Spinosad

Spinosad
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: Rabin Bista, M.B.B.S. [2]

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Overview

Spinosad is a Dermatological Agent that is FDA approved for the treatment of head lice. Common adverse reactions include application site erythema and ocular erythema.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Spinosad Topical Suspension is indicated for the topical treatment of head lice infestation in patients four (4) years of age and older.

1.2 Adjunctive Measures Spinosad Topical Suspension 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.

Dosage

For topical use only. Spinosad Topical Suspension is not for oral, ophthalmic, or intravaginal use.

Shake bottle well. Apply sufficient Spinosad Topical Suspension to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair. Leave on for 10 minutes, then thoroughly rinse off Spinosad Topical Suspension with warm water. If live lice are seen 7 days after the first treatment, a second treatment should be applied. Avoid contact with eyes.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Spinosad in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Spinosad in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

Spinosad Topical Suspension is indicated for the topical treatment of head lice infestation in patients four (4) years of age and older.

1.2 Adjunctive Measures Spinosad Topical Suspension 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.

Dosage

For topical use only. Spinosad Topical Suspension is not for oral, ophthalmic, or intravaginal use.

Shake bottle well. Apply sufficient Spinosad Topical Suspension to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair. Leave on for 10 minutes, then thoroughly rinse off Spinosad Topical Suspension with warm water. If live lice are seen 7 days after the first treatment, a second treatment should be applied. Avoid contact with eyes.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Spinosad in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Spinosad in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Spinosad in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Spinosad in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Spinosad with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Spinosad with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Spinosad with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Spinosad in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Spinosad in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Spinosad in the drug label.

Pharmacology

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

Mechanism of Action

Structure

File:Spinosad01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Spinosad in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Spinosad in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Precautions with Alcohol

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

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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