Azithromycin 200 mg/5mL Powder, For Suspension
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Macrolide Antimicrobial class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Azithromycin is used to treat infections caused by bacteria. It is also used to treat and prevent disseminated Mycobacterium avium complex (MAC) infection [a type of lung infection that affects people with a suppressed immune system). Azithromycin is in a class of medications called macrolide antibiotics. It works by stopping the growth of bacteria. Antibiotics such as azithromycin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Azithromycin — tap one for details:
Azithromycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII UKE75GEA7F
Hydroxypropyl cellulose is a plant-based polymer used as a binder and thickener. It helps hold tablet ingredients together, controls how fast the medicine dissolves, and improves the texture of liquid formulations.
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UNII SX01TZO3QZ
A mineral salt made from sodium and phosphate. It acts as a buffer to maintain the medicine's pH level and can help bind ingredients together in solid dosage forms.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.298 | $4.47 / 15 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.6232 | $9.35 / 15 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.3238 | $4.86 / 15 ml |
| Medicare Part B allowsASP · Q0144 | No ASP payment limit on file for Q0144 this quarter. | |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Azithromycin 200 mg/5mL 24658-0708-34 | PURACAP | 30 ml | $0.210 | AB | Availability likely | save 30% |
| Azithromycin 200 mg/5mL 42806-0151-34 | Epic | 30 ml | $0.210 | AB | Availability likely | save 30% |
| Azithromycin 200 mg/5mL 62135-0705-43 | Chartwell | 30 ml | $0.210 | AB | Availability likely | save 30% |
| Azithromycin 200 mg/5mL 70710-1460-02 | Zydus | 1 bottle | $0.210 | AB | Availability likely | save 30% |
| azithromycin dihydrate 200 mg/5mL 70436-0222-36 | Slate | 1 bottle | $0.219 | AB | Availability likely | save 27% |
| Azithromycin 200 mg/5mL 24658-0707-33 | PURACAP | 22.5 ml | $0.231 | AB | Availability likely | save 22% |
| Azithromycin 200 mg/5mL 42806-0150-33 | Epic | 22.5 ml | $0.231 | AB | Availability likely | save 22% |
| Azithromycin 200 mg/5mL 70710-1459-02 | Zydus | 1 bottle | $0.231 | AB | Availability likely | save 22% |
| azithromycin dihydrate 200 mg/5mL 70436-0228-49 | Slate | 1 bottle | $0.238 | AB | Availability likely | save 20% |
| Azithromycin 200 mg/5mL 00093-2026-23 | Teva | 15 ml | $0.298 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 11788-0129-13 | AiPing | 1 bottle | $0.298 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 24658-0706-32 | PURACAP | 15 ml | $0.298 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 42806-0149-32 | Epic | 15 ml | $0.298 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 59651-0008-15 | Aurobindo | 1 bottle | $0.298 | AB | Availability likely | — |
| Azithromycin 200 mg/5mLthis 70710-1458-02 | Zydus | 1 bottle | $0.298 | AB | Availability likely | — |
| azithromycin dihydrate 200 mg/5mL 70436-0221-34 | Slate | 1 bottle | $0.325 | AB | Availability likely | +9% |
| Zithromax 200 mg/5mL 00069-3120-19 | Pfizer | 1 bottle | — | AB | FDA listed | — |
| Zithromax 200 mg/5mL 00069-3130-19 | Pfizer | 1 bottle | — | AB | FDA listed | — |
| Zithromax 200 mg/5mL 00069-3140-19 | Pfizer | 1 bottle | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 50090-4458-00 | A-S | 1 bottle | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 50090-6226-00 | A-S | 22.5 ml | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 50090-6267-00 | A-S | 1 bottle | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 50090-6296-00 | A-S | 15 ml | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 55695-0003-00 | STATE | 30 ml | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 63187-0093-15 | Proficient | 15 ml | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 67296-2141-01 | Redpharm | 1 bottle | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 68071-3897-02 | NuCare | 22.5 ml | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 68071-4773-05 | NuCare | 15 ml | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 68071-4779-03 | NuCare | 30 ml | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 68071-4795-03 | NuCare | 30 ml | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 68788-7549-03 | Preferred | 30 ml | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 68788-8246-03 | Preferred | 1 bottle | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 70771-1423-02 | Zydus | 1 bottle | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 70771-1424-02 | Zydus | 1 bottle | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 70771-1425-02 | Zydus | 1 bottle | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 71205-0216-30 | Proficient | 1 bottle | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 71205-0253-30 | Proficient | 30 ml | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 71205-0566-15 | Proficient | 15 ml | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 72189-0314-22 | DirectRx | 22.5 ml | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 72673-0081-60 | Zhejiang | 1 bottle | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 72673-0082-90 | Zhejiang | 1 bottle | — | AB | FDA listed | — |
| Azithromycin 200 mg/5mL 72673-0083-12 | Zhejiang | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70710-1458-02 You're viewing this | 1 BOTTLE in 1 CARTON (70710-1458-2) / 15 mL in 1 BOTTLE | 2018-08-06 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Azithromycin is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 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 (6 months of age and older) (1.2) Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2) Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2) Limitation of Use : Azithromycin is not recommended 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 and other antibacterial drugs, azithromycin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.4)
1.1Indications in Adult Patients Azithromycin is indicated in adult patients for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 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.
