Pharyngitis/Tonsillitis: Caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first¾line therapy.

NOTE: Penicillin by the intramuscular route is the usual drug of choice in the treatment of Streptococcus pyogenes infection and the prophylaxis of rheumatic fever. Azithromycin is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to azithromycin, susceptibility tests should be performed when patients are treated with azithromycin. Data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available.

Uncomplicated Skin and Skin Structure Infections: Due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae. Abscesses usually require surgical drainage.

Urethritis and Cervicitis: Due to Chlamydia trachomatis or Neisseria gonorrhoeae.

Genital Ulcer Disease: In men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

Azithromycin, at the recommended dose, should not be relied upon to treat syphilis. Antimicrobial agents used in high doses for short periods of time to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. All patients with sexually-transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis. Appropriate antimicrobial therapy and follow-up tests for these diseases should be initiated if infection is confirmed.

Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with azithromycin may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.

Pediatric Patients

(See CLINICAL STUDIES, Pediatric Patients.)

Acute Otitis Media: Caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. (For specific dosage recommendation, see

DOSAGE AND ADMINISTRATION

Community-Acquired Pneumonia: Due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy. (For specific dosage recommendation, see

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.

Patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).

Pharyngitis/Tonsillitis: Caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. (For specific dosage recommendation, see

DOSAGE AND ADMINISTRATION

INDICATIONS

AND USAGE and CLINICAL PHARMACOLOGY.)

Adults

The recommended dose of azithromycin for the treatment of mild to moderate acute bacterial exacerbations of chronic obstructive pulmonary disease, community-acquired pneumonia of mild severity, pharyngitis/tonsillitis (as second-line therapy), and uncomplicated skin and skin structure infections due to the indicated organisms is: 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Azithromycin capsules should be given at least 1 hour before or 2 hours after a meal. Azithromycin capsules should not be taken with food.

Azithromycin tablets can be taken with or without food.

The recommended dose of azithromycin for the treatment of genital ulcer disease due to Haemophilus ducreyi (chancroid), non-gonococcal urethritis and cervicitis due to C. trachomatis is: a single 1 gram (1000 mg) dose of azithromycin.

The recommended dose of azithromycin for the treatment of urethritis and cervicitis due to Neisseria gonorrhoeae is a single 2 gram (2000 mg) dose of azithromycin.

Pediatric Patients

Acute Otitis Media and Community¾Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of children with acute otitis media and community-acquired pneumonia is 10 mg/kg as a single dose on the first day (not to exceed 500 mg/day) followed by 5 mg/kg on days 2 through 5 (not to exceed 250 mg/day). (See TABLE 14.)

Azithromycin fororal suspension should be given at least 1 hour before or 2 hours after a meal.

Azithromycin for oral suspension should not be taken with food.

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA

(Age 6 months and above, see PRECAUTIONS, Pediatric Use.)

Based on Body Weight.

OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA.

Weight		100 mg/5 ml Suspension		200 mg/5 ml Suspension		Total ml per Treatment
TABLE 14 Dosing Calculated on 10 mg/kg on Day 1 Dose, Followed by 5 mg/kg on Days 2 to 5.
Kg	lbs	Day 1	Days 2-5	Day 1	Days 2-5
10	22	5 ml	2.5 ml			15 ml
20	44			5 ml	2.5 ml	15ml
30	66			7.5 ml	3.75 ml	22.5 ml
40	88			10 ml	5 ml	30 ml

Pharyngitis/Tonsillitis: The recommended dose for children with pharyngitis/tonsillitis is 12 mg/kg once a day for 5 days (not to exceed 500 mg/day). (See TABLE 15.)

Azithromycin for oral suspension should be given at least 1 hour before or 2 hours after a meal.

Azithromycin for oral suspension should not be taken with food.

PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS (Age 2 years and above, see PRECAUTIONS, Pediatric Use.)

Based on Body Weight.

PHARYNGITIS/TONSILLITIS.

Dosing Calculated on 12 mg/kg once daily days 1 to 5.

Weight		200 mg/5 ml Suspension	Total ml per Treatment Course
TABLE 15
Kg	lbs	Day 1-5
8	18	2.5 ml	12.5 ml
17	37	5 ml	25 ml
25	55	7.5 ml	37.5 ml
33	73	10 ml	50 ml
40	88	12.5 ml	62.5 ml

Constituting instructions for azithromycin oral suspension, 300, 600, 900, 1200 mg bottles. TABLE 16 below indicates the volume of water to be used for constitution:

Amount of Water to be Added	Total Volume After Constitution (Azithromycin Content)	Azithromycin Concentration After Constitution
TABLE 16
9 ml (300 mg)	15 ml (300 mg)	100 mg/5 ml
9 ml (600 mg)	15 ml (600 mg)	200 mg/5 ml
12 ml (900 mg)	22.5 ml (900 mg)	200 mg/5 ml
15 ml (1200 mg)	30 ml (1200 mg)	200 mg/5 ml

HOW SUPPLIED

Tablets

Zithromax tablets are supplied as red modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. Zithromax tablets are engraved with ��PFIZER�� on one side and ��306�� on the other.

Storage: Zithromax tablets should be stored between 15�� to 30�� C (59�� to 86��F).

Suspension

Storage: Store constituted suspension between 5�� to 30��C (41�� to 86��F) and discard when full dosing is completed or within 10 days. Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.

Zithromax for oral suspension after constitution contains a flavored suspension.

Storage: Store dry powder below 30�� C (86�� F).

REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically¾Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December 1993.

2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests¾Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December 1993.