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In stock Manufacturer GALDERMA LABORA 00299382345
$582.30 / 45 Grams Tube

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Uses

Pediculosis Capitis

Ivermectin 0.5% lotion is used for the topical treatment of pediculosis capitis (head lice infestation) in adults and pediatric patients 6 months of age or older.

Efficacy and safety of ivermectin 0.5% lotion for the topical treatment of pediculosis capitis were established in 2 identical, randomized, double-blind, vehicle-controlled phase 3 clinical studies in adults and children 6 months of age or older with active head lice infestation. In 289 index cases (i.e., youngest infested member of the household), 76.1 and 71.4% of those who applied ivermectin in studies 1 and 2, respectively, were lice free at 14 days compared with 16.2 and 18.9%, respectively, of those who applied the vehicle. In the 781 individuals in the extended intent-to-treat population (index patients plus enrolled household members), more patients were free from live lice 14 days after a single application of ivermectin 0.5% lotion compared with application of the vehicle.

The American Academy of Pediatrics (AAP) and other experts usually recommend topical treatment with an over-the-counter (OTC) preparation of permethrin 1% or pyrethrins with piperonyl butoxide for initial treatment of head lice infestations; other topical pediculicides (e.g., malathion 0.5%, benzyl alcohol 5%, spinosad 0.9%) are recommended if the OTC preparations are ineffective or permethrin or pyrethrin resistance is suspected. Oral ivermectin has been recommended as an alternative for treatment of head lice infestations that do not respond to or are resistant to topical agents.

For further information on treatment of pediculosis,

Dosage and Administration

General

Measures to Avoid Reinfestation and Transmission of Lice

Ivermectin 0.5% lotion should be used for the treatment of pediculosis capitis (head lice infestation) in the context of an overall lice management program. Other family members and close contacts of the individual with pediculosis capitis should be evaluated and treated if lice infestation is present. Some clinicians suggest treating family members who share a bed with the infested individual, even if no live lice are found on this family member. Ideally, all infested household members and close contacts should be treated at the same time.

To avoid reinfestation or transmission of lice, most experts recommend that clothing, hats, bed linen, and towels that were worn or used by the infested individual during the 2 days prior to treatment should be decontaminated (machine-washed in hot water and dried in a hot dryer). Items that cannot be laundered can be dry-cleaned or sealed in a plastic bag for 2 weeks. Combs, brushes, and hair clips used by the infested individual can be disinfected by soaking in hot water (temperature exceeding 54°C for 5-10 minutes). It also is recommended that car seats, upholstered furniture, and floors of rooms inhabited by the infested individual be vacuumed. Fumigation of living areas is not necessary and is not recommended.

A fine-toothed comb or nit comb often is used to remove any remaining nits (eggs) or nit shells from the hair. Some clinicians do not consider nit removal necessary since only live lice can be transmitted, but recommend it for aesthetic reasons and to decrease diagnostic confusion and unnecessary retreatment. Other clinicians recommend removal of nits (especially those within 1 cm of the scalp) to decrease the risk of reinfestation since no pediculicide is 100% ovicidal and potentially viable nits may remain on the hair after treatment. Although many schools will not allow children with nits to attend, the American Academy of Pediatrics (AAP) and other experts consider these no-nit policies excessive.

Administration

Topical Administration

Ivermectin 0.5% lotion should be applied topically to scalp and hair.

Ivermectin 0.5% lotion is for external use only. The lotion should not be administered orally or intravaginally and should not be applied topically to the eyes.

Ivermectin 0.5% lotion should be applied to dry scalp and hair in an amount sufficient to thoroughly coat the hair and scalp. The lotion should be left on the hair and scalp for 10 minutes and then thoroughly rinsed off using warm (not hot) water. Rinsing the hair at a sink, instead of in a shower or bath tub, may minimize exposing other areas of the skin to the drug.

Contact of the lotion with the eyes should be avoided. If contact occurs, the affected eye(s) should be immediately flushed with water.

Any unused portion of the lotion remaining in the single-use tube should be discarded.

Pediatric patients should be supervised by an adult during application of ivermectin 0.5% lotion, including having an adult apply and rinse the lotion for the child.(See Inadvertent Ingestion in Pediatric Patients under Cautions: Warnings/Precautions.)

Individuals applying ivermectin 0.5% lotion should wash their hands after application.

Dosage

Pediculosis Capitis

For the topical treatment of pediculosis capitis (head lice infestation) in adults and pediatric patients 6 months of age or older, the manufacturer recommends a single application of ivermectin 0.5% lotion.

Ivermectin 0.5% lotion should be applied to dry scalp and hair in an amount sufficient to completely coat the hair and scalp and should not exceed a single tube of lotion (120 mL). After 10 minutes, the lotion should be thoroughly rinsed off with water.(See Dosage and Administration: Administration.)

Special Populations

No special population dosage recommendations.

Cautions

Contraindications

The manufacturer states there are no contraindications to use of ivermectin 0.5% lotion.

Warnings/Precautions

Inadvertent Ingestion in Pediatric Patients

To prevent ingestion in pediatric patients, ivermectin 0.5% lotion should only be administered to pediatric patients under the direct supervision of an adult.(See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

Specific Populations

Pregnancy

Category C.

Lactation

Orally administered ivermectin is distributed into milk in low concentrations. Since it is not known if ivermectin is distributed into milk following topical administration, the 0.5% lotion should be used with caution in nursing women.

Pediatric Use

Safety and efficacy of ivermectin 0.5% lotion have not been established in children younger than 6 months of age. Because these young children have a greater skin surface area to body mass ratio and potentially immature skin barrier, systemic absorption may be increased and children younger than 6 months of age may be at increased risk of ivermectin toxicity. Ivermectin 0.5% lotion should not be used in children younger than 6 months of age.

The lotion should be kept out of the reach of children and should be used only under the direct supervision of an adult.

Geriatric Use

Clinical studies of ivermectin 0.5% lotion did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger adults; other clinical experience has not identified differences in response between geriatric and younger patients.

Common Adverse Effects

Conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and burning skin sensation were reported in less than 1% of patients 6 months of age or older after a single 10-minute topical application of ivermectin 0.5% lotion.

Drug Interactions

Drug interaction studies have not been performed to date with ivermectin 0.5% lotion.

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