firvanq kit
Pharmaranks rates Firvanq Kit 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Firvanq Kit (Vancomycin Hydrochloride) is a glycopeptide antibacterial used to treat Diarrhea, Bacterial Endocarditis, Pseudomembranous Enterocolitis, Pneumococcal Meningitis.
Vancomycin Hydrochloride · by Azurity
Available as a generic: Vancomycin Hydrochloride
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Vancomycin Hydrochloride
- Drug class
- Glycopeptide Antibacterial
- Form
- Kit
- Strength
- Vancomycin Hydrochloride EQ 25MG BASE/ML · Vancomycin Hydrochloride EQ 50MG BASE/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Azurity
- What the pharmacy pays
- ~$1.49 per ml — not your price
- FDA application
- NDA208910
What is Firvanq Kit?
From the FDA label:Vancomycin hydrochloride for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis ), which has the chemical formula C 66 H 75 Cl 2 N 9 O 24 •HCl. The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula: Each vancomycin hydrochloride for oral solution kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 3 . Table 3: Vancomycin Strength, Diluent Volume and Vancomycin Concentration after Reconstitution Vancomycin Strength per Bottle Equivalent Amount of Vancomycin Hydrochloride per Bottle Diluent Volume for Vancomycin hydrochloride Vancomycin Concentration after Reconstitution 3.75 g 3.84 g 147 mL 25 mg/mL 7.5 g 7.7 g 295 mL 7.5 g 7.7 g 145 mL 50 mg/mL 15.0 g 15.4 g 289 mL The Grape‑Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor, citric acid (anhydrous), D&C Yellow No. 10, FD&C Red No. 40, purified water, sodium benzoate and sucralose. Vancomycin hydrochloride structural formula
How to use
C. difficile‑ associated diarrhea: Adult Patients (18 years of age and older): 125 mg orally 4 times daily for 10 days. ( 2.2 ) Pediatric Patients (less than 18 years of age): 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. ( 2.3 ) Staphylococcal enterocolitis: Adult Patients (18 years of age and older): 500 mg to 2 g orally in 3 or 4 divided doses for 7 to 10 days. ( 2.2 ) Pediatric Patients (less than 18 years of age): 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. ( 2.3 ) See Full Prescribing Information for preparation and important administration information. ( 2.1 ) 2.1 Important Administration Instructions Prior to oral administration, the supplied vancomycin hydrochloride powder must be reconstituted by the healthcare provider (i.e., a pharmacist) to produce the oral solution [ see Dosage and Administration ( 2.4 ) ]. 2.2 Adults C. difficile ‑associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days. 2.3 Pediatric Patients (less than 18 years of age) For both C. difficile ‑associated diarrhea and staphylococcal enterocolitis, the usual daily dosage of vancomycin hydrochloride is 40 mg/kg in 3 or 4 divided…
Side effects
The most common adverse reactions (≥ 10%) were nausea (17%), abdominal pain (15%), and hypokalemia (13%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals at 1-877-495-6856, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to vancomycin hydrochloride in 260 adult subjects in two Phase 3 clinical trials for the treatment of C. difficile ‑associated diarrhea. In both trials, subjects received vancomycin hydrochloride 125 mg orally four times daily. The mean duration of treatment was 9.4 days. The median age of patients was 67, ranging between 19 and 96 years of age. Patients were predominantly Caucasian (93%), and 52% were male. Adverse reactions occurring in ≥ 5% of vancomycin hydrochloride‑treated subjects are shown in Table 2 . The most common adverse reactions associated with vancomycin hydrochloride (≥ 10%) were nausea, abdominal pain, and hypokalemia. Table 2: Common (≥ 5%) Adverse Reactions* for Vancomycin Hydrochloride Reported in Clinical Trials for Treatment of C. difficile Associated Diarrhea * Adverse…
Warnings
Important safety information
Vancomycin hydrochloride must be given orally for treatment of C. difficile ‑associated diarrhea and staphylococcal enterocolitis. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. ( 5.1 ) Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin hydrochloride for C. difficile ‑associated diarrhea. Monitoring of serum concentrations may be appropriate in some instances. ( 5.2 ) Nephrotoxicity has occurred following oral vancomycin hydrochloride therapy and can occur either during or after completion of therapy. The risk is increased in geriatric patients. Monitor renal function. ( 5.3 ) Ototoxicity has occurred in patients receiving vancomycin hydrochloride. Assessment of auditory function may be appropriate in some instances. ( 5.4 ) Severe Dermatologic Reactions: Discontinue vancomycin hydrochloride at the first appearance of skin rashes, mucosal lesions, or blisters. ( 5.5 ) Prescribing vancomycin hydrochloride in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ( 5.7 ) 5.1 Oral Use Only Vancomycin hydrochloride must be given orally for treatment of C. difficile ‑associated diarrhea and staphylococcal enterocolitis. Orally administered vancomycin is not effective for treatment of other types of infections. Parenteral administration of vancomycin is not effective for treatment of C. difficile ‑associated diarrhea and staphylococcal enterocolitis. If parenteral vancomycin therapy is desired, use an intravenous preparation of vancomycin and consult the Full Prescribing Information accompanying that preparation. 