Ivermectin (topical)

Ivermectin (topical)
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: Adeel Jamil, M.D. [2]

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Overview

Ivermectin (topical) is an anthelmintic and anti-infective agent that is FDA approved for the treatment of head lice infestations in patients 6 months of age and older. Common adverse reactions include pruritus and urticaria.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indication

• SKLICE™ Lotion is indicated for the topical treatment of head lice infestations in patients 6 months of age and older.

Adjunctive Measures

• SKLICE Lotion should be used in the context of an overall lice management program:

• Wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding and towels.
• Wash personal care items such as combs, brushes and hair clips in hot water.
• A fine-tooth comb or special nit comb may be used to remove dead lice and nits.

Dosing Information

• For topical use only. SKLICE Lotion is not for oral, ophthalmic, or intravaginal use.

• Apply SKLICE Lotion to dry hair in an amount sufficient (up to 1 tube) to thoroughly coat the hair and scalp. Leave SKLICE Lotion on the hair and scalp for 10 minutes, and then rinse off with water.

• The tube is intended for single use; discard any unused portion.

• Avoid contact with eyes.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ivermectin (topical) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ivermectin (topical) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Ivermectin (topical) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ivermectin (topical) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ivermectin (topical) in pediatric patients.

Contraindications

There is limited information regarding Ivermectin (topical) Contraindications in the drug label.

Warnings

Ingestion in Pediatric Patients

• In order to prevent ingestion, SKLICE Lotion should only be administered to pediatric patients under the direct supervision of an adult.

Adverse Reactions

Clinical Trials Experience

Clinical Trial Experience=

• Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

• The data described below reflect exposure to a single 10 minute treatment of SKLICE Lotion in 379 patients, ages 6 months and older, in placebo-controlled trials. Of these subjects, 47 subjects were age 6 months to 4 years, 179 subjects were age 4 to 12 years, 56 subjects were age 12 to 16 years and 97 subjects were age 16 or older. Adverse reactions, reported in less than 1% of subjects treated with SKLICE Lotion, include conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation.

Postmarketing Experience

There is limited information regarding Ivermectin (topical) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Ivermectin (topical) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Ivermectin (topical) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ivermectin (topical) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Ivermectin (topical) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Ivermectin (topical) in geriatric settings.

Gender

There is no FDA guidance on the use of Ivermectin (topical) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ivermectin (topical) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ivermectin (topical) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ivermectin (topical) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ivermectin (topical) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ivermectin (topical) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Topical

Monitoring

There is limited information regarding Ivermectin (topical) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Ivermectin (topical) and IV administrations.

Overdosage

There is limited information regarding Ivermectin (topical) 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 Ivermectin (topical) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Ivermectin (topical) Mechanism of Action in the drug label.

Structure

There is limited information regarding Ivermectin (topical) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Ivermectin (topical) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Ivermectin (topical) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Ivermectin (topical) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Ivermectin (topical) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Ivermectin (topical) How Supplied in the drug label.

Storage

There is limited information regarding Ivermectin (topical) 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 Ivermectin (topical) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Ivermectin (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Sklice

Look-Alike Drug Names

There is limited information regarding Ivermectin (topical) 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.