September 4, 2020 No specific drug interaction studies have been performed to evaluate potential drug-drug interactions. Drug Interactions: Pharmacokinetic Parameters for Azithromycin in the Presence of Co-administered Drugs. Skin rash may be a sign of a more serious reaction to ZITHROMAX.Stop taking ZITHROMAX and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. ZITHROMAX ® (Zith-roe-maks) (azithromycin) Tablets. Due to the current critical shortage of Azithromycin tablet products in the United States (U.S.) market, HEC Pharm USA Inc. (HEC), in conjunction with Lannett Company, Inc. (Lannett), is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of the drug. To read the full Health Canada Advisory, visit Health Canada's web site at If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., verapamil, atazanavir), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.This medication may also cause a decrease in liver function. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.The following side effects have been reported by at least 1% of people taking this medication. Each bundle (10 cartons per bundle) of imported azithromycin contains an English translated package leaflet and one copy of this DHCP Letter. 6.1 … Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C In fertility studies conducted in male and female rats, oral administration of azithromycin for 64 to 66 days (males) or 15 days (females) prior to and during cohabitation resulted in decreased pregnancy rate at 20 mg/kg/day and 30 mg/kg/day when both males and females were treated with azithromycin. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen) It has been demonstrated in numerous organ systems (e.g., eye, dorsal root ganglia, liver, gallbladder, kidney, spleen, and/or pancreas) in dogs and rats treated with azithromycin at doses which, expressed on the basis of body surface area, are similar to or less than the highest recommended adult human dose. Taking the medication with food may help to avoid stomach upset.It is important to take this medication exactly as prescribed by your doctor. Various sugars and waxes may be used to mask an unpleasant taste or make the pill chewable for children. Brand name: Zithromax. the ingredients and make the tablet pleasing to the eye. For the 321 subjects who were evaluated at End of Treatment, the clinical success rate (cure plus improvement) was 87% for azithromycin, and 88% for the comparator. Copy the URL below and paste it into your RSS Reader application. These can be signs of a serious reaction to ZITHROMAX (a liver problem).These are not all the possible side effects of ZITHROMAX. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Breastmilk (colostrum) samples obtained between 12 and 48 hours after dosing revealed that azithromycin persisted in breastmilk up to 48 hours.Safety and effectiveness in the treatment of pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established. Do not use azithromycin tablets for a condition for which it was not prescribed. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by FDA has not approved HEC’s Azithromycin Tablets manufactured for the German market.Effective immediately and during this temporary period, Lannett will distribute the presentations listed in below Table.- The imported azithromycin product labeling contains German only text used and approved for marketing in Germany. For the 304 patients analyzed in the modified intent-to-treat analysis at the Days 21 to 24 visit, the clinical cure rate for 3 days of azithromycin was 85% (125/147) compared to 82% (129/157) for 10 days of clarithromycin.The following outcomes were the clinical cure rates at the Days 21 to 24 visit for the bacteriologically evaluable patients by pathogen:In a randomized, double-blind, double-dummy controlled clinical trial of acute bacterial sinusitis, azithromycin (500 mg once daily for 3 days) was compared with amoxicillin/clavulanate (500/125 mg three times a day for 10 days). Its molecular formula is C Azithromycin Tablets USP, 250 mg are debossed "OE" on one side and "250" on the other side. 0527-2750-17 There may be new information. Health Canada has issued information concerning the use of azithromycin. For the 362 patients who were evaluated at the Days 24 to 28 visit, the clinical success rate was 74% for azithromycin and 69% for the control agent.Efficacy using azithromycin 30 mg/kg given as a single doseA double-blind, controlled, randomized trial was performed at nine clinical centers.