Vancomycin 125mg Capsules
It is used to treat certain types of bowel infections. This includes an infection called C diff.
Drug Class
Antibiotic, Anti-infective
Pharmacologic Class
Glycopeptide antibiotic
Pregnancy Category
Category C
FDA Approved
Jan 1986
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vancomycin capsules are an antibiotic used to treat a specific type of severe diarrhea caused by a 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 get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry location, avoiding bathrooms. Keep all medications in a secure place, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 the missed one.
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry location, avoiding bathrooms. Keep all medications in a secure place, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 the missed one.
Lifestyle & Tips
- Take the medicine exactly as prescribed, even if you start feeling better. Do not skip doses or stop early.
- Maintain good hydration, especially if you have severe diarrhea.
- Practice good hand hygiene (frequent hand washing with soap and water) to prevent the spread of C. diff.
- Avoid alcohol and other medications that can worsen diarrhea unless advised by your doctor.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
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:
Clostridioides difficile-associated diarrhea (CDAD) - Initial episode, non-severe:
125 mg orally four times daily for 10 days
Clostridioides difficile-associated diarrhea (CDAD) - Initial episode, severe:
125 mg orally four times daily for 10 days
Clostridioides difficile-associated diarrhea (CDAD) - Fulminant infection:
500 mg orally four times daily for 10-14 days (often with IV metronidazole)
Clostridioides difficile-associated diarrhea (CDAD) - Recurrent episodes (tapered/pulsed regimen):
Various regimens, e.g., 125 mg orally four times daily for 10-14 days, then 125 mg twice daily for 1 week, then 125 mg once daily for 1 week, then 125 mg every 2-3 days for 2-8 weeks.
Pediatric Dosing
Neonatal:
Not established for oral capsules for CDI. IV vancomycin dosing is different.
Infant:
10 mg/kg orally three to four times daily for 10 days (max 500 mg/dose)
Child:
10 mg/kg orally three to four times daily for 10 days (max 500 mg/dose)
Adolescent:
125 mg orally four times daily for 10 days (or 10 mg/kg up to 500 mg/dose)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for oral use in CDI due to minimal systemic absorption.
Moderate:
No adjustment needed for oral use in CDI due to minimal systemic absorption.
Severe:
No adjustment needed for oral use in CDI due to minimal systemic absorption.
Dialysis:
No adjustment needed for oral use in CDI due to minimal systemic absorption. Vancomycin is not significantly removed by hemodialysis when given orally.
Hepatic Impairment:
Mild:
No adjustment needed for oral use in CDI due to minimal systemic absorption.
Moderate:
No adjustment needed for oral use in CDI due to minimal systemic absorption.
Severe:
No adjustment needed for oral use in CDI due to minimal systemic absorption.
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. This prevents the transglycosylation and transpeptidation steps, leading to cell lysis. For oral administration, its action is primarily local within the gastrointestinal lumen against susceptible bacteria, particularly *Clostridioides difficile*.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (systemic absorption from oral administration is negligible in patients with normal intestinal mucosa)
Tmax:
Not clinically relevant for oral use (local action)
FoodEffect:
Minimal impact on local efficacy for CDI, 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 distribution)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant for oral use (systemic half-life is 4-6 hours if absorbed, but absorption is minimal)
Clearance:
Not clinically relevant for oral use (primarily fecal excretion of unchanged drug)
ExcretionRoute:
Fecal (primarily unchanged drug)
Unchanged:
>90% (excreted unchanged in feces after oral administration)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2-4 days for CDI.
PeakEffect:
Not applicable for systemic effect; local effect in gut lumen.
DurationOfAction:
Maintained as long as dosing continues, targeting local bacterial eradication.
Confidence:
High
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 immediate medical attention:
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
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Gas
Feeling tired or weak
Back pain
* Headache
This is not an exhaustive list of possible side effects. If you have concerns or questions, 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.
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, 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
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Gas
Feeling tired or weak
Back pain
* Headache
This is not an exhaustive list of possible side effects. If you have concerns or questions, 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.
Seek Immediate Medical Attention If You Experience:
- Worsening diarrhea or no improvement after a few days of treatment.
- Severe abdominal pain or cramping.
- Fever that does not go away.
- Signs of dehydration (e.g., extreme thirst, decreased urination, dizziness, lightheadedness).
- New or worsening skin rash, itching, or hives (signs of allergic reaction).
- Difficulty breathing or swelling of the face, lips, tongue, or throat (signs of severe allergic reaction - seek immediate medical attention).
