Azithromycin (Page 3 of 9)

Pediatric Patients

Single and Multiple-dose regimens: The types of adverse reactions in pediatric patients were comparable to those seen in adults, with different incidence rates for the dosage regimens recommended in pediatric patients.

Acute Otitis Media: For the recommended total dosage regimen of 30 mg/kg, the most frequent adverse reactions (≥ 1%) attributed to treatment were diarrhea, abdominal pain, vomiting, nausea, and rash [see Dosage and Administration ( 2) and Clinical Studies ( 14.2)] .

The incidence, based on dosing regimen, is described in the table below:

Dosage Regimen

Diarrhea %

Abdominal Pain %

Vomiting %

Nausea %

Rash %

1 day

4.3%

1.4%

4.9%

1%

1%

3 day

2.6%

1.7%

2.3%

0.4%

0.6%

5 day

1.8%

1.2%

1.1%

0.5%

0.4%

Community-Acquired Pneumonia: For the recommended dosage regimen of 10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5, the most frequent adverse reactions attributed to treatment were diarrhea/loose stools, abdominal pain, vomiting, nausea, and rash.

The incidence is described in the table below:

Dosage Regimen

Diarrhea/Loose stools %

Abdominal Pain %

Vomiting %

Nausea %

Rash %

5 day

5.8%

1.9%

1.9%

1.9%

1.6%

Pharyngitis/tonsillitis: For the recommended dosage regimen of 12 mg/kg on Days 1 to 5, the most frequent adverse reactions attributed to treatment were diarrhea, vomiting, abdominal pain, nausea, and headache.

The incidence is described in the table below:

Dosage Regimen

Diarrhea %

Abdominal Pain %

Vomiting %

Nausea %

Rash %

Headache %

5 day

5.4%

3.4%

5.6%

1.8%

0.7%

1.1%

With any of the treatment regimens, no other adverse reactions occurred in pediatric patients treated with azithromycin with a frequency greater than 1%. Adverse reactions that occurred with a frequency of 1% or less included the following:

Cardiovascular: Chest pain.

Gastrointestinal: Dyspepsia, constipation, anorexia, enteritis, flatulence, gastritis, jaundice, loose stools, and oral moniliasis. Hematologic and Lymphatic: Anemia and leukopenia.

Nervous System: Headache (otitis media dosage), hyperkinesia, dizziness, nervousness, and insomnia.

General: Fever, face edema, fatigue, fungal infection, malaise, and pain.

Allergic: Rash and allergic reaction.

Respiratory: Increased cough, pharyngitis, pleural effusion, and rhinitis.

Skin and Appendages: Eczema, fungal dermatitis, pruritus, sweating, urticaria, and vesiculobullous rash.

Special Senses: Conjunctivitis.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of azithromycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions reported with azithromycin during the postmarketing 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 reports of QT prolongation and torsades de pointes.

Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and reports of tongue discoloration.

General: Asthenia, paresthesia, fatigue, malaise, and anaphylaxis.

Genitourinary: Interstitial nephritis and acute renal failure and vaginitis.

Hematopoietic: Thrombocytopenia.

Liver/Biliary: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure [ see Warnings and Precautions ( 5.2)].

Nervous System: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation, and syncope. Psychiatric: Aggressive reaction and anxiety.

Skin/Appendages: Pruritus, 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.

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