Vancomycin Hydrochloride for Oral Solution

vancomycin hydrochloride · KIT · Wilshire Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Vancomycin hydrochloride oral solution is a prescription antibiotic used to treat certain bacterial infections, particularly those caused by *Clostridioides difficile* in the colon. It works by killing bacteria and is taken by mouth as directed by your doctor.

Key Facts

Brand Name: Vancomycin Hydrochloride for Oral Solution
Generic Name: vancomycin hydrochloride
NDC Code (Product): 52536-107
Manufacturer: Wilshire Pharmaceuticals, Inc.
Dosage Form: KIT
Marketing Status
Application #: NDA208910
Marketing Start: 03/31/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective824 reports

acute kidney injury470 reports

off label use455 reports

pyrexia413 reports

rash296 reports

drug reaction with eosinophilia and systemic symptoms290 reports

drug hypersensitivity280 reports

condition aggravated263 reports

pneumonia258 reports

diarrhoea252 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Vancomycin hydrochloride is indicated for the treatment of Clostridium difficil e‑associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride 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 and other antibacterial drugs, vancomycin hydrochloride 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…

Dosage & 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 ) 2.1 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 f…

Contraindications

4 CONTRAINDICATIONS Vancomycin hydrochloride is contraindicated in patients with known hypersensitivity to vancomycin. Hypersensitivity to vancomycin ( 4 )

Drug Interactions

7 DRUG INTERACTIONS No drug interaction studies have been conducted using orally administered vancomycin hydrochloride products.

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 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 hydrochl…

Frequently Asked Questions

What is Vancomycin Hydrochloride for Oral Solution used for?

Is Vancomycin Hydrochloride for Oral Solution a controlled substance?

Vancomycin Hydrochloride for Oral Solution is not classified as a controlled substance by the DEA.

What is the generic name for Vancomycin Hydrochloride for Oral Solution?

The generic name for Vancomycin Hydrochloride for Oral Solution is vancomycin hydrochloride. There are 12 other brand versions of vancomycin hydrochloride.

What is the NDC code for Vancomycin Hydrochloride for Oral Solution ?

The NDC (National Drug Code) for Vancomycin Hydrochloride for Oral Solution is 52536-107, listed by Wilshire Pharmaceuticals, Inc..

Product NDC

52536-107

Package NDC

52536-107-10

Other Vancomycin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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