Azithromycin 200 mg/5mL Powder, For Suspension, 30 mL — NDC 63187-093-30 (Billing 63187-0093-30)
This is a package of 30 mL of Azithromycin 200 mg/5mL Powder, For Suspension from Proficient Rx LP, marketed since Dec 2010 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 63187-093-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 63187 labeler · 093 product · 30 package
- Package marketed since
- Jul 1, 2014
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0363187093150
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 018544
- GCN: 61199
- HICL (First Databank): 006334
- AHFS class code: 08:12.12.08
- RxCUI (RxNorm): 141963
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Macrolide Antimicrobial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It treats certain mild to moderate bacterial infections, like sinus, throat, ear, lung, skin and some genital infections. The IV form is for pneumonia and pelvic inflammatory disea...
- Tablets can be taken with or without food. If it upsets your stomach, taking it with food may help. Take it exactly as your prescriber and label direct, and finish the course.
- The most common are diarrhea, nausea, stomach pain and vomiting. They are usually mild. Call your doctor if they are severe or don't settle.
- Get emergency help for facial or throat swelling, trouble breathing, or a severe blistering rash. Call promptly for yellow skin or eyes, a racing or irregular heartbeat, fainting,...
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.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | 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 | $0.3238 | $9.71 / 30 ml |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 63187-0093-15 63187-093-15 Main listing | 15 mL in 1 BOTTLE | 2014-07-01 | — | Active |
| 63187-0093-30 You're viewing this | 30 mL in 1 BOTTLE | 2014-07-01 | — | Active |
| 63187-0093-22 63187-093-22 | 22.5 mL in 1 BOTTLE | 2024-04-03 | — | Active |
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 63187-0093-15?
What NDC number is used to bill for this package of Azithromycin 200 mg/5mL Powder, For Suspension?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Azithromycin 200 mg/5mL 24658-0708-34 | PURACAP | 30 ml | $0.205 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 42806-0151-34 | Epic | 30 ml | $0.205 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 62135-0705-43 | Chartwell | 30 ml | $0.205 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 70710-1460-02 | Zydus | 1 bottle | $0.205 | AB | Availability likely | — |
| azithromycin dihydrate 200 mg/5mL 70436-0222-36 | Slate | 1 bottle | $0.219 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 24658-0707-33 | PURACAP | 22.5 ml | $0.238 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 42806-0150-33 | Epic | 22.5 ml | $0.238 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 70710-1459-02 | Zydus | 1 bottle | $0.238 | AB | Availability likely | — |
| azithromycin dihydrate 200 mg/5mL 70436-0228-49 | Slate | 1 bottle | $0.238 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 00093-2026-23 | Teva | 15 ml | $0.285 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 11788-0129-13 | AiPing | 1 bottle | $0.285 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 24658-0706-32 | PURACAP | 15 ml | $0.285 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 42806-0149-32 | Epic | 15 ml | $0.285 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 59651-0008-15 | Aurobindo | 1 bottle | $0.285 | AB | Availability likely | — |
| Azithromycin 200 mg/5mL 70710-1458-02 | Zydus | 1 bottle | $0.285 | AB | Availability likely | — |
| azithromycin dihydrate 200 mg/5mL 70436-0221-34 | Slate | 1 bottle | $0.325 | AB | Availability likely | — |
| 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/5mLthis 63187-0093-30 | Proficient | 30 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?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Proficient Rx LP labeler code 63187
- Fluoxetine 10 mg Capsule NDC 63187-081-30
- meloxicam 7.5 mg Tablet NDC 63187-082-06
- meloxicam 15 mg Tablet NDC 63187-083-10
- Tramadol Hydrochloride and Acetaminophen 37.5 mg; 325 mg Tablet NDC 63187-084-30
- Methocarbamol 500 mg Tablet NDC 63187-087-00
- Lovastatin 20 mg Tablet NDC 63187-090-30
- Cyclobenzaprine Hydrochloride 5 mg Tablet, Film Coated NDC 63187-094-10
- Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g Cream NDC 63187-095-15
- Lisinopril 10 mg Tablet NDC 63187-098-30
- Loratadine Allergy Relief 10 mg Tablet NDC 63187-100-10
- Paroxetine 20 mg Tablet, Film Coated NDC 63187-105-30
- Acetaminophen and Codeine Phosphate 300 mg; 30 mg Tablet NDC 63187-106-15
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Azithromycin contents per bottle 600 mg
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Azithromycin for oral suspension USP is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS ) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations. Adults Acute bacterial exacerbations of chronic obstructive pulmonary disease 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. NOTE: 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 nosocomially acquired 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).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. NOTE: Penicillin by the intramuscular route is the usual drug of choice in the treatment of Streptococcus pyogenes infection and the prophylaxis of rheumatic fever. Azithromycin for oral suspension USP is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx.
