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AZITHROMYCIN

Dispensing Solutions Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

AZITHROMYCIN DESCRIPTION

D-xylo
3872212
AZITHROMYCIN3872212

CLINICAL PHARMACOLOGY


Pharmacokinetics

0-72maxmax

minmax


Day 1Day 5
max
max
0-24
min




0–∞



max
0–∞
1/2  



0-288






max

max

max







AZITHROMYCIN CONCENTRATIONS FOLLOWING A 500 mg DOSE (TWO 250 mg CAPSULES) IN ADULTS1

TISSUE OR FLUID TIME AFTER
DOSE (h)		 TISSUE OR FLUID
CONCENTRATION
(mcg/g or mcg/mL)		 CORRESPONDING
PLASMA OR SERUM LEVEL (mcg/mL)		 TISSUE (FLUID)
PLASMA (SERUM) RATIO
SKIN 72-96 0.4 0.012 35
LUNG 72-96 4 0.012 >100
SPUTUM* 2-4 1 0.64 2
SPUTUM** 10-12 2.9 0.1 30
TONSIL*** 9-18 4.5 0.03 >100
TONSIL*** 180 0.9 0.006 >100
CERVIX**** 19 2.8 0.04 70
1


















max0-120max0-120DOSAGE AND ADMINISTRATION











maxmax0-24maxmax0-24







Pharmacokinetic Parameter
[mean (SD)]
 3-Day Regimen
(20 mg/kg x 3 days)
 5-Day Regimen
(12 mg/kg x 5 days)
n
 11
 17
Cmax (mcg/mL)
 1.1 (0.4)
 0.5 (0.4)
Tmax (hr)
 2.7 (1.9)
 2.2 (0.8)
Auc0-24 mcg•hr/mL
 7.9 (2.9)
 3.9 (1.9)
0–∞
DOSAGE AND ADMINISTRATION

Drug-Drug Interactions





max PRECAUTIONS - Drug Interactions


Co-administered Drug Dose of Co-administered Drug

 Dose of Azithromycin

 n
 Ratio (with/without azithromycin)
of Co-administered Drug
Pharmacokinetic Parameters
(90% CI); No Effect = 1




Mean Cmax    Mean AUC
Atorvastatin 10 mg/day x 8 days 500 mg/day PO on days 6-8 12
 0.83
(0.63 to 1.08)		 1.01
(0.81 to 1.25)
Carbamazepine 200 mg/day x 2 days, then 200 mg
BID x 18 days		 500 mg/day PO for days 16-18 7
 0.97
(0.88 to 1.06)		 0.96
(0.88 to 1.06)
Cetirizine 20 mg/day x 11 days 500 mg PO on day 7, then 250 mg/day on days 8-11 14
 1.03
(0.93 to 1.14)		 1.02
(0.92 to 1.13)
Didanosine 200 mg PO BID x 21 days 1,200 mg/day PO on days 8-21 6
 1.44
(0.85 to 2.43)		 1.14
(0.83 to 1.57)
Efavirenz 400 mg/day x 7 days 600 mg PO on day 7 14
 1.04* 0.95*
Fluconazole 200 mg PO single dose 1,200 mg PO single dose 18
 1.04
(0.98 to 1.11)		 1.01
(0.97 to 1.05)
Indinavir 800 mg TID x 5 days 1,200 mg PO on day 5 18
 0.96
(0.86 to 1.08)		 0.90
(0.81 to 1.00)
Midazolam 15 mg PO on day 3 500 mg/day PO x 3 days 12
 1.27
(0.89 to 1.81)		 1.26
(1.01 to 1.56)
Nelfinavir 750 mg TID x 11 days 1,200 mg PO on day 9 14
 0.90
(0.81 to 1.01)		 0.85
(0.78 to 0.93)
Rifabutin 300 mg/day x 10 days 500 mg PO on day 1, then 250 mg/day on days 2-10 6
 See footnote
below		 NA
Sildenafil
 100 mg on days 1 and 4 500 mg/day PO x 3 days 12
 1.16
(0.86 to 1.57)		 0.92
(0.75 to 1.12)
Theophylline 4 mg/kg IV on days 1, 11, 25 500 mg PO on day 7, 250 mg/day on days 8-11 10
 1.19
(1.02 to 1.40)		 1.02
(0.86 to 1.22)
Theophylline 300 mg PO BID x 15 days 500 mg PO on day 6, then 250 mg/day on days 7-10 8
 1.09
(0.92 to 1.29)		 1.08
(0.89 to 1.31)
Triazolam 0.125 mg on day 2 500 mg PO on day 1, then 250 mg/day on day 2 12
 1.06* 1.02*
Trimethoprim/ Sulfamethoxazole 160 mg/800mg/day PO x 7 days 1,200 mg PO on day 7 12
 0.85
(0.75 to 0.97)/		 0.87
(0.80 to 0.95/
0.96
(0.88 to 1.03)
Zidovudine 500 mg/day PO x 21 days 600 mg/day PO x 14 days 5
 1.12
(0.42 to 3.02)
 0.94
(0.52 to 1.70)
Zidovudine 500 mg/day PO x 21 days 1,200 mg/day PO x 14 days 4
 1.31
(0.43 to 3.97)		 1.30
(0.69 to 2.43)





