Azithromycin is a macrolide antimicrobial sold in the U.S. under 4 brand and generic names, for chlamydia infections, haemophilus infections and nontuberculous mycobacterium infections. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Azithromycin (application ANDA207566). Other azithromycin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
[see Indications and Usage (1) ] Azithromycin can be taken with or without food. However, increased tolerability has been observed when tablets are taken with food. For pediatric suspension see the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles. Mycobacterial Infections ( 2.2 ) 2.2 Mycobacterial Infections Prevention of Disseminated MAC Infections The recommended dose of azithromycin tablets for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1,200 mg taken once weekly. This dose of azithromycin tablets may be combined with the approved dosage regimen of rifabutin. Treatment of Disseminated MAC Infections Azithromycin should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Infantile Hypertrophic Pyloric Stenosis (IHPS) [see Warnings and Precautions (5.3) ] QT Prolongation [see Warnings and Precautions (5.4) ] Cardiovascular Death [see Warnings and Precautions (5.5) ] Clostridiodes difficile-Associated Diarrhea (CDAD) [see Warnings and Precautions (5.6) ] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.7) ] The most common adverse reactions are diarrhea (5%), nausea (3%), abdominal pain (3%), or vomiting, (no percent given). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Precision Dose, Inc. at 1-800-397-9228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 adverse reactions were mild to moderate in severity and were reversible upon discontinuation of the drug. Approximately 0.7% of the patients from the multiple-dose clinical trials discontinued azithromycin therapy because of treatment-related…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Drops | Generic | $9 | View → | |
| 2 | 56/100 | Prescription | Injectable | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 67;D | 500 mg | white | oval | — |
| 66;D | 250 mg | white | capsule | — |
| OE;500 | 500 mg | red | oval | — |
| L70 | 250 mg | white | capsule | — |
| L95 | 500 mg | white | capsule | — |
| OE;500 | 500 mg | red |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
The elimination half-life of azithromycin is about 68 hours. The unusually long half-life reflects the parent drug's extensive uptake into and slow release from body tissues, not an active metabolite (azithromycin is largely eliminated unchanged); the value is from single 500 mg dosing in adults with normal organ function.
ZITHROMAX (azithromycin) tablets and for oral suspension — FDA prescribing information (DailyMed) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibiotic. ( 4.1 ) Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. ( 4.2 ) 4.1 Hypersensitivity Azithromycin tablets are contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug. 4.2 Hepatic Dysfunction Azithromycin tablets are contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
Nelfinavir: Close monitoring for known side effects of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. ( 7.1 ) Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time. ( 7.2 ) 7.1 Nelfinavir Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. [see Adverse Reactions (6) ] 7.2 Warfarin Spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly. 7.3 Potential Drug-Drug Interaction with Macrolides Interactions with digoxin, colchicine or phenytoin have not been reported in clinical trials with azithromycin. No specific drug interaction studies have been performed to evaluate potential drug-drug interaction. However, drug interactions…
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| 3 | Not yet rated | Prescription | Suspension | Generic | $9 | View → |
| 4 | Not yet rated | Prescription | Suspension | Generic | $9 | View → |
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