ZITHROMAX

ZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-l3- [(2,6-dideoxy-3-C-methyl-3-O-methyl-a-L- ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopyranosyl]oxy]-l-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.0. Azithromycin has the following structural formula:

Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12•2H2O and a molecular weight of 785.0.

ZITHROMAX tablets contain azithromycin dihydrate equivalent to 600 mg azithromycin. The tablets are supplied as white, modified oval-shaped, film-coated tablets. 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 (azithromycin) 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.

Do not use this medication if you have ever had an allergic reaction to azithromycin or similar drugs such as erythromycin (E-Mycin, Ery-Tab, E.E.S.), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).

There are many other medicines that can interact with azithromycin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Azithromycin will not treat a viral infection such as the common cold or flu.

Take azithromycin on an empty stomach 1 hour before or 2 hours after meals.

Do not take antacids that contain aluminum or magnesium within 2 hours before or after you take azithromycin. This includes Rolaids, Maalox, Mylanta, Milk of Magnesia, Pepcid Complete, and others. These antacids can make azithromycin less effective when taken at the same time.

What are the possible side effects of azithromycin?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• diarrhea that is watery or bloody;
• chest pain, uneven heartbeats;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

  Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, constipation;
  • stomach pain or upset;
  • dizziness, tired feeling, or headache;
  • nervous feeling, sleep problems (insomnia);
  • vaginal itching or discharge;
  • mild itching or skin rash;
  • ringing in your ears, problems with hearing; or
  • decreased sense of taste or smell.

  This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.