Lotilaner

Lotilaner
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rithish Nimmagadda,MBBS.[2]

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Overview

Lotilaner is a gamma-aminobutyric acid (GABA)-gated chloride channel inhibitor that is FDA approved for the {{{indicationType}}} of ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis. Common adverse reactions include The most common adverse reaction was instillation site stinging and burning.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

still one drop of lotilaner in each eye twice daily (approximately 12 hours apart) for 6 weeks.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in pediatric patients below the age of 18 years have not been established

Off-Label Use and Dosage (Pediatric)

Contraindications

None.

Warnings

Risk of Contamination

Do not allow the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Use with Contact Lenses

Contact lenses should be removed prior to instillation of lotilaner and may be reinserted 15 minutes following its administration.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Lotilaner Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Lotilaner Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Lotilaner Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Lotilaner in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lotilaner in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Lotilaner during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Lotilaner in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Lotilaner in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Lotilaner in geriatric settings.

Gender

There is no FDA guidance on the use of Lotilaner with respect to specific gender populations.

Race

There is no FDA guidance on the use of Lotilaner with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Lotilaner in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Lotilaner in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Lotilaner in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Lotilaner in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Lotilaner Administration in the drug label.

Monitoring

There is limited information regarding Lotilaner Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Lotilaner and IV administrations.

Overdosage

There is limited information regarding Lotilaner overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Lotilaner Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Lotilaner Mechanism of Action in the drug label.

Structure

There is limited information regarding Lotilaner Structure in the drug label.

Pharmacodynamics

There is limited information regarding Lotilaner Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Lotilaner Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Lotilaner Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Lotilaner Clinical Studies in the drug label.

How Supplied

Instruct patients to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of lotilaner.

Advise patients that lotilaner contains potassium sorbate, which may discolor soft contact lenses. [ref] Contact lenses should be removed prior to instillation of lotilaner and may be reinserted 15 minutes following its administration.

Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes between applications.

Advise patients that if one dose is missed, treatment should continue with the next dose.

Storage

There is limited information regarding Lotilaner Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Lotilaner Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Lotilaner interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

Xdemvy®

Look-Alike Drug Names

There is limited information regarding Lotilaner Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.