Lotilaner Ophthalmic

Lotilaner Ophthalmic is a prescription medication used for the treatment of demodex blepharitis.

• Lotilaner Ophthalmic is available under the following different brand names: Xdemvy

Common side effects of Lotilaner Ophthalmic include:

• stinging and burning?
• chalazion/hordeolum
• punctate keratitis

Serious side effects of Lotilaner Ophthalmic include:

• not available

Rare side effects of Lotilaner Ophthalmic include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Ophthalmic solution

• 0.25% (2.5 mg/mL)

Demodex blepharitis

Adult dosage

• Instill 1 drop in each eye two times a day (approximately 12 hours apart) for 6 weeks

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Lotilaner Ophthalmic has no noted severe interactions with any other drugs
• Lotilaner Ophthalmic has no noted serious interactions with any other drugs
• Lotilaner Ophthalmic has no noted moderate interactions with any other drugs
• Lotilaner Ophthalmic has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lotilaner Ophthalmic?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lotilaner Ophthalmic?”

Cautions

• Remove contact lenses before instillation; may reinsert 15 minutes after administration
• In the event of intercurrent ocular condition (e.g., trauma or infection), ocular surgery, or ocular reactions, particularly conjunctivitis and eyelid reactions, contact a health-care practitioner for advice concerning the continued use
• Contaminated solution
  • Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions
  • To minimize contamination, do not allow the tip of the dispensing container to contact with the eye, surrounding structures, fingers, or any other surface

Pregnancy and Lactation

• There are no available data on use in pregnant women to inform any drug-associated risk; however, systemic exposure to Lotilaner from ocular administration is low
• Animal reproduction studies did not produce malformations at clinically relevant doses
• Lactation
  • There are no data on the presence of Lotilaner in human milk, its effects on breastfed infants, or milk production
  • Systemic exposure to Lotilaner following 6 weeks of topical ocular administration is low, and the drug is above 99% protein bound in plasma; therefore, it is unknown whether measurable levels would be present in maternal milk following topical ocular administration