VANCOMYCIN HYDROCHLORIDE
Generic: VANCOMYCIN HYDROCHLORIDE
Basic Information
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
ae6efaaf-37eb-4510-ba71-5f3dc3abdbd3
Indications & Usage
1 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 capsule 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 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 capsules is a glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: ( 1 ) • Clostridioides 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 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.
( 1 )
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 capsule 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 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 capsules is a glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: ( 1 ) • Clostridioides 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 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.
( 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 PAI Pharma at 1-800-845-8210 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 capsule in 260 adult subjects in two Phase 3 clinical trials for the treatment of diarrhea associated with C.
difficile .
In both trials, subjects received vancomycin hydrochloride capsule 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 1.
The most common adverse reactions associated with vancomycin hydrochloride capsule (≥ 10%) were nausea, abdominal pain, and hypokalemia.
Table 1: Common (≥ 5%) Adverse Reactions a for Vancomycin Hydrochloride Capsule Reported in Clinical Trials for Treatment of Diarrhea Associated with C.
difficile System / Organ Class Adverse Reaction Vancomycin Hydrochloride Capsule % ( N = 260 ) Gastrointestinal disorders Nausea 17 Abdominal pain 15 Vomiting 9 Diarrhea 9 Flatulence 8 General disorders and administration Pyrexia 9 site conditions 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 a 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 capsule.
Nephrotoxicity following vancomycin hydrochloride capsule typically first occurred within one week after completion of treatment (median day of onset was Day 16).
Nephrotoxicity following vancomycin hydrochloride capsule occurred in 6% of subjects >65 years of age and 3% of subjects ≤65 years of age [see Warnings and Precautions ( 5.3 )].
The incidences of hypokalemia, urinary tract infection, peripheral edema, insomnia, constipation, anemia, depression, vomiting, and hypotension were higher among subjects >65 years of age than in subjects ≤65 years of age [see Use in Specific Populations ( 8.5 )].
Discontinuation of study drug due to adverse events occurred in 7% of subjects treated with vancomycin hydrochloride capsule.
The most common adverse events leading to discontinuation of vancomycin hydrochloride capsule 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 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 [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 IgA 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 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 ("vancomycin infusion reaction"), 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 PAI Pharma at 1-800-845-8210 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 capsule in 260 adult subjects in two Phase 3 clinical trials for the treatment of diarrhea associated with C.
difficile .
In both trials, subjects received vancomycin hydrochloride capsule 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 1.
The most common adverse reactions associated with vancomycin hydrochloride capsule (≥ 10%) were nausea, abdominal pain, and hypokalemia.
Table 1: Common (≥ 5%) Adverse Reactions a for Vancomycin Hydrochloride Capsule Reported in Clinical Trials for Treatment of Diarrhea Associated with C.
difficile System / Organ Class Adverse Reaction Vancomycin Hydrochloride Capsule % ( N = 260 ) Gastrointestinal disorders Nausea 17 Abdominal pain 15 Vomiting 9 Diarrhea 9 Flatulence 8 General disorders and administration Pyrexia 9 site conditions 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 a 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 capsule.
Nephrotoxicity following vancomycin hydrochloride capsule typically first occurred within one week after completion of treatment (median day of onset was Day 16).
Nephrotoxicity following vancomycin hydrochloride capsule occurred in 6% of subjects >65 years of age and 3% of subjects ≤65 years of age [see Warnings and Precautions ( 5.3 )].
The incidences of hypokalemia, urinary tract infection, peripheral edema, insomnia, constipation, anemia, depression, vomiting, and hypotension were higher among subjects >65 years of age than in subjects ≤65 years of age [see Use in Specific Populations ( 8.5 )].
Discontinuation of study drug due to adverse events occurred in 7% of subjects treated with vancomycin hydrochloride capsule.
The most common adverse events leading to discontinuation of vancomycin hydrochloride capsule 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 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 [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 IgA 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 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 ("vancomycin infusion reaction"), pain and muscle spasm of the chest and back.
These reactions usually resolve within 20 minutes but may persist for several hours.