Active Ingredients: Azithromycin
Dosage Forms and Strengths Zithromax 600 mg tablets engraved on front with "PFIZER" and on back with "308" are supplied as white, modified oval-shaped, film-coated tablets containing azithromycin dihydrate equivalent to 600 mg azithromycin.
These are packaged in bottles of 30 tablets.
Contraindications Hypersensitivity Zithromax is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug. Warnings and Precautions Hypersensitivity 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 rarely in patients on azithromycin therapy.
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.
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.
Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs. QT Prolongation Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen with treatment with macrolides, including azithromycin.
Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin.
Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including: patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure patients on drugs known to prolong the QT interval patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA quinidine, procainamide or Class III dofetilide, amiodarone, sotalol antiarrhythmic agents.
Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C.
Hypertoxin-producing strains of C.
CDAD must be considered in all patients who present with diarrhea following antibiotic use. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.
Exacerbation of Myasthenia Gravis Exacerbations of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
Use in Sexually Transmitted Infections Zithromax, single dose 1 g packet at the recommended dose, should not be relied upon to treat gonorrhea or 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 antibacterial therapy and follow-up tests for these diseases should be initiated if infection is confirmed. Development of Drug-Resistant Bacteria Prescribing Zithromax 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.