Vancomycin Hydrochloride (Page 2 of 2)

Pregnancy

Animal reproduction studies have not been conducted with vancomycin. It is not known whether vancomycin can affect reproduction capacity. In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin on infants were evaluated when the drug was administered intravenously to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. Vancomycin was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted. One infant whose mother received vancomycin in the third trimester experienced conductive hearing loss that was not attributed to the administration of vancomycin. Because the number of patients treated in this study was limited and vancomycin was administered only in the second and third trimesters, it is not known whether vancomycin causes fetal harm. Vancomycin Hydrochloride for Oral Solution should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Vancomycin is excreted in human milk based on information obtained with the intravenous administration of vancomycin. However, systemic absorption of vancomycin is very low following oral administration of Vancomycin Hydrochloride for Oral Solution (see CLINICAL PHARMACOLOGY). It is not known whether oral vancomycin is excreted in human milk, as no studies of vancomycin concentration in human milk after oral administration have been done. Caution should be exercised when Vancomycin Hydrochloride for Oral Solution is administered to a nursing woman. Because of the potential for adverse events, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Geriatric Use

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.

Patients over 65 years of age may take longer to respond to therapy compared to patients 65 years of age and younger. 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.

ADVERSE REACTIONS

Nephrotoxicity

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. 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.

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%).

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. Vertigo, dizziness, and tinnitus have been reported rarely.

Hematopoietic

Reversible neutropenia, usually starting 1 week or more after onset of intravenous therapy with vancomycin or after a total dosage of more than 25 g, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has rarely been reported.

Miscellaneous

Anaphylaxis, drug fever, chills, nausea, eosinophilia, rashes (including exfoliative dermatitis), Stevens-Johnson syndrome, toxic epidermal necrolysis, and rare cases of vasculitis have been reported 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.

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.

For current information on the management of overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

DOSAGE AND ADMINISTRATION

Adults

Vancomycin Hydrochloride for Oral Solution is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and staphylococcal enterocolitis. Vancomycin Hydrochloride for Oral Solution is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.

Pediatric Patients

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.

PREPARATION AND STABILITY

Mix the contents of the bottle with water as directed below. When reconstituted, each 5 mL contains approximately 250 mg of vancomycin. These mixtures may be kept for two weeks in a refrigerator without significant loss of potency.

Directions for mixing Vancomycin Hydrochloride for Oral Solution USP:

80 mL – Slowly add 80 mL water and shake vigorously.

150 mL – Slowly add 150 mL water and shake vigorously.

300 mL – Slowly add 300 mL water and shake vigorously.

The appropriate oral solution dose may be diluted in 1 oz of water and given to the patient to drink. The diluted material may be administered via nasogastric tube.

HOW SUPPLIED

Vancomycin Hydrochloride for Oral Solution USP equivalent to 250 mg per 5 mL vancomycin is available as:

80 mL bottle (4 g*) NDC 62559-830-80
150 mL bottle (7.5 g*) NDC 62559-830-55
300 mL bottle (15 g*) NDC 62559-830-03
* Equivalent to vancomycin

Store at refrigerated conditions, 2° to 8°C (36° to 46°F).
After mixing, refrigerate and use within two weeks. Shake well before using. Keep tightly closed.

Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
logo
10192 Rev 03/19

PRINCIPAL DISPLAY PANEL

NDC 62559-830-80
Vancomycin Hydrochloride for Oral Solution USP
250 mg per 5 mL*
FOR ORAL USE ONLY
Rx only
80 mL (when mixed)

Label
(click image for full-size original)

VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-830
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
SODIUM BENZOATE
SUCRALOSE
Product Characteristics
Color WHITE (light pink) Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-830-80 80 mL in 1 BOTTLE, PLASTIC None
2 NDC:62559-830-55 150 mL in 1 BOTTLE, PLASTIC None
3 NDC:62559-830-03 300 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061667 09/09/2019
Labeler — ANI Pharmaceuticals, Inc. (145588013)
Registrant — ANI Pharmaceuticals, Inc. (145588013)

Revised: 09/2019 ANI Pharmaceuticals, Inc.

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