Vancomycin 250mg/5ml Oral Solution
It is used to treat certain types of bowel infections. This includes an infection called C diff.
Drug Class
Anti-infective
Pharmacologic Class
Glycopeptide antibiotic
Pregnancy 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). Unlike other antibiotics that get absorbed into your body, this medicine stays mostly in your intestines to kill the C. diff bacteria there.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Preparation: Before you receive your medication, your pharmacist will need to mix it. Once mixed, shake the medication well before use.
3. Measuring Liquid Doses: To ensure accurate dosing, measure the liquid medication carefully using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring device.
4. Continuing Your Medication: Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Important Safety Precautions
* Do not use the medication if the solution appears hazy or contains particles. Instead, contact your doctor or pharmacist for guidance on what to do.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
1. Refrigerate: Store the medication in a refrigerator.
2. Avoid Freezing: Do not freeze the medication.
3. Protect from Light: Keep the medication away from direct light.
4. Secure the Lid: Ensure the lid is tightly closed when not in use.
Missing a Dose
If you miss a dose:
1. Take as Soon as Possible: Take the missed dose as soon as you remember.
2. Skip if Close to Next Dose: If it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.
3. Avoid Double Dosing: Do not take two doses at the same time or take extra doses.
To ensure you get the most out of your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Preparation: Before you receive your medication, your pharmacist will need to mix it. Once mixed, shake the medication well before use.
3. Measuring Liquid Doses: To ensure accurate dosing, measure the liquid medication carefully using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring device.
4. Continuing Your Medication: Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Important Safety Precautions
* Do not use the medication if the solution appears hazy or contains particles. Instead, contact your doctor or pharmacist for guidance on what to do.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
1. Refrigerate: Store the medication in a refrigerator.
2. Avoid Freezing: Do not freeze the medication.
3. Protect from Light: Keep the medication away from direct light.
4. Secure the Lid: Ensure the lid is tightly closed when not in use.
Missing a Dose
If you miss a dose:
1. Take as Soon as Possible: Take the missed dose as soon as you remember.
2. Skip if Close to Next Dose: If it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.
3. Avoid Double Dosing: Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take the medicine exactly as prescribed by your doctor, even if you start feeling better. Do not skip doses or stop early.
- Shake the oral solution well before each use.
- Use an accurate measuring device (oral syringe or measuring spoon) to ensure the correct dose.
- Stay well-hydrated, especially if you have severe diarrhea.
- Practice good hand hygiene to prevent the spread of C. diff (wash hands thoroughly with soap and water).
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 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_fulminant_CDI:
500 mg orally four times daily for 10-14 days (often with IV metronidazole)
first_recurrence_CDI:
125 mg orally four times daily for 10 days (after standard course)
multiple_recurrences_CDI:
Tapered and pulsed regimens (e.g., 125 mg QID for 10-14 days, then BID for 7 days, then daily for 7 days, then every 2-3 days for 2-8 weeks)
Pediatric Dosing
Neonatal:
10 mg/kg orally every 6 hours for 7-10 days (for CDI)
Infant:
10 mg/kg orally every 6 hours for 7-10 days (for CDI), max 125 mg/dose
Child:
10 mg/kg orally every 6 hours for 7-10 days (for CDI), max 500 mg/dose
Adolescent:
125 mg orally four times daily for 10 days (for CDI)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (due to minimal systemic absorption)
Moderate:
No adjustment needed (due to minimal systemic absorption)
Severe:
No adjustment needed (due to minimal systemic absorption)
Dialysis:
No adjustment needed for oral use (not significantly removed by dialysis as it's not systemically absorbed)
Hepatic Impairment:
Mild:
No adjustment needed (due to minimal systemic absorption)
Moderate:
No adjustment needed (due to minimal systemic absorption)
Severe:
No adjustment needed (due to minimal systemic absorption)
Pharmacology
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 units. This binding prevents the transglycosylation and transpeptidation steps necessary for peptidoglycan elongation and cross-linking, leading to cell lysis. For oral administration, its action is primarily local within the gastrointestinal tract against susceptible bacteria, notably *Clostridioides difficile*.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (systemic absorption from oral administration is negligible)
Tmax:
Not clinically relevant for oral use (local action in GI tract)
FoodEffect:
Minimal impact on local GI concentration; can be taken with or without food.
Distribution:
Vd:
Not clinically relevant for oral use (minimal systemic distribution)
ProteinBinding:
Not clinically relevant for oral use (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant for systemic half-life for oral use (primarily excreted in feces)
Clearance:
Not clinically relevant for systemic clearance for oral use
ExcretionRoute:
Primarily fecal (unchanged drug)
Unchanged:
>90% (excreted unchanged in feces after oral administration)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically within 2-4 days for CDI
PeakEffect:
Not applicable for systemic effect; local antibacterial effect in GI tract
DurationOfAction:
Maintained throughout dosing interval due to local GI concentration
Safety & Warnings
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 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
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Signs of a urinary tract infection (UTI), including:
+ 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
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that can affect internal 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
Other Possible Side Effects
Most people do not experience severe side effects, and some may have only minor issues. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Gas
Feeling tired or weak
Back pain
* Headache
Reporting Side Effects
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.
