AZITHROMYCIN
These highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION.AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
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HUMAN PRESCRIPTION DRUG LABEL
Dec 27, 2023
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
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Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
AZITHROMYCIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
AZITHROMYCIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
INDICATIONS & USAGE SECTION
1 INDICATIONS AND USAGE
Azithromycin for oral suspension USP is 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)]
Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
- Acute bacterial exacerbations of chronic bronchitis in adults (1.1)
- Acute bacterial sinusitis in adults (1.1)
- Uncomplicated skin and skin structure infections in adults (1.1)
- Urethritis and cervicitis in adults (1.1)•Genital ulcer disease in men (1.1)
- Acute otitis media in pediatric patients (1.2)
- Community-acquired pneumonia in adults and pediatric patients (1.1, 1.2)
- Pharyngitis/tonsillitis in adults and pediatric patients (1.1, 1.2)
Limitation 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. (1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension USP and other antibacterial drugs, azithromycin for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.4)
WARNINGS AND PRECAUTIONS SECTION
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including 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.
5.2 Hepatotoxicity
Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.
5.3 Infantile Hypertrophic Pyloric Stenosis(IHPS)
Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.
5.4 QT Prolongation
Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen with treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including:
- patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure
- patients on drugs known to prolong the QT interval
- patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
Elderly patients may be more susceptible to drug-associated effects on the QT interval.
5.5 Clostridium difficile-Associated Diarrhea (CDAD)
Clostridium difficile-associated diarrhea has been reported with use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile.
C. difficileproduces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficilecause increased morbidity and mortality, as these infections can be refractory to antibacterial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
5.6 Exacerbation of Myasthenia Gravis
Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
5.7 Use in Sexually Transmitted Infections
Azithromycin, at the recommended dose, should not be relied upon to treat syphilis. Antibacterial agents used 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 testing for gonorrhea performed at the time of diagnosis. Appropriate antibacterial therapy and follow-up tests for these diseases should be initiated if infection is confirmed.
5.8 Development of Drug-Resistant Bacteria
Prescribing azithromycin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
•
Serious (including fatal) allergic and skin reactions: Discontinue azithromycin if reaction occurs. (5.1)
•
Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur. (5.2)
•
Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs. (5.3)
•
Prolongation of QT interval and cases of torsades de pointes have been reported. This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval. (5.4)
•
Clostridium difficile-associated diarrhea: Evaluate patients if diarrhea occurs. (5.5)
•
Azithromycin may exacerbate muscle weakness in persons with myasthenia gravis. (5.6)
DRUG INTERACTIONS SECTION
7 DRUG INTERACTIONS
7.1 Nelfinavir
Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. [see Adverse Reactions (6)]
7.2 Warfarin
Spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly.
7.3 Potential Drug-Drug Interaction with Macrolides
Interactions with digoxin, colchicine or phenytoin have not been reported in clinical trials with azithromycin. No specific drug interaction studies have been performed to evaluate potential drug-drug interaction. However, drug interactions have been observed with other macrolide products. Until further data are developed regarding drug interactions when digoxin or phenytoin are used with azithromycin careful monitoring of patients is advised.
•
Nelfinavir: Close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. (7.1)
•
Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time. (7.2)
NONCLINICAL TOXICOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential. Azithromycin has shown no mutagenic potential in standard laboratory tests: mouse lymphoma assay, human lymphocyte clastogenic assay, and mouse bone marrow clastogenic assay. In fertility studies conducted in male and female rats, oral administration of azithromycin for 64 to 66 days (males) or 15 days (females) prior to and during cohabitation resulted in decreased pregnancy rate at 20 and 30 mg/kg/day when both males and females were treated with azithromycin. This minimal effect on pregnancy rate (approximately 12% reduction compared to concurrent controls) did not become more pronounced when the dose was increased from 20 to 30 mg/kg/day (approximately 0.4 to 0.6 times the adult daily dose of 500 mg based on body surface area) and it was not observed when only one animal in the mated pair was treated. There were no effects on any other reproductive parameters, and there were no effects on fertility at 10 mg/kg/day. The relevance of these findings to patients being treated with azithromycin at the doses and durations recommended in the prescribing information is uncertain.
