AZITHROMYCIN 250 mg Tablet, Film Coated, 6-count
🆔 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 L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
9 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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.5357 | $3.21 / 6 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| azithromycin 250 mg 00527-2370-32 | Lannett | 30 tablets | $0.268 | AB | Availability likely | — |
| Azithromycin 250 mg 00781-8089-26 | Sandoz | 1 tablet | $0.268 | AB | Availability likely | — |
| azithromycin 250 mg 00904-7350-06 | Major | 50 tablets | $0.268 | AB | Availability likely | — |
| Azithromycin 250 mg 50111-0787-10 | Teva | 30 tablets | $0.268 | AB | Availability likely | — |
| Azithromycin 250 mg 60687-0742-01 | American | 100 tablets | $0.268 | AB | Availability likely | — |
| Azithromycin Dihydrate 250 mg 68094-0900-06 | Precision | 6 tablets | $0.268 | AB | Availability likely | — |
| azithromycin 250 mg 68180-0861-06 | Lupin | 30 tablets | $0.268 | AB | Availability likely | — |
| Azithromycin 250 mg 69452-0171-04 | Bionpharma | 6 tablets | $0.268 | AB | Availability likely | — |
| Azithromycin Dihydrate 250 mg 50268-0074-13 | AvPAK | 1 tablet | $0.357 | AB | Discontinued | — |
| Azithromycin Dihydrate 250 mg 51224-0022-06 | TAGI | 6 tablets | $0.357 | AB | FDA listed | — |
| Zithromax 250 mg 00069-4061-01 | Pfizer | 30 tablets | $2.067 | AB | Availability likely | — |
| Azithromycin 250 mg 42291-0082-06 | AvKARE | 6 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 46708-0057-06 | Alembic | 6 tablets | — | AB | FDA listed | — |
| Azithromycin Dihydrate 250 mg 50090-4527-00 | A-S | 4 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 50090-6436-00 | A-S | 4 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 50090-7550-00 | A-S | 4 tablets | — | AB | FDA listed | — |
| azithromycin 250 mg 55154-3374-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Azithromycin 250 mg 62332-0251-06 | Alembic | 6 tablets | — | AB | FDA listed | — |
| azithromycin 250 mg 64980-0727-03 | Rising | 30 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 65862-0641-01 | Aurobindo | 100 tablets | — | AB | FDA listed | — |
| azithromycin 250 mg 67046-0508-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Azithromycin Dihydrate 250 mg 67046-1502-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Zithromax 250 mg 67296-0020-01 | Redpharm | 4 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 68071-2266-04 | NuCare | 4 tablets | — | AB | FDA listed | — |
| Azithromycin Dihydrate 250 mg 68071-3715-04 | NuCare | 4 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 68071-4812-04 | NuCare | 4 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 68071-4902-06 | NuCare | 6 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 70518-0784-01 | REMEDYREPACK | 4 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 70518-2433-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| azithromycin 250 mg 70518-4356-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Azithromycin Dihydrate 250 mg 71093-0174-01 | ACI | 30 tablets | — | — | FDA listed | — |
| Azithromycin 250 mg 71205-0158-03 | Proficient | 3 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 72162-2668-03 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mgthis 72189-0087-06 | DIRECT | 6 tablets | — | AB | FDA listed | — |
| Azithromycin Dihydrate 250 mg 72789-0081-02 | PD-Rx | 2 tablets | — | AB | FDA listed | — |
| Azithromycin Dihydrate 250 mg 72789-0483-02 | PD-Rx | 2 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 69306-0250-06 | Doc | 6 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 71205-0424-06 | Proficient | 6 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 76420-0649-06 | Asclemed | 6 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 71205-0645-06 | Proficient | 1 tablet | — | AB | FDA listed | — |
| Azithromycin 250 mg 85766-0008-06 | Sportpharm | 1 tablet | — | AB | FDA listed | — |
| Azithromycin 250 mg 50090-4721-03 | A-S | 6 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 68788-8702-06 | Preferred | 6 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 72189-0093-06 | DIRECT | 6 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 76420-0213-06 | Asclemed | 1 tablet | — | AB | FDA listed | — |
| Azithromycin 250 mg 50090-4720-00 | A-S | 6 tablets | — | AB | FDA listed | — |
| azithromycin 250 mg 82804-0214-06 | Proficient | 6 tablets | — | AB | FDA listed | — |
| Azithromycin 250 mg 68788-8124-06 | Preferred | 1 tablet | — | AB | FDA listed | — |
| Azithromycin 250 mg 50090-8012-00 | A-S | 6 tablets | — | 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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72189-0087-06 You're viewing this | 6 TABLET, FILM COATED in 1 BOTTLE (72189-087-06) | 2020-06-15 | Active |
| 72189-0087-10 | 10 TABLET, FILM COATED in 1 BOTTLE (72189-087-10) | 2020-06-15 | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 72189-0087-06?
