vancomycin hydrochloride Kit
Other active recalls for Vancomycin Hydrochloride (different manufacturers) — 2 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Glycopeptide Antibacterial class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- It depends on what you're being treated for. If you have a serious infection like a bloodstream infection, heart valve infection, or bone infection, the oral form of vancomycin sim...
- Why do I need an IV antibiotic — can't I just take a pill?
- The two biggest things to watch for are changes in your hearing and changes in your urination. If you notice ringing in your ears, muffled hearing, or dizziness, let your doctor kn...
- What should I watch out for while taking vancomycin?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Vancomycin Hydrochloride — tap one for details:
Vancomycin Hydrochloride may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vancomycin Hydrochloride 67877-0750-58 | Ascend | 1 kit | $0.395 | AA | Availability likely | — |
| Vancomycin Hydrochloride for Oral Solution 52536-0107-10 | Wilshire | 1 kit | $0.395 | AA | Availability likely | — |
| Firvanq 65628-0205-10 | Azurity | 1 kit | $0.471 | AA | FDA listed | — |
| Vancomycin Hydrochloride for Oral Solution 52536-0104-05 | Wilshire | 1 kit | $0.661 | AA | Availability likely | — |
| Vancomycin Hydrochloride for Oral Solution 52536-0106-05 | Wilshire | 1 kit | $0.742 | AA | Availability likely | — |
| Vancomycin Hydrochloride 67877-0751-58 | Ascend | 1 kit | $0.801 | AA | Availability likely | — |
| Vancomycin Hydrochloride for Oral Solution 52536-0108-10 | Wilshire | 1 kit | $0.801 | AA | Availability likely | — |
| Firvanq 65628-0206-05 | Azurity | 1 kit | $1.186 | AA | Availability likely | — |
| Firvanq 65628-0204-05 | Azurity | 1 kit | — | AA | FDA listed | — |
| Firvanq 65628-0208-10 | Azurity | 1 kit | — | AA | FDA listed | — |
| vancomycin hydrochloride 59651-0670-03 | Aurobindo | 1 kit | — | AA | FDA listed | — |
| vancomycin hydrochloridethis 59651-0669-03 | Aurobindo | 1 kit | — | AA | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59651-0669-03 You're viewing this | 1 KIT in 1 CARTON (59651-669-03) * 147 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE * 3.75 g in 1 BOTTLE | 2026-08-07 | Active |
| 59651-0669-55 | 1 KIT in 1 CARTON (59651-669-55) * 147 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE * 3.75 g in 1 BOTTLE | 2026-08-07 | Active |
Pack size FAQ
What quantity is in NDC 59651-0669-03?
What NDC number is used to bill for this package of vancomycin hydrochloride Kit?
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Vancomycin hydrochloride for oral solution is indicated for the treatment of Clostridium difficil e-associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride for oral solution is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.
Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for oral solution and other antibacterial drugs, vancomycin hydrochloride for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Vancomycin hydrochloride is a glycopeptide antibacterial indicated in adults and pediatric patients less than 18 years of age for the treatment of: ( 1 ) Clostridium difficile -associated diarrhea Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) Important Limitations of Use: ( 1 ) ( 5.1 ) Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for oral solution and other antibacterial drugs, vancomycin hydrochloride for oral solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 )
2.1Important 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) ].
2.2Adults 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.
2.3Pediatric Patients (less than 18 years of age) For both C. difficile -associated diarrhea and staphylococcal enterocolitis, the usual daily dosage of vancomycin hydrochloride for oral solution is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.
2.4Preparation and Storage of Solutions of Vancomycin Hydrochloride for Oral Solution Each vancomycin hydrochloride for oral solution kit contains 1 bottle of vancomycin hydrochloride USP powder and 1 bottle of pre-measured Grape-Flavored Diluent to be added to the vancomycin bottle. A healthcare provider (i.e., a pharmacist) must reconstitute vancomycin hydrochloride USP powder with the Grape-Flavored Diluent provided in the kit. Vancomycin hydrochloride for oral solution is available in various strengths and volumes in the kit as shown in Table 1.
Table 1: Vancomycin Concentration and Volume after Reconstitution Vancomycin Concentration after Reconstitution Final Volume of Vancomycin Hydrochloride for Oral Solution after Reconstitution Vancomycin Strength per Bottle Diluent for Vancomycin Hydrochloride for Oral Solution 25 mg/mL 150 mL 3.75 g 147 mL 300 mL 7.5 g 295 mL 50 mg/mL 150 mL 7.5 g 145 mL 300 mL 15 g 289 mL Steps for the Preparation of Solutions of Vancomycin Hydrochloride for Oral Solution 1. Hold the neck of the bottle containing the vancomycin hydrochloride USP powder for oral solution (see Table 1), and tap the bottom edges on a hard surface to loosen the powder.
