Zithromax (azithromycin tablets and oral suspension) contains the active ingredient azithromycin, a macrolide antibacterial drug , for oral administration.

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Zithromax tablets contain azithromycin dihydrate equivalent to 600 mg azithromycin. They also contain the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, and an aqueous film coat consisting of hypromellose, titanium dioxide, lactose, and triacetin.

Zithromax for oral suspension is supplied in a single-dose packet containing azithromycin dihydrate equivalent to 1 g azithromycin. It also contains the following inactive ingredients: colloidal silicon dioxide, sodium phosphate tribasic, anhydrous; spray dried artificial banana flavor, spray dried artificial cherry flavor, and sucrose.

Indications

Zithromax (azithromycin) for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Community-Acquired Pneumonia

due to Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy.

Pelvic Inflammatory Disease

due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Zithromax.

Zithromax for injection should be followed by Zithromax by the oral route as required.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Zithromax (azithromycin) and other antibacterial drugs, Zithromax (azithromycin) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Dosage and Administration

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release suspension):
  • For treatment of pneumonia:
    • Adults—2 grams (g) once as a single dose.
    • Children weighing 34 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is usually 2 grams once a day, taken as a single dose.
    • Children 6 months of age and older weighing less than 34 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 60 milligrams (mg) per kilogram (kg) of body weight once a day, taken as a single dose.
  • For treatment of sinusitis:
    • Adults—2 grams (g) once a day as a single dose.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage forms (suspension or tablets):
  • For treatment of infections:
    • Adults—500 to 2000 milligrams (mg) once a day, taken as a single dose. Depending on the type of infection, this may be followed with doses of 250 to 500 mg once a day for several days.
    • Children 6 months of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 10 to 30 milligrams (mg) per kilogram (kg) of body weight once a day, taken as a single dose. Depending on the type of infection, this may be followed with doses of 5 to 10 mg per kg of body weight once a day for several days.
    • Children younger than 6 months of age—Use and dose must be determined by your doctor.
  • For treatment of pharyngitis or tonsillitis:
    • Adults—500 milligrams (mg) on Day 1 (the first day), taken as a single dose. Then, 250 mg on Day 2 through Day 5.
    • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 12 milligrams (mg) per kilogram (kg) of body weight once a day for 5 days.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Side effects

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials of intravenous azithromycin for community-acquired pneumonia, in which 2 to 5 IV doses were given, the reported adverse reactions were mild to moderate in severity and were reversible upon discontinuation of the drug. The majority of patients in these trials had one or more comorbid diseases and were receiving concomitant medications. Approximately 1.2% of the patients discontinued intravenous Zithromax therapy, and a total of 2.4% discontinued azithromycin therapy by either the intravenous or oral route because of clinical or laboratory side effects. In clinical trials conducted in patients with pelvic inflammatory disease, in which 1 to 2 IV doses were given, 2% of women who received monotherapy with azithromycin and 4% who received azithromycin plus metronidazole discontinued therapy due to clinical side effects.

Storage

Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Do not refrigerate or freeze the Zmax extended-release oral suspension. After water has been added to the powder, use the dose within 12 hours and throw away any unused liquid after your dose. You may store the Zithromax oral liquid at room temperature or in the refrigerator. Do not freeze the bottle. Do not keep the oral liquid for more than 10 days. Throw away any unused liquid after all doses are completed.