Because some strains are resistant to azithromycin for oral suspension USP, susceptibility tests should be performed when patients are treated with azithromycin for oral suspension USP. Data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available. Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae.
Abscesses usually require surgical drainage. 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. Azithromycin for oral suspension USP, at the recommended dose, should not be relied upon to treat syphilis. Antimicrobial agents used in high doses for short periods of time 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 cultures for gonorrhea performed at the time of diagnosis. Appropriate antimicrobial therapy and follow-up tests for these diseases should be initiated if infection is confirmed. Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin, USP.
Therapy with azithromycin for oral suspension USP may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly. 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 or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, th… [Excerpted — this section continues on DailyMed.]
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY . Adults Infection DUE TO THE INDICATED ORGANISMS (see INDICATIONS AND USAGE ). 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 obstructive pulmonary disease (mild to moderate) 500 mg QD x 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 QD x 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 Renal Insufficiency No dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min).
The mean AUC 0-120 was similar in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency ). Hepatic Insufficiency The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established.
No dose adjustment recommendations can be made in patients with impaired hepatic function (see CLINICALPHARMACOLOGY, Special Populations, Hepatic Insufficiency ). No dosage adjustment is recommended based on age or gender (see CLINICAL PHARMACOLOGY, Special Populations ). Pediatric Patients Azithromycin for oral suspension can be taken with or without food.
Acute Otitis Media: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.) Acute Bacterial Sinusitis: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.) Community-Acquired Pneumonia: The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5.
(See chart below.) PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS, Pediatric Use .) Based on Body Weight OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5 Day Regimen) Effectiveness of the 3 day or 1 day regimen in pediatric patients with community-acquired pneumonia has not been established. Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs.
Day 1 Days 2 to 5 Day 1 Days 2 to 5 5 11 2.5 mL (½ tsp) 1.25 mL ( 1 / 4 tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 2.5 mL ( 1 / 2 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 2.5 mL (½ tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 3.75 mL (¾ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 5 mL (1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2½ tsp) 6.25 mL (1¼ tsp) 37.5 mL 1500 mg OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3 Day Regimen) Effectiveness of the 5 day or 1 day regimen in pediatric patients with acute bacterial sinusitis has not been established.
Dosing Calculated on 10 mg/kg/day. Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Lbs. Day 1 to 3 Day 1 to 3 5 11 2.5 mL (½ tsp) 7.5 mL 150 mg 10 22 5 mL (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 22.5 mL 900 mg… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin any macrolide or ketolide antibiotic. Azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
⚠️ Warnings ▾
WARNINGS Hypersensitivity Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely in patients on azithromycin therapy. Although rare, fatalities have been reported (see CONTRAINDICATIONS ). 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 unknown at present. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted.
Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued. 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.
Treatment of Pneumonia In the treatment of pneumonia, azithromycin has only been shown to be safe and effective in the treatment of community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilusinfluenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. 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 thefollowing: patients with cystic fibrosis, patients with nosocomially acquired 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 totheir illness (including immunodeficiency or functional asplenia).
Clostridium Difficile- associated Diarrhea Clostridium difficile- associated diarrhea (CDAD) 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 antimicrobial 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. QT Prolongation Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsade de pointes, have been seen in treatment with macrolides, including azithromycin.
Cases of torsade 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 torsade de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure • patients on drugs known to prolong the QT interval • patients with ongoing p… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 side effects of angioedema and cholestatic jaundice were reported rarely. 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 side effects.
In adults given 500 mg/day for 3 days, the discontinuation rate due to treatment-related side effects 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 side effects was approximately 1% (see DOSAGE AND ADMINISTRATION ). Most of the side effects leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain (see CLINICAL STUDIES, Pediatric Patients ).