2. Remove the cap from the vancomycin hydrochloride USP powder for oral solution bottle (“Powder Bottle”). 3.
Tap the top of the induction seal liner to loosen any powder that may have adhered to the liner. 4. Carefully and slowly peel the inner foil seal liner from the Powder Bottle.
5. Shake the Grape-Flavored Diluent (see Table 1) for a few seconds. 6.
Remove the cap from the diluent bottle. 7. Carefully and slowly peel the inner foil seal from the diluent bottle.
8. Transfer approximately one-half the contents of Grape-Flavored Diluent into the Powder Bottle. 9.
Replace the Powder Bottle cap, tighten onto the Powder Bottle, and shake the Powder Bottle vertically for approximately 45 seconds. NOTE: DO NOT use the diluent cap on the Powder Bottle as it may cause the solution to leak from the bottle. 10.
Re-open the Powder Bottle and add the remaining Grape-Flavored Diluent into the Powder Bottle. 11. Replace the Powder Bottle cap, tighten onto the Powder Bottle, and shake the Powder Bottle for approximately 30 seconds.
NOTE: DO NOT use the diluent cap on the Powder Bottle as it may cause the solution to leak from the bottle. 12. Dispense the Powder Bottle containing reconstituted solution of vancomycin hydrochloride oral solution to the patient [see Patient Counseling…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Each vancomycin hydrochloride for oral solution, USP kit contains vancomycin hydrochloride USP as white to almost white or tan to brown powder for oral solution, equivalent to 3.75 g, 7.5 g or 15 g vancomycin, and Grape-Flavored Diluent for reconstitution. Each vancomycin hydrochloride for oral solution, USP kit contains: vancomycin hydrochloride USP, powder for oral solution, equivalent to 3.75 g, 7.5 g or 15 g vancomycin, and Grape-Flavored Diluent. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Vancomycin hydrochloride for oral solution is contraindicated in patients with known hypersensitivity to vancomycin. Hypersensitivity to vancomycin ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 )
5.1Oral 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.
5.2Potential 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.
5.3Nephrotoxicity 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.
5.4Ototoxicity 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) ].
5.5Severe Dermatologic Reactions Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (≥ 10%) were nausea (17%), abdominal pain (15%), and hypokalemia (13%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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 System/Organ Class Adverse Reaction Vancomycin Hydrochloride (%) (N=260) Gastrointestinal disorders Nausea 17 Abdominal pain 15 Vomiting 9 Diarrhea 9 Flatulence 8 General disorders and administration site conditions Pyrexia 9 Edema peripheral 6 Fatigue 5 Infections and infestations Urinary tract infection 8 Metabolism and nutrition disorders Hypokalemia 13 Musculoskeletal and connective tissue disorders Back pain 6 Nervous system disorders Headache 7 * Adverse reaction rates were derived from the incidence of treatment-emergent adverse events.
Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) occurred in 5% of subjects treated with vancomycin hydrochloride. Nephrotoxicity following vancomycin hydrochloride typically first occurred within one week after completion of treatment (median day of onset was Day 16). Nephrotoxicity following vancomycin hydrochloride occurred in 6% of subjects over 65 years of age and 3% of subjects 65 years of age and younger [ see Warnings and Precautions (5.3) ].
Nephrotoxicity can also occur during oral vancomycin administration. The incidences of hypokalemia, urinary tract infection, peripheral edema, insomnia, constipation, anemia, depression, vomiting, and hypotension were higher among subjects over 65 years of age than in subjects 65 years of age and younger [ see Use in Specific Populations (8.5) ]. Discontinuation of study drug due to adverse events occurred in 7% of subjects treated with vancomycin hydrochloride.
The most common adverse events leading to discontinuation of vancomycin hydrochloride were C. difficile colitis (< 1%), nausea (< 1%), and vomiting (< 1%).
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of vancomycin hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ototoxicity : Cases of hearing loss associated with intravenously administered vancomycin have been reported.
Most of these patients had kidney dysfunction or a preexisting hearing loss or were receiving concomitant treatment with an ototoxic drug [ see Warnings and Precautions (5.4) ]. Vertigo, dizziness, and tinnitus have been reported. Skin and Subcutaneous Tissue Disorders: Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthemato…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug interaction studies have been conducted using orally administered vancomycin hydrochloride products.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Geriatrics : 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. ( 5.3 ) ( 6.1 ) ( 8.5 ) ( 14.1 )
8.1Pregnancy Risk Summary There are no available data on vancomycin hydrochloride use in pregnant women to inform a drug-associated risk of major birth defects or miscarriage. Available published data on vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy-related outcomes (see Data) . Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose based on body surface area (see Data) .