1.2Indications in Pediatric Patients Azithromycin is indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: [see Use in Specific Populations (8.4) and Clinical Studies (14.2)]. Acute otitis media caused by Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae, in pediatric patients 6 months of age and older. Community-acquired pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae , or Streptococcus pneumoniae in pediatric patients 6 months of age and older 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 in pediatric patients 2 years of age and older.
1.3Limitations of Use Azithromycin is not recommended 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 devel…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended Dosage for Adult Patients (2.1) 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 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. Recommended Dosage for Pediatric Patients (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.
2.1Recommended Dosage for Adult Patients Recommended dosages and durations of therapy in adult patient populations vary by indications [see Indications and Usage ( 1.1 ) and Clinical Pharmacology ( 12.3 )]. Azithromycin for oral suspension can be taken with or without food. Table 1.
Recommended dosage for Adult Patients by Indication 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 microorganisms [see Indications and Usage (1.1)].
2.2Recommended Dosage for Pediatric Patients Recommended dosages and durations of therapy in pediatric patient populations vary by indications [see Indications and Usage (1.2) and Clinical Pharmacology (12.3)] . Azithromycin for oral suspension can be taken with or without food. Table 2.
Recommended dose for Pediatric Patients by Indication Infection * Recommended Dose/Duration of Therapy 1 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 microorganisms [see Indications and Usage (1.2) and Use in Specific Populations (8.4)]. 1 see dosing tables below for maximum doses evaluated by indication. 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 Table 3.
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 to 5 Day 1 Days 2 to 5 5 2.5 mL; (½ tsp) 1.25mL; (¼ tsp) 7.5 mL 150 mg 10 5 mL; (1tsp) 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 ts…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Azithromycin for oral suspension USP, 100 mg/ 5mL or 200 mg/5 mL [each teaspoonful (5 mL) contains Azithromycin Dihydrate equivalent to Azithromycin USP, 100 mg or 200 mg] is supplied in bottles. Azithromycin for oral suspension, USP is white to light pink granular powder filled in translucent HDPE bottle with child-resistant cap and after constitution with water contains a red colored flavored suspension. Azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. (4.1) Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. (4.2)
4.1Hypersensitivity Azithromycin for oral suspension is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug.
4.2Hepatic Dysfunction Azithromycin for oral suspension is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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) Cardiovascular Death: Some observational studies have shown an approximately two-fold increased short-term potential risk of acute cardiovascular death in adults exposed to azithromycin relative to other antibacterial drugs, including amoxicillin. Consider balancing this potential risk with treatment benefits when prescribing azithromycin.
(5.5) Clostridioides difficile -Associated Diarrhea: Evaluate patients if diarrhea occurs. (5.6) Azithromycin may exacerbate muscle weakness in persons with myasthenia gravis. (5.7)
5.1Hypersensitivity 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.
5.2Hepatotoxicity 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.
5.3Infantile Hypertrophic Pyloric Stenosis 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.
5.4QT 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,…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Infantile Hypertrophic Pyloric Stenosis (IHPS) [see Warnings and Precautions (5.3)] QT Prolongation [see Warnings and Precautions (5.4)] Cardiovascular Death [see Warnings and Precautions (5.5)] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions (5.6)] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.7)] Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%).
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Potentially serious adverse reactions of angioedema and cholestatic jaundice were reported.
Approximately 0.7% of the patients (adults and pediatric patients) from the 5-day multiple-dose clinical trials discontinued azithromycin therapy because of treatment-related adverse reactions. In adults given 500 mg/day for 3 days, the discontinuation rate due to treatment-related adverse reactions was 0.6%. In clinical trials in pediatric patients given 30 mg/kg, either as a single dose or over 3 days, discontinuation from the trials due to treatment-related adverse reactions was approximately 1%.
