VANCOMYCIN HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VANCOMYCIN HYDROCHLORIDE (UNII: 71WO621TJD) (VANCOMYCIN - UNII:6Q205EH1VU)

Available from:

Lupin Pharmaceuticals, Inc.

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Composition:

VANCOMYCIN 125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficil e -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 effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules 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. Vancomycin Hydrochloride is contraindicated in patients with known hypersensitivity to vancomycin. Risk Summary Systemic absorption of vancomycin is low following oral administration of vancomycin hydrochloride capsules; however, absorption may vary depending on various factors [see  Clinical Pharmacology (12.3)]. 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 (see Data) . Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose (see Data) . Data Human Data There are no available data on first trimester use of vancomycin in pregnant women to assess a risk of major birth defects or miscarriage. A published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenous vancomycin for suspected or documented methicillin-resistant Staphylococcal aureus in the second or third trimester. The comparison groups were 10 uninfected non-intravenous drug-dependent patients who received no treatment and 10 uninfected untreated intravenous drug-dependent patients. No infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity. A published prospective study assessed outcomes in 55 pregnant women with a positive Group B streptococcus culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered intravenous vancomycin at the time of delivery. Vancomycin dosing ranged from the standard dose of 1 g intravenously every 12 hours to a dose of 20 mg/kg intravenously every 8 hours (maximum individual dose 2 g). No major adverse reactions were recorded either in the mothers or their newborns. None of the newborns had sensorineural hearing loss. Neonatal renal function was not examined, but all of the newborns were discharged in good condition. Animal Data Vancomycin did not cause fetal malformation when administered intravenously during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose of 200 mg/kg/day to rats or 120 mg/kg/day to rabbits. No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area). Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). Risk Summary 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 capsules [see  Clinical Pharmacology (12.3)] ; 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 capsules and any potential adverse effects on the breastfed infant from vancomycin hydrochloride capsules or from the underlying maternal condition. Vancomycin hydrochloride capsules 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) [see Indications and Usage (1) and Dosage and Administration  (2.2)] . 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 diarrhea associated with Clostridioides difficile 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 >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 [see Warnings and Precautions (5.3), Adverse Reactions (6.1), and, Clinical Studies (14.1)]. Patients >65 years of age may take longer to respond to therapy compared to patients ≤65 years of age [see Clinical Studies (14.1)]. Clinicians should be aware of the importance of appropriate duration of vancomycin hydrochloride treatment in patients >65 years of age and not discontinue or switch to alternative treatment prematurely.

Product summary:

Vancomycin Hydrochloride Capsules, USP are available in: The 125 mg (equivalent to vancomycin): Size 2, Hard gelatin capsules having an opaque blue cap imprinted with "LU" in white ink and opaque brown body imprinted with "S01" in white ink containing cream coloured hard mass. They are available in: Unit Dose Carton: 20 capsules (2 blister cards containing 10 capsules per card)      NDC # 68180-166-13 The 250 mg (equivalent to vancomycin): Size 0, Hard gelatin capsules having an opaque blue cap imprinted with "LU" in white ink and opaque lavender body imprinted with "S02" in white ink containing cream coloured hard mass. They are available in: Unit Dose Carton: 20 capsules (2 blister cards containing 10 capsules per card)      NDC # 68180-167-13 Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE CAPSULE
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VANCOMYCIN
HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
VANCOMYCIN HYDROCHLORIDE CAPSULES.
VANCOMYCIN HYDROCHLORIDE CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 1986
RECENT MAJOR CHANGES
Warnings and Precautions, Severe Dermatologic Reactions (5.5) 12/2020
INDICATIONS AND USAGE
Vancomycin hydrochloride capsule is a glycopeptide antibacterial
indicated in adult and pediatric patients
(less than 18 years of age) for the treatment of: (1)
_Clostridioide difficile_ -associated diarrhea
Enterocolitis caused by _Staphylococcus aureus _(including methicillin
resistant strains)
LIMITATIONS OF USE: (1) (5.1)
Parenteral administration of vancomycin is not effective for the above
infections; therefore, vancomycin
hydrochloride capsule 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
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. (1)
DOSAGE AND ADMINISTRATION
• _C. difficile-_associated diarrhea:
Adult Patients (18 years of age or greater): 125 mg orally 4 times
daily for 10 days. (2.1)
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. (2.2)
• Staphylococcal enterocolitis:
Adult Patients (18 years of age or greater): 500 mg to 2 g orally in 3
or 4 divided doses for 7 to 10
days. (2.1)
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. (2.2)
DOSAGE FORMS AND