All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A published study evaluated hearing loss and nephrotoxicity in infants of pregnant intravenous drug users treated with vancomycin for suspected or documented methicillin-resistant S. aureus in the second or third trimester.
The comparison groups were 10 non-intravenous drug-dependent patients who received no treatment, and 10 untreated intravenous drug-dependent patients served as substance abuse controls. No infant in the vancomycin-exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity. A published prospective study assessed outcomes in 55 pregnant women with a positive Group B Streptococcus culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin at the time of delivery.
Vancomycin dosing ranged from the standard 1 g intravenously every 12 hours to 20 mg/kg intravenous every 8 hours (maximum individual dose 2 g). No major adverse reactions were recorded either in the mothers or their newborns. None of the newborns had sensorineural hearing loss.
Neonatal renal function was not examined, but all of the newborns were discharged in good condition. Animal Data Vancomycin did not cause fetal malformations when administered during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose (based on body surface area comparisons) of 200 mg/kg/day IV to rats or 120 mg/kg/day IV to rabbits. No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area, respectively).
Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above).
8.2Lactation Risk Summary There are insufficient data to inform the levels of vancomycin in human milk. However, systemic absorption of vancomycin following oral administration is expected to be minimal [ see Clinical Pharmacology (12.3) ] . There are no data on the effects of vancomycin hydrochloride on the breastfed infant or milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for vancomycin hydrochloride and any potential adverse effects on the breastfed infant from vancomycin hydrochloride or from the underlying maternal condition.
8.4Pediatric Use Vancomycin hydrochloride is indicated in pediatric patients less than 18 years of age for the treatment of C. difficile -associated diarrhea and enterocolitis caused by S. aureus (including methicillin-resistant strains) [ see Indications and Usage (1) and Dosage and Administration (2.3) ].
8.5 Geriatric Use In clinical trials…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on vancomycin hydrochloride use in pregnant women to inform a drug-associated risk of major birth defects or miscarriage. Available published data on vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy-related outcomes (see Data) . Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose based on body surface area (see Data) .
All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A published study evaluated hearing loss and nephrotoxicity in infants of pregnant intravenous drug users treated with vancomycin for suspected or documented methicillin-resistant S. aureus in the second or third trimester.
The comparison groups were 10 non-intravenous drug-dependent patients who received no treatment, and 10 untreated intravenous drug-dependent patients served as substance abuse controls. No infant in the vancomycin-exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity. A published prospective study assessed outcomes in 55 pregnant women with a positive Group B Streptococcus culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin at the time of delivery.
Vancomycin dosing ranged from the standard 1 g intravenously every 12 hours to 20 mg/kg intravenous every 8 hours (maximum individual dose 2 g). No major adverse reactions were recorded either in the mothers or their newborns. None of the newborns had sensorineural hearing loss.
Neonatal renal function was not examined, but all of the newborns were discharged in good condition. Animal Data Vancomycin did not cause fetal malformations when administered during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose (based on body surface area comparisons) of 200 mg/kg/day IV to rats or 120 mg/kg/day IV to rabbits. No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area, respectively).
Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above).
🧒 Pediatric Use ▾
8.4Pediatric Use Vancomycin hydrochloride is indicated in pediatric patients less than 18 years of age for the treatment of C. difficile -associated diarrhea and enterocolitis caused by S. aureus (including methicillin-resistant strains) [ see Indications and Usage (1) and Dosage and Administration (2.3) ].
🧓 Geriatric Use ▾
8.5Geriatric Use In clinical trials, 54% of vancomycin hydrochloride-treated subjects were > 65 years of age. Of these, 40% were between the ages of > 65 and 75, and 60% were > 75 years of age. Clinical studies with vancomycin hydrochloride in C. difficile -associated diarrhea have demonstrated that geriatric subjects are at increased risk of developing nephrotoxicity following treatment with oral vancomycin hydrochloride, which may occur during or after completion of therapy.
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 [ see Warnings and Precautions (5.3) , Adverse Reactions (6.1) and Clinical Studies (14.1) ]. Patients over 65 years of age may take longer to respond to therapy compared to patients 65 years of age and younger [ see Clinical Studies (14.1) ]. Clinicians should be aware of the importance of appropriate duration of vancomycin hydrochloride treatment in patients over 65 years of age and not discontinue or switch to alternative treatment prematurely.