What is the difference between NDC 72189-0087-06 and NDC 72189-0087-10?
What NDC number is used to bill for this package of AZITHROMYCIN 250 mg Tablet, Film Coated?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
Azithromycin tablets are 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)]
1.1Adult 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.
1.2Pediatric 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 pneumoniae, 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.
1.3Limitations 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).
1.4Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin tablets 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.
⏱️ Dosage and Administration ▾
2.1Adult Patients [see Indications and Usage (1.1) and Clinical Pharmacology (12.3)] * DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)] 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 Azithromycin tablets can be taken with or without food.
2.2Pediatric 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 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 * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. 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) 1.25 mL; (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 tsp) 3.75 mL; (¾ tsp) 22.5 mL 900 mg 40 10 mL; (2 tsp) 5 mL; (1 tsp) 30 mL 1,200 mg 50 and above 12.5 mL; (2½ tsp) 6.25 mL; (1¼ tsp) 37.5 mL 1,500 mg * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis 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 to 3 Days 1 to 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 1,200 mg 50 and above 12.5 mL; (2 ½ tsp) 37.5 mL 1,500 mg 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 1 Day Regimen 5 3.75 mL;(3/4 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 1,200 mg 50 and above 37.5 mL;(7½ tsp) 37.5 mL 1,500 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, [see Use in Specific Populations (8.4)]) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/…
💊 Dosage Forms and Strengths ▾
Azithromycin tablets, USP 250 mg are supplied as white, oblong, biconvex, film-coated tablets containing azithromycin dihydrate, USP equivalent to 250 mg of azithromycin. Azithromycin tablets, USP 250 mg are debossed with “250” on one side. These are packaged in bottles and blister cards of 6 tablets.
Azithromycin tablets, USP 500 mg are supplied as white, oblong, biconvex, film-coated tablets containing azithromycin dihydrate, USP equivalent to 500 mg of azithromycin. Azithromycin tablets, USP 500 mg are debossed with “500” on one side. These are packaged in bottles and blister cards of 3 tablets.
⛔ Contraindications ▾
4.1Hypersensitivity Azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug.
4.2Hepatic Dysfunction Azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
⚠️ Warnings and Cautions ▾
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 (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.
5.4QT 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, sotalol) antiarrhythmic agents.
Elderly patients may be more susceptible to drug-associated effects on the QT interval.
5.5Clostridium 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. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C. difficile cause 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.
5.6Exacerbation of Myasthenia Gravis Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patie…
🤒 Adverse Reactions ▾
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)] 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.
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% 1.0% 1.0% 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 stool…
🔄 Drug Interactions ▾
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 ▾
8.1Pregnancy 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 to 4 weeks after dosing. In another study, a single dose of azithromycin 500 mg was administered intravenously to 8 women prior to incision for…
🆘 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 ▾
12.1Mechanism 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 (1,000 mg) alone or in combination with oral azithromycin (500 mg, 1,000 mg, and 1,500 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, 1,000 mg and 1,500 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 AUC0-72 = 4.3 (1.2) mcg·hr/mL; Cmax = 0.5 (0.2) mcg/mL; Tmax = 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 1,500 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 AUC0-∞ for the fitted concentration profile was comparable between the 5-day and 3-day regimens. * Total AUC for the entire 3-day and 5-day regimens. 3-Day Regimen 5-Day Regimen Pharmacokinetic Parameter [mean (SD)] Day 1 Day 3 Day 1 Day 5 Cmax (serum, mcg/mL) 0.44 (0.22) 0.54 (0.25) 0.43 (0.20) 0.24 (0.06) Serum AUC0-∞ (mcg∙hr/mL) 17.4 (6.2)* 14.9 (3.1)* Serum T1/2 71.8 hr 68.9 hr 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 Cmax by 23% but had no effect on AUC. When azithromycin oral suspension was administered with food to 28 adult healthy male subjects, Cmax 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. Metabolism In vitro and in vivo studies to assess the metabolism of azithromycin have not been performed.