Clinical Adults Multiple-dose regimens: Overall, the most common treatment-related side effects 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 treatment-related side effects occurred in patients on the multiple-dose regimens of azithromycin with a frequency greater than 1%. Side effects 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 side effects 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.
Side effects that occurred in patients on the single one-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 side effects in patients receiving a single 2 gram dose of azithromycin were related to the gastrointestinal system. Side effects 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 side effects 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 side effects (≥ 1%) attributed to treatment were diarrhea, abdominal pain, vomiting, nausea and rash (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES, Pediatric Patients ).
The incidence, based on dosing regimen, is described in the table below: Dosage Regimen Diarrhea, % Abdominal Pain, % Vomiting, % Nausea, % Rash, % 1 day 4.3% 1.4% 4.9% 1% 1% 3 day 2.6% 1.7% 2.3% 0.4% 0.6% 5 day 1.8% 1.2% 1.1% 0.5% 0.4% Community-Acquired Pneumonia: For the recommended dosage regimen of 10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5, the most frequent side effects attributed to treatment were diarrhea/loose stools, abdominal pain, vomiting, nausea and rash. The incidence is described in the table below: Dosage Regimen Diarrhea/Loose stools, % Abdominal Pain, % Vomiting, % Nausea, % Rash, % 5 day 5.8% 1.9% 1.9% 1.9% 1.6% Pharyngitis/tonsillitis: For the recommended dosage r… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
Drug Interactions Coadministration 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 side effects of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted (see ADVERSE REACTIONS ). Although, in a study of 22 healthy men, a 5 day course of azithromycin did not affect the prothrombin time from a subsequently administered dose of warfarin, spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants.
Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly. Drug interaction studies were performed with azithromycin and other drugs likely to be coadministered (see CLINICAL PHARMACOLOGY, Drug-Drug Interactions ). When used in therapeutic doses, azithromycin had a modest effect on the pharmacokinetics of atorvastatin, carbamazepine, cetirizine, didanosine, efavirenz, fluconazole, indinavir, midazolam, rifabutin, sildenafil, theophylline (intravenous and oral), triazolam, trimethoprim/sulfamethoxazole or zidovudine.
Coadministration with efavirenz, or fluconazole had a modest effect on the pharmacokinetics of azithromycin. No dosage adjustment of either drug is recommended when azithromycin is coadministered with any of the above agents. Interactions with the drugs listed below have not been reported in clinical trials with azithromycin; however, no specific drug interaction studies have been performed to evaluate potential drug-drug interaction.
Nonetheless, they have been observed with macrolide products. Until further data are developed regarding drug interactions when azithromycin and these drugs are used concomitantly, careful monitoring of patients is advised: Digoxin–elevated digoxin concentrations. Ergotamine or dihydroergotamine–acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.
Terfenadine, cyclosporine, hexobarbital and phenytoin concentrations.
🔄 Drug / Laboratory Test Interactions ▾
Laboratory Test Interactions There are no reported laboratory test interactions.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rats and mice at doses up to moderately maternally toxic dose concentrations (i.e., 200 mg/kg/day). These doses, based on a mg/m 2 basis, are estimated to be 4 and 2 times, respectively, the human daily dose of 500 mg. In the animal studies, no evidence of harm to the fetus due to azithromycin was found.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use See CLINICAL PHARMACOLOGY , INDICATIONS AND USAGE , and DOSAGE AND ADMINISTRATION . Acute Otitis Media (total dosage regimen: 30 mg/kg, see DOSAGE AND ADMINISTRATION ): Safety and effectiveness in the treatment of pediatric patients with otitis media under 6 months of age have not been established. Acute Bacterial Sinusitis (dosage regimen: 10 mg/kg on Days 1 to 3): Safety and effectiveness in the treatment of pediatric patients with acute bacterial sinusitis under 6 months of age have not been established.
Use of azithromycin for the treatment of acute bacterial sinusitis in pediatric patients (6 months of age or greater) is supported by adequate and well-controlled studies in adults, similar pathophysiology of acute sinusitis in adults and pediatric patients, and studies of acute otitis media in pediatric patients. Community-Acquired Pneumonia (dosage regimen: 10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5): Safety and effectiveness in the treatment of pediatric patients with community-acquired pneumonia under 6 months of age have not been established.
