Sklice topical

Contraindications

• No known contraindications.1

Warnings/Precautions

Inadvertent Ingestion in Pediatric Patients

To prevent ingestion in pediatric patients, use only under direct supervision of an adult.1 (See Pediatric Use under Cautions.)

Specific Populations

Category C.1

Not known whether distributed into milk after topical application.1 Use with caution in nursing women.1

Safety and efficacy not established in infants <6 months of age;1 greater skin surface area to body mass ratio and potentially immature skin barrier in this age group may increase systemic absorption and toxicity.1 Use only in infants and children ≥6 months of age.1

Keep out of the reach of children;1 use only under direct supervision of an adult.1

Insufficient experience in adults ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1

Common Adverse Effects

Conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, burning skin sensation.1

No formal drug interaction studies to date.1

Absorption

Bioavailability

In 20 pediatric patients (6 months to 3 years of age) with head lice infestation, mean peak plasma concentration following single topical application of ivermectin 0.5% lotion was 0.24 ng/mL (lower limit of quantitation 0.05 ng/mL).1 10

Distribution

Extent

Following topical application, not known whether distributed into milk.1

Elimination

Metabolism

Systemically absorbed ivermectin metabolized in liver, principally by CYP3A4, and eliminated almost exclusively in feces.5

• An avermectin-derivative anthelmintic, pediculicide, and scabicide;1 5 6 7 a macrocyclic lactone similar to macrolide antibacterials but possesses no antibacterial properties.6 7

• Binds selectively and with high affinity to glutamate-gated chloride ion channels in nerve and muscle cells of invertebrates, leading to increased cell membrane permeability to chloride ions; cellular hyperpolarization ensues, followed by paralysis and death.1 6 8 Also appears to interact with other ligand-gated chloride channels, such as those gated by GABA.1 6

• Topically applied ivermectin has activity against Pediculus humanus capitis; has shown in vitro activity against a permethrin-resistant strain.11 12

• Pediculicidal; not ovicidal.3 11 12 Some evidence suggests ivermectin may interfere with louse mouthparts, resulting in impaired feeding in treated lice.12 Topical administration has resulted in death of nearly all newly hatched nymphs and adult lice within 48 hours.11 12

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• Use exactly as prescribed. Your healthcare provider will prescribe the treatment that is right for you. Do not change your treatment unless you talk to your healthcare provider.
• Use when your hair is dry.
• It is important to use enough lotion to completely coat all of your hair and scalp. Leave on your hair and scalp for a full 10 minutes.
• You need to completely cover all the scalp and hair with lotion. Make sure that you and anyone who helps you apply Sklice Lotion reads and understands this leaflet.
• Children will need an adult to apply Sklice Lotion for them.
• Do not swallow. If swallowed, call your healthcare provider or go to the nearest emergency room right away.
• Do not get the lotion into your eyes. If it gets in your eye, gently flush with water.
• Wash your hands after application.

When you complete your dose of Sklice Lotion, do not use again without talking to your healthcare provider first.

The most common side effects include:

• eye redness or soreness
• eye irritation
• dandruff
• dry skin
• burning sensation of the skin

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Store at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze.
• Safely throw away any unused Sklice Lotion.

Keep all medicines out of reach of children.