PRECAUTIONS - Drug Interactions.

Co-administered
Drug		 Dose of
Co-administered
Drug		 Dose of
Azithromycin
n Ratio (with/without
co-administered drug) of
Azithromycin Pharmacokinetic
Parameters (90% CI);
 No Effect = 1




Mean Cmax Mean AUC
Efavirenz 400 mg/day x 7 days 600 mg PO on day 7 14
 1.22
(1.04 to 1.42)		 0.92*
Fluconazole 200 mg PO single dose 1,200 mg PO single dose 18
 0.82
(0.66 to 1.02)		 1.07
(0.94 to1.22)
Nelfinavir 750 mg TID x 11 days 1,200 mg PO on day 9 14
 2.36
(1.77 to 3.15)		 2.12
(1.80 to 2.50)
Rifabutin 300 mg/day x 10 days 500 mg PO on day 1, then 250 mg/day on days 2-10 6
 See footnote
below		 NA


Microbiology:



in vitroIn vivo

in vitroINDICATIONS AND USAGE

Aerobic and facultative gram-positive microorganisms
                Staphylococcus aureus
                Streptococcus agalactiae
                Streptococcus pneumoniae
                Streptococcus pyogenes

Enterococcus faecalis

Aerobic and facultative gram-negative microorganisms
                Haemophilus ducreyi
                Haemophilus influenzae
                Moraxella catarrhalis
                Neisseria gonorrhoeae

“Other” microorganisms
                Chlamydia pneumoniae
                Chlamydia trachomatis
                Mycoplasma pneumoniae


in vitro but their clinical significance is unknown.


Aerobic and facultative gram-positive microorganisms



Aerobic and facultative gram-negative microorganisms
                Bordetella pertussis
                Legionella pneumophila

Anaerobic microorganisms
                Peptostreptococcus species
                Prevotella bivia

“Other” microorganisms
                Ureaplasma urealyticum

Susceptibility Testing Methods:
in vitro

Dilution techniques:
1,3

Diffusion techniques:
2,3

Table 1. Susceptibility Interpretive Criteria for Azithromycin
Susceptibility Test Result Interpretive Criteria

                                                        Minimum Inhibitory                                            Disk Diffusion
Pathogen                                   Concentrations (mcg/mL)                                (zone diameters in mm)
                                                   S                I                Ra                            S                        I                       Ra
Haemophilus
Staphylococcus aureus 

S. pneumoniaeb 


a
bS. pneumoniae

Neisseria gonorrhoeae



QUALITY CONTROL:


Table 2. Acceptable Quality Control Ranges for Azithromycin

QC Strain                                                         Minimum Inhibitory                                            Disk Diffusion
                                                                    Concentrations (mcg/mL)                            (zone diameters in mm)
Haemophilus influenzae 

Staphylococcus aureus  

Staphylococcus aureus  

Streptococcus pneumoniae    

AZITHROMYCIN INDICATIONS AND USAGE

WARNINGSAs recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.

Adults:

Acute bacterial exacerbations of chronic obstructive pulmonary diseaseHaemophilus influenzaeMoraxella catarrhalis or Streptococcus pneumoniae.

Acute bacterial sinusitisHaemophilus influenzae, Moraxella catarrhalis or Streptococcus  pneumoniae.

Community-acquired pneumonia Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate

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/tonsillitisStreptococcus pyogenes

Streptococcus pyogenesStreptococcus pyogenes

Uncomplicated skin and skin structure infectionsStaphylococcus aureus, Streptococcus pyogenes,Streptococcus agalactiae

Urethritis and cervicitisChlamydia trachomatisNeisseria gonorrhoeae.