Safety and effectiveness for pneumonia due to Chlamydophilapneumoniae and Mycoplasma pneumoniae were documented in pediatric clinical trials. Safety and effectiveness for pneumonia due to Haemophilus influenzae and Streptococcus pneumoniae were not documented bacteriologically in the pediatric clinical trial due to difficulty in obtaining specimens. Use of azithromycin for these two microorganisms is supported, however, by evidence from adequate and well-controlled studies in adults.
Pharyngitis/Tonsillitis (dosage regimen: 12 mg/kg on Days 1 to 5): Safety and effectiveness in the treatment of pediatric patients with pharyngitis/tonsillitis under 2 years of age have not been established. Studies evaluating the use of repeated courses of therapy have not been conducted (see CLINICAL PHARMACOLOGY and ANIMAL TOXICOLOGY ).
🧓 Geriatric Use ▾
Geriatric Use Pharmacokinetic parameters in older volunteers (65 to 85 years old) were similar to those in younger volunteers (18 to 40 years old) for the 5 day therapeutic regimen. Dosage adjustment does not appear to be necessary for older patients with normal renal and hepatic function receiving treatment with this dosage regimen (see CLINICAL PHARMACOLOGY ). 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 torsade de pointes arrhythmia than younger patients (see WARNINGS ). Azithromycin for oral suspension USP, 100 mg/5 mL contains 8.8 mg of sodium per 5 mL of constituted solution.
Azithromycin for oral suspension USP, 200 mg/5 mL contains 8.8 mg of sodium per 5 mL of constituted solution.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics 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·h/mL; C max = 0.5 (0.2) mcg/mL; T max = 2.2 (0.9) hours. With a regimen of 500 mg (two 250 mg capsules*) on day 1, followed by 250 mg daily (one 250 mg capsule) on days 2 through 5, the pharmacokinetic parameters of azithromycin in plasma in healthy young adults (18 to 40 years of age) are portrayed in the chart below.
C min and C max remained essentially unchanged from day 2 through day 5 of therapy. *Azithromycin 250 mg tablets are bioequivalent to 250 mg capsules in the fasted state. Azithromycin 250 mg capsules are no longer commercially available. Pharmacokinetic Parameters (Mean) Total n = 12 Day 1 Day 5 C max (mcg/mL) 0.41
0.24T max (h) 2.5
3.2AUC 0-24 (mcg·h/mL) 2.6
2.1C min (mcg/mL) 0.05
0.05Urinary Excret. (% dose) 4.5
6.5In 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 AUC 0-∞ for the fitted concentration profile was comparable between the 5 day and 3 day regimens.
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 Median azithromycin exposure (AUC 0-288 ) in mononuclear (MN) and polymorphonuclear (PMN) leukocytes following either the 5 day or 3 day regimen was more than a 1000 fold and 800 fold greater than in serum, respectively. Administration of the same total dose with either the 5 day or 3 day regimen may be expected to provide comparable concentrations of azithromycin within MN and PMN leukocytes.
Two azithromycin 250 mg tablets are bioequivalent to a single 500 mg tablet. 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 suspension was administered with food to 28 adult healthy male subjects, C max increased by 56% and AUC was unchanged. The AUC of azithromycin was unaffected by coadministration of an antacid containing aluminum and magnesium hydroxide with azithromycin capsules; however, the C max was reduced by 24%. Administration of cimetidine (800 mg) two hours prior to azithromycin had no effect on azithromycin absorption.
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. Following oral administration, azithromycin is widely distributed throughout the body with an apparent steady-state volume of distribution of
31.1L/kg. Greater azithromycin concentrations in tissues than in plasma or serum were observed. High tissue concentrations should not be interpreted to be quantitatively related to clinical efficacy.
The antimicrobial 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. Selected tissue (or fluid) concentration and tissue (or fluid) to plasma/serum concentration ratios are shown in the following table: AZITHROMYCIN CONCENTRATIONS FOLLOWING A 500 mg DOSE (TWO 250 mg CAPSULES) IN ADULTS TISSUE OR FLUID TIME AFTER DOSE (h) TISSUE OR FLUID CONCENTRATION (mcg/g or mcg/mL… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
Mechanism of Action Azithromycin binds to the 23S rRNA of the bacterial 50S ribosomal subunit. It blocks protein synthesis by inhibiting the transpeptidation/translocation step of protein synthesis and by inhibiting the assembly of the 50S ribosomal subunit. Azithromycin concentrates in phagocytes and fibroblasts as demonstrated by in vitro incubation techniques.