🆘 Overdosage ▾
10 OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Vancomycin is an antibacterial drug [ see Microbiology (12.4 ) ].
12.3Pharmacokinetics Vancomycin is poorly absorbed after oral administration. During multiple dosing of vancomycin hydrochloride capsules at 250 mg every 8 hours for 7 doses, fecal concentrations of vancomycin in volunteers exceeded 100 mcg/g in the majority of samples. No blood concentrations were detected and urinary recovery did not exceed 0.76%.
In anephric subjects with no inflammatory bowel disease who received vancomycin oral solution 2 g for 16 days, blood concentrations of vancomycin were ≤ 0.66 mcg/mL in 2 of 5 subjects. No measurable blood concentrations were attained in the other 3 subjects. Following doses of 2 g daily, concentrations of drug were > 3100 mcg/g in the feces and < 1 mcg/mL in the serum of subjects with normal renal function who had C. difficile -associated diarrhea.
After multiple-dose oral administration of vancomycin, measurable serum concentrations may occur in patients with active C. difficile -associated diarrhea, and, in the presence of renal impairment, the possibility of accumulation exists. It should be noted that the total systemic and renal clearances of vancomycin are reduced in the elderly [see Use in Specific Populations (8.5) ] .
12.4Microbiology Mechanism of Action The bactericidal action of vancomycin against the vegetative cells of C. difficile and S. aureus results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis. Mechanism of Resistance C. difficile Isolates of C. difficile generally have vancomycin minimal inhibitory concentrations (MICs) of < 1 mcg/mL; however, vancomycin MICs ranging from 4 mcg/mL to 16 mcg/mL have been reported.
The mechanism which mediates C. difficile 's decreased susceptibility to vancomycin has not been fully elucidated. S. aureus S. aureus isolates with vancomycin MICs as high as 1024 mcg/mL have been reported. The exact mechanism of this resistance is not clear but is believed to be due to cell wall thickening and potentially the transfer of genetic material.
Vancomycin has been shown to be active against susceptible isolates of the following bacteria in clinical infections [ see Indications and Usage (1) ]. Anaerobic gram-positive bacteria C. difficile isolates associated with C. difficile -associated diarrhea. Gram-positive bacteria S. aureus (including methicillin-resistant isolates) associated with enterocolitis.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Vancomycin is an antibacterial drug [ see Microbiology (12.4 ) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Each vancomycin hydrochloride for oral solution, USP 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 5. Table 5: Vancomycin Strength, Diluent Volume and National Drug Code (NDC) Numbers Vancomycin Strength per Bottle Diluent Volume for Vancomycin Hydrochloride for Oral Solution NDC Numbers 3.75 g 147 mL 59651-669-55 7.5 g 295 mL 59651-669-03 7.5 g 145 mL 59651-670-55 15 g 289 mL 59651-670-03 Storage and Handling Store the vancomycin hydrochloride for oral solution, USP kit at refrigerated conditions, 2°C to 8°C (36°F to 46°F).
Store reconstituted solutions of vancomycin hydrochloride for oral solution, USP at 2°C to 8°C [ see Dosage and Administration (2.4) ]. Do not freeze. Keep container tightly closed.
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📋 Description ▾
11 DESCRIPTION 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, USP 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 for Oral Solution 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 g 15.4 g 289 mL The Grape-Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor (contains glycerine and propylene glycol), citric acid anhydrous, D&C Yellow No.
10, FD&C Red No. 40, methylparaben, propylparaben, purified water, sodium hydroxide and sucralose. str
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Severe Dermatologic Reactions Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking vancomycin hydrochloride for oral solution immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions or blisters, [ see Warnings and Precautions (5.5) ] . Antibacterial Resistance Patients should be counseled that antibacterial drugs including vancomycin hydrochloride for oral solution should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When vancomycin hydrochloride for oral solution is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by vancomycin hydrochloride for oral solution or other antibacterial drugs in the future.
Important Administration and Storage Instructions Instruct the patient or caregiver to [ see Dosage and Administration (2.4) ]: Shake the reconstituted solutions of vancomycin hydrochloride for oral solution well before each use and to use an oral dosing device that measures the appropriate volume of the oral solution in milliliters. Store the reconstituted solutions of vancomycin hydrochloride for oral solution at refrigerated conditions, 2°C to 8°C (36°F to 46°F) when not in use. Discard reconstituted solutions of vancomycin hydrochloride for oral solution after 14 days, or if it appears hazy or contains particulates.
Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: January 2025