Genital ulcer diseaseHaemophilus ducreyi





Pediatric Patients:

PRECAUTIONS—Pediatric Use CLINICAL STUDIES IN PEDIATRIC PATIENTS

Acute otitis media Haemophilus influenzae, Moraxella catarrhalisStreptococcus pneumoniaeDOSAGE AND ADMINISTRATION

Community-acquired pneumoniaChlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniaeStreptococcus pneumoniae DOSAGE AND ADMINISTRATION.

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 Streptococcus pyogenesDOSAGE AND ADMINISTRATION

Streptococcus pyogenes

AZITHROMYCIN CONTRAINDICATIONS

WARNINGS

CONTRAINDICATIONSrecurred 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 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 C. difficile.

C. difficileC. difficile

C. difficileC. difficile

PRECAUTIONS


General: CLINICAL PHARMACOLOGY - Special Populations - Renal Insufficiency.





Information for Patients:








Drug Interactions:

ADVERSE REACTIONS



CLINICAL PHARMACOLOGY-Drug-Drug Interactions.







Laboratory Test Interactions:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pregnancy:



Nursing Mothers:

Pediatric Use:

CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE,DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION



Chlamydia pneumoniaeMycoplasma pneumoniaeHaemophilus influenzaeStreptococcus pneumoniae



Studies evaluating the use of repeated courses of therapy have not been conducted.CLINICAL PHARMACOLOGYANIMAL TOXICOLOGY.

Geriatric Use:

CLINICAL PHARMACOLOGY.




AZITHROMYCIN ADVERSE REACTIONS

DOSAGE AND ADMINISTRATION.CLINICAL STUDIES IN PEDIATRIC PATIENTS.

Clinical:

Adults:
Multiple-dose regimens:



Cardiovascular:
Gastrointestinal:
Genitourinary:
Nervous System:
General:
Allergic:

Single 1-gramdose regimen:



Single 2-gram dose regimen:

Pediatric Patients:
Single and Multiple-dose regimens:

DOSAGE AND ADMINISTRATIONCLINICAL STUDIES IN PEDIATRIC PATIENTS

Dosage
Regimen

 Diarrhea, %
 Abdominal
Pain, %
 Vomiting, %
 Nausea, %
 Rash, %
         1-day           4.3%            1.4%                            4.9%               1.0%


       1.0%
         3-day

           2.6%

           1.7%

                           2.3%           0.4%

          0.6%
         5-day          1.8%         1.2%                           1.1%            0.5%         0.4%



Dosage
Regimen		 Diarrhea/Loose stools, % Abdominal
Pain, %		 Vomiting, % Nausea, % Rash, %






   5-day
           5.8%
            1.9%
            1.9%
            1.9%
           1.6%





Dosage
Regimen		 Diarrhea, % Abdominal
Pain, % 		Vomiting, % Nausea, % Rash, % Headache%







  5-day
   5.4%
   3.4%
   5.6%
   1.8%
   0.7%   1.1%











Cardiovascular:
Gastrointestinal:
Hematologic and Lymphatic:
Nervous System:
General:
Allergic:
Respiratory:
Skin and Appendages:
Special Senses:

Post-Marketing Experience:


Allergic:
Cardiovascular:torsades de pointes
Gastrointestinal:
General:
Genitourinary:
Hematopoietic:
Liver/Biliary:
Nervous System:
Psychiatric:
Skin/Appendages:
Special Senses:

Laboratory Abnormalities:

Adults:



Pediatric Patients:
One, Three and Five Day Regimens
33DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION

INDICATIONS AND USAGE CLINICAL PHARMACOLOGY

Adults:

Infection* Recommended Dose/Duration of Therapy
Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second line therapy)
Skin/skin structure (uncomplicated)		 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) 500 mg QD x 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Acute bacterial sinusitis 500 mg QD x 3 days
Genital ulcer disease (chancroid) One single 1 gram dose
Non-gonoccocal urethritis and cervicitis One single 1 gram dose
Gonococcal urethritis and cervicitis One single 2 gram dose
* DUE TO THE INDICATED ORGANISMS (See INDICATIONS AND USAGE.)


0-120CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.


CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.

CLINICAL PHARMACOLOGY, Special Populations.