The ratio of intracellular to extracellular concentration was > 30 after one hour incubation. In vivo studies suggest that concentration in phagocytes may contribute to drug distribution to inflamed tissues.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Azithromycin for oral suspension USP after constitution contains a flavored pink suspension. Azithromycin for oral suspension USP is supplied to provide 200 mg/5 mL suspension in bottles as follows: 200mg/5ml Suspension 15ml NDC (63187-093-15) 200mg/5ml Suspension 22.5ml NDC (63187-093-22) 200mg/5ml Suspension 30ml NDC (63187-093-30) Azithromycin contents per bottle 600 mg See DOSAGE AND ADMINISTRATION for constitution instructions with each bottle type. Storage: Store dry powder at 20° to 25°C (68° to 77°F)[See USP Controlled Room Temperature].
Store constituted suspension between 5° to 25°C (41° to 77°F) and discard when full dosing is completed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
📋 Description ▾
DESCRIPTION Azithromycin for oral suspension USP contains the active ingredient azithromycin, USP, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin, USP 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, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring.
Azithromycin, USP has the following structural formula: C 38 H 72 N 2 O 12 M.W. 749.0 Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C 38 H 72 N 2 O 12 •H 2 O and a molecular weight of 767.0. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No.
40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP. Chemical structure
💬 Information for Patients ▾
Information for Patients Azithromycin for oral suspension can be taken with or without food. Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously. The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur.
Patients should be counseled that antibacterial drugs including azithromycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When azithromycin 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 or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 antibiotic.
If this occurs, patients should contact their physician as soon as possible.
⚠️ Precautions ▾
PRECAUTIONS General Because azithromycin is principally eliminated via the liver, caution should be exercised when azithromycin is administered to patients with impaired hepatic function. Due to the limited data in subjects with GFR < 10 mL/min, caution should be exercised when prescribing azithromycin in these patients (see CLINICAL PHARMACOLOGY, Special Populations, Renal Insufficiency ). Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
Prescribing azithromycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Information for Patients Azithromycin for oral suspension can be taken with or without food. Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously.
The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur. Patients should be counseled that antibacterial drugs including azithromycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
When azithromycin 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 or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.
Sometimes after starting treatment with antibiotics, 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 antibiotic. If this occurs, patients should contact their physician as soon as possible. Drug Interactions Coadministration 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 side effects of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted (see ADVERSE REACTIONS ). Although, in a study of 22 healthy men, a 5 day course of azithromycin did not affect the prothrombin time from a subsequently administered dose of warfarin, spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants.
Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly. Drug interaction studies were performed with azithromycin and other drugs likely to be coadministered (see CLINICAL PHARMACOLOGY, Drug-Drug Interactions ). When used in therapeutic doses, azithromycin had a modest effect on the pharmacokinetics of atorvastatin, carbamazepine, cetirizine, didanosine, efavirenz, fluconazole, indinavir, midazolam, rifabutin, sildenafil, theophylline (intravenous and oral), triazolam, trimethoprim/sulfamethoxazole or zidovudine.
Coadministration with efavirenz, or fluconazole had a modest effect on the pharmacokinetics of azithromycin. No dosage adjustment of either drug is recommended when azithromycin is coadministered with any of the above agents. Interactions with the drugs listed below have not been reported in clinical trials with azithromycin; however, no specific drug interaction studies have been performed to evaluate potential drug-drug interaction.
Nonetheles… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.
🧬 Pharmacodynamics ▾
Pharmacodynamics 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 azithromycin (500 mg, 1000 mg, and 1500 mg once daily). Coadministration 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 coadministration of 500 mg, 1000 mg and 1500 mg azithromycin, respectively.
🔬 Clinical Studies ▾
CLINICAL STUDIES See INDICATIONS AND USAGE and Pediatric Use . Pediatric Patients From the perspective of evaluating pediatric clinical trials, Days 11 to 14 were considered on-therapy evaluations because of the extended half-life of azithromycin. Day 11 to 14 data are provided for clinical guidance.
