SKLICE- ivermectin lotion
Sanofi Pasteur, Inc
1 INDICATIONS AND USAGE
1.1 Indication
SKLICE� Lotion is indicated for the topical treatment of head lice infestations in patients 6 months of age and older.
1.2 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.
2 DOSAGE AND ADMINISTRATION
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.
3 DOSAGE FORMS AND STRENGTHS
Lotion: 0.5%; each gram of lotion contains 5 mg of ivermectin. SKLICE Lotion is an off-white to tan lotion.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 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.
DESCRIPTION
SKLICE (ivermectin) Lotion, for topical administration, is an off-white/tan lotion containing 0.5% ivermectin.
Ivermectin, the active ingredient, is a pediculicide, derived from the fermentation of a soil dwelling actinomycete, Streptomyces avermitilis.
Ivermectin is a mixture containing at least 90% 5-O -demethyl-22,23-dihydroavermectin A1a and less than 10% 5-O -demethyl-25-de(1-methylpropyl)-22,23-dihydro25-(1-methylethyl) avermectin A1a , generally referred to as 22,23-dihydroavermectin B1a and B1b , or H2 B1a and H2 B1b , respectively. The respective empirical formulas are C48 H74 O14 and C47 H72 O14 , with molecular weights of 875.10 and 861.07, respectively.
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Ivermectin, a member of the avermectin class, causes death of parasites, primarily through binding selectively and with high affinity to glutamate-gated chloride channels, which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The selective activity of compounds of this class is attributable to the fact that some mammals do not have glutamate-gated chloride channels, the avermectins have a low affinity for mammalian ligand-gated chloride channels, and ivermectin does not readily cross the blood-brain barrier in humans.
PATIENT COUNSELING INFORMATION
"See FDA-approved patient labeling (Patient Information)".
Inform the patient and caregiver of the following instructions:
Apply SKLICE Lotion to dry scalp and dry scalp hair.
Avoid contact with eyes.
Do not swallow SKLICE Lotion.
Keep out of reach of children. Use on children should be under the direct supervision of an adult.
For single use only; do not retreat.
Discard tube after use.
Wash hands after applying SKLICE Lotion.