Most of the adverse reactions leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain. [see Clinical Studies (14.2)] Clinical Trials Experience in Adults Multiple-dose regimens: Overall, the most common treatment-related adverse reactions in adult patients receiving multiple-dose regimens of azithromycin were related to the gastrointestinal system with diarrhea/loose stools (4 to 5%), nausea (3%), and abdominal pain (2 to 3%) being the most frequently reported.
No other adverse reactions occurred in patients on the multiple-dose regimens of azithromycin with a frequency greater than 1%. Adverse reactions that occurred with a frequency of 1% or less included the following: Cardiovascular: Palpitations, chest pain. Gastrointestinal: Dyspepsia, flatulence, vomiting, melena, and cholestatic jaundice.
Genitourinary: Monilia, vaginitis, and nephritis. Nervous System: Dizziness, headache, vertigo, and somnolence. General: Fatigue.
Allergic: Rash, pruritus, photosensitivity, and angioedema. Single 1-gram dose regimen: Overall, the most common adverse reactions in patients receiving a single-dose regimen of 1 gram of azithromycin were related to the gastrointestinal system and were more frequently reported than in patients receiving the multiple-dose regimen. Adverse reactions that occurred in patients on the single 1-gram dosing regimen of azithromycin with a frequency of 1% or greater included diarrhea/loose stools (7%), nausea (5%), abdominal pain (5%), vomiting (2%), dyspepsia (1%), and vaginitis (1%).
Single 2-gram dose regimen: Overall, the most common adverse reactions in patients receiving a single 2-gram dose of azithromycin were related to the gastrointestinal system. Adverse reactions that occurred in patients in this study with a frequency of 1% or greater included nausea (18%), diarrhea/loose stools (14%), vomiting (7%), abdominal pain (7%), vaginitis (2%), dyspepsia (1%), and dizziness (1%). The majority of these complaints were mild in nature.
Clinical Trials Experience in Pediatric Patients Single and Mult…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 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)
7.1Nelfinavir 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)]
7.2Warfarin 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.
7.3Potential 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, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Geriatric use: Elderly patients may be more susceptible to development of torsades de pointes arrhythmias. (8.5)
8.1Pregnancy Risk Summary Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area.
Decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area (see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with azithromycin use in pregnant women. Limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications.
Animal Data Azithromycin administered during the period of organogenesis did not cause fetal malformations in rats and mice at oral doses up to 200 mg/kg/day (moderately maternally toxic). Based on body surface area, this dose is approximately 4 (rats) and 2 (mice) times an adult human daily dose of 500 mg. In rabbits administered azithromycin at oral doses of 10, 20, and 40 mg/kg/day during organogenesis, reduced maternal body weight and food consumption were observed in all groups; no evidence of fetotoxicity or teratogenicity was observed at these doses, the highest of which is estimated to be 2 times an adult human daily dose of 500 mg based on body surface area.
In a pre- and postnatal development study, azithromycin was administered orally to pregnant rats from day 6 of pregnancy until weaning at doses of 50 or 200 mg/kg/day. Maternal toxicity (reduced food consumption and body weight gain; increased stress at parturition) was observed at the higher dose. Effects in the offspring were noted at 200 mg/kg/day during the postnatal development period (decreased viability, delayed developmental landmarks).
These effects were not observed in a pre- and postnatal rat study when up to 200 mg/kg/day of azithromycin was given orally beginning on day 15 of pregnancy until weaning.
8.2Lactation Risk Summary Azithromycin is present in human milk (see Data). Non-serious adverse reactions have been reported in breastfed infants after maternal administration of azithromycin (see Clinical Considerations). There are no available data on the effects of azithromycin on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for azithromycin and any potential adverse effects on the breastfed infant from azithromycin or from the underlying maternal condition. Clinical Considerations Advise women to monitor the breastfed infant for diarrhea, vomiting, or rash. Data Azithromycin breastmilk concentrations were measured in 20 women after receiving a single 2 g oral dose of azithromycin during labor.
Breastmilk samples collected on days 3 and 6 postpartum as well as 2 and 4 weeks postpartum revealed the presence of azithromycin in breastmilk up t…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area.
Decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area (see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with azithromycin use in pregnant women. Limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications.