Day 24 to 32 evaluations were considered the primary test of cure endpoint. Acute Otitis Media Safety and efficacy using azithromycin 30 mg/kg given over 5 days Protocol 1 In a double-blind, controlled clinical study of acute otitis media performed in the United States, azithromycin (10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5) was compared to amoxicillin/clavulanate potassium (4:1). For the 553 patients who were evaluated for clinical efficacy, the clinical success rate (i.e., cure plus improvement) at the Day 11 visit was 88% for azithromycin and 88% for the control agent.
For the 521 patients who were evaluated at the Day 30 visit, the clinical success rate was 73% for azithromycin and 71% for the control agent. In the safety analysis of the above study, the incidence of treatment-related adverse events, primarily gastrointestinal, in all patients treated was 9% with azithromycin and 31% with the control agent. The most common side effects were diarrhea/loose stools (4% azithromycin vs.
20% control), vomiting (2% azithromycin vs. 7% control), and abdominal pain (2% azithromycin vs. 5% control).
Protocol 2 In a non-comparative clinical and microbiologic trial performed in the United States, where significant rates of beta-lactamase producing organisms (35%) were found, 131 patients were evaluable for clinical efficacy. The combined clinical success rate (i.e., cure and improvement) at the Day 11 visit was 84% for azithromycin. For the 122 patients who were evaluated at the Day 30 visit, the clinical success rate was 70% for azithromycin.
Microbiologic determinations were made at the pre-treatment visit. Microbiology was not reassessed at later visits. The following presumptive bacterial/clinical cure outcomes (i.e., clinical success) were obtained from the evaluable group: Presumed Bacteriologic Eradication Day 11 Azithromycin Day 30 Azithromycin S. pneumoniae 61/74 (82%) 40/56 (71%) H. influenzae 43/54 (80%) 30/47 (64%) M. catarrhalis 28/35 (80%) 19/26 (73%) S. pyogenes 11/11 (100%) 7/7 Overall 177/217 (82%) 97/137 (73%) In the safety analysis of this study, the incidence of treatment-related adverse events, primarily gastrointestinal, in all patients treated was 9%.
The most common side effect was diarrhea (4%). Protocol 3 In another controlled comparative clinical and microbiologic study of otitis media performed in the United States, azithromycin was compared to amoxicillin/clavulanate potassium (4:1). This study utilized two of the same investigators as Protocol 2 (above), and these two investigators enrolled 90% of the patients in Protocol 3.
For this reason, Protocol 3 was not considered to be an independent study. Significant rates of beta-lactamase producing organisms (20%) were found. Ninety-two (92) patients were evaluable for clinical and microbiologic efficacy.
The combined clinical success rate (i.e., cure and improvement) of those patients with a baseline pathogen at the Day 11 visit was 88% for azithromycin vs. 100% for control; at the Day 30 visit, the clinical success rate was 82% for azithromycin vs. 80% for control.
Microbiologic determinations were made at the pre-treatment visit. Microbiology was not reassessed at later visits. At the Day 11 and Day 30 visits, the following presumptive bacterial/clinical cure outcomes (i.e., clinical success) were obtained from the evaluable group: Presumed Bacteriologic Eradication Day 11 Day 30 Azithromycin Control Azithromycin Control S. pneumoniae 25/29 (86%) 26/26 (100%) 22/28 (79%) 18/22 (82%) H. influenzae 9/11 (82%) 9/9 8/10 (80%) 6/8 M. catarrhalis 7/7 5/5 5/5 2/3 S. pyogenes 2/2 5/5 2/2 4/4 Overall 43/49 (88%) 45/45 (100%) 37/45 (82%) 30/37 (81%) In the s… [Excerpted — this section continues on DailyMed.]
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
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. No evidence of impaired fertility due to azithromycin was found.
📚 References ▾
REFERENCES • Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Ninth Edition . CLSI document M07-A9.
CLSI 950 West Valley Rd, Suite 250, Wayne, PA 19087, 2012. • CLSI, Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement. CLSI document M100-S22 . CLSI, Wayne, PA 19087, 2012. • CLSI.
Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - Eleventh Edition. CLSI document M02-A11. CLSI, Wayne, PA 19087, 2012.
Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. E 2/2013 Relabeled by: PROFICIENT RX LP Thousand Oaks, CA 91320
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL 63187-093-15
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