VANCOMYCIN HYDROCHLORIDE
Generic: VANCOMYCIN HYDROCHLORIDE
Basic Information
Manufacturer
Ascend Laboratories, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
b9a7c728-750b-467f-bf61-54dd836dba1b
Indications & Usage
1 INDICATIONS AND USAGE Vancomycin hydrochloride for oral solution is indicated for the treatment of Clostridium difficile-associated diarrhea in adults and pediatric patients less than 18 years of age.
Vancomycin hydrochloride for oral solution is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients less than 18 years of age.
Important Limitations of Use • Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.
• Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.
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.
Vancomycin hydrochloride for oral solution is a glycopeptide antibacterial indicated in adults and pediatric patients less than 18 years of age for the treatment of: ( 1 ) • Clostridium difficile -associated diarrhea • Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) Important Limitations of Use: ( 1 ) ( 5.1 ) • Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.
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 bacteria.
( 1 )
Vancomycin hydrochloride for oral solution is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients less than 18 years of age.
Important Limitations of Use • Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.
• Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.
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.
Vancomycin hydrochloride for oral solution is a glycopeptide antibacterial indicated in adults and pediatric patients less than 18 years of age for the treatment of: ( 1 ) • Clostridium difficile -associated diarrhea • Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) Important Limitations of Use: ( 1 ) ( 5.1 ) • Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.
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 bacteria.
( 1 )
Adverse Reactions
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 Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901); 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 hydrochloride in 260 adult subjects in two Phase 3 clinical trials for the treatment of C.
difficile -associated diarrhea.
In both trials, subjects received vancomycin hydrochloride 125 mg orally four times daily.
The mean duration of treatment was 9.4 days.
The median age of patients was 67, ranging between 19 and 96 years of age.
Patients were predominantly Caucasian (93%) and 52% were male.
Adverse reactions occurring in ≥ 5% of vancomycin hydrochloride-treated subjects are shown in Table 2.
The most common adverse reactions associated with vancomycin hydrochloride (≥ 10%) were nausea, abdominal pain, and hypokalemia.
Table 2: Common (≥ 5%) Adverse Reactions* for Vancomycin Hydrochloride Reported in Clinical Trials for Treatment of C.
difficile -Associated Diarrhea System/Organ Class Adverse Reaction Vancomycin Hydrochloride (%) (N = 260) Gastrointestinal disorders Nausea 17 Abdominal pain 15 Vomiting 9 Diarrhea 9 Flatulence 8 General disorders and administration site conditions Pyrexia 9 Edema peripheral 6 Fatigue 5 Infections and infestations Urinary tract infection 8 Metabolism and nutrition disorders Hypokalemia 13 Musculoskeletal and connective tissue disorders Back pain 6 Nervous system disorders Headache 7 * Adverse reaction rates were derived from the incidence of treatment-emergent adverse events.
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 [ see Warnings and Precautions ( 5.3 ) ].
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 [ see Use in Specific Populations ( 8.5 ) ].
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%).
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of vancomycin hydrochloride.
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 [ see Warnings and Precautions ( 5.4 ) ].
Vertigo, dizziness, and tinnitus have been reported.
Skin and Subcutaneous Tissue Disorders : 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 lgA bullous dermatosis (LABD) [see Warnings and Precautions ( 5.5 )] , rashes (including exfoliative dermatitis).
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.
Neutropenia appears to be promptly reversible when vancomycin is discontinued.
Thrombocytopenia has been reported.
Miscellaneous: Anaphylaxis, drug fever, chills, nausea, eosinophilia, and vasculitis have been reported with the administration of vancomycin.
A condition has been reported with oral vancomycin 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.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901); 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 hydrochloride in 260 adult subjects in two Phase 3 clinical trials for the treatment of C.
difficile -associated diarrhea.
In both trials, subjects received vancomycin hydrochloride 125 mg orally four times daily.
The mean duration of treatment was 9.4 days.
The median age of patients was 67, ranging between 19 and 96 years of age.
Patients were predominantly Caucasian (93%) and 52% were male.
Adverse reactions occurring in ≥ 5% of vancomycin hydrochloride-treated subjects are shown in Table 2.
The most common adverse reactions associated with vancomycin hydrochloride (≥ 10%) were nausea, abdominal pain, and hypokalemia.
Table 2: Common (≥ 5%) Adverse Reactions* for Vancomycin Hydrochloride Reported in Clinical Trials for Treatment of C.
difficile -Associated Diarrhea System/Organ Class Adverse Reaction Vancomycin Hydrochloride (%) (N = 260) Gastrointestinal disorders Nausea 17 Abdominal pain 15 Vomiting 9 Diarrhea 9 Flatulence 8 General disorders and administration site conditions Pyrexia 9 Edema peripheral 6 Fatigue 5 Infections and infestations Urinary tract infection 8 Metabolism and nutrition disorders Hypokalemia 13 Musculoskeletal and connective tissue disorders Back pain 6 Nervous system disorders Headache 7 * Adverse reaction rates were derived from the incidence of treatment-emergent adverse events.
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 [ see Warnings and Precautions ( 5.3 ) ].
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 [ see Use in Specific Populations ( 8.5 ) ].
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%).
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of vancomycin hydrochloride.
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 [ see Warnings and Precautions ( 5.4 ) ].
Vertigo, dizziness, and tinnitus have been reported.
Skin and Subcutaneous Tissue Disorders : 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 lgA bullous dermatosis (LABD) [see Warnings and Precautions ( 5.5 )] , rashes (including exfoliative dermatitis).
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.
Neutropenia appears to be promptly reversible when vancomycin is discontinued.
Thrombocytopenia has been reported.
Miscellaneous: Anaphylaxis, drug fever, chills, nausea, eosinophilia, and vasculitis have been reported with the administration of vancomycin.
A condition has been reported with oral vancomycin 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.