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. The structural formulas are:
|Component H2 B1a : R = CH2 CH3 Component H2 B1b : R = CH3|
Ivermectin Lotion contains the following inactive ingredients: butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan AWS, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate anhydrous, sorbitan tristearate and stearyl alcohol.
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.
The pharmacodynamics of Ivermectin Lotion are unknown.
The absorption of ivermectin from Ivermectin Lotion was evaluated in a clinical study in subjects aged from 6 months to 3 years. This study evaluated pharmacokinetics in 20 lice infested subjects, and 13 of these subjects weighed 15 kg or less (overall weight range 8.5 to 23.9 kg). All enrolled subjects received a single treatment with Ivermectin Lotion. The systemic ivermectin exposure was evaluated using an assay with a lower limit of quantitation of 0.05 ng/mL. The mean (± standard deviation) plasma maximum concentration (Cmax ) and area under the concentration-time curve from 0 to time of last measurable concentration (AUC0-tlast ) were 0.24 ± 0.23 ng/mL and 6.7 ± 11.2 hr∙ng/mL, respectively. These levels are much lower than those observed following oral administration of 165 mcg/kg dose of ivermectin.
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Ivermectin Lotion or ivermectin.
Ivermectin was not genotoxic in vitro in the Ames test, the mouse lymphoma assay, or the unscheduled DNA synthesis assay in human fibroblasts.
Ivermectin had no adverse effects on fertility in rats at repeated oral doses of up to 3.6 mg/kg/day.
Two identical multi-center, randomized, double-blind, vehicle-controlled studies were conducted in subjects 6 months of age and older with head lice infestation. All subjects received a single application of either Ivermectin Lotion or vehicle control with instructions not to use a nit comb. For the evaluation of efficacy, the youngest subject from each household was considered to be the index subject of the household (N=289). Other enrolled infested household members received the same treatment as the youngest subject and were evaluated for all safety parameters [see Adverse Reactions (6.1)].
The primary efficacy was assessed as the proportion of index subjects who were free of live lice at day 2 and through day 8 to the final evaluation 14 (+2) days following a single application. Subjects with live lice present at any time up to the final evaluation were considered treatment failures. Table 1 contains the proportion of subjects who were free of live lice in each of the two trials.
|Study||Vehicle% (n/N)||Ivermectin Lotion% (n/N)|
|Study 1||16.2% (12/74)||76.1% (54/71)|
|Study 2||18.9% (14/74)||71.4% (50/70)|
Ivermectin Lotion, 0.5% is supplied in a 4 oz (117 g) white laminate tube (NDC 51672-4211-8).
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze.
Inform the patient and caregiver of the following instructions:
- Use Ivermectin Lotion in the context of an overall lice management program.
- Apply Ivermectin Lotion to dry scalp and dry scalp hair.
- Wash hands after applying Ivermectin Lotion.
- Leave Ivermectin Lotion on the hair and scalp for 10 minutes, and then rinse off with water.
- For single use only; do not re-treat.
- It is recommended to wait 24 hours before applying shampoo to hair and scalp.
- Discard tube after use.
- Avoid contact with eyes.
- Do not swallow Ivermectin Lotion.
- Keep out of reach of children. Use on children should be under the direct supervision of an adult.
- Advise a lactating woman to avoid accidental transfer of Ivermectin Lotion directly to breast area where the infant might directly ingest the drug.
Manufactured by: Taro Pharmaceutical Industries Ltd.
Haifa Bay, Israel, 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Issued: December, 2019
|Patient Information Ivermectin (eye” ver mek’ tin) Lotion, 0.5%|
|Important: For use on scalp hair and scalp only. Do not use Ivermectin Lotion in your eyes, mouth, or vagina.|
|What is Ivermectin Lotion? Ivermectin Lotion is a prescription medicine for topical use on the hair and scalp only. Ivermectin Lotion is used to treat head lice in people 6 months of age and older. It is not known if Ivermectin Lotion is safe and effective for children under 6 months of age.|
|Before you use Ivermectin Lotion, tell your healthcare provider about all of your medical conditions, including if you or your child: |
|How should I use Ivermectin Lotion? |
|What are the possible side effects of Ivermectin Lotion?The most common side effects of Ivermectin Lotion include: |
| How should I store Ivermectin Lotion? |
|General information about the safe and effective use of Ivermectin Lotion. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Ivermectin Lotion for a condition for which it was not prescribed. Do not give Ivermectin Lotion to other people, even if they have the same symptoms you have. It may harm them. You can also ask your healthcare provider or pharmacist for information about Ivermectin Lotion that is written for health professionals.|
|What are the ingredients in Ivermectin Lotion? Active: Ivermectin 0.5%Inactive ingredients: butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan AWS, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate anhydrous, sorbitan tristearate and stearyl alcohol.Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel, 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Issued: December, 2019 21180-1219-0 809|
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