13.2 Animal Toxicology and/or Pharmacology
Phospholipidosis (intracellular phospholipid accumulation) has been observed in some tissues of mice, rats, and dogs given multiple doses of azithromycin. It has been demonstrated in numerous organ systems (e.g., eye, dorsal root ganglia, liver, gallbladder, kidney, spleen, and/or pancreas) in dogs and rats treated with azithromycin at doses which, expressed on the basis of body surface area, are similar to or less than the highest recommended adult human dose. This effect has been shown to be reversible after cessation of azithromycin treatment. Based on the pharmacokinetic data, phospholipidosis has been seen in the rat (50 mg/kg/day dose) at the observed maximal plasma concentration of 1.3 mcg/mL (1.6 times the observed Cmax of 0.821 mcg/mL at the adult dose of 2 g). Similarly, it has been shown in the dog (10 mg/kg/day dose) at the observed maximal serum concentration of 1 mcg/mL (1.2 times the observed Cmax of 0.821 mcg/mL at the adult dose of 2 g). Phospholipidosis was also observed in neonatal rats dosed for 18 days at 30 mg/kg/day, which is less than the pediatric dose of 60 mg/kg based on the surface area. It was not observed in neonatal rats treated for 10 days at 40 mg/kg/day with mean maximal serum concentrations of 1.86 mcg/mL, approximately 1.5 times the Cmax of 1.27 mcg/mL at the pediatric dose. Phospholipidosis has been observed in neonatal dogs (10 mg/kg/day) at maximum mean whole blood concentrations of 3.54 mcg/mL, approximately 3 times the pediatric dose Cmax. The significance of these findings for animals and for humans is unknown.
DOSAGE & ADMINISTRATION SECTION
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 Patients1
|
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)] 1see 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, [seeUse 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 |
Day 1 |
Days 2-5 |
Day 1 |
Days 2-5 | ||
|
5 |
2.5 mL; (½ tsp) |
1.25 mL; (¼ tsp) |
7.5 mL |
150 mg | ||
|
10 |
5 mL; (1 tsp) |
2.5 mL; (½ tsp) |
15 mL |
300 mg | ||
|
20 |
5 mL; (1 tsp) |
2.5 mL; (½ tsp) |
15 mL |
600 mg | ||
|
30 |
7.5 mL; (1½ tsp) |
3.75 mL; (¾ tsp) |
22.5 mL |
900 mg | ||
|
40 |
10 mL; (2 tsp) |
5 mL; (1 tsp) |
30 mL |
1200 mg | ||
|
50 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 |
Days 1-3 |
Days 1-3 | ||
|
5 |
2.5 mL; (½ tsp) |
7.5 mL |
150 mg | |
|
10 |
5 mL; (1 tsp) |
15 mL |
300 mg | |
|
20 |
5 mL (1 tsp) |
15 mL |
600 mg | |
|
30 |
7.5 mL (1½ tsp) |
22.5 mL |
900 mg | |
|
40 |
10 mL (2 tsp) |
30 mL |
1200 mg | |
|
50 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 30mg/kg as a single dose. | |||
|
Weight |
200 mg/5 mL |
Total mL per Treatment Course |
Total mg per Treatment Course |
|
Kg |
1-Day Regimen | ||
|
5 |
3.75 mL; (¾ tsp) |
3.75 mL |
150 mg |
|
10 |
7.5 mL; (1½ tsp) |
7.5 mL |
300 mg |
|
20 |
15 mL; (3 tsp) |
15 mL |
600 mg |
|
30 |
22.5 mL; ( 4½ tsp) |
22.5 mL |
900 mg |
|
40 |
30 mL;(6 tsp) |
30 mL |
1200 mg |
|
50 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, 8 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,[seeUse 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 |
Day 1-5 | ||
|
8 |
2.5 mL; (½ tsp) |
12.5 mL |
500 mg |
|
17 |
5 mL; (1 tsp) |
25 mL |
1000 mg |
|
25 |
7.5 mL; (1½ tsp) |
37.5 mL |
1500 mg |
|
33 |
10 mL; (2 tsp) |
50 mL |
2000 mg |
|
40 |
12.5 mL; (2½ tsp) |
62.5 mL |
2500 mg |
Constituting instructions for Azithromycin 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.
*Adult Patients (2.1)
|
Infection |
Recommended Dose/Duration of Therapy |
|
Community-acquired pneumonia (mile 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 bronchitis (mild to moderate) |
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days. |
|
Acute bacterial sinusitis |
500 mg once daily for 3 days. |
|
Genital ulcer disease (chancroid) Non-gonococcal urethritis and cervicitis |
One single 1 gram dose. |
|
Gonococcal urethritis and cervicitis |
One single 2 gram dose. |
*Pediatric Patient(2.2)
|
Infection |
Recommended Dose/Duration of Therapy |
|
Acute otitis media (6 months of age and older) |
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 (6 months of age and older) |
10 mg/kg once daily for 3 days. |
|
Community-acquired pneumonia (6 months of age and older) |
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5. |
|
Pharyngitis/tonsillitis (2 years of age and older) |
12 mg/kg once daily for 5 days. |