Vancomycin 50mg/ml Oral Solution
It is used to treat certain types of bowel infections. This includes an infection called C diff.
Drug Class
Glycopeptide antibiotic
Pharmacologic Class
Cell wall synthesis inhibitor
Pregnancy Category
Category B
FDA Approved
Mar 1986
DEA Schedule
Not Controlled
Overview
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 bacteria in your intestines that cause the infection. This medicine is not absorbed into your body, so it only works where the infection is, in your gut.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from 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 prepare it for you.
Just before using your medication, shake the liquid well to mix it thoroughly.
When measuring your liquid dose, use the measuring device that comes with your medication. If one is not provided, ask your pharmacist for a suitable measuring device to ensure accurate dosing.
Continue taking your medication as instructed by your doctor or healthcare provider, even if you start to feel better.
Important: Checking Your Medication
Before using your medication, check the solution for any signs of cloudiness 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 effectiveness and safety of your medication:
Store it in the refrigerator at all times. Do not freeze your medication.
Protect it from light to prevent degradation.
Keep the lid tightly closed when not in use.
Missing a Dose
If you miss a dose of your medication:
Take the missed dose 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.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
To ensure you get the most benefit from 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 prepare it for you.
Just before using your medication, shake the liquid well to mix it thoroughly.
When measuring your liquid dose, use the measuring device that comes with your medication. If one is not provided, ask your pharmacist for a suitable measuring device to ensure accurate dosing.
Continue taking your medication as instructed by your doctor or healthcare provider, even if you start to feel better.
Important: Checking Your Medication
Before using your medication, check the solution for any signs of cloudiness 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 effectiveness and safety of your medication:
Store it in the refrigerator at all times. Do not freeze your medication.
Protect it from light to prevent degradation.
Keep the lid tightly closed when not in use.
Missing a Dose
If you miss a dose of your medication:
Take the missed dose 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.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Stay well-hydrated by drinking plenty of fluids to prevent dehydration from diarrhea.
- Follow your doctor's instructions regarding diet. Some people may need to avoid certain foods that worsen diarrhea.
- Practice good hand hygiene to prevent the spread of C. diff infection to others.
Available Forms & Alternatives
Available Strengths:
- Vancomycin 1000mg Inj
- Vancomycin 500mg Vial Forinjection
- Vancomycin 500mg Inj, 1 Vial
- Vancomycin 10gm Inj, 1 Vial
- Vancomycin 5gm Inj, 1 Vial
- Vancomycin 1000mg Inj (ad-Vantage)
- Vancomycin 5gm Inj, 1 Vial
- Vancomycin 750mg Inj, 1 Vial
- Vancomycin 1gm Inj, 1 Vial
- Vancomycin 125mg Capsules
- Vancomycin 250mg Capsules
- Vancomycin 1gm/200m Inj 12x200ml
- Vancomycin 250mg/5ml Oral Solution
- Vancomycin 10gm Inj, 1 Vial
- Vancomycin 1.25gm Inj 1 Vial
- Vancomycin 25mg/ml Oral Soln 300ml
- Vancomycin 25mg/ml Oral Soln 150ml
- Vancomycin 25mg/ml Oral Soln 300ml
- Vancomycin 25mg/ml Oral Soln 150ml
- Vancomycin 50mg/ml Oral Solution
- Vancomycin 1.5mg Inj, 1 Vial
- Vancomycin 1.75gm/350ml Inj, 350ml
- Vancomycin 750mg/150ml Inj, 150ml
- Vancomycin 1.5gm/300ml Inj, 300ml
- Vancomycin 500mg/100ml Inj, 100ml
- Vancomycin 125mg Capsules
- Vancomycin 250mg Capsules
- Vancomycin Hcl 1.75gm Inj, 1 Vial
- Vancomycin Hcl 2gm Sdv Inj, 1 Vial
Dosing & Administration
Adult Dosing
Standard Dose:
125 mg orally 4 times daily for 10 days
Dose Range:
125 - 500 mg
Condition-Specific Dosing:
Initial C. difficile infection (CDI):
125 mg orally 4 times daily for 10 days
Fulminant CDI:
500 mg orally 4 times daily for 10-14 days (often with IV metronidazole)
Recurrent CDI (first recurrence):
Standard 125 mg orally 4 times daily for 10 days
Recurrent CDI (second or subsequent recurrence, tapered/pulsed regimen):
125 mg orally 4 times daily for 10-14 days, then 125 mg orally 2 times daily for 7 days, then 125 mg orally once daily for 7 days, then 125 mg orally every 2-3 days for 2-8 weeks
Pediatric Dosing
Neonatal:
10 mg/kg orally 4 times daily for 10 days (for CDI)
Infant:
10 mg/kg orally 4 times daily for 10 days (for CDI), not to exceed 500 mg/dose
Child:
10 mg/kg orally 4 times daily for 10 days (for CDI), not to exceed 500 mg/dose
Adolescent:
125 mg orally 4 times daily for 10 days (for CDI)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for oral use as systemic absorption is minimal.
