VANCOMYCIN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE capsules, for oral use

VANCOMYCIN HYDROCHLORIDE

Vancomycin Hydrochloride Capsule, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24•HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol.

The 125 mg capsules contain vancomycin hydrochloride equivalent to 125 mg (0.08 mmol) vancomycin.

These capsules also contain FD&C Blue No. 2, gelatin, iron oxide yellow and red, polyethylene glycol, titanium dioxide.

The 250 mg capsules contain vancomycin hydrochloride equivalent to 250 mg (0.17 mmol) vancomycin.

These capsules also contain FD&C Blue No. 2, gelatin, iron oxide red and black, polyethylene glycol, titanium dioxide.

Both 125 mg and 250 mg capsules are imprinted with white ink which may contain purified shellac, purified titanium dioxide and FD&C Blue No. 1 Lake.

INDICATIONS AND USAGE

Vancomycin hydrochloride capsule is indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsule is 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 injection must be given orally for these infections.
  • Orally administered Vancomycin Hydrochloride Capsule is not effective for other types of infections.
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsule and other antibacterial drugs, vancomycin hydrochloride capsule should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Mechanism of Action

The bactericidal action of vancomycin against Staphylococcus aureus and the vegetative cells of Clostridioides difficile results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.

DOSAGE AND ADMINISTRATION

Adults: Vancomycin hydrochloride capsule are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  • 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.

Pediatric Patients (less than 18 years of age)

For both C. difficile-associated diarrhea and staphylococcal enterocolitis, the usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

CONTRAINDICATIONS

Vancomycin hydrochloride capsule is contraindicated in patients with known hypersensitivity to vancomycin.

WARNINGS AND PRECAUTIONS

Oral Use Only: Vancomycin hydrochloride capsule for the treatment of colitis is for oral use only and is not systemically absorbed. Vancomycin hydrochloride capsule must be given orally for treatment of staphylococcal enterocolitis and Clostridioides difficile-associated diarrhea. Orally administered vancomycin hydrochloride capsule is not effective for other types of infections.

Parenteral administration of vancomycin is not effective for treatment of staphylococcal enterocolitis and

C. difficile-associated diarrhea. If parenteral vancomycin therapy is desired, use an intravenous preparation of vancomycin and consult the package insert accompanying that preparation.

Potential for Systemic Absorption: Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin hydrochloride capsule for active C. difficile-associated diarrhea. 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 capsule; 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 antibiotic.

Nephrotoxicity: Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) has occurred following oral vancomycin hydrochloride capsule therapy in randomized controlled clinical studies, and can occur either during or after completion of therapy. The risk of nephrotoxicity is increased in patients >65 years of age.

Ototoxicity: 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

Severe Dermatologic Reactions: 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 IgA bullous dermatosis (LABD) have been reported in association with the use of vancomycin.

Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters. Discontinue vancomycin hydrochloride capsule at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD.

Development of Drug-Resistant Bacteria: Prescribing vancomycin hydrochloride capsule in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria.

ADVERSE REACTIONS

The following adverse reactions have been identified during post-approval use of vancomycin hydrochloride capsule. 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

Skin and Subcutaneous Tissue Disorders: Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drugU reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD)

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 for several dozen patients. Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has been reported.

Miscellaneous: Patients have been reported to have had anaphylaxis, drug fever, chills, nausea, eosinophilia, and cases of vasculitis in association with the administration of vancomycin.

A condition has been reported 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 (“Red Man Syndrome”), pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours.

DRUG INTERACTIONS

No drug interaction studies have been conducted.

USE IN SPECIFIC POPULATIONS

Geriatrics: In patients >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 injection to detect potential vancomycin induced nephrotoxicity.

Pregnancy: Systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride capsule; however, absorption may vary depending on various factors

There are no available data on vancomycin use in pregnant women to assess a risk of major birth defects or miscarriage. Available published data on intravenous vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse maternal or fetal outcomes

Lactation: There are no data on the presence of vancomycin in human milk, the effects on the breastfed infant, or the effect on milk production following oral administration. Systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride capsule; therefore, it is unlikely to result in clinically relevant exposure in breastfeeding infants. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for vancomycin hydrochloride capsule and any potential adverse effects on the breastfed infant from vancomycin hydrochloride capsule or from the underlying maternal condition.

Pediatric Use: Vancomycin hydrochloride capsule 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)

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.

To obtain current information about the treatment of overdose, contact a certified Poison Control Center (1-800-222-1222 or www.poison.org). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics.

HOW SUPPLIED/STORAGE AND HANDLING

Vancomycin Hydrochloride Capsules, USP are available in: The 125 mg* capsules have an opaque blue cap and opaque brown body imprinted with “741” on the cap and “125 mg” on the body in white ink. They are available in:

NDC 17478-741-02 Vancomycin HCl 125 mg*; each carton contains 2 blister cards of 10 capsules each, for a total of 20 capsules.

The 250 mg* capsules have an opaque blue cap and opaque lavender body imprinted with “742” on the cap and “250 mg” on the body in white ink. They are available in: NDC 17478-742-02 Vancomycin HCl 250 mg*; each carton contains 2 blister cards of 10 capsules each, for a total of 20 capsules.

*Equivalent to vancomycin

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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