Active Ingredient: Azithromycin
+ free Zithromax pill.
View All Indications and Usage for Zithromax Zithromax 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.
Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Zithromax and other antibacterial drugs, Zithromax should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
Laboratory abnormalities seen in clinical trials for the prevention of disseminated Mycobacterium avium disease in severely immunocompromised HIV-infected patients. Causality of these laboratory abnormalities due to the use of study drug has not been established.
Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly. Potential Drug-Drug Interaction with Macrolides Interactions with digoxin, colchicine or phenytoin have not been reported in clinical trials with azithromycin.
No specific drug interaction studies have been performed to evaluate potential drug-drug interaction. However, drug interactions have been observed with other macrolide products.
Until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised.
Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 3, and 1 times, respectively, an adult human daily dose of 600 mg based on body surface area.
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.
Data Human Data Available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with azithromycin use in pregnant women.
Limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications.
Based on body surface area, this dose is approximately 3 rats and 2 mice times an adult human daily dose of 600 mg. Maternal toxicity reduced food consumption and body weight gain; increased stress at parturition was observed at the higher dose.
Lactation Risk Summary Azithromycin is present in human milk see Data.
There are no available data on the effects of azithromycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Zithromax and any potential adverse effects on the breastfed infant from Zithromax or from the underlying maternal condition.
Clinical Considerations Advise women to monitor the breastfed infant for diarrhea, vomiting, or rash.
Data Azithromycin breastmilk concentrations were measured in 20 women after receiving a single 2 g oral dose of azithromycin during labor.
Breastmilk samples collected on days 3 and 6 postpartum as well as 2 and 4 weeks postpartum revealed the presence of azithromycin in breastmilk up to 4 weeks after dosing.