Azelastine (ophthalmic)
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Contraindications
Azelastine hydrochloride ophthalmic solution is contraindicated in persons with known or suspected hypersensitivity to any of its components.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for azelastine (ophthalmic). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
Pregnancy Teratogenic Effects Azelastine hydrochloride has been shown to be embryotoxic, fetotoxic, and teratogenic (external and skeletal abnormalities) in mice at an oral dose of 68.6 mg/kg/day (57,000 times the recommended ocular human use level). At an oral dose of 30 mg/kg/day (25,000 times the recommended ocular human use level), delayed ossification (undeveloped metacarpus), and the incidence of 14th rib were increased in rats. At 68.6 mg/kg/day (57,000 times the maximum recommended ocular human use level) azelastine hydrochloride caused resorption and fetotoxic effects in rats. The relevance to humans of these skeletal findings noted at only high drug exposure levels in unknown.
There are no adequate and well-controlled studies in pregnant women. Azelastine hydrochloride ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation
Nursing Mothers It is not known whether azelastine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azelastine hydrochloride ophthalmic solution is administered to a nursing woman.
Breastfeeding (LactMed)
Small occasional doses of azelastine nasal spray would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use of the nasal spray may cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. Infant rejection of the breast might occur because of the bitter taste of the drug. The oral, nonsedating antihistamines are preferred alternatives. Because absorption from the eye is limited, azelastine would not be expected to cause any adverse effects in breastfed infants. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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