Vancomycin Hydrochloride Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
vancomycin hydrochloride is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use •Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections. •Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections. To reduce the development of drug-resistant bacteria and maintain the.
What should I know before taking it?
Vancomycin Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to vancomycin.
What important warnings are listed?
5 WARNINGS AND PRECAUTIONS • Vancomycin Hydrochloride Capsules must be given orally for treatment of staphylococcal enterocolitis and C. difficile -associated diarrhea. Orally administered Vancomycin Hydrochloride Capsules is not effective for 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 Capsules for active C. difficile -associated diarrhea. Monitoring of serum concentrations may be appropriate in some instances. ( 5.2 ) • Nephrotoxicity has occurred following oral Vancomycin Hydrochloride Capsule therapy and can occur either during or after completion of.
How is this medication usually taken?
Vancomycin Hydrochloride Capsules USP, 125 mg (equivalent to vancomycin) have an opaque blue cap and opaque brown body imprinted with “3125” on the cap and “VANCOCIN HCL 125 MG” on the body in white ink. Vancomycin Hydrochloride Capsules USP, 250 mg (equivalent to vancomycin) have an opaque blue cap and opaque lavender body imprinted with “3126” on the cap and “VANCOCIN HCL 250 MG” on the body in white ink.
What side effects are listed?
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 ANI Pharmaceuticals, Inc. at 1-855-204-1431 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 in 260 adult subjects in two Phase 3 clinical trials for the treatment.
What interactions are listed?
No drug interaction studies have been conducted.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3707ad2e-5c82-4111-a370-e518e5e7e4c5
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.