Animal Data Azithromycin administered during the period of organogenesis did not cause fetal malformations in rats and mice at oral doses up to 200 mg/kg/day (moderately maternally toxic). Based on body surface area, this dose is approximately 4 (rats) and 2 (mice) times an adult human daily dose of 500 mg. In rabbits administered azithromycin at oral doses of 10, 20, and 40 mg/kg/day during organogenesis, reduced maternal body weight and food consumption were observed in all groups; no evidence of fetotoxicity or teratogenicity was observed at these doses, the highest of which is estimated to be 2 times an adult human daily dose of 500 mg based on body surface area.
In a pre- and postnatal development study, azithromycin was administered orally to pregnant rats from day 6 of pregnancy until weaning at doses of 50 or 200 mg/kg/day. Maternal toxicity (reduced food consumption and body weight gain; increased stress at parturition) was observed at the higher dose. Effects in the offspring were noted at 200 mg/kg/day during the postnatal development period (decreased viability, delayed developmental landmarks).
These effects were not observed in a pre- and postnatal rat study when up to 200 mg/kg/day of azithromycin was given orally beginning on day 15 of pregnancy until weaning.
🧒 Pediatric Use ▾
8.4Pediatric Use [see Clinical Pharmacology (12.3), Indications and Usage (1.2), and Dosage and Administration (2.2)] Safety and effectiveness in the treatment of pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established. Use of azithromycin for the treatment of acute bacterial sinusitis and community-acquired pneumonia in pediatric patients (6 months of age or greater) is supported by adequate and well-controlled trials in adults.
Pharyngitis/Tonsillitis: Safety and effectiveness in the treatment of pediatric patients with pharyngitis/tonsillitis under 2 years of age have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use In multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4949) and 3% of patients (144/4949) were at least 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients. [see Warnings and Precautions (5.4)]
🆘 Overdosage ▾
10 OVERDOSAGE Adverse reactions experienced at higher than recommended doses were similar to those seen at normal doses particularly nausea, diarrhea, and vomiting. In the event of overdosage, general symptomatic and supportive measures are indicated as required.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Azithromycin is a macrolide antibacterial drug. [see Microbiology (12.4)]
12.2Pharmacodynamics Based on animal models of infection, the antibacterial activity of azithromycin appears to correlate with the ratio of area under the concentration-time curve to minimum inhibitory concentration (AUC/MIC) for certain pathogens ( S. pneumoniae and S. aureus ). The principal pharmacokinetic/pharmacodynamic parameter best associated with clinical and microbiological cure has not been elucidated in clinical trials with azithromycin. Cardiac Electrophysiology QTc interval prolongation was studied in a randomized, placebo-controlled parallel trial in 116 healthy subjects who received either chloroquine (1000 mg) alone or in combination with oral azithromycin (500 mg, 1000 mg, and 1500 mg once daily).
Co-administration of azithromycin increased the QTc interval in a dose- and concentration- dependent manner. In comparison to chloroquine alone, the maximum mean (95% upper confidence bound) increases in QTcF were 5 (10) ms, 7 (12) ms and 9 (14) ms with the co-administration of 500 mg, 1000 mg and 1500 mg azithromycin, respectively.
12.3Pharmacokinetics Following oral administration of a single 500 mg dose (two 250 mg tablets) to 36 fasted healthy male volunteers, the mean (SD) pharmacokinetic parameters were AUC 0–72 =4.3 (1.2) mcg∙hr/mL; C max =0.5 (0.2) mcg/mL; T max =2.2 (0.9) hours. Two azithromycin 250 mg tablets are bioequivalent to a single 500 mg tablet. In a two-way crossover study, 12 adult healthy volunteers (6 males, 6 females) received 1500 mg of azithromycin administered in single daily doses over either 5 days (two 250 mg tablets on day 1, followed by one 250 mg tablet on days 2 to 5) or 3 days (500 mg per day for days 1 to 3).
Due to limited serum samples on day 2 (3-day regimen) and days 2 to 4 (5-day regimen), the serum concentration-time profile of each subject was fit to a 3-compartment model and the AUC 0–∞ for the fitted concentration profile was comparable between the 5-day and 3-day regimens. Table 11. Pharmacokinetic Parameters for Adult Patients Receiving a 3‑Day and 5‑Day Oral Regimen 3-Day Regimen 5-Day Regimen Pharmacokinetic Parameter [mean (SD)] Day 1 Day 3 Day 1 Day 5 C max (serum, mcg/mL) 0.44 (0.22) 0.54 (0.25) 0.43 (0.20) 0.24 (0.06) Serum AUC 0–∞ (mcg∙hr/mL) 17.4 (6.2) * 14.9 (3.1) * Serum T 1/2 71.8 hr 68.9 hr * Total AUC for the entire 3-day and 5-day regimens.
