Azithromycin
FULL PRESCRIBING INFORMATION: CONTENTS*
- AZITHROMYCIN DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- AZITHROMYCIN CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- DRUG INTERACTIONS
- LABORATORY TESTS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- AZITHROMYCIN ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- CLINICAL STUDIES
- ANIMAL PHARMACOLOGY & OR TOXICOLOGY
- REFERENCES
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
AZITHROMYCIN DESCRIPTION
CLINICAL PHARMACOLOGY
PharmacokineticsDrug-Drug Interactions
0.83 (0.63 to 1.08)
Microbiology:
Aerobic and facultative gram-positive microorganisms
Aerobic and facultative gram-negative microorganisms
Othermicroorganisms
Aerobic and facultative gram-positive microorganisms
Aerobic and facultative gram-negative microorganisms
Anaerobic microorganisms
Othermicroorganisms
Susceptibility Testing Methods:
Dilution techniques:
Diffusion techniques:
INDICATIONS & USAGE
Adults:
Acute bacterial exacerbations of chronic obstructive pulmonary disease
Community-acquired pneumonia
NOTE: 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).
Pharyngitis/tonsillitis
Uncomplicated skin and skin structure infections
Urethritis and cervicitis
Genital ulcer disease
Pediatric Patients:
Acute otitis media
Community-acquired pneumonia
NOTE: Azithromycin 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/tonsillitis
AZITHROMYCIN CONTRAINDICATIONS
WARNINGS
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).
PRECAUTIONS
General:INFORMATION FOR PATIENTS
DRUG INTERACTIONS
LABORATORY TESTS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
NURSING MOTHERS
PEDIATRIC USE
GERIATRIC USE
AZITHROMYCIN ADVERSE REACTIONS
Clinical:
Adults:
Cardiovascular:
Gastrointestinal:
Genitourinary:
Nervous System:
General:
Allergic:
Pediatric Patients:
Dosage RegimenDiarrhea, %Abdominal Pain, %Vomiting, %Nausea, %Rash, %
Dosage RegimenDiarrhea/Loose stools, %Abdominal Pain, %Vomiting, %Nausea, %Rash, %
Dosage RegimenDiarrhea, %Abdominal Pain, %Vomiting, %Nausea, %Rash, %
Cardiovascular:
Gastrointestinal:
Hematologic and Lymphatic:
Nervous System:
General:
Allergic:
Respiratory:
Skin and Appendages:
Special Senses:
Post-Marketing Experience:
Allergic
Cardiovascular:
Gastrointestinal:
General:
Genitourinary:
Hematopoietic:
Liver/Biliary:
Nervous System:
Psychiatric:
Skin/Appendages:
Special Senses:
Laboratory Abnormalities:
Adults:
Pediatric Patients:
One, Three and Five Day Regimens
DOSAGE & ADMINISTRATION
Adults:
* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)Azithromycin tablets can be taken with or without food.
Pediatric Patients:
Acute Otitis Media:
Acute bacterial Sinusitis:
Community-Acquired Pneumonia:
OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.Weight100 mg/5 mL200 mg/5 mLTotal mL per Treatment Course
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1.Weight100 mg/5 mL200 mg/5 mLTotal mL per Treatment Course
OTITIS MEDIA : (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single doseWeight200 mg/5 mLTotal mL per Treatment courseTotal mg per Treatment course
Pharyngitis/Tonsillitis:
PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS /TONSILLITIS
(Age 2 years and above, see PRECAUTIONS-Pediatric Use.)
Based on Body weight
PHARYNGITIS/TONSILITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 daysWeight200mg/5mLTotal mL per Treatment courseTotal mg per Treatment course
HOW SUPPLIED
CLINICAL STUDIES
Pediatric Patients
Acute Otitis Media
Safety and efficacy using azithromycin 30 mg/kg given over 5 days
Day 11AzithromycinControlAzithromycinControl
Safety and efficacy using azithromycin 30 mg/kg given over 3 days
Safety and efficacy using azithromycin 30 mg/kg given as a single dose
Pharyngitis/Tonsillitis
Azithromycin vs. Penicillin VEFFICACY RESULTS
Adult Patients
Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease
Acute Bacterial Sinusitis
Azithromycin (500 mg per day for 3 Days)Day 7Day 28
ANIMAL PHARMACOLOGY & OR TOXICOLOGY
REFERENCES
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
AzithromycinAzithromycin Anhydrous TABLET
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
