Azithromycin Dihydrate: Package Insert and Label Information

AZITHROMYCIN DIHYDRATE- azithromycin dihydrate tablet, film coated
Medsource Pharmaceuticals

1 INDICATIONS AND USAGE

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​ Azithromycin tablets, are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications . Azithromycin tablets, are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration ( 2)] .

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1.1 Adult Patients

• Acute bacterial exacerbations of chronic bronchitis 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.
• Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
• Uncomplicated skin and skin structure infections due to Staphylococcus aureus , Streptococcus pyogenes , or Streptococcus agalactiae.
• 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.

1.2 Pediatric Patients

[see Use in Specific Populations ( 8.4) and Clinical Studies ( 14.2)]

• Acute otitis media (>6 months of age) caused by Haemophilus influenzae , Moraxella catarrhalis , or Streptococcus pneumoniae

• Community-acquired pneumonia (>6 months of age) due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumonia, or Streptococcus pneumoniae in patients appropriate for oral therapy.

• Pharyngitis/tonsillitis (>2 years of age) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.

1.3 Limitations of Use

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 nosocomial 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).

1.4 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat 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.

2 DOSAGE AND ADMINISTRATION

2.1 Adult Patients

[see Indications and Usage ( 1.1) and Clinical Pharmacology ( 12.3)]

Infection*	Recommended Dose/Duration of Therapy
Community-acquired pneumonia 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	500 mg once daily for 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 once daily for 3 days
Genital ulcer disease (chancroid)	One single 1 gram dose
Non-gonococcal 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 ( 1.1)]

Azithromycin tablets can be taken with or without food.

2.2 Pediatric Patients ¹

Infection *	Recommended Dose/Duration of Therapy
Acute otitis media	30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis	10 mg/kg once daily for 3 days.
Community-acquired pneumonia	10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis	12 mg/kg once daily for 5 days.
* DUE TO THE INDICATED ORGANISMS [see Indications and Usage ( 1.2)] 1 see dosing tables below for maximum doses evaluated by indication

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

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, [see Use in Specific Populations ( 8.4)] ) 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 to 5	Day 1	Days 2 to 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) *
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.	Days 1 to 3		Days 1 to 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; (2½ 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.	1-Day Regimen
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; (4½ 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; (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 Use in Specific Populations ( 8.4 )]) 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 to 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

3 DOSAGE FORMS AND STRENGTHS

Azithromycin Tablets, USP 250 mg are supplied as white, oval, biconvex film coated tablets engraved “APO” on one side and “AZ250” on the other side.

Azithromycin Tablets, USP 500 mg are supplied as white, oval, biconvex film coated tablets engraved “APO” on one side and “AZ500” on the other side.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Azithromycin tablets are contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug.

4.2 Hepatic Dysfunction

Azithromycin tablets are contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Acute Generalized Exanthematous Pustulosis (AGEP), Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported in patients on azithromycin therapy [see Contraindications ( 4.1)] .

Fatalities have been reported. Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure. These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is presently unknown.

If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that allergic symptoms may reappear when symptomatic therapy has been discontinued.