Azithromycin description, usages, side effects, indications, overdosage, supplying and lots more!

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Azithromycin

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

AZITHROMYCIN DESCRIPTION


Azithromycin




CLINICAL PHARMACOLOGY

Pharmacokinetics
























































































Drug-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


Acute bacterial sinusitis

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

recurred soon thereafter in some patients without further azithromycin exposure.



In the treatment of pneumonia, azithromycin has only been shown to be safe and effective in the treatment of community-acquired pneumonia due toin 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











Studies evaluating the use of repeated courses of therapy have not been conducted. (See CLINICAL PHARMACOLOGY and ANIMAL TOXICOLOGY.)

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:











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:





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
















STORAGE AND HANDLING



CLINICAL STUDIES

(See INDICATIONS AND USAGE and Pediatric Use.)
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














Azithromycin

Azithromycin

Azithromycin

Azithromycin TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:24236-906(NDC:64679-964)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AZITHROMYCIN azithromycin 500 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
FD&C RED NO. 40
MAGNESIUM STEARATE
FD&C YELLOW NO. 6
ALUMINUM OXIDE
HYPROMELLOSE 2910 (15 MPA.S)
lactose monohydrate
STARCH, CORN
SODIUM LAURYL SULFATE
talc
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
white 17 mm W964 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24236-906-38 3 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065405 2011-11-15


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