Safety

Lastacaft (alcaftadine ophthalmic solution)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

September 2015

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • … These reactions include …lacrimation increased, vision blurred, hypersensitivity reactions including swelling of the face or allergic dermatitis…

 

December 2014

Summary View

CONTRAINDICATIONS

*The following was added:

  • Lastacaft is contraindicated in patients with hypersensitivity to any component in the product.

WARNINGS AND PRECAUTIONS

*The following was added:

Potential for Eye Injury and Contamination
  • To minimize eye injury and contamination of the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.

ADVERSE REACTIONS

Postmarketing Experience
  • The following adverse reactions have been identified during postmarketing use of LASTACAFT® in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions include: eye discharge, eye swelling, erythema of eyelid, eyelid edema, hypersensitivity, and somnolence.

PATIENT COUNSELING INFORMATION

*Modified to read:

Potential for Eye Injury and Sterility of Dropper Tip
  • To minimize eye injury and contamination of the dropper tip and solution, patients should be advised to not touch the eyelids or surrounding areas with the dropper tip, as this may contaminate the contents.
Concomitant Use with other Ophthalmic Products or Contact Lenses
  • If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
  • Patients should be advised not to wear a contact lens if their eye is red. Patients should be advised that LASTACAFT® should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of LASTACAFT®. The preservative in LASTACAFT®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of LASTACAFT®.
Topical Ophthalmic Use Only
  • For topical ophthalmic administration only.

 

Page Last Updated: 10/09/2015
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