To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX (azithromycin) and other bacterial drugs, ZITHROMAX (azithromycin) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 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 )- 13-[(2,6-dideoxy-3- C -methyl-3- O -methyl-(alpha)- 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)-(beta)- D-xylo -hexopyranosyl]oxy]-1-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 C O and a molecular weight of 785.0. ZITHROMAX is supplied for oral administration as film-coated, modified capsular shaped tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin and D&C Red #30 aluminum lake. ZITHROMAX for oral suspension is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla and banana flavors. This medicine comes with a patient information leaflet. Shake well the bottle of Zithromax® oral liquid before each use. You may take Zithromax® oral liquid or tablets with or without food. Measure your dose correctly with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Measure the Zmax® extended-release oral suspension with a marked measuring spoon, syringe, or cup. You or your child must take this medicine within 12 hours after it has been mixed with water. It is best to take the Zmax® extended-release oral suspension on an empty stomach or at least 1 hour before or 2 hours after a meal.
Azithromycin is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible microorganisms (see section 5.1): - bronchitis - community-acquired pneumonia - sinusitis - pharyngitis/tonsillitis (see section 4.4 regarding streptococcal infections) - otitis media - skin and soft tissue infections - uncomplicated genital infections due to Chlamydia trachomatis and Neisseria gonorrhoeae. Considerations should be given to official guidance regarding the appropriate use of antibacterial agents. Zithromax Suspension can be taken with or without food. Children over 45 kg body weight and adults, including elderly patients: The total dose of azithromycin is 1500 mg which should be given over three days (500 mg once daily). In uncomplicated genital infections due to Chlamydia trachomatis, the dose is 1000 mg as a single oral dose. For susceptible Neisseria gonorrhoeae the recommended dose is 1000 mg or 2000 mg of azithromycin in combination with 250 mg or 500 mg ceftriaxone according to local clinical treatment guidelines. For patients who are allergic to penicillin and/or cephalosporins, prescribers should consult local treatment guidelines. Paediatric population: In children under 45 kg body weight: Zithromax Suspension should be used for children under 45 kg. Each 5 ml prepared suspension contains 204.8 mg azithromycin monohydrate equivalent to 200 mg azithromycin. Each 1 ml prepared suspension contains 40.96 mg azithromycin monohydrate equivalent to 40 mg azithromycin. Excipients with known effect: • Sucrose 3.70 g/ 5 ml • Aspartame (E951) 0.030 g/ 5 ml • Sodium 7.739 mg (0.336 mmol) /5 ml For the full list of excipients, see section 6.1. Azithromycin powder for oral suspension is indicated for the treatment of the following infections, when caused by micro-organisms sensitive to azithromycin (see section 4.4 and 5.1): - acute bacterial sinusitis (adequately diagnosed) - acute bacterial otitis media (adequately diagnosed) - pharyngitis, tonsillitis - acute exacerbation of chronic bronchitis (adequately diagnosed) - mild to moderately severe community acquired pneumonia - skin and soft tissue infections - uncomplicated Chlamydia trachomatis urethritis and cervicitis Considerations should be given to official guidance on the appropriate use of antibacterial agents. Adults In uncomplicated Chlamydia trachomatis urethritis and cervicitis, the dose is 1,000 mg in one single oral dose. For all other indications the dose is 1,500 mg, to be administered as 500 mg per day for three consecutive days. Alternatively the same total dose (1,500 mg) can also be given over a period of 5 days with 500 mg on the first day and then 250 mg on days 2 to 5.
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. For questions about a Pfizer Clinical Trial, call (800) 718-1021 or email Pfizer Rx Pathways® connects eligible patients, regardless of their insurance status, to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, 8 patients who vomited within 30 minutes of dosing were re-dosed at the same total dose. For more information, please call (844) 989-7284 or visit Eligible patients can register for valuable savings offers for nearly 40 brand name medications. After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985 You may also contact the U. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or gov/Med Watch If you are looking for information about Pfizer studies currently recruiting new patients in your area, you can begin your search on our website. Operations Manager Born in South Africa, educated in England, Scotland, Japan, and the United States, Andrew Mc Intyre has lived a settled existence in San Francisco since 1999. He speaks French, Spanish, Portuguese, and Japanese. in Hispanic Studies, and master’s degrees in Comparative Literature and Economic History. He is the author of a collection of 34 short stories, (he owns the complete set in English), Graham Greene, George Orwell, and Sven Hassel, among others. His favorite authors also include Carlos Fuentes, James Joyce, Joseph Conrad, Ernest Hemingway, William Faulkner, Paul Bowles, Jack Kerouac, Neal Cassady, William Burroughs, Niall Ferguson, John Keegan, A.
ZITHROMAX for oral suspension 100 mg/5 mL and 200 mg/5 mL 3. 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Azithromycin 200 mg/ 5 ml Powder for Oral Suspension. 2. For all other indications the dose is 1,500 mg, to be administered as 500 mg per day for three.