Firvanq (vancomycin) 50mg/ml Sol
It is used to treat certain types of bowel infections. This includes an infection called C diff.
Drug Class
Anti-infective, Antibiotic
Pharmacologic Class
Glycopeptide antibiotic
Pregnancy Category
Category B
FDA Approved
Mar 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Firvanq is an antibiotic liquid used to treat a serious type of diarrhea caused by a specific germ called *Clostridioides difficile* (C. diff). It works by killing the C. diff germs in your intestines. It is not absorbed into your body, so it only works where the infection is.
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 using the liquid form of this medication, make sure to:
Shake the bottle well before each use
Measure your dose carefully using the measuring device that comes with the medication
If a measuring device is not provided, ask your pharmacist for one to ensure accurate dosing
Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better.
Important: Checking the Medication
Before using the 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 quality and effectiveness of your medication:
Store it in the refrigerator
Avoid freezing the medication
Protect it from light
* Keep the lid tightly closed
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. Do not take two doses at the same time or take extra doses to make up for the missed one.
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 using the liquid form of this medication, make sure to:
Shake the bottle well before each use
Measure your dose carefully using the measuring device that comes with the medication
If a measuring device is not provided, ask your pharmacist for one to ensure accurate dosing
Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better.
Important: Checking the Medication
Before using the 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 quality and effectiveness of your medication:
Store it in the refrigerator
Avoid freezing the medication
Protect it from light
* Keep the lid tightly closed
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. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Stay well-hydrated by drinking plenty of fluids.
- Follow your doctor's instructions regarding diet.
- Practice good hand hygiene to prevent spread of C. diff.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
125 mg orally four times daily for 10 days
Dose Range:
125 - 500 mg
Condition-Specific Dosing:
initial_CDI:
125 mg orally four times daily for 10 days
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, followed by a tapered and/or pulsed regimen
multiple_recurrences_CDI:
Tapered and/or pulsed regimen (e.g., 125 mg QID for 10-14 days, then BID for 1 week, then daily for 1 week, then every 2-3 days for several weeks)
Pediatric Dosing
Neonatal:
Not established for oral C. difficile treatment; use caution. Dosing for necrotizing enterocolitis (NEC) is different.
Infant:
10 mg/kg orally four times daily for 10 days (max 500 mg/dose)
Child:
10 mg/kg orally four times daily for 10 days (max 500 mg/dose)
Adolescent:
125 mg orally four times daily for 10 days (or 10 mg/kg orally four times daily, max 500 mg/dose)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for oral administration due to minimal systemic absorption.
Moderate:
No adjustment needed for oral administration due to minimal systemic absorption.
Severe:
No adjustment needed for oral administration due to minimal systemic absorption.
Dialysis:
No adjustment needed for oral administration due to minimal systemic absorption. Vancomycin is not significantly removed by dialysis when given orally.
Hepatic Impairment:
Mild:
No adjustment needed for oral administration due to minimal systemic absorption.
Moderate:
No adjustment needed for oral administration due to minimal systemic absorption.
Severe:
No adjustment needed for oral administration 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 and bacterial death. For oral administration, its action is primarily local within the gastrointestinal lumen against *Clostridioides difficile*.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (systemic absorption from oral administration is negligible)
Tmax:
Not clinically relevant for systemic effect (oral administration)
FoodEffect:
Minimal effect on local gut concentration; can be taken with or without food.
Distribution:
Vd:
Not clinically relevant for systemic effect (oral administration)
ProteinBinding:
Not clinically relevant for systemic effect (oral administration)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant for systemic effect (oral administration); primarily eliminated via feces.
Clearance:
Not clinically relevant for systemic effect (oral administration)
ExcretionRoute:
Primarily fecal (unchanged drug)
Unchanged:
>90% (excreted unchanged in feces after oral administration)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2-4 days for C. difficile infection.
PeakEffect:
Not applicable for systemic effect; local gut concentration is relevant.
DurationOfAction:
Maintained as long as dosing continues in the gut lumen.
