AZASITE (azithromycin)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

There are 5 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Contact dermatitis Corneal erosion Fungal infection of eye Punctate keratitis Urticaria

There are 9 less severe adverse reactions.

More Frequent	Less Frequent
None.	Ocular irritation

Rare/Very Rare
Blurred vision Dry eye Dysgeusia Facial edema Nasal congestion Ocular discharge Sinusitis Skin rash

Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes . Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 200 mg/kg/day. The doses used in these studies were orders of magnitude in excess of the clinical exposure that would be possible following topical ocular administration of azithromycin.

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.S.

general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 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 oral or topical ophthalmic 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.

Azithromycin is present in human milk. Non-serious adverse reactions have been reported in breastfed infants after maternal administration of oral azithromycin. 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 azithromycin and any potential adverse effects on the breastfed infant from the drug.

No overall differences in safety or effectiveness have been observed between elderly and younger patients.