No

Antibiotic, Macrolide

Dental: Alternate antibiotic in the treatment of common orofacial infections caused by aerobic gram-positive cocci and susceptible anaerobes; alternate antibiotic for the prevention of bacterial endocarditis in patients undergoing dental procedures

Medical:

Children: Treatment of acute otitis media due to H. influenzae, M. catarrhalis, or S. pneumoniae; pharyngitis/tonsillitis due to S. pyogenes

Adults:

Treatment of mild to moderate upper and lower respiratory tract infections, infections of the skin and skin structure, and sexually transmitted diseases due to susceptible strains of C. trachomatis, M. catarrhalis, H. influenzae, S. aureus, S. pneumoniae, Mycoplasma pneumoniae, and C. psittaci; community-acquired pneumonia, pelvic inflammatory disease (PID)

For preventing or delaying the onset of infection with Mycobacterium avium complex (MAC)

Prophylaxis of bacterial endocarditis in patients who are allergic to penicillin and undergoing surgical or dental procedures

B

Hepatic impairment, known hypersensitivity to azithromycin, other macrolide antibiotics, or any azithromycin components; use with pimozide

Use with caution in patients with hepatic dysfunction; hepatic impairment with or without jaundice has occurred chiefly in older children and adults; it may be accompanied by malaise, nausea, vomiting, abdominal colic, and fever; discontinue use if these occur; may mask or delay symptoms of incubating gonorrhea or syphilis, so appropriate culture and susceptibility tests should be performed prior to initiating azithromycin; pseudomembranous colitis has been reported with use of macrolide antibiotics; safety and efficacy have not been established in children <6 months of age with acute otitis media and in children <2 years of age with pharyngitis/tonsillitis

1% to 10%: Gastrointestinal: Diarrhea, nausea, abdominal pain, cramping, vomiting (especially with high single-dose regimens)

<1%: Ventricular arrhythmias, fever, headache, dizziness, rash, angioedema, hypertrophic pyloric stenosis, vaginitis, eosinophilia, elevated LFTs, cholestatic jaundice, thrombophlebitis, ototoxicity, nephritis, allergic reactions

Symptoms of overdose include nausea, vomiting, diarrhea, prostration

Treatment is supportive and symptomatic

May inhibit CYP3A3/4 enzyme (mild)

Increased effect/toxicity: Azithromycin may increase levels of tacrolimus, phenytoin, ergot alkaloids, alfentanil, astemizole, terfenadine, bromocriptine, carbamazepine, cyclosporine, digoxin, disopyramide, and triazolam; azithromycin did not affect the response to warfarin or theophylline although caution is advised when administered together

Avoid use with pimozide due to significant risk of cardiotoxicity

Store intact vials of injection at room temperature. Reconstitute the 500 mg vial with 4.8 mL of sterile water for injection and shake until all of the drug is dissolved. Each mL contains 100 mg azithromycin. Reconstituted solution is stable for 24 hours when stored below 30°C/86°F.

Inhibits RNA-dependent protein synthesis at the chain elongation step; binds to the 50S ribosomal subunit resulting in blockage of transpeptidation

Absorption: Rapid from the GI tract

Distribution: Extensive tissue distribution; distributes well into skin, lungs, sputum, tonsils, and cervix; penetration into the CSF is poor

Protein binding: 7% to 50% (concentration-dependent)

Metabolism: In the liver

Bioavailability: 37%, decreased by food

Half-life, terminal: 68 hours

Peak serum concentration: 2.3-4 hours

Elimination: 4.5% to 12% of dose is excreted in urine; 50% of dose is excreted unchanged in bile

Oral:

Children greater than or equal to 6 months: Otitis media and community-acquired pneumonia: 10 mg/kg on day 1 (maximum: 500 mg/day) followed by 5 mg/kg/day once daily on days 2-5 (maximum: 250 mg/day)

Children greater than or equal to 2 years: Pharyngitis, tonsillitis: 12 mg/kg/day once daily for 5 days (maximum: 500 mg/day)

Children: M. avium-infected patients with acquired immunodeficiency syndrome: Not currently FDA approved for use; 10-20 mg/kg/day once daily (maximum: 40 mg/kg/day) has been used in clinical trials; prophylaxis for first episode of MAC: 5-12 mg/kg/day once daily (maximum: 500 mg/day)

Adolescents greater than or equal to 16 years and Adults:

Respiratory tract, skin and soft tissue infections: 500 mg on day 1 followed by 250 mg/day on days 2-5 (maximum: 500 mg/day)

Uncomplicated chlamydial urethritis/cervicitis or chancroid: Single 1 g dose

Gonococcal urethritis/cervicitis: Single 2 g dose

Prophylaxis of disseminated M. avium complex disease in patient with advanced HIV infection: 1200 mg once weekly (may be combined with rifabutin)

Prophylaxis for bacterial endocarditis: 500 mg 1 hour prior to the procedure

I.V.: Adults:

Community-acquired pneumonia: 500 mg as a single dose for at least 2 days, follow I.V. therapy by the oral route with a single daily dose of 500 mg to complete a 7-10 day course of therapy

Pelvic inflammatory disease (PID): 500 mg as a single dose for 1-2 days, follow I.V. therapy by the oral route with a single daily dose of 250 mg to complete a 7 day course of therapy

Food: Rate and extent of GI absorption decreased; take on an empty stomach

Liver function tests, CBC with differential

Macrolides have been reported to cause nightmares, confusion, anxiety, and mood lability

Contraindicated with pimozide; may increase concentration of bromocriptine, carbamazepine and triazolam

No information available to require special precautions

No effects or complications reported

Take as directed. Take all of prescribed medication. Do not discontinue until prescription is completed. Take suspension 1 hour before or 2 hours after meals; tablet form may be taken with meals to decrease GI effects. Do not take with aluminum- or magnesium-containing antacids. May cause transient abdominal distress, diarrhea, headache. Report signs of additional infections (eg, sores in mouth or vagina, vaginal discharge, unresolved fever, severe vomiting, or diarrhea). Breast-feeding precautions: Consult prescriber if breast-feeding.

Do not administer concurrently with aluminum or magnesium antacids

Monitor liver function tests; tolerance to medication; respiratory, cardiac, and fluid status of nursing home patients being treated for pneumonia

Parenteral: Infusate concentration and rate of infusion for azithromycin for injection should be either 1 mg/mL over 3 hours or 2 mg/mL over 1 hour

Powder for injection: 500 mg

Powder for oral suspension, as dihydrate: 100 mg/5 mL (15 mL); 200 mg/5 mL (15 mL, 22.5 mL); 1 g (single-dose packet)

Tablet, as dihydrate: 250 mg, 600 mg

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