Vancomycin Hydrochloride for Oral Solution

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 doses for 7 to 10 days.
• The total daily dosage should not exceed 2 g.
• 2.4 Preparation and Storage of Solutions of Vancomycin Hydrochloride 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 after Reconstitution Vancomycin Strength per Bottle Diluent for Vancomycin Hydrochloride 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 15.0 g 289 mL Steps for the Preparation of Solutions of Vancomycin Hydrochloride 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.
• Remove the cap from the vancomycin hydrochloride USP powder for oral solution bottle (“Powder Bottle”).
• Tap the top of the induction seal liner to loosen any powder that may have adhered to the liner.
• Carefully and slowly peel back the inner foil seal liner from the Powder Bottle.
• Shake the Grape‑Flavored Diluent (see ) for a few seconds.
• Remove the cap from the diluent bottle.
• Carefully and slowly peel back the inner foil seal from the diluent bottle.
• Transfer approximately one-half the contents of Grape-Flavored Diluent into the Powder Bottle.
• 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.
• Re-open the Powder Bottle and add the remaining Grape‑Flavored Diluent into the Powder Bottle.
• 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.
• Dispense the Powder Bottle containing reconstituted solution of vancomycin hydrochloride oral solution to the patient [ see Patient Counseling Information ( 17 ) ].
• Instruct the patient to shake the reconstituted solution of vancomycin hydrochloride 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 solution of vancomycin hydrochloride at refrigerated conditions, 2°C to 8°C (36°F to 46°F) when not in use.
• Discard the reconstituted solution of vancomycin hydrochloride after 14 days, or if it appears hazy or contains particulates.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

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 ) ].

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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.

Quoted from the official label, section “Geriatric Use”.

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 reaction rates were derived from the incidence of treatment‑emergent adverse events.
• 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 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%).
• 6.2 Postmarketing 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 exanthematous pustulosis (AGEP), and linear lgA bullous dermatosis (LABD) [ see Warnings and Precautions ( 5.5 ) ], rashes (including exfoliative dermatitis).
• Hematopoietic :
• Reversible neutropenia, usually starting 1 week or more after onset of intravenous therapy with vancomycin or after a total dose of more than 25 g, has been reported.
• Neutropenia appears to be promptly reversible when vancomycin is discontinued.
• Thrombocytopenia has been reported.
• Miscellaneous :
• Anaphylaxis, drug fever, chills, nausea, eosinophilia, and vasculitis have been reported with the administration of vancomycin.
• A condition has been reported with oral vancomycin that is similar to the IV–induced syndrome with symptoms consistent with anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, pruritus, flushing of the upper body (“vancomycin infusion reaction”), pain and muscle spasm of the chest and back.
• These reactions usually resolve within 20 minutes but may persist for several hours.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Severe Dermatologic Reactions Advise patients about the signs and symptoms of serious skin manifestations.
• Instruct patients to stop taking vancomycin hydrochloride 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 should only be used to treat bacterial infections.
• They do not treat viral infections (e.g., the common cold).
• When vancomycin hydrochloride 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 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 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 at refrigerated conditions, 2° C to 8° C (36° F to 46° F) when not in use.
• Discard reconstituted solutions of vancomycin hydrochloride after 14 days, or if it appears hazy or contains particulates.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Each vancomycin hydrochloride for oral solution 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 15.0 g vancomycin, and Grape‑Flavored Diluent for reconstitution.
• Each vancomycin hydrochloride for oral solution kit contains:
• vancomycin hydrochloride USP, powder for oral solution, equivalent to 3.75 g, 7.5 g or 15.0 g vancomycin, and Grape‑Flavored Diluent.
• ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• How Supplied 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 5:
• Vancomycin Strength, Diluent Volume and National Drug Code (NDC) Numbers Vancomycin Strength per Bottle Diluent Volume for Vancomycin Hydrochloride NDC Numbers 3.75 g 147 mL 52536-104-05 7.5 g 295 mL 52536-107-10 7.5 g 145 mL 52536-106-05 15.0 g 289 mL 52536-108-10 Storage and Handling Store the vancomycin hydrochloride for oral solution kit at refrigerated conditions, 2°C to 8°C (36°F to 46°F).
• Store reconstituted solutions of vancomycin hydrochloride at 2°C to 8°C [ see Dosage and Administration ( 2.4 ) ].
• Do not freeze.
• Keep container tightly closed.
• Protect from light.

Quoted from the official label, section “How Supplied”.

What is in it

• 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

Quoted from the official label, section “Description”.

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Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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