Philippe Ovetchkine, Michael J Rieder; Canadian Paediatric Society, Drug Therapy and Hazardous Substances Committee Paediatr Child Health 2013;18(6):311-3 Azithromycin is an antibiotic that is commonly prescribed for upper and lower respiratory tract infections in children. While it has proven benefits, some concerns regarding azithromycin use have arisen in recent years. This practice point considers azithromycin therapy for acute respiratory infections in otherwise healthy children. Pharmacokinetics, spectrum of activity, the problem of resistant bacteria and clinical aspects are considered, along with recommendations for use and contraindications. Azithromycin should be avoided in patients with a significant risk of bacteremia. It is associated with pneumococcal resistance and, with stated exceptions, is generally not recommended for the treatment of acute pharyngitis, acute otitis media or pneumococcal community-acquired pneumonia in the paediatric population. Key Words: Antibiotics; Azithromycin; Infections; Macrolides; Resistance; Treatment Azithromycin, the first azalide from the macrolide class of antibiotics, has rapidly become one of the more common antibiotics prescribed by paediatricians, particularly for respiratory infections. Azithromycin is easily administered to children as an oral suspension, with once-a-day dosing for a relatively short treatment duration (three to five days) and a favourable side effect profile. 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. 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.
Community-acquired pneumonia Pharyngitis/tonsillitis second-line therapy Skin/skin structure uncomplicated, 500 mg as a single dose on Day 1, followed by. ZITHROMAX ORAL SUSP prescription and dosage sizes information for physicians and healthcare professionals. Pharmacology, adverse reactions, warnings.