Pediatric Patients:


Acute Otitis Media:

Acute bacterial Sinusitis:

Community-Acquired Pneumonia:


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
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.
    Weight
                   100 mg/5 mL
                                200 mg/5 mL
Total mL     per Treatment Course  Total mg per
 Treatment Course
Kg  Lbs.     Day 1
 Days 2-5
              Day 1   Days 2-5

5
 11
 2.5 mL (½ tsp)
1.25 mL (¼ tsp)

                7.5 mL
             
        150 mg
10
 22
   5 mL  (1 tsp)
 2.5 mL (½ tsp)

                15 mL
          300 mg
20
 44

          5 mL (1 tsp)   2.5 mL (½ tsp)                 15 mL
           
          600 mg
30
 66

    7.5 mL (1½ tsp)  3.75 mL (3/4tsp)               22.5 mL
            900 mg
40
 88

       10 mL (2  tsp)
       
    5 mL (1tsp)

                 30 mL
          1200 mg
50 and above


12.5 mL (2 ½ tsp)
  6.25 mL (1¼ tsp)              37.5 mL
         1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1.
    Weight
   100 mg/5 mL     200 mg/5 mL Total mL per
 Treatment Course		 Total mg per
 Treatment Course
Kg  Lbs.            Day 1-3              Day 1-3

5
 11
            2.5 mL (½ tsp)
                7.5 mL
              150 mg
10
 22
            5 mL (1 tsp)
                15 mL
              300 mg

20
44
         
               5 mL (1 tsp)		                 15 mL
              600 mg
30
 66
       
             7.5 mL (1½ tsp)
                 22.5 mL
             900 mg
40
 88
      
              10 mL (2 tsp)

                 30 mL
            1200 mg
50 and above
 110 and above
              12.5 mL (2 ½ tsp )
                37.5 mL
           1500 mg

OTITIS MEDIA : (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose
Weight
200 mg/5 mL
 Total mL per Treatment course
 Total mg per Treatment course
Kg Lbs.
Day1

5
 11
 3.75 mL (3/4 tsp)
                             3.75  mL
                               150 mg
10
 22
 7.5 mL (1½ tsp)
                               7.5 mL
                               300 mg
20
 44
 15 mL (3 tsp)                               15 mL
                               600 mg
30
 66
 22.5 mL (4 ½ tsp)                               22.5 mL
                               900 mg
40
 88
 30 mL (6tsp)                               30 mL
                               1200 mg
50 and above
 110 and above
 37.5 mL (7½ tsp)                               37.5 mL
                               1500 mg



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 days
Weight
200mg/5mL
 Total mL per Treatment course
 Total mg per Treatment course
Kg Lbs.
           Day 1-5

8
 18
          2.5 mL (½ tsp)
                             12.5  mL
                               500 mg
17
 37
          5 mL (1 tsp)
                               25 mL
                               1000 mg
25
 55
         7.5 mL (1 ½ tsp)                               37.5 mL
                              1500 mg
33
 73
         10 mL (2  tsp)                               50 mL
                              2000 mg
40
 88
         12.5 mL (2 ½ tsp)                               62.5 mL
                              2500 mg

HOW SUPPLIED


Azithromycin tablets 250 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W961 on one side and other side plain containing anhydrous azithromycin 250 mg.
Azithromycin tablets 500 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W964 on one side and other side plain containing anhydrous azithromycin 500 mg.

They are supplied by Dispensing Solutions Inc. as follows:

NDC Strength Quantity/Form Color Source NDC
68258-3012-1 500 mg 3 Tablets on a Blister Pack white film-coated 64679-964-03

This product was Manufactured By:

Wockhardt Limited
Mumbai, India

Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA

And Relabeled By:

Dispensing Solutions Inc.
3000 West Warner Ave
Santa Ana, CA 92704
United States

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

CLINICAL STUDIES

(See INDICATIONS AND USAGE and Pediatric Use.)
Pediatric Patients
From the perspective of evaluating pediatric clinical trials, Days 11-14 were considered on-therapy evaluations because of the extended half-life of azithromycin. Day 11-14 data are provided for clinical guidance. Day 24-32 evaluations were considered the primary test of cure endpoint.

Acute Otitis Media
Safety and efficacy using azithromycin 30 mg/kg given over 5 days
Protocol 1
In a double-blind, controlled clinical study of acute otitis media performed in the United States, azithromycin (10 mg/kg on Day 1 followed by 5 mg/kg on Days 2-5) was compared to amoxicillin/clavulanate potassium (4:1). For the 553 patients who were evaluated for clinical efficacy, the clinical success rate (i.e., cure plus improvement) at the Day 11 visit was 88% for azithromycin and 88% for the control agent. For the 521 patients who were evaluated at the Day 30 visit, the clinical success rate was 73% for azithromycin and 71% for the control agent.

