AZITHROMYCIN (Page 5 of 7)

Post-Marketing Experience:

Adverse events reported with azithromycin during the post-marketing period in adult and/or pediatric patients for which a causal relationship may not be established include:
Allergic: Arthralgia, edema, urticaria and angioedema.
Cardiovascular: Arrhythmias including ventricular tachycardia and hypotension. There have been rare reports of QT prolongation and torsades de pointes.
Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea rarely resulting in dehydration, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and rare reports of tongue discoloration.
General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis (rarely fatal).
Genitourinary: Interstitial nephritis and acute renal failure and vaginitis.
Hematopoietic: Thrombocytopenia.
Liver/Biliary: Abnormal liver function including hepatitis and cholestatic jaundice, as well as rare cases of hepatic necrosis and hepatic failure, some of which have resulted in death.
Nervous System: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope.
Psychiatric: Aggressive reaction and anxiety.
Skin/Appendages: Pruritus, rarely serious skin reactions including erythema multiforme, Stevens Johnson Syndrome and toxic epidermal necrolysis.
Special Senses: Hearing disturbances including hearing loss, deafness and/or tinnitus and reports of taste/smell perversion and/or loss.

Laboratory Abnormalities:

Adults:
Clinically significant abnormalities (irrespective of drug relationship) occurring during the clinical trials were reported as follows: with an incidence of greater than 1%: decreased hemoglobin, hematocrit, lymphocytes, neutrophils and blood glucose; elevated serum creatine phosphokinase, potassium, ALT, GGT, AST, BUN, creatinine, blood glucose, platelet count, lymphocytes, neutrophils and eosinophils; with an incidence of less than 1%: leukopenia, neutropenia, decreased sodium, potassium, platelet count, elevated monocytes, basophils, bicarbonate, serum alkaline phosphatase, bilirubin, LDH and phosphate. The majority of subjects with elevated serum creatinine also had abnormal values at baseline. When follow-up was provided, changes in laboratory tests appeared to be reversible.
In multiple-dose clinical trials involving more than 5000 patients, four patients discontinued therapy because of treatment-related liver enzyme abnormalities and one because of a renal function abnormality.

Pediatric Patients:
One, Three and Five Day Regimens
Laboratory data collected from comparative clinical trials employing two 3-day regimens (30 mg/kg or 60 mg/kg in divided doses over 3 days), or two 5-day regimens (30 mg/kg or 60 mg/kg in divided doses over 5 days) were similar for regimens of azithromycin and all comparators combined, with most clinically significant laboratory abnormalities occurring at incidences of 1-5%. Laboratory data for patients receiving 30 mg/kg as a single dose were collected in one single center trial. In that trial, an absolute neutrophil count between 500-1500 cells/mm3 was observed in 10/64 patients receiving 30 mg/kg as a single dose, 9/62 patients receiving 30 mg/kg given over 3 days, and 8/63 comparator patients. No patient had an absolute neutrophil count <500 cells/mm3. (See DOSAGE AND ADMINISTRATION.)

In multiple-dose clinical trials involving approximately 4700 pediatric patients, no patients discontinued therapy because of treatment-related laboratory abnormalities.

DOSAGE AND ADMINISTRATION

(See INDICATIONS AND USAGE and 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.)Azithromycin 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:
Azithromycin for oral suspension can be taken with or without food.

Acute Otitis Media: The recommended dose of azithromycin 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 azithromycin 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 azithromycin 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 (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
*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)*
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
*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)
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

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 azithromycin 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/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

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