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) medications, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial 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. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
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) medications, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial 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. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
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 increase the risk of a second 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 increase the risk of a second 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 overdose is unlikely with oral vancomycin.
- Large oral doses may cause gastrointestinal upset (nausea, vomiting, diarrhea).
What to Do:
Call 1-800-222-1222 (Poison Control). In case of severe symptoms, seek immediate medical attention.
Drug Interactions
Moderate Interactions
- Nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, cisplatin, cyclosporine, NSAIDs, tacrolimus): Although systemic absorption of oral vancomycin is minimal, theoretical risk of additive nephrotoxicity if significant absorption occurs (e.g., in patients with inflammatory bowel disease or impaired renal function).
- Ototoxic drugs (e.g., aminoglycosides, loop diuretics): Theoretical risk of additive ototoxicity if significant absorption occurs.
Monitoring
Baseline Monitoring
Diagnosis of *Clostridioides difficile* infection (CDI)
Rationale: Confirm presence of toxin-producing *C. difficile* to ensure appropriate therapy.
Timing: Prior to initiation of therapy
Baseline renal function (SCr, BUN)
Rationale: Although systemic absorption is minimal, it's prudent to assess baseline renal function, especially in patients with compromised gut integrity where absorption might be increased.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (resolution of diarrhea, abdominal pain, fever)
Frequency: Daily
Target: Improvement of symptoms
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: Daily, especially in severe CDI
Target: Normal hydration, electrolyte levels
Action Threshold: Dehydration or electrolyte imbalances require intervention.
Renal function (SCr, BUN)
Frequency: Periodically, especially if prolonged therapy or risk factors for increased absorption
Target: Within patient's baseline range
Action Threshold: Significant increase may warrant investigation, though unlikely due to oral vancomycin.
Symptom Monitoring
- Resolution of watery diarrhea
- Decrease in abdominal pain/cramping
- Absence of fever
- Improvement in appetite and general well-being
- Monitoring for signs of dehydration (e.g., dry mouth, decreased urination, dizziness)
- Monitoring for signs of allergic reaction (rash, itching, swelling)
Special Patient Groups
Pregnancy
Vancomycin is classified as Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Oral absorption is minimal, reducing systemic exposure to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but systemic exposure is minimal with oral use.
Second Trimester:
Limited data, but systemic exposure is minimal with oral use.
Third Trimester:
Limited data, but systemic exposure is minimal with oral use.
Lactation
Vancomycin is excreted in human milk after intravenous administration. However, systemic absorption from oral administration is minimal, and therefore, infant exposure via breast milk is expected to be very low. It is considered L3 (moderately safe) by some sources. Monitor breastfed infant for changes in bowel habits (e.g., diarrhea) or rash.
Infant Risk:
Low risk due to minimal maternal systemic absorption. Potential for alteration of infant gut flora or allergic sensitization, but unlikely.
Pediatric Use
Oral vancomycin is used in pediatric patients for CDI. Dosing is weight-based. Close monitoring for clinical response is important. Due to minimal systemic absorption, systemic adverse effects are rare.
Geriatric Use
No specific dose adjustment is required for oral vancomycin in elderly patients with normal renal function. Elderly patients may be more susceptible to CDI and its complications. Monitor for dehydration and electrolyte imbalances.
Clinical Information
Clinical Pearls
- Oral vancomycin is the preferred treatment for initial and recurrent episodes of non-severe and severe *Clostridioides difficile* infection (CDI).
- It is crucial to distinguish oral vancomycin from intravenous vancomycin. Oral vancomycin has minimal systemic absorption and acts locally in the gut, whereas IV vancomycin is absorbed systemically and used for systemic infections.
- Therapeutic drug monitoring (TDM) of vancomycin serum levels is NOT indicated or necessary for oral vancomycin used to treat CDI.
- Renal and hepatic impairment do not necessitate dose adjustments for oral vancomycin in CDI due to its negligible systemic absorption.
- For fulminant CDI, oral vancomycin is often used in combination with intravenous metronidazole.
- Patients should complete the full course of therapy, even if symptoms improve, to prevent recurrence.
Alternative Therapies
- Fidaxomicin (oral): Another macrolide antibiotic specifically approved for CDI, often preferred for recurrent CDI due to lower recurrence rates, but more expensive.
- Metronidazole (oral): Used for initial, non-severe CDI, but less effective than vancomycin for severe CDI or recurrent episodes.
- Fecal Microbiota Transplantation (FMT): Used for recurrent CDI after failed antibiotic therapies.
Cost & Coverage
Average Cost:
$100 - $500 per 20 capsules (125mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often preferred over fidaxomicin for initial CDI episodes)
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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.