In the safety analysis of the above study, the incidence of treatment-related adverse events, primarily gastrointestinal, in all patients treated was 9% with azithromycin and 31% with the control agent. The most common side effects were diarrhea/loose stools (4% azithromycin vs. 20% control), vomiting (2% azithromycin vs. 7% control), and abdominal pain (2% azithromycin vs. 5% control).

Protocol 2
In a non-comparative clinical and microbiologic trial performed in the United States, where significant rates of beta-lactamase producing organisms (35%) were found, 131 patients were evaluable for clinical efficacy. The combined clinical success rate (i.e., cure and improvement) at the Day 11 visit was 84% for azithromycin. For the 122 patients who were evaluated at the Day 30 visit, the clinical success rate was 70% for azithromycin.

Microbiologic determinations were made at the pre-treatment visit. Microbiology was not reassessed at later visits. The following presumptive bacterial/clinical cure outcomes (i.e., clinical success) were obtained from the evaluable group


Presumed Bacteriologic Eradication




Day 11
Azithromycin
 Day 30
Azithromycin
S. pneumoniae
61/74 (82%)
 40/56 (71%)
H. influenzae 43/54 (80%)
 30/47 (64%)
M. catarrhalis
28/35 (80%)
 19/26 (73%)
S. pyogenes
11/11 (100%)
 7/7
Overall
177/217 (82%)
 97/137 (73%)

In the safety analysis of this study, the incidence of treatment-related adverse events, primarily gastrointestinal, in all patients treated was 9%. The most common side effect was diarrhea (4%).

Protocol 3
In another controlled comparative clinical and microbiologic study of otitis media performed in the United States, azithromycin was compared to amoxicillin/clavulanate potassium (4:1). This study utilized two of the same investigators as Protocol 2 (above), and these two investigators enrolled 90% of the patients in Protocol 3. For this reason, Protocol 3 was not considered to be an independent study. Significant rates of beta-lactamase producing organisms (20%) were found. Ninety-two (92) patients were evaluable for clinical and microbiologic efficacy. The combined clinical success rate (i.e., cure and improvement) of those patients with a baseline pathogen at the Day 11 visit was 88% for azithromycin vs. 100% for control; at the Day 30 visit, the clinical success rate was 82% for azithromycin vs. 80% for control.
Microbiologic determinations were made at the pre-treatment visit. Microbiology was not reassessed at later visits. At the Day 11 and Day 30 visits, the following presumptive bacterial/clinical cure outcomes (i.e., clinical success) were obtained from the evaluable group


Presumed Bacteriologic Eradication
Day 11
 Day 30

Azithromycin
 Control 
Azithromycin
 Control
S. pneumoniae
25/29 (86%)
 26/26 (100%)
22/28 (79%)
18/22 (82%)
H. influenzae 9/11 (82%)
 9/9
8/10 (80%)
6/8
M. catarrhalis 7/7
5/5
5/5
2/3
S. pyogenes 2/2
5/5
 2/2
4/4
Overall    
43/49 (88%)
 45/45 (100%)
 37/45 (82%)
 30/37 (81%)













In the safety analysis of the above study, the incidence of treatment-related adverse events, primarily gastrointestinal, in all patients treated was 4% with azithromycin and 31% with the control agent. The most common side effect was diarrhea/loose stools (2% azithromycin vs. 29% control).

Safety and efficacy using azithromycin 30 mg/kg given over 3 days
Protocol 4
In a double-blind, controlled, randomized clinical study of acute otitis media in pediatric patients from 6 months to 12 years of age, azithromycin (10 mg/kg per day for 3 days) was compared to amoxicillin/clavulanate potassium (7:1) in divided doses q12h for 10 days. Each patient received active drug and placebo matched for the comparator.
For the 366 patients who were evaluated for clinical efficacy at the Day 12 visit, the clinical success rate (i.e., cure plus improvement) was 83% for azithromycin and 88% for the control agent. For the 362 patients who were evaluated at the Day 24-28 visit, the clinical success rate was 74% for azithromycin and 69% for the control agent.
In the safety analysis of the above study, the incidence of treatment-related adverse events, primarily gastrointestinal, in all patients treated was 10.6% with azithromycin and 20% with the control agent. The most common side effects were diarrhea/loose stools (5.9% azithromycin vs. 14.6% control), vomiting (2.1% azithromycin vs. 1.1% control), and rash (0% azithromycin vs. 4.3% control).

