Zithromax Z-Pak (Azithromycin) Prescription

Generic Name: Azithromycin

Common Brand Name: Zithromax, Z-Pac

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Common medical uses:
Zithromax (Azithromycin) is a broad-spectrum macrolode antibiotic with activity against a range of Gram-positive, Gram-negative, atypicals and anaerobes.

It is indicated for the treatment of patients with mild to moderate infections:

• Lower Respiratory Tract infections: acute bacterial exacerbations of chronic obstructive pulmonary disease; community-acquired pneumonia of mild severity.
• Upper Respiratory Tract infections: pharyngitis, tonsillitis, otitis media, sinusitis
• Skin and Skin Structure infections: uncomplicated skin and skin structure infections. Abscesses usually require surgical drainage.
• Chancroid (genital ulcer disease in men): due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.
• Sexually Transmitted Diseases: urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
• Mycobacterial Infections.

Zithromax dosage:

• Bacterial Infections
  Adults: 500 mg as single dose on first day, then 250mg/day on days 2 through 5.
• Acute Bacterial Sinusitis
  Adults: 500 mg every day for 3 days.
  Children 6 mo of age and older: 10 mg/kg oral suspension once daily for 3 days.
• Acute Otitis Media
  Children 6 mo of age and older: 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10mg/kg as a single dose on the first day (not to exceed 500mg/day) followed by 5 mg/kg on days 2 through 5 (not to exceed 250 mg/day).
• Community-Acquired Pneumonia
  Adults and children 16 yr of age and older: 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.
  Children 6 mo of age and older: 10 mg/kg as a single dose on the first day (not to exceed 500 mg/day), followed by 5mg/kg on days 2 through 5 (not to exceed 250mg/day).
• Chancroid (Genital Ulcer Disease caused by Haemophilus ducreyi)
  Adults: Single 1 g dose.
• Nongonococcal Urethritis/Cervicitis caused by Chlamydia trachomatis
  Adults: Single 1 g dose.
• Gonorrhea
  Adults: Single 2 g dose.
• Mild to Moderate Acute Bacterial Exacerbations of COPD
  Adults and children 16 yr of age and older: 500 mg/day for 3 days or 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.
• Pelvic Inflammatory Disease
  Adults: IV 500 mg as a single daily dose for 1 to 2 days. Follow IV therapy by the oral route at a single daily dose of 250 mg to complete a 7-day course of therapy.
• Pharyngitis, Tonsillitis
  Adults and children 16 yr of age and older: 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.
  Children 2 yr of age and older: 12mg/kg/day for 5 days, not to exceed 500 mg/day.
• Uncomplicated Skin and Skin Structure Infections
  Adults and children 16 yr of age and older : 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.

Side effects:

• Cardiovascular: Palpitations, chest pain; arrhythmias, hypotension, QT prolongation, torsades de pointes (postmarketing).
• CNS: Dizziness, headache, vertigo, somnolence, fatigue; agitation, aggressive behavior, anxiety, asthenia, convulsions, hyperactivity, malaise, nervousness, paresthesia, syncope (postmarketing).
• Dermatologic: Rash, photosensitivity; erythema multiforme, Stevens-Johnson syndrome, pruritus, toxic epidermal necrolysis, urticaria (postmarketing).
• Eye-ear-nose-throat: Deafness, hearing disturbances, hearing loss, tinnitus (postmarketing).
• Gastrointestinal: Diarrhea, nausea, vomiting, abdominal pain, dyspepsia, flatulence, melena; anorexia, oral candidiasis, constipation, pseudomembranous colitis, pancreatitis, tongue discoloration (postmarketing).
• Genitourinary: Vaginitis, monilia, nephritis; acute renal failure, interstitial nephritis (postmarketing).
• Hematologic: Thrombocytopenia (postmarketing).
• Hepatic: Cholestatic jaundice; abnormal LFTs, hepatitis, hepatic failure, hepatic necrosis (postmarketing).
• Musculoskeletal: Arthralgia (postmarketing).
• Miscellaneous: Angioedema, anaphylaxis; edema (postmarketing).

Precautions:

• Sensitivity. Review results of culture and sensitivity testing as appropriate.
• STD testing. May mask or delay symptoms of incubating gonorrhea or syphilis, so appropriate culture and susceptibility tests should be performed prior to starting antibiotic prescription.
• Hypersensitivity. Serious reactions, including anaphylaxis, have occurred.
• Superinfection. Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea and pseudomembranous colitis.
• Cardiac effects. Serious cardiovascular events have occurred with other macrolide antibiotics, including prolonged cardiac repolarization and QT interval.
• Pneumonia. Only effective for mild community-acquired pneumonia.
• Hepatic impairment. Azithromycin is eliminated via the liver. Use with caution in patients with pre-existing liver disease; hepatic impairment, including hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been observed. Discontinue if symptoms of malaise, nausea, vomiting, abdominal colic, and fever.
• Renal impairment. Use with caution in patients with severe renal impairment.

Drug interactions

Food reduces Zithromax Z-pack absorption rate therefore it should be taken one hour before or two hours after a meal.

• Aluminum- and magnesium-containing antacids. Antacids affect Zithromax absorption rate. An interval of at least two hours between administration of azithromycin and an antacid is recommended.
• Colchicine. Macrolides may increase the toxic effects of colchicine.
• Digoxin, cyclosporin, astemizole, triazolam, midazolam. Macrolide antibiotics are known to interact with these medications. Although there are no data about interactions of Zithromax and above mentioned drugs, careful monitoring of concomitant use of these drugs is recommended.
• HMG-CoA reductase inhibitors (eg, lovastatin). Increased risk of myopathy and rhabdomyolysis.
• Nelfinavir. Zithromax levels may be elevated, increasing the risk of side effects.
• Tacrolimus. Increased tacrolimus plasma levels with increased risk of toxicity.
• Theophylline, terphenadine, warfarine, carbamazepine, methylprednisolone and cimetedine. The effect of azithromycin on the blood levels of theophylline, terphenadine, warfarine, carbamazepine, methylprednisolone and cimetedine has not been observed.

Pregnancy & Lactation:
Zithromax Pregnancy Risk Factor: B
Reproduction studies have been performed in animals and no evidence of impaired fertility or harm to fetus was found. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Zithromax should be used during pregnancy only if clearly needed.

Azithromycin has been shown to cross the placenta. It has been used as an alternative treatment of Chlamydia in late-term pregnancy.

Breast-Feeding:
Zithromax is excreted in low amounts into breast milk. The manufacturer recommends that caution be exercised when administering the drug to nursing women. Compared to erythromycin, Zithromax achieves higher tissue concentrations when compared to serum concentrations. Since serum concentrations determine infant exposure, Zithromax may achieve treatment results in the mother with less exposure to the breast-feeding infant. Nondose-related effects could include modification of bowel flora.

Overdose:
Symptoms of overdose include nausea, vomiting, diarrhea, and prostration. Treatment is supportive and symptomatic.

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References:

• 1. U.S. Food and Drug Administration. Zithromax U.S. Prescribing Information. Available at (PDF format): Prescribing Information