FDA Approved Oral Vancomycin Hydrochloride for Oral Solution USP

 Vancomycin Hydrochloride for Oral Solution USP - Web

 

Vancomycin Hydrochloride for Oral Solution USP is a generic equivalent to Vancocin® for Oral Solution. Edge Pharma offers FDA approved Vancomycin Hydrochloride for hospitals, surgery centers, and clinics.

 

Vancomycin Hydrochloride for Oral Solution USP (250 mg per 5 mL*)

 

Simple reconstitution: when prepared as directed, each 5 mL of solution contains vancomycin hydrochloride equivalent to approximately 250 mg of vancomycin.

 

Why Vancomycin Hydrochloride for Oral Solution USP

 

  • Oral Solution dosage form is easier to swallow for younger patients and those with dysphagia
  • Dye-free, pre-flavored convenience with a mixed berry taste
  • Convenient single bottle storage, refrigeration required
  • Ability to administer via nasogastric tube
  • Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)

 

While 150 mL is the most common bottle size, 80 mL and 300 mL bottles are also available. 80 mL bottles are often used for tapering or post hospital discharge, and 300 mL bottles are commonly prescribed for patients needing 14-day therapy.

 

How supplied (250 mg per 5 mL*)

Reconstitution Volume Total Content National Drug Code (NDC) Common Use
80 mL 4,000 mg 62559-830-80 Tapering or post hospital discharge
150 mL 7,500 mg 62559-830-55 Most common
300 mL 15,000 mg 62559-830-03 For patients needing 14-day therapy

 

Important Safety Information About Vancomycin Hydrochloride For Oral Solution USP

 

Indications and Usage

 

Vancomycin Hydrochloride for Oral Solution is a prescription medication administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by Clostridium difficile. Parenteral administration of vancomycin is not effective for the above indications; therefore, Vancomycin Hydrochloride for Oral Solution must be given orally for these infections. Orally administered Vancomycin Hydrochloride for Oral solution is not effective for other types of infection.

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.

 

Contraindications


Vancomycin Hydrochloride for Oral Solution is contraindicated in patients with known hypersensitivity to vancomycin.

 

Warnings and Precautions

 

  • 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 oral solution; 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.
  • 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. 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 oral solution to detect potential vancomycin induced nephrotoxicity.
  • Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given excessive 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.
  • Use of vancomycin may result in the overgrowth of non-susceptible bacteria. If superinfection occurs during therapy, appropriate measures should be taken.
  • Prescribing vancomycin 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.
  • 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.

 

Adverse Reactions

 

The most common adverse reactions include C-difficile colitis, nausea, vomiting, hypokalemia, and nephrotoxicity. This is not a complete list of side affects and others may occur. Please see the full Prescribing Information for a complete list of adverse reactions. 

To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use Vancomycin Hydrochloride for Oral solution USP safely and effectively. See full Prescribing Information for Vancomycin Hydrochloride for Oral Solution USP. 

 


 

Manufactured by ANI Pharmaceuticals, Inc and supplied by EDGE Pharma.

For additional information, please call 1-800-434-1121 or visit www.anipharmaceuticals.com.

* When prepared as directed, each 5 mL of solution contains vancomycin hydrochloride equivalent to approximately 250 mg of vancomycin.
† Vancomycin Hydrochloride for Oral Solution USP [package insert]. Baudette, MN: ANI Pharmaceuticals, Inc.
‡ Content of vancomycin per bottle.

Vancocin® is a registered trademark of ANI Pharmaceuticals, Inc.

Rev. VOS06182020

 


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