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Controlled release dosage forms of azithromycin and alcohol

Contraindications

Documented hypersensitivity

History of cholestatic jaundice or hepatic impairment associated with prior azithromycin use

Coadministration with pimozide

Cautions

Use with caution in 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

Injection-site reactions can occur with IV route

In treatment of gonorrhea or syphilis, perform susceptibility culture tests before initiating azithromycin therapy; may mask or delay symptoms of incubating gonorrhea or syphilis.

Bacterial or fungal superinfection may result from prolonged use

Prolonged QT interval: Cases of torsades de pointes have been reported during postmarketing surveillance; use with caution in patients with known QT prolongation, history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure; also use with caution if coadministering with drugs that prolong QT interval or proarrhythmic conditions (eg, hypokalemia, hypomagnesemia); elderly patients may be more susceptible to drug-associated effects on QT interval

Pneumonia: PO azithromycin is safe and effective only for community-acquired pneumonia (CAP) due to C pneumoniae, H influenzae, M pneumoniae, or S pneumoniae

Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) reported; despite successful symptomatic treatment of allergic symptoms, when symptomatic therapy was discontinued, allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure; if allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted; physicians should be aware that allergic symptoms may reappear when symptomatic therapy discontinued

Endocarditis prophylaxis: Indicated only for high-risk patients, per current AHA guidelines

Use caution in renal impairment (CrCl <10 mL/min)

Use with caution in patients with myasthenia gravis (exacerbation may occur)

Immediate release and extended release suspensions are not interchangeable

Use extended release suspension only for treatment of infections that are proven or strongly suspected to be caused by susceptible bacteria

Clostridium difficile associated diarrhea (CDAD) reported and may range in severity from mild diarrhea to fatal colitis; treatment with antibacterial agents alters the normal flora of colon leading to overgrowth of Clostridium difficile

Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome, and toxic epidermal reported ; if allergic reaction occurs, drug should be discontinued and appropriate therapy instituted; physicians should be aware that allergic symptoms may reappear after symptomatic therapy has been discontinued

Following use in neonates (treatment up to 42 days of life), infantile hypertrophic pyloric stenosis reported; direct parents and caregivers to contact physician if vomiting or irritability with feeding occurs

Prescribing antibiotics in absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria


Source: http://reference.medscape.com/drug/zithromax-zmax-azithromycin-342523


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