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Zithromax

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Zithromax

Zithromax

INDICATIONS

ZITHROMAX (azithromycin) is indicated for the treatment of patients with mild to moderate infections (pneumonia: see 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 see DOSAGE AND ADMINISTRATION for specific dosing recommendations.

Adults

Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.

Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.

Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.

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 caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line 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. ZITHROMAX is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to ZITHROMAX, susceptibility tests should be performed when patients are treated with ZITHROMAX. 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.

ZITHROMAX, 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 ZITHROMAX may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Pediatric Patients: (See PRECAUTIONS—Pediatric Use and Clinical Studies In 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 Chlamydophila 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, or

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.)

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. ZITHROMAX is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to ZITHROMAX, susceptibility tests should be performed when patients are treated with ZITHROMAX. Data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available.

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

DOSAGE AND ADMINISTRATION

(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)

Adults

Infection* Recommended Dose/Duration of Therapy
Community-aquired 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.)

ZITHROMAX tablets can be taken with or without food.

Renal Insufficiency

No dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 was similar in subjects with GFR 10-80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency.)

Hepatic Insufficiency

The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dose adjustment recommendations can be made in patients with impaired hepatic function (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency.)

No dosage adjustment is recommended based on age or gender. (See CLINICAL PHARMACOLOGY, Special Populations.)

Pediatric Patients

ZITHROMAX for oral suspension can be taken with or without food.

Acute Otitis Media: The recommended dose of ZITHROMAX for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)

Acute Bacterial Sinusitis: The recommended dose of ZITHROMAX for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)

Community-Acquired Pneumonia: The recommended dose of ZITHROMAX for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)

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 (¾ tsp) 22.5 mL 900 mg
40 88     10 mL (2 tsp) 5 mL (1 tsp) 30 mL 1200 mg
50 and above 110 and above     12.5 mL (2½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.

OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*

OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day
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 (1 ½ 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
*Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.

OTITIS MEDIA: (1-Day Regimen)

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. Day 1
5 11 3.75 mL (3/4 tsp) 3.75 mL 150 mg
10 22 7.5 mL (1 ½ 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 (6 tsp) 30 mL 1200 mg
50 and above 110 and above 37.5 mL (7 ½ tsp) 37.5 mL 1500 mg

The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.

Pharyngitis/Tonsillitis: The recommended dose of ZITHROMAX for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)

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 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 (1½ tsp) 37.5 mL 1500 mg
33 73 10 mL (2 tsp) 50 mL 2000 mg
40 88 12.5 mL (2½ tsp) 62.5 mL 2500 mg

Constituting instructions for ZITHROMAX Oral Suspension, 300, 600, 900, 1200 mg bottles. The table 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
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

Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.

After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.

HOW SUPPLIED

ZITHROMAX 250 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. ZITHROMAX 250 mg tablets are engraved with “PFIZER” on one side and “306” on the other. These are packaged in bottles and blister cards of 6 tablets (Z-PAKS®) as follows:

Bottles of 30 NDC 0069-3060-30
Boxes of 3 (Z-PAKS® of 6) NDC 0069-3060-75
Unit Dose package of 50 NDC 0069-3060-86

ZITHROMAX 500 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin. ZITHROMAX 500 mg tablets are engraved with “Pfizer” on one side and “ZTM500” on the other. These are packaged in bottles and blister cards of 3 tablets (TRI-PAKS™) as follows:

Bottles of 30 NDC 0069-3070-30
Boxes of 3 (TRI-PAKS™ of 3 tablets) NDC 0069-3070-75
Unit Dose package of 50 NDC 0069-3070-86

ZITHROMAX tablets should be stored between 15° to 30°C (59° to 86°F).

ZITHROMAX for oral suspension after constitution contains a flavored suspension. ZITHROMAX® for oral suspension is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows:

Azithromycin contents per bottle NDC
300 mg 0069-3110-19
600 mg 0069-3120-19
900 mg 0069-3130-19
1200 mg 0069-3140-19

See DOSAGE AND ADMINISTRATION for constitution instructions with each bottle type.

Storage: Store dry powder below 30°C (86°F). Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed.

Licensed from Pliva. Distributed by Pfizer labs, Division of Pfizer Inc, NY, NY 10017. Revised: January 2013

Last reviewed on RxList: 3/12/2013
This monograph has been modified to include the generic and brand name in many instances.

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