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 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
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Signs of a urinary tract infection (UTI), including:
+ 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
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that can affect internal 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
Other Possible Side Effects
Most people do not experience severe side effects, and some may have only minor issues. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Gas
Feeling tired or weak
Back pain
* Headache
Reporting Side Effects
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.
Seek Immediate Medical Attention If You Experience:
- Worsening diarrhea or abdominal pain after starting the medication.
- Signs of an allergic reaction: rash, itching, hives, swelling of the face/lips/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., very little or no urine, swelling in feet or ankles) - very rare with oral use.
- Severe or persistent headache.
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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Do not initiate, discontinue, or modify 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 symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Do not initiate, discontinue, or modify 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.
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.
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.
Overdose Information
Overdose Symptoms:
- Due to minimal systemic absorption, systemic toxicity from oral overdose is unlikely unless there is significant GI mucosal damage allowing absorption.
- Potential for increased GI side effects (nausea, vomiting, diarrhea).
What to Do:
Contact a poison control center immediately or seek emergency medical attention. In the US, call 1-800-222-1222. Management is primarily supportive care.
Drug Interactions
Moderate Interactions
- Cholestyramine (may bind vancomycin in the gut, reducing its efficacy; administer vancomycin several hours before or after cholestyramine)
- Other nephrotoxic or ototoxic drugs (e.g., aminoglycosides, amphotericin B, cisplatin, loop diuretics, NSAIDs): While systemic absorption is minimal, theoretical risk of additive toxicity if significant absorption occurs in patients with compromised GI mucosa or high doses. Monitor for signs of toxicity.
Monitoring
Baseline Monitoring
Diagnosis of *Clostridioides difficile* infection (CDI)
Rationale: Confirm presence of toxin-producing C. difficile
Timing: Prior to initiation of therapy
Baseline renal function (SCr, BUN)
Rationale: Although systemic absorption is minimal, prudent to assess baseline, especially in patients with compromised GI mucosa or severe disease where some absorption might occur.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical symptoms of CDI (diarrhea, abdominal pain, fever)
Frequency: Daily
Target: Resolution or improvement of symptoms
Action Threshold: Worsening or lack of improvement after 3-5 days may indicate treatment failure or need for re-evaluation.
Fluid and electrolyte balance
Frequency: Daily, especially in severe cases
Target: Normal hydration and electrolyte levels
Action Threshold: Signs of dehydration or electrolyte imbalance require intervention.
Symptom Monitoring
- Resolution of diarrhea
- Decrease in abdominal pain/cramping
- Resolution of fever
- Improvement in appetite and general well-being
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of ototoxicity (hearing loss, tinnitus, vertigo) - rare with oral use
- Signs of nephrotoxicity (decreased urine output, swelling) - rare with oral use
Special Patient Groups
Pregnancy
Generally considered safe for use during pregnancy for CDI due to minimal systemic absorption. Category B.
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
Considered compatible with breastfeeding. Minimal systemic absorption means very little drug is excreted into breast milk. Monitor infant for changes in bowel habits (e.g., diarrhea) or rash.
Infant Risk:
Low risk (L3 - probably compatible)
Pediatric Use
Dosing is weight-based. Generally well-tolerated. Important to use accurate dosing devices. Efficacy and safety established for CDI in pediatric patients.
Geriatric Use
No specific dose adjustment needed based on age alone for oral use due to minimal systemic absorption. However, elderly patients may be more susceptible to dehydration from diarrhea and require careful monitoring of fluid and electrolyte status.
Clinical Information
Clinical Pearls
- Oral vancomycin is the preferred treatment for non-severe and severe *Clostridioides difficile* infection (CDI).
- It is NOT used for systemic infections because it is poorly absorbed from the gastrointestinal tract.
- Do not confuse oral vancomycin with intravenous vancomycin; they have different indications and pharmacokinetic profiles.
- No therapeutic drug monitoring (serum vancomycin levels) is required for oral vancomycin therapy for CDI.
- The goal of oral vancomycin is to achieve high concentrations in the colon to eradicate *C. difficile*.
- For severe and complicated CDI, oral vancomycin may be used in combination with intravenous metronidazole.
- Ensure patients understand the importance of completing the full course of therapy to prevent recurrence.
Alternative Therapies
- Fidaxomicin (another oral antibiotic for CDI, often preferred for recurrent CDI due to lower recurrence rates)
- Metronidazole (oral, for initial non-severe CDI, less effective than vancomycin for severe CDI)
- Bezlotoxumab (monoclonal antibody, used as an adjunct to antibiotic treatment to prevent CDI recurrence)
- Fecal microbiota transplantation (FMT) (for recurrent CDI)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 150ml (250mg/5ml) bottle
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.