Safety and efficacy using azithromycin 30 mg/kg given as a single dose
Protocol 5
A double blind, controlled, randomized trial was performed at nine clinical centers. Pediatric patients from 6 months to 12 years of age were randomized 1:1 to treatment with either azithromycin (given at 30 mg/kg as a single dose on Day 1) or amoxicillin/clavulanate potassium (7:1), divided q12h for 10 days. Each child received active drug, and placebo matched for the comparator.
Clinical response (Cure, Improvement, Failure) was evaluated at End of Therapy (Day 12-16) and Test of Cure (Day 28-32). Safety was evaluated throughout the trial for all treated subjects. For the 321 subjects who were evaluated at End of Treatment, the clinical success rate (cure plus improvement) was 87% for azithromycin, and 88% for the comparator. For the 305 subjects who were evaluated at Test of Cure, the clinical success rate was 75% for both azithromycin and the comparator.
In the safety analysis, the incidence of treatment-related adverse events, primarily gastrointestinal, was 16.8% with azithromycin, and 22.5% with the comparator. The most common side effects were diarrhea (6.4% with azithromycin vs. 12.7% with the comparator), vomiting (4% with each agent), rash (1.7% with azithromycin vs. 5.2% with the comparator) and nausea (1.7% with azithromycin vs. 1.2% with the comparator).

Protocol 6
In a non-comparative clinical and microbiological trial, 248 patients from 6 months to 12 years of age with documented acute otitis media were dosed with a single oral dose of azithromycin (30 mg/kg on Day 1).
For the 240 patients who were evaluable for clinical modified Intent-to-Treat (MITT) analysis, the clinical success rate (i.e., cure plus improvement) at Day 10 was 89% and for the 242 patients evaluable at Day 24-28, the clinical success rate (cure) was 85%

Presumed Bacteriologic Eradication

Day 10
 Day 24-28
S. pneumoniae 70/76 (92%)
 67/76 (88%)
H. influenzae 30/42 (71%)
 28/44 (64%)
M. catarrhalis 10/10 (100%)
 10/10 (100%)
Overall    
110/128 (86%)
 105/130 (81%)



Pharyngitis/Tonsillitis


Three U.S. Streptococcal Pharyngitis Studies
Azithromycin vs. Penicillin V

  EFFICACY RESULTS

Day 14
 Day 30
Bacteriologic Eradication

Azithromycin   
323/340 (95%)
 255/330 (77%)
Penicillin V
 242/332 (73%)
 206/325 (63%)
Clinical Success (Cure plus improvement)

Azithromycin
 336/343 (98%)
 310/330 (94%)
Penicillin V
 284/338 (84%)
 241/325 (74%)





Adult Patients

Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease



 Pathogen Azithromycin
(3 Days) 		Clarithromycin
(10 Days)
S. pneumoniae 29/32 (91%)
 21/27 (78%)
H. influenzae 12/14 (86%)
 14/16 (88%)
M. catarrhalis 11/12 (92%)
 12/15 (80%)
ADVERSE REACTIONS.

Acute Bacterial Sinusitis


ADVERSE REACTIONS

Pathogen Azithromycin
(500 mg per day for 3 Days)

    Day 7 Day 28
S. pneumoniae
 23/26 (88%) 21/25 (84%)
H. influenzae 28/32 (87%) 24/32 (75%)
M. catarrhalis 14/15 (93%) 13/15 (87%)
ADVERSE REACTIONS

ANIMAL TOXICOLOGY

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REFERENCES:
  • National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically – Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol. 20, No. 2 (ISBN 1-56238-394-9). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, January 2000.
  • National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests - Seventh Edition. Approved Standard NCCLS Document M2-A7, Vol. 20, No. 1 (ISBN 1-56238-393-0). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, January 2000.
  • National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing – Eleventh Informational Supplement. NCCLS Document M100-S11, Vol. 21, No. 1 (ISBN 1-56238-426-0). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898, January 2001.

AZITHROMYCIN

AZITHROMYCIN

AZITHROMYCIN TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:68258-3012(NDC:64679-964-03)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AZITHROMYCIN ANHYDROUS AZITHROMYCIN ANHYDROUS 500 mg

Product Characteristics

Color Size Imprint Code Shape
white (white film-coated) 17 mm W964 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68258-3012-1 3 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065405 2008-05-30


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