Firvanq (vancomycin) 25mg/ml Sol
It is used to treat certain types of bowel infections. This includes an infection called C diff.
Drug Class
Antibiotic
Pharmacologic Class
Glycopeptide antibiotic
Pregnancy Category
B
FDA Approved
Mar 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Firvanq is an antibiotic liquid used to treat a severe type of diarrhea caused by a specific germ called Clostridioides difficile (C. diff). It works by killing the C. diff bacteria in your intestines. Because it stays in your intestines and is not absorbed into your body, it has very few side effects compared to other forms of vancomycin.
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, make sure to:
Shake the liquid well before each use
Measure your dose accurately 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 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 medication's effectiveness, store it in a refrigerator at a temperature between 39°F and 46°F (4°C and 8°C). Avoid freezing the medication. Additionally, protect it from light and keep the lid tightly closed.
Missing 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 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, make sure to:
Shake the liquid well before each use
Measure your dose accurately 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 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 medication's effectiveness, store it in a refrigerator at a temperature between 39°F and 46°F (4°C and 8°C). Avoid freezing the medication. Additionally, protect it from light and keep the lid tightly closed.
Missing 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
- Stay well-hydrated by drinking plenty of fluids, especially if you have diarrhea.
- Follow your doctor's instructions regarding diet.
- Practice good hand hygiene to prevent the spread of infection.
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:
Clostridioides difficile-associated diarrhea (CDAD):
125 mg orally four times daily for 10 days
Severe/Fulminant CDAD:
500 mg orally four times daily for 10-14 days, potentially with IV metronidazole
Pediatric Dosing
Neonatal:
10 mg/kg orally every 6-8 hours (max 500 mg/dose) for 7-10 days for CDAD
Infant:
10 mg/kg orally every 6-8 hours (max 500 mg/dose) for 7-10 days for CDAD
Child:
10 mg/kg orally every 6-8 hours (max 500 mg/dose) for 7-10 days for CDAD (typically 40 mg/kg/day divided into 3-4 doses, max 2 g/day)
Adolescent:
125 mg orally four times daily for 10 days for CDAD
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)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Vancomycin inhibits bacterial cell wall synthesis by binding with high affinity to the D-Ala-D-Ala terminus of the peptidoglycan precursor units. This prevents the transglycosylation and transpeptidation steps, leading to cell lysis and bacterial death. For oral administration, its action is primarily local within the gastrointestinal lumen against susceptible bacteria, particularly Clostridioides difficile.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (systemic absorption), high local concentration in GI tract
Tmax:
Not applicable for systemic effect (oral use)
FoodEffect:
Minimal effect on local action in GI tract; can be taken with or without food.
Distribution:
Vd:
Not applicable for systemic effect (oral use)
ProteinBinding:
Not applicable for systemic effect (oral use)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable for systemic effect (oral use); systemic half-life is 4-6 hours if absorbed
Clearance:
Not applicable for systemic effect (oral use)
ExcretionRoute:
Primarily fecal (unchanged drug)
Unchanged:
>90% (in feces)
Pharmacodynamics
OnsetOfAction:
Within 24-48 hours (clinical improvement for CDAD)
PeakEffect:
Within 2-4 days (resolution of symptoms)
DurationOfAction:
Maintained as long as dosing continues
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 (long-term use may increase the risk; do not use this medication longer than prescribed by your doctor)
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions (which can affect body 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 medications can cause side effects, but many people experience none or only mild symptoms. 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 persist:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Gas
Fatigue or weakness
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 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 (long-term use may increase the risk; do not use this medication longer than prescribed by your doctor)
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions (which can affect body 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 medications can cause side effects, but many people experience none or only mild symptoms. 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 persist:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Gas
Fatigue or weakness
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 or persistent diarrhea
- Severe stomach pain or cramping
- Fever that does not go away
- Bloody or black, tarry stools
- Signs of dehydration (e.g., decreased urination, dry mouth, dizziness)
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) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
This drug can cause kidney problems, including kidney failure, in some individuals. If you have a history of kidney problems, be sure to notify your doctor.