Absorption The absolute bioavailability of azithromycin 250 mg capsules is 38%. In a two-way crossover study in which 12 healthy subjects received a single 500 mg dose of azithromycin (two 250 mg tablets) with or without a high fat meal, food was shown to increase C max by 23% but had no effect on AUC. When azithromycin oral suspension was administered with food to 28 adult healthy male subjects, C max increased by 56% and AUC was unchanged.
Distribution The serum protein binding of azithromycin is variable in the concentration range approximating human exposure, decreasing from 51% at 0.02 mcg/mL to 7% at 2 mcg/mL. The antibacterial activity of azithromycin is pH related and appears to be reduced with decreasing pH, However, the extensive distribution of drug to tissues may be relevant to clinical activity. Azithromycin has been shown to penetrate into human tissues, including skin, lung, tonsil, and cervix.
Extensive tissue distribution was confirmed by examination of additional tissues and fluids (bone, ejaculum, prostate, ovary, uterus, salpinx, stomach, liver, and gallbladder). As there are no data from adequate and well-controlled studies of azithromycin treatment of infections in these additional body sites, the clinical significance of these tissue concentration data is unknown. Following a regimen of 500 mg on the first day and 250 mg daily for 4 days, very low concentrations were noted in cerebrospinal fluid (less than 0.01 mcg/mL) in the presence of noninflamed meninges.
Elimination Met…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Azithromycin is a macrolide antibacterial drug. [see Microbiology (12.4)]
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Azithromycin for oral suspension USP, 100 mg/ 5mL or 200 mg/5 mL [each teaspoonful (5 mL) contains Azithromycin Dihydrate equivalent to Azithromycin USP, 100 mg or 200 mg] is supplied in bottles. Azithromycin for oral suspension, USP is white to light pink granular powder filled in translucent HDPE bottle with child-resistant cap and after constitution with water contains a red colored flavored suspension. Azithromycin for oral suspension, USP 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 (15 mL bottle) 70710-1457-1 600 mg (15 mL bottle) 70710-1458-2 900 mg (22.5 mL bottle) 70710-1459-2 1200 mg (30 mL bottle) 70710-1460-2 [see Dosage and Administration (2)] for constitution instructions with each bottle type.
Azithromycin for oral suspension, USP is supplied with child-resistant closure. Storage and Handling: Store dry powder at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature]. Store constituted suspension between 5°C to 30°C (41°F to 86°F) and discard when full dosing is completed [see Dosage and Administration (2)].
📋 Description ▾
11 DESCRIPTION Azithromycin for oral suspension, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring.
Its molecular formula is C 38 H 72 N 2 O 12 and its molecular weight is 749. Azithromycin dihydrate, USP has the following structural formula: Azithromycin dihydrate, USP, is a white or almost white powder with a molecular formula of C 38 H 72 N 2 O 12 . 2 H 2 O and a molecular weight of 785.02.
It is freely soluble in anhydrous ethanol and in methylene chloride and practically insoluble in water. Azithromycin for oral suspension, USP is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; trisodium phosphate anhydrous, hydroxypropyl cellulose; xanthan gum; FD&C Red #40; cherry flavor, ripe banana flavor. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin. img
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Important Administration Instructions Azithromycin oral suspension can be taken with or without food. Concomitant Administration with Aluminum and Magnesium Containing Antacids Advise patients not to take aluminum and magnesium containing antacids and azithromycin simultaneously.
Allergic Reactions Direct patients to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur [see warnings and Precautions (5.1)] . Vomiting, Irritability, Diarrhea or Rash with Feeding in Infants Direct parents or caregivers to contact their physician if vomiting, irritability, diarrhea or rash with feeding occurs in the infant [see Warnings and Precautions (5.3) and Use in Specific Population (8.2)] . Antibacterial Resistance Patients should be counseled that antibacterial drugs including Azithromycin for oral suspension should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When Azithromycin for oral suspension is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Azithromycin for oral suspension or other antibacterial drugs in the future.
Diarrhea Diarrhea is a common problem caused by antibacterials, including Azithromycin for oral suspension which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.6)].
Manufactured by: Zydus Lifesciences Ltd. Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc.
Pennington, NJ 08534 Rev.: 08/26