5.2 Potential for Systemic Absorption Significant systemic absorption has been reported in some patients (e.g., patients with renal insufficiency and/or colitis) who have taken multiple oral doses of vancomycin hydrochloride for C. difficile ‑associated diarrhea. In these patients, serum vancomycin concentrations reached therapeutic levels for the treatment of systemic infections. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin hydrochloride; therefore, monitoring of serum concentrations of vancomycin may be appropriate in some instances, e.g., in patients with renal insufficiency and/or colitis or in those receiving concomitant therapy with an aminoglycoside antibacterial drug. 5.3 Nephrotoxicity Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) has occurred following oral vancomycin hydrochloride therapy in randomized controlled clinical trials and can occur either during or after completion of therapy. The risk of nephrotoxicity is increased in patients over 65 years of age [ see Adverse Reactions ( 6.1 ) and Use in Specific Populations ( 8.5 ) ]. In patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with vancomycin hydrochloride to detect potential vancomycin- induced nephrotoxicity. 5.4 Ototoxicity Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given high intravenous doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity [ see Adverse Reactions ( 6.2 ) ]. 5.5 Severe Dermatologic Reactions Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear lgA bullous dermatosis (LABD) have been reported in association with the use of vancomycin. Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters. Discontinue vancomycin hydrochloride at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD. 5.6 Potential for Microbial Overgrowth Use of vancomycin hydrochloride may result in the overgrowth of non‑susceptible bacteria. If superinfection occurs during therapy, appropriate measures should be taken. 5.7 Development of Drug-Resistant Bacteria Prescribing vancomycin hydrochloride in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug‑resistant bacteria. 5.8 Hemorrhagic Occlusive Retinal Vasculitis (HORV) Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or intravitreal route have not been established by adequate and well‑controlled studies. Vancomycin is not indicated for prophylaxis of endophthalmitis.
Who should not take Firvanq Kit
Vancomycin hydrochloride is contraindicated in patients with known hypersensitivity to vancomycin. Hypersensitivity to vancomycin ( 4 )
Overdose — what happens if you take too much
Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance. For current information on the management of overdosage, contact the National Poison Control Center at 1‑800‑222‑1222 or www.poison.org .
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No drug interaction studies have been conducted using orally administered vancomycin hydrochloride products.
Drug class
May treat (source: NIH RxClass)
- diarrhea
- bacterial endocarditis
- pseudomembranous enterocolitis
- pneumococcal meningitis
- neutropenia
- postoperative complications
See how Firvanq Kit ranks — best-rated glycopeptide antibacterial for:
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Firvanq Kit treat?
- Firvanq Kit (Vancomycin Hydrochloride) may be used to treat diarrhea, bacterial endocarditis, pseudomembranous enterocolitis, pneumococcal meningitis, neutropenia, postoperative complications, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Firvanq Kit rated?
- pharmaranks gives Firvanq Kit a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Firvanq Kit cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.49 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Firvanq Kit?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Firvanq Kit. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Firvanq Kit?
- Firvanq Kit is marketed by Azurity. You can see Azurity's full profile, rating, and other products on pharmaranks.
- Is Firvanq Kit a brand-name or generic drug?
- Firvanq Kit is a brand-name product with the active ingredient Vancomycin Hydrochloride. Lower-cost generic equivalents containing Vancomycin Hydrochloride are available — ask your pharmacist.
- Is Firvanq Kit available over the counter?
- No. Firvanq Kit is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Firvanq Kit come in?
- Firvanq Kit is currently marketed as kit, per the FDA's National Drug Code Directory.
- What class of drug is Firvanq Kit?
- Firvanq Kit is classified as glycopeptide antibacterial, per the FDA's Established Pharmacologic Class.
- Is Firvanq Kit FDA-registered?
- Firvanq Kit is on record with the U.S. FDA under application number NDA208910. You can verify this on its official FDA label.
- Has Firvanq Kit been recalled by the FDA?
- Yes. Firvanq Kit has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Firvanq Kit safe?
- There's no single safe-or-not verdict. pharmaranks gives Firvanq Kit a recall-safety score of 70/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Firvanq Kit?
- Firvanq Kit's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (≥ 10%) were nausea (17%), abdominal pain (15%), and hypokalemia (13%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals at 1-877-495-6856, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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firvanq kit
70/100