Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

Indications¹

Zithromax® is indicated for the treatment of infections caused by susceptible organisms; lower respiratory tract infections including bronchitis and pneumonia; skin and soft tissue infections; acute otitis media; upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis; uncomplicated genital infections due to Chlamydia trachomatis and non-multiresistant Neisseria gonorrhoea; chancroid due to Haemophilus ducreyi; alone or in combination with rifabutin for prophylaxis against Mycobacterium avium intracellulare complex (MAC) infection; in combination with ethambutol for disseminated MAC (DMAC) infection in patients with advanced HIV infection.

Intravenous (IV) route: Community acquired pneumonia (CAP) caused by susceptible organisms, including Legionella pneumophila and pelvic inflammatory diseases (PID) due to C. trachomatis, N. gonorrhoea, Mycoplasma hominis.

Clinical Evidence

Three-day Zithromax® is as effective as 7-day amoxicillin-clavulanate for CAP²

End of therapy (day 8 to 12)

This randomized, open-label, non-inferiority study demonstrated that 3-day oral Zithromax® 1 g od was at least as effective as a standard 7-day course of oral amoxicillin-clavulanate 875/125 mg bid in the treatment of outpatients with CAP.2
Three-day Zithromax® is as effective as 10-day amoxicillin-clavulanate for acute bacterial sinusitis (ABS)³

This is a randomized, double-blind, multicenter study. Three-day Zithromax® was shown to yield clinical efficacy equal to that of standard 10-day amoxicillin-clavulanate regime in the treatment of ABS and resulted in fewer adverse events and better subject compliance.3
Three-day Zithromax® is as effective as 10-day clarithromycin for acute exacerbation of chronic bronchitis⁴

Safety Profile¹

CONTRAINDICATIONS: Hypersensitivity to azithromycin, erythromycin or any macrolide or ketolide antibiotic, or to any excipient

WARNINGS and PRECAUTIONS: Rare serious allergic reactions, including angioedema and anaphylaxis (rarely fatal), have been reported. Because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be coadministered. Clostridium difficile-associated diarrhea (CDAD) has been reported, ranging in severity from mild diarrhea to fatal colitis.

CAUTION IN DIABETIC PATIENTS: 5 ml of reconstituted suspension contains 3.87 g of sucrose, thus, azithromycin is not indicated for persons with fructose intolerance. Prolonged cardiac repolarization and QT interval may occur.

SIDE EFFECTS OBSERVED IN CLINICAL TRIALS: Mild neutropenia, hearing impairment, gastrointestinal disorders, abnormal liver function, rash and angioedema, pain and inflammation at injection site, dyspepsia, headache, arthralgia and abnormal vision.

POST-MARKETING UNDESIRABLE EFFECTS: Moniliasis, vaginitis, thrombocytopenia, anaphylaxis, anorexia, aggressive reaction, nervousness, agitation, anxiety, dizziness, convulsions, headache, hyperactivity, hypoesthesia, paresthesia, somnolence, syncope, vertigo, palpitations, arrhythmias, hypotension, gastrointestinal disorders, hepatitis, cholestatic jaundice, allergic reactions including pruritus, rash, photosensitivity, edema, urticaria, angioedoma, arthralgia, interstitial nephritis, acute renal failure and asthenia.

INTERACTIONS: Antacids, digoxin, ergot derivatives, cyclosporin, coumarin-type oral anticoagulants and nelfinavir.

PREGNANCY and LACTATION: Pregnancy Category B – Zithromax™ should not be used in lactating women unless the potential benefits justify the potential risks. It is not known whether azithromycin is excreted in human milk; caution should be exercised when administered to a nursing woman.

Dosages¹

Adults:

Sexually transmitted diseases caused by C. trachomatis, H. ducreyi or N. gonorrhea: 1000 mg single oral dose
Prophylaxis against MAC infections in HIV patients: 1200 mg once per week
DMAC infections in advanced HIV patients: 600 mg od
CAP: IV 500 mg as a single dose for at least 2 days followed by oral 500 mg od to complete a 7–10 day course of therapy
PID: IV 500 mg as a single dose for 1 or 2 days followed by oral 250 mg od to complete a 7-day course.
Other indications: 500 mg daily for 3 days

Children: 10mg/kg daily for 3 days; Streptococcal pharyngitis: 10 or 20 mg/kg for 3 days; maximum dose: 500 mg/day; maximum total dose for any treatment: 1500 mg

Strengths¹

Film-coated tablets: 250 mg
Powder for oral suspension: 200 mg/5 mL
Powder for IV solution: 500 mg

Packing¹

Film-coated tablets: 250 mg (6 tablets/box)
Powder for oral suspension: 200 mg/5 mL (1 bottle/box)
Powder for IV Solution: 500mg (1 vial/box)

Please refer to the full prescribing information for more safety information.

References

1. Zithromax™ (azithromycin) Prescribing Information. Pfizer Corporation Hong Kong Limited: 15 January 2009.

2. Paris R, Confalonieri M, Dal Negro R, et al. Efficacy and safety of azithromycin 1 g once daily for 3 days in the treatment of community-acquired pneumonia: an open-label randomized comparison with amoxicillin-clavulanate 875/125 mg twice daily for 7 days. J Chemother 2008; 20:77-86.

3. Henry DC, Riffer E, Sokol WN, et al. Randomized double-blind study comparing 3- and 6-day regimens of azithromycin with a 10-day amoxicillin-clavulanate regimen for treatment of acute bacterial sinusitis. Antimicrob Agents Chemother 2003;47:2770-2774.

4. Swanson RN, Lainez-Ventosilla A, De Salvo MC, et al. Once-daily azithromycin for 3 days compared with clarithromycin for 10 days for acute exacerbation of chronic bronchitis: A multicenter, double-blind, randomized study. Treat Respir Med 2005;4:31-39.

Please review the full product information or package insert before prescribing.

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