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 immediately or seek 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 (this risk may increase 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)
+ Other serious reactions that may affect body organs and can 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 experience either no side effects or only mild side effects. However, if you notice any of the following symptoms or if they persist or bother you, contact your doctor:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Gas
Feeling tired or weak
Back pain
* Headache
This list is not exhaustive, and you may experience other 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.
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 immediately or seek 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 (this risk may increase 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)
+ Other serious reactions that may affect body organs and can 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 experience either no side effects or only mild side effects. However, if you notice any of the following symptoms or if they persist or bother you, contact your doctor:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Gas
Feeling tired or weak
Back pain
* Headache
This list is not exhaustive, and you may experience other 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.
Seek Immediate Medical Attention If You Experience:
- Worsening diarrhea or abdominal pain
- Fever that does not improve
- Signs of dehydration (e.g., extreme thirst, decreased urination, dizziness)
- New or severe allergic reactions (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
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 interact with other drugs or worsen certain health problems.
To ensure safe treatment, 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
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication with your other treatments and health conditions.
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 interact with other drugs or worsen certain health problems.
To ensure safe treatment, 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
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication with your other treatments and health conditions.
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 are 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 are 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, oral overdose is unlikely to cause systemic toxicity.
- May cause gastrointestinal upset (e.g., nausea, vomiting, diarrhea).
What to Do:
Contact a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive.
Drug Interactions
Moderate Interactions
- Cholestyramine
- Colestipol
Monitoring
Routine Monitoring
Clinical symptoms of C. difficile infection (e.g., diarrhea, abdominal pain, fever)
Frequency: Daily during treatment
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.
Hydration status
Frequency: Daily
Target: Adequate hydration
Action Threshold: Signs of dehydration (e.g., decreased urine output, dry mucous membranes) require fluid replacement.
Symptom Monitoring
- Resolution of diarrhea
- Decrease in abdominal pain/cramping
- Resolution of fever
- Improvement in appetite
- Return to normal bowel habits
Special Patient Groups
Pregnancy
Category B. Studies in animals have not shown harm to the fetus, and human data suggest minimal systemic absorption. Use during pregnancy is generally considered safe when indicated for C. difficile infection.
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
L3 (Moderately Safe). Oral vancomycin is poorly absorbed systemically by the mother, and therefore, very little is expected to be excreted into breast milk. Any amount ingested by the infant would also be poorly absorbed. Monitor breastfed infant for changes in bowel habits (e.g., diarrhea) or rash.
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption by the infant.
Pediatric Use
Oral vancomycin is effective and generally well-tolerated in pediatric patients for C. difficile infection. Dosing is weight-based. Close monitoring for clinical response is important.
Geriatric Use
No specific dose adjustment is needed for oral vancomycin in elderly patients. However, elderly patients may be more susceptible to dehydration from C. difficile infection and should be monitored closely for fluid and electrolyte balance.
Clinical Information
Clinical Pearls
- Firvanq (vancomycin oral solution) is specifically formulated for oral administration and is NOT for intravenous use. It is used to treat *Clostridioides difficile* infection (CDI) in the gut.
- Unlike IV vancomycin, oral vancomycin has minimal systemic absorption, meaning it primarily acts locally in the intestines. Therefore, systemic monitoring (e.g., serum vancomycin levels, renal function) is generally not required for oral use.
- It is crucial to differentiate between oral and IV vancomycin; they are used for different types of infections and have different pharmacokinetic profiles and monitoring requirements.
- For recurrent CDI, a tapered and/or pulsed regimen of oral vancomycin may be used after the initial 10-day course to prevent further recurrences.
Alternative Therapies
- Fidaxomicin (Dificid) for C. difficile infection
- Metronidazole (Flagyl) for initial, non-severe C. difficile infection (less effective than vancomycin for severe disease)
Cost & Coverage
Average Cost:
$1000 - $2500 per 150 mL bottle (50 mg/mL)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization for C. difficile infection)
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 happened.