Moderate:
No adjustment needed for oral use as systemic absorption is minimal.
Severe:
No adjustment needed for oral use as systemic absorption is minimal. However, in cases of severe colitis or inflammatory bowel disease, some systemic absorption may occur. Monitor for systemic adverse effects (e.g., ototoxicity, nephrotoxicity) if significant absorption is suspected, but dose adjustment for the oral therapy is generally not required.
Dialysis:
No adjustment needed for oral use as systemic absorption is minimal. Vancomycin is not significantly removed by hemodialysis when administered orally.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Pharmacology
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, thereby preventing transpeptidation and transglycosylation. This leads to disruption of cell wall integrity and bacterial cell death. It is bactericidal against susceptible organisms.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (systemic absorption from oral administration is very poor)
Tmax:
Not clinically relevant for oral use (local action in gut)
FoodEffect:
Minimal effect on local action in the gut; can be taken with or without food.
Distribution:
Vd:
Not clinically relevant for oral use (minimal systemic distribution)
ProteinBinding:
Approximately 10-50% (systemic, not relevant for oral use)
CnssPenetration:
Limited (systemic, not relevant for oral use)
Elimination:
HalfLife:
4-6 hours (systemic, not relevant for oral use); primarily eliminated in feces when given orally.
Clearance:
Not clinically relevant for oral use (minimal systemic clearance)
ExcretionRoute:
Primarily fecal (unchanged drug)
Unchanged:
>90% (fecal excretion)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2-4 days for CDI.
PeakEffect:
Not applicable for local gut action.
DurationOfAction:
Maintains therapeutic concentrations in the gut lumen for the dosing interval.
Safety & Warnings
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: 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 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:
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, 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.
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: 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 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:
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, 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.
Seek Immediate Medical Attention If You Experience:
- Worsening diarrhea or no improvement after a few days of treatment.
- Severe stomach pain or cramping.
- Fever that doesn't go away.
- Signs of an allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
- New or worsening hearing problems (e.g., ringing in ears, hearing loss) - very rare with oral use.
- Signs of kidney problems (e.g., change in amount of urine) - very rare with oral use.
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 information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting 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 information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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 drug, you may need to undergo hearing tests, so be sure to consult with your doctor about this requirement.
Do not exceed the prescribed duration of treatment, as this can lead to a secondary infection. Additionally, 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, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
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 drug, you may need to undergo hearing tests, so be sure to consult with your doctor about this requirement.
Do not exceed the prescribed duration of treatment, as this can lead to a secondary infection. Additionally, 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, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Due to very poor systemic absorption, overdose with oral vancomycin is unlikely to cause systemic toxicity.
- Possible symptoms might include severe gastrointestinal upset (nausea, vomiting, diarrhea).
What to Do:
Contact a poison control center immediately (Call 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive, as systemic toxicity is rare.
Drug Interactions
Moderate Interactions
- Nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, NSAIDs, cyclosporine, tacrolimus, loop diuretics): While systemic absorption of oral vancomycin is minimal, concurrent use with other nephrotoxic agents could theoretically increase the risk of nephrotoxicity if significant systemic absorption occurs (e.g., in severe inflammatory bowel disease).
