Azithromycin
Generic: AZITHROMYCIN
Basic Information
Manufacturer
Hospira, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
d2f4907f-b952-403b-229e-cc5b8327a773
Indications & Usage
1 INDICATIONS AND USAGE Azithromycin for Injection, USP is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: • Community-acquired pneumonia in adults ( 1.1 ) • Pelvic inflammatory disease ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
( 1.3 ) 1.1 Community-Acquired Pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Legionella pneumophila , Moraxella catarrhalis , Mycoplasma pneumoniae , Staphylococcus aureus , or Streptococcus pneumoniae in patients who require initial intravenous therapy.
1.2 Pelvic Inflammatory Disease due to Chlamydia trachomatis , Neisseria gonorrhoeae , or Mycoplasma hominis in patients who require initial intravenous therapy.
If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Azithromycin for Injection, USP should be followed by azithromycin the oral route as required [ see Dosage and Administration (2) ] .
1.3 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat 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.
Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: • Community-acquired pneumonia in adults ( 1.1 ) • Pelvic inflammatory disease ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
( 1.3 ) 1.1 Community-Acquired Pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Legionella pneumophila , Moraxella catarrhalis , Mycoplasma pneumoniae , Staphylococcus aureus , or Streptococcus pneumoniae in patients who require initial intravenous therapy.
1.2 Pelvic Inflammatory Disease due to Chlamydia trachomatis , Neisseria gonorrhoeae , or Mycoplasma hominis in patients who require initial intravenous therapy.
If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Azithromycin for Injection, USP should be followed by azithromycin the oral route as required [ see Dosage and Administration (2) ] .
1.3 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat 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.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Hypersensitivity [see Warnings and Precautions (5.1) ] • Hepatotoxicity [see Warnings and Precautions (5.2) ] • Infantile Hypertrophic Pyloric Stenosis (IHPS) [see Warnings and Precautions (5.3) ] • QT Prolongation [see Warnings and Precautions (5.4) ] • Cardiovascular Death [see Warnings and Precautions (5.5) ] • Clostridioides difficile- Associated Diarrhea (CDAD) [see Warnings and Precautions (5.6) ] • Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.7) ] Most common adverse reactions are nausea (4%), diarrhea (4%), abdominal pain (3%), or vomiting (1%).
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc.
at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials of intravenous azithromycin for community-acquired pneumonia, in which 2 to 5 IV doses were given, the reported adverse reactions were mild to moderate in severity and were reversible upon discontinuation of the drug.
The majority of patients in these trials had one or more co-morbid diseases and were receiving concomitant medications.
Approximately 1.2% of the patients discontinued intravenous Azithromycin for Injection therapy, and a total of 2.4% discontinued azithromycin therapy by either the intravenous or oral route because of clinical or laboratory side effects.
In clinical trials conducted in patients with pelvic inflammatory disease, in which 1 to 2 IV doses were given, 2% of women who received monotherapy with azithromycin and 4% who received azithromycin plus metronidazole discontinued therapy due to clinical side effects.
Clinical adverse reactions leading to discontinuations from these studies were gastrointestinal (abdominal pain, nausea, vomiting, diarrhea) and rashes; laboratory side effects leading to discontinuation were increases in transaminase levels and/or alkaline phosphatase levels.
Overall, the most common adverse reactions associated with treatment in adult patients who received IV/Oral Azithromycin in studies of community-acquired pneumonia were related to the gastrointestinal system with diarrhea/loose stools (4.3%), nausea (3.9%), abdominal pain (2.7%) and vomiting (1.4%) being the most frequently reported.
Approximately 12% of patients experienced a side effect related to the intravenous infusion; most common were pain at the injection site (6.5%) and local inflammation (3.1%).
The most common adverse reactions associated with treatment in adult women who received IV/Oral Azithromycin in trials of pelvic inflammatory disease were related to the gastrointestinal system.
Diarrhea (8.5%) and nausea (6.6%) were most commonly reported, followed by vaginitis (2.8%), abdominal pain (1.9%), anorexia (1.9%), rash and pruritus (1.9%).
When azithromycin was co-administered with metronidazole in these trials, a higher proportion of women experienced adverse reactions of nausea (10.3%), abdominal pain (3.7%), vomiting (2.8%), infusion site reaction, stomatitis, dizziness, or dyspnea (all at 1.9%).
Adverse reactions that occurred with a frequency of 1% or less included the following: Gastrointestinal: Dyspepsia, flatulence, mucositis, oral moniliasis and gastritis.
Nervous system: Headache, somnolence.
Allergic: Bronchospasm.
Special senses: Taste perversion.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of azithromycin.
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.
Adverse reactions reported with azithromycin during the postmarketing period in adult and/or pediatric patients for which a causal relationship may not be established include: Allergic: Arthralgia, edema, urticaria and angioedema.
Cardiovascular: Arrhythmias including ventricular tachycardia and hypotension.
There have been reports of QT prolongation, torsades de pointes, and cardiovascular death.
Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and reports of tongue discoloration.
General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis (including fatalities).
