Azithromycin
FULL PRESCRIBING INFORMATION: CONTENTS*
- USE
- AZITHROMYCIN DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- AZITHROMYCIN CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- AZITHROMYCIN ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- CLINICAL STUDIES
- ANIMAL TOXICOLOGY
- REFERENCES
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
USE
AZITHROMYCIN DESCRIPTION
CLINICAL PHARMACOLOGY
Pharmacokinetics*
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AZITHROMYCIN CONCENTRATIONS FOLLOWING A 500 mg DOSE (TWO 250 mg CAPSULES) IN ADULTS *
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DOSAGE AND ADMINISTRATION).
DOSAGE AND ADMINISTRATION).
Table 1and the effect of other drugs on the pharmacokinetics of azithromycin are shown inTable 2.
Table 1.No dosage adjustment of drugs listed inTable 1is recommended when coadministered with azithromycin.
Table 2(seePRECAUTIONS,Drug Interactions).
Table 1. Drug Interactions: Pharmacokinetic Parameters for Coadministered Drugs in the Presence of Azithromycin
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Table 2. Drug Interactions: Pharmacokinetic Parameters for Azithromycin in the Presence of Coadministered Drugs (see PRECAUTIONS, Drug Interactions).
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Microbiology
INDICATIONS AND USAGEsection.
Aerobic and Facultative Gram-Positive Microorganisms
Aerobic and Facultative Gram-Negative Microorganisms
Microorganisms
but their clinical significance is unknown.
Aerobic and Facultative Gram-Positive Microorganisms
Aerobic and Facultative Gram-Negative Microorganisms
Anaerobic Microorganisms
Microorganisms
Susceptibility Testing Methods
Dilution Techniques
Table 3.
Diffusion Techniques
Table 3.
Table 3. Susceptibility Interpretive Criteria for Azithromycin Susceptibility Test Result Interpretive Criteria
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Pathogen **
Quality Control
Table 4.Quality control microorganisms are specific strains of organisms with intrinsic biological properties. QC strains are very stable strains which will give a standard and repeatable susceptibility pattern. The specific strains used for microbiological quality control are not clinically significant.
Table 4. Acceptable Quality Control Ranges for Azithromycin
QC Strain Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion (Zone Diameters in mm)
INDICATIONS & USAGE
WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below.As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please seeDOSAGE AND ADMINISTRATIONfor specific dosing recommendations.Adults
Acute bacterial exacerbations of chronic obstructive pulmonary diseasedue to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Acute bacterial sinusitisdue to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Community-acquired pneumoniadue to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.
NOTE: Azithromycin, USP should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
patients with cystic fibrosis,
patients with nosocomially acquired infections,
patients with known or suspected bacteremia,
patients requiring hospitalization,
elderly or debilitated patients, or
patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
Pharyngitis/tonsillitiscaused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Uncomplicated skin and skin structure infectionsdue to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae. Abscesses usually require surgical drainage.
Urethritis and cervicitisdue to Chlamydia trachomatis or Neisseria gonorrhoeae.
Genital ulcer diseasein men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin, USP in the treatment of chancroid in women has not been established.
Pediatric Patients
PRECAUTIONS,Pediatric UseandCLINICAL STUDIES,Pediatric Patients.)
Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. (For specific dosage recommendation, seeDOSAGE AND ADMINISTRATION.)
Community-acquired pneumoniadue to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy. (For specific dosage recommendation, seeDOSAGE AND ADMINISTRATION.)
NOTE: Azithromycin, USP should not be used in pediatric patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
patients with cystic fibrosis,
patients with nosocomially acquired infections,
patients with known or suspected bacteremia,
patients requiring hospitalization, or
patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
Pharyngitis/tonsillitiscaused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. (For specific dosage recommendation, seeDOSAGE AND ADMINISTRATION.)
AZITHROMYCIN CONTRAINDICATIONS
WARNINGS
HypersensitivityCONTRAINDICATIONS). Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptomsrecurred soon thereafter in some patients without further azithromycin exposure.These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is unknown at present.
Hepatotoxicity
Treatment of Pneumonia
In the treatment of pneumonia, azithromycin has only been shown to be safe and effective in the treatment of community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy. Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
Clostridium Difficile-Associated Diarrhea
QT Prolongation
PRECAUTIONS
GeneralCLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
Information for Patients
Drug Interactions
ADVERSE REACTIONS).
CLINICAL PHARMACOLOGY,Drug-Drug Interactions). When used in therapeutic doses, azithromycin had a modest effect on the pharmacokinetics of atorvastatin, carbamazepine, cetirizine, didanosine, efavirenz, fluconazole, indinavir, midazolam, rifabutin, sildenafil, theophylline (intravenous and oral), triazolam, trimethoprim/sulfamethoxazole or zidovudine. Coadministration with efavirenz or fluconazole had a modest effect on the pharmacokinetics of azithromycin. No dosage adjustment of either drug is recommended when azithromycin is coadministered with any of the above agents.
Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Nursing Mothers
Pediatric Use
CLINICAL PHARMACOLOGY,INDICATIONS AND USAGE, andDOSAGE AND ADMINISTRATION.)
DOSAGE AND ADMINISTRATION. Safety and effectiveness in the treatment of pediatric patients with otitis media under 6 months of age have not been established.
Studies evaluating the use of repeated courses of therapy have not been conducted(seeCLINICAL PHARMACOLOGYandANIMAL TOXICOLOGY).
Geriatric Use
CLINICAL PHARMACOLOGY).
WARNINGS).
AZITHROMYCIN ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION). Most of the side effects leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain (seeCLINICAL STUDIES,Pediatric Patients).Clinical
Cardiovascular:Palpitations, chest pain.
Gastrointestinal:Dyspepsia, flatulence, vomiting, melena and cholestatic jaundice.
Genitourinary:Monilia, vaginitis and nephritis.
Nervous System:Dizziness, headache, vertigo and somnolence.
General:Fatigue.
Allergic:Rash, pruritus, photosensitivity and angioedema.
Acute Otitis Media
DOSAGE AND ADMINISTRATIONandCLINICAL STUDIES,Pediatric Patients).
Community-Acquired Pneumonia
Pharyngitis/Tonsillitis
Cardiovascular:Chest pain.
Gastrointestinal:Dyspepsia, constipation, anorexia, enteritis, flatulence, gastritis, jaundice, loose stools and oral moniliasis.
Hematologic and Lymphatic:Anemia and leukopenia.
Nervous System:Headache (otitis media dosage), hyperkinesia, dizziness, agitation, nervousness and insomnia.
General:Fever, face edema, fatigue, fungal infection, malaise and pain.
Allergic:Rash and allergic reaction.
Respiratory:Cough increased, pharyngitis, pleural effusion and rhinitis.
Skin and Appendages:Eczema, fungal dermatitis, pruritus, sweating, urticaria and vesiculobullous rash.
Special Senses:Conjunctivitis.
Postmarketing Experience
Allergic:Arthralgia, edema, urticaria and angioedema.
Cardiovascular:Arrhythmias including ventricular tachycardia and hypotension. There have been rare reports of QT prolongation and torsade de pointes.
Gastrointestinal:Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea rarely resulting in dehydration, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and rare reports of tongue discoloration.
General:Asthenia, paresthesia, fatigue, malaise and anaphylaxis (rarely fatal).
Genitourinary:Interstitial nephritis and acute renal failure and vaginitis.
Hematopoietic:Thrombocytopenia.
Liver/Biliary:Adverse reactions related to hepatic dysfunction have been reported in postmarketing experience with azithromycin (see WARNINGS,Hepatotoxicity).
Nervous System:Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope.
Psychiatric:Aggressive reaction and anxiety.
Skin/Appendages:Pruritus, rarely serious skin reactions including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Special Senses:Hearing disturbances including hearing loss, deafness and/or tinnitus and reports of taste/smell perversion and/or loss.
Laboratory Abnormalities
DOSAGE AND ADMINISTRATION).
DOSAGE & ADMINISTRATION
INDICATIONS AND USAGEandCLINICAL PHARMACOLOGY.)Adults
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DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE). *
CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency).
CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).
CLINICAL PHARMACOLOGY, Special Populations).
Pediatric Patients
PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 Months and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight
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OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen) * Dosing Calculated on 10 mg/kg/day Day 1and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse Kg Lbs. Day 1 Days 2 to 5 Day 1 Days 2 to 5
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*Weight 100 mg/5 mL 200 mg/5 mL Total mL perTreatmentCourse Total mg perTreatmentCourse
OTITIS MEDIA: (1 Day Regimen) Dosing Calculated on 30 mg/kg as a Single Dose Weight 200 mg/5 mL Total mL perTreatment Course Total mg perTreatment Course Kg Lbs. Day 1
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 Years and Above, see PRECAUTIONS, Pediatric Use.) Based on Body Weight
PHARYNGITIS/TONSILLITIS: (5 Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Total mL per TreatmentCourse Total mg per TreatmentCourse Kg Lbs. Day 1 to 5
HOW SUPPLIED
STORAGE AND HANDLING
CLINICAL STUDIES
INDICATIONS AND USAGEandPediatric Use.)Pediatric Patients
Protocol 1
Protocol 2
Protocol 3
Protocol 4
Protocol 5
Protocol 6
Adult Patients
Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease
Pathogen Azithromycin (3 Days) Clarithromycin (10 Days)
ADVERSE REACTIONS).
Acute Bacterial Sinusitis
ADVERSE REACTIONS).
Pathogen Azithromycin (500 mg per day for 3 Days) Day 7 Day 28
ADVERSE REACTIONS).
ANIMAL TOXICOLOGY
REFERENCES
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
AzithromycinAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