Regular blood work and other laboratory tests, as directed by your doctor, are crucial to monitor your condition while taking this medication.
You may require periodic hearing tests during treatment with this drug. Consult with your doctor to discuss the necessity of these tests.
Do not exceed the recommended duration of treatment with this medication, as this can increase the risk of a second infection.
If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or are breast-feeding, 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.
This drug can cause kidney problems, including kidney failure, in some individuals. If you have a history of kidney problems, be sure to notify your doctor.
Regular blood work and other laboratory tests, as directed by your doctor, are crucial to monitor your condition while taking this medication.
You may require periodic hearing tests during treatment with this drug. Consult with your doctor to discuss the necessity of these tests.
Do not exceed the recommended duration of treatment with this medication, as this can increase the risk of a second infection.
If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or are breast-feeding, 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.
Overdose Information
Overdose Symptoms:
- Due to minimal systemic absorption, systemic toxicity from oral overdose is unlikely unless there is significant inflammation of the GI tract allowing absorption. Symptoms would be similar to IV vancomycin toxicity: ototoxicity (hearing loss, ringing in ears), nephrotoxicity (kidney damage), 'Red Man Syndrome' (flushing, rash, itching).
What to Do:
Call 1-800-222-1222 (Poison Control Center). Treatment is generally supportive. Hemodialysis is not effective for removing vancomycin from the body.
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis of Clostridioides difficile infection (CDI)
Rationale: Confirm appropriate indication for oral vancomycin
Timing: Prior to initiation of therapy
Baseline renal function (CrCl, SCr)
Rationale: Although systemic absorption is minimal, it's good practice to have baseline data, especially if there's concern for compromised gut integrity or prolonged high-dose use.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of diarrhea
Frequency: Daily
Target: Normal bowel movements
Action Threshold: Persistent or worsening diarrhea after 48-72 hours may indicate treatment failure or alternative diagnosis.
Fever, abdominal pain, leukocytosis
Frequency: Daily
Target: Absence of symptoms
Action Threshold: Persistence or worsening may indicate severe disease or complications.
Symptom Monitoring
- Resolution of diarrhea
- Decrease in abdominal pain
- Reduction in fever
- Improvement in appetite
- Return to normal bowel habits
Special Patient Groups
Pregnancy
Oral vancomycin is generally considered safe during pregnancy due to minimal systemic absorption. It is classified as Pregnancy 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
Oral vancomycin is considered compatible with breastfeeding (Lactation Risk L2). Minimal amounts are absorbed systemically by the mother, and even less would be transferred into breast milk. Any amount ingested by the infant would also be poorly absorbed.
Infant Risk:
Low risk. Potential for disruption of infant gut flora or allergic sensitization, but systemic absorption by the infant is negligible.
Pediatric Use
Dosing is weight-based for pediatric patients. Oral vancomycin is a standard treatment for CDAD in children. Close monitoring for clinical response is important.
Geriatric Use
No specific dose adjustment is needed for elderly patients based on age alone, as systemic absorption is minimal. However, elderly patients may be more susceptible to dehydration from severe diarrhea and should be monitored closely for fluid and electrolyte balance.
Clinical Information
Clinical Pearls
- Oral vancomycin is specifically used for Clostridioides difficile infection (CDI) because it acts locally in the gut and is poorly absorbed systemically. It is NOT used for systemic infections.
- Do not confuse oral vancomycin with intravenous (IV) vancomycin, which is used for systemic infections and requires therapeutic drug monitoring.
- Firvanq is a liquid formulation, which can be beneficial for patients who have difficulty swallowing capsules.
- Ensure patients understand the importance of completing the full course of therapy, even if symptoms improve, to prevent recurrence of CDI.
- Recurrent CDI is common; consider alternative strategies (e.g., fidaxomicin, fecal microbiota transplant) for subsequent recurrences.
Alternative Therapies
- Fidaxomicin (oral)
- Metronidazole (oral, for initial non-severe CDI)
- Fecal microbiota transplantation (FMT) for recurrent CDI
Cost & Coverage
Average Cost:
Varies widely, typically $1000-$3000+ per 150ml (25mg/ml) 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.