Genitourinary: Interstitial nephritis and acute renal failure and vaginitis.
Hematopoietic: Thrombocytopenia.
Liver/biliary: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure [ see Warnings and Precautions (5.2) ].
Nervous system: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope.
Psychiatric: Aggressive reaction and anxiety.
Skin/appendages: Pruritus, serious skin reactions including, erythema multiforme, AGEP, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS.
Special senses: Hearing disturbances including hearing loss, deafness and/or tinnitus and reports of taste/smell perversion and/or loss.
6.3 Laboratory Abnormalities Significant abnormalities (irrespective of drug relationship) occurring during the clinical trials were reported as follows: • elevated ALT (SGPT), AST (SGOT), creatinine (4 to 6%) • elevated LDH, bilirubin (1 to 3%) • leukopenia, neutropenia, decreased platelet count, and elevated serum alkaline phosphatase (less than 1%) When follow-up was provided, changes in laboratory tests appeared to be reversible.
In multiple-dose clinical trials involving more than 750 patients treated with azithromycin (IV/Oral), less than 2% of patients discontinued azithromycin therapy because of treatment-related liver enzyme abnormalities.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc.
at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials of intravenous azithromycin for community-acquired pneumonia, in which 2 to 5 IV doses were given, the reported adverse reactions were mild to moderate in severity and were reversible upon discontinuation of the drug.
The majority of patients in these trials had one or more co-morbid diseases and were receiving concomitant medications.
Approximately 1.2% of the patients discontinued intravenous Azithromycin for Injection therapy, and a total of 2.4% discontinued azithromycin therapy by either the intravenous or oral route because of clinical or laboratory side effects.
In clinical trials conducted in patients with pelvic inflammatory disease, in which 1 to 2 IV doses were given, 2% of women who received monotherapy with azithromycin and 4% who received azithromycin plus metronidazole discontinued therapy due to clinical side effects.
Clinical adverse reactions leading to discontinuations from these studies were gastrointestinal (abdominal pain, nausea, vomiting, diarrhea) and rashes; laboratory side effects leading to discontinuation were increases in transaminase levels and/or alkaline phosphatase levels.
Overall, the most common adverse reactions associated with treatment in adult patients who received IV/Oral Azithromycin in studies of community-acquired pneumonia were related to the gastrointestinal system with diarrhea/loose stools (4.3%), nausea (3.9%), abdominal pain (2.7%) and vomiting (1.4%) being the most frequently reported.
Approximately 12% of patients experienced a side effect related to the intravenous infusion; most common were pain at the injection site (6.5%) and local inflammation (3.1%).
The most common adverse reactions associated with treatment in adult women who received IV/Oral Azithromycin in trials of pelvic inflammatory disease were related to the gastrointestinal system.
Diarrhea (8.5%) and nausea (6.6%) were most commonly reported, followed by vaginitis (2.8%), abdominal pain (1.9%), anorexia (1.9%), rash and pruritus (1.9%).
When azithromycin was co-administered with metronidazole in these trials, a higher proportion of women experienced adverse reactions of nausea (10.3%), abdominal pain (3.7%), vomiting (2.8%), infusion site reaction, stomatitis, dizziness, or dyspnea (all at 1.9%).
Adverse reactions that occurred with a frequency of 1% or less included the following: Gastrointestinal: Dyspepsia, flatulence, mucositis, oral moniliasis and gastritis.
Nervous system: Headache, somnolence.
Allergic: Bronchospasm.
Special senses: Taste perversion.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of azithromycin.
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.
Adverse reactions reported with azithromycin during the postmarketing period in adult and/or pediatric patients for which a causal relationship may not be established include: Allergic: Arthralgia, edema, urticaria and angioedema.
Cardiovascular: Arrhythmias including ventricular tachycardia and hypotension.
There have been reports of QT prolongation, torsades de pointes, and cardiovascular death.
Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and reports of tongue discoloration.
General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis (including fatalities).
Genitourinary: Interstitial nephritis and acute renal failure and vaginitis.
Hematopoietic: Thrombocytopenia.
Liver/biliary: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure [ see Warnings and Precautions (5.2) ].
Nervous system: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope.
Psychiatric: Aggressive reaction and anxiety.
Skin/appendages: Pruritus, serious skin reactions including, erythema multiforme, AGEP, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS.
Special senses: Hearing disturbances including hearing loss, deafness and/or tinnitus and reports of taste/smell perversion and/or loss.
6.3 Laboratory Abnormalities Significant abnormalities (irrespective of drug relationship) occurring during the clinical trials were reported as follows: • elevated ALT (SGPT), AST (SGOT), creatinine (4 to 6%) • elevated LDH, bilirubin (1 to 3%) • leukopenia, neutropenia, decreased platelet count, and elevated serum alkaline phosphatase (less than 1%) When follow-up was provided, changes in laboratory tests appeared to be reversible.
In multiple-dose clinical trials involving more than 750 patients treated with azithromycin (IV/Oral), less than 2% of patients discontinued azithromycin therapy because of treatment-related liver enzyme abnormalities.