recommended duration of treatment with this medication, as this can increase the risk of 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, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Due to minimal systemic absorption, oral overdose is unlikely to cause systemic toxicity.
  • Potential for gastrointestinal upset (nausea, vomiting, diarrhea).

What to Do:

Contact a poison control center immediately (Call 1-800-222-1222). Management is generally supportive. Activated charcoal may be considered if recent ingestion and significant systemic absorption is suspected (e.g., in patients with inflammatory bowel disease).

Drug Interactions

Monitoring

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Routine Monitoring

Clinical symptoms of CDI (e.g., diarrhea, abdominal pain, fever)

Frequency: Daily

Target: Resolution or improvement of symptoms

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

Stool consistency and frequency

Frequency: Daily

Target: Return to normal bowel habits

Action Threshold: Persistent watery stools or increasing frequency.

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Symptom Monitoring

  • Resolution of diarrhea
  • Decrease in abdominal pain/cramping
  • Resolution of fever
  • Improvement in appetite and general well-being
  • Absence of nausea or vomiting

Special Patient Groups

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Pregnancy

Generally considered safe for use in pregnancy for *Clostridioides difficile* infection due to minimal systemic absorption. Consult with a healthcare provider.

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

Considered compatible with breastfeeding. Minimal amounts are absorbed systemically by the mother and even less would be transferred into breast milk. Infant exposure is expected to be negligible.

Infant Risk: Low risk
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Pediatric Use

Oral vancomycin is a recommended treatment for CDI in pediatric patients. Dosing is weight-based. Close monitoring for clinical response is important.

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Geriatric Use

No specific dose adjustment is needed for elderly patients with normal renal function, as systemic absorption is minimal. However, elderly patients may be more susceptible to dehydration from CDI and should be monitored closely for fluid and electrolyte balance.

Clinical Information

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Clinical Pearls

  • Oral vancomycin is the preferred first-line treatment for non-severe and severe *Clostridioides difficile* infection (CDI).
  • Its efficacy for CDI relies on its poor systemic absorption, allowing high concentrations to remain in the gut lumen.
  • Systemic monitoring (e.g., serum trough levels, renal function) is generally NOT required for oral vancomycin when used for CDI, unlike intravenous vancomycin.
  • The 25mg/ml concentration allows for flexible dosing, especially in pediatric patients.
  • Ensure patients complete the full course of therapy to minimize recurrence, even if symptoms improve quickly.
  • For recurrent CDI, tapered and pulsed regimens of oral vancomycin are often used.
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Alternative Therapies

  • Fidaxomicin (for CDI, especially recurrent or severe cases)
  • Metronidazole (for initial, non-severe CDI, though vancomycin is often preferred)
  • Bezlotoxumab (monoclonal antibody, used as adjunct to antibiotic treatment for recurrent CDI prevention)
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Cost & Coverage

Average Cost: Price range varies widely by generic manufacturer and pharmacy per 300ml bottle (25mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often preferred over brand for CDI)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, 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 reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.