Ivermectin (topical)
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.