- Ototoxic drugs (e.g., aminoglycosides, loop diuretics): Similar to nephrotoxicity, theoretical risk if systemic absorption occurs.
Monitoring
Baseline Monitoring
Baseline renal function (SCr, BUN)
Rationale: Although systemic absorption is minimal, it's prudent to assess baseline renal function, especially in patients with severe colitis where some systemic absorption might occur, or if concurrent nephrotoxic agents are used.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (resolution of diarrhea, fever, abdominal pain)
Frequency: Daily
Target: Improvement of symptoms
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or need for alternative therapy.
Stool frequency and consistency
Frequency: Daily
Target: Return to normal bowel habits
Action Threshold: Persistent diarrhea.
Signs/symptoms of adverse effects (e.g., nausea, vomiting, abdominal discomfort, rash, hearing changes, dizziness)
Frequency: Daily
Target: Absence of significant adverse effects
Action Threshold: Development of new or worsening symptoms.
Symptom Monitoring
- Resolution of diarrhea
- Decrease in abdominal pain/cramping
- Resolution of fever
- Improvement in appetite
- Absence of nausea or vomiting
- Monitoring for signs of hypersensitivity reactions (rash, itching, swelling)
- Monitoring for signs of ototoxicity (tinnitus, hearing loss, vertigo) - rare with oral use
- Monitoring for signs of nephrotoxicity (decreased urine output, swelling) - rare with oral use
Special Patient Groups
Pregnancy
Vancomycin is considered Category B in pregnancy. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Oral vancomycin has minimal systemic absorption, making systemic exposure to the fetus very low. It is generally considered safe for use in pregnancy when indicated for CDI.
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.
Lactation
Vancomycin is excreted in breast milk in small amounts after intravenous administration. Oral vancomycin has very poor systemic absorption, leading to negligible levels in maternal serum and thus in breast milk. It is considered L3 (moderately safe) by some sources, but the risk to the infant from oral vancomycin is likely very low. Monitor breastfed infants for changes in bowel habits (e.g., diarrhea) or rash.
Infant Risk:
Low risk. Minimal systemic exposure to the infant. Potential for alteration of infant gut flora or allergic sensitization, but unlikely to cause significant adverse effects.
Pediatric Use
Oral vancomycin is commonly used and effective for the treatment of CDI in pediatric patients, including neonates, infants, children, and adolescents. Dosing is weight-based for younger children. Close monitoring for clinical response is important.
Geriatric Use
No specific dose adjustment is required for oral vancomycin in elderly patients based on age alone, as systemic absorption is minimal. However, elderly patients may be more susceptible to dehydration from diarrhea and should be monitored closely for fluid and electrolyte balance. Renal function should be assessed at baseline, especially if there's concern for systemic absorption in severe cases.
Clinical Information
Clinical Pearls
- Oral vancomycin is indicated ONLY for the treatment of *Clostridioides difficile* infection (CDI) and staphylococcal enterocolitis. It is NOT effective for systemic infections because it is poorly absorbed from the gastrointestinal tract.
- The 50 mg/ml oral solution is often prepared by compounding from vancomycin powder for injection or by using a commercially available oral solution (e.g., Firvanq). Ensure proper preparation and storage instructions are followed.
- For CDI, vancomycin is superior to metronidazole for severe infection and for recurrent infection.
- Patients should complete the full course of therapy, even if symptoms improve, to prevent recurrence.
- Hydration is crucial during CDI treatment due to fluid loss from diarrhea.
Alternative Therapies
- Fidaxomicin (for C. difficile infection)
- Metronidazole (for mild to moderate C. difficile infection, or in combination with vancomycin for fulminant CDI)
- Bezlotoxumab (monoclonal antibody, adjunctive therapy to prevent CDI recurrence)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and formulation (e.g., compounded solution vs. brand/generic capsules) per 10-day course
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization for brand, generic may be preferred)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 occurred.