Elimination Plasma concentrations of…
📦 How Supplied / Storage and Handling ▾
Azithromycin tablets, USP are supplied in the following strengths and package configurations: Azithromycin tablets, USP 250 mg are supplied as white, oblong, biconvex, film-coated tablets, containing azithromycin dihydrate, USP equivalent to 250 mg azithromycin. Azithromycin tablets, USP 250 mg are debossed with “250” on one side. These are packaged in bottles and blister cards of 6 tablets as follows: Azithromycin tablets, USP 500 mg are supplied as white, oblong, biconvex, film-coated tablets, containing azithromycin dihydrate, USP equivalent to 500 mg azithromycin.
Azithromycin tablets, USP 500 mg are debossed with “500” on one side. These are packaged in bottles and blister cards of 3 tablets as follows: Azithromycin tablets, USP should be stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
📋 Description ▾
Azithromycin tablets, 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 C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula: [Structure] Azithromycin, as the dihydrate, is a white or almost white powder with a molecular formula of C38H72N2O12•2H2O and a molecular weight of 785.02. Azithromycin is supplied as tablets containing azithromycin dihydrate, USP equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.
💬 Patient Medication Information ▾
Azithromycin (ay zith" roe mye' sin) Tablets Read this Patient Information leaflet before you start taking azithromycin tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What are azithromycin tablets? Azithromycin tablets are macrolide antibiotic prescription medicine used in adults 18 years or older to treat certain infections caused by certain germs called bacteria. These bacterial infections include: acute worsening of chronic bronchitis acute sinus infection community-acquired pneumonia infected throat or tonsils skin infections infections of the urethra or cervix genital ulcers in men Azithromycin tablets are also used in children to treat: ear infections community-acquired pneumonia infected throat or tonsils Azithromycin should not be taken by people who cannot tolerate oral medications because they are very ill or have certain other risk factors including: have cystic fibrosis have hospital acquired infections have known or suspected bacteria in the blood need to be in the hospital are elderly have any medical problems that can lower the ability of the immune system to fight infections Azithromycin tablets are not for viral infections such as the common cold.
It is not known if azithromycin tablets are safe and effective for genital ulcers in women. It is not known if azithromycin tablets are safe and effective for children with ear infections, sinus infections, and community-acquired pneumonia under 6 months of age. It is not known if azithromycin tablets are safe and effective for infected throat or tonsils in children under 2 years of age.
Who should not take azithromycin tablets? Do not take azithromycin tablets if you: have had a severe allergic reaction to certain antibiotics known as macrolides or ketolides including azithromycin and erythromycin. have a history of cholestatic jaundice or hepatic dysfunction that happened with the use of azithromycin. What should I tell my healthcare provider before taking azithromycin tablets?
Before you take azithromycin tablets, tell your healthcare provider if you: have pneumonia have cystic fibrosis have known or suspected bacteremia (bacterial infection in the blood) have liver or kidney problems have an irregular heartbeat, especially a problem called "QT prolongation". have a problem that causes muscle weakness (myasthenia gravis) have any other medical problems are pregnant or plan to become pregnant. It is not known if azithromycin tablets will harm your unborn baby. are breastfeeding or plan to breastfeed.
Azithromycin has been reported to pass into breast milk. Talk to your healthcare provider about the best way to feed your baby while you take azithromycin tablets. Contact your healthcare provider immediately if you are giving azithromycin tablets to a young child (less than 6 weeks of age) and he or she vomits or becomes irritable when fed.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Azithromycin tablets and other medicines may affect each other causing side effects. Azithromycin tablets may affect the way other medicines work, and other medicines may affect how azithromycin tablets work.
Especially tell your healthcare provider if you take: nelfinavir a blood thinner (warfarin) digoxin colchicine phenytoin an antacid that contains aluminum or magnesium Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take azithromycin tablets?
Take azithromycin tablets exactly as your healthcare provider tells you to take it. Azithromycin tablets can be taken with or without food. Do not skip any doses of azithromycin tablets or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unl…