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Ivermectin (topical): Drug information

Ivermectin (topical): Drug information
(For additional information see "Ivermectin (topical): Patient drug information" and see "Ivermectin (topical): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Sklice [DSC];
  • Soolantra
Brand Names: Canada
  • Rosiver
Pharmacologic Category
  • Antiparasitic Agent, Topical;
  • Pediculocide
Dosing: Adult
Head lice

Head lice: Topical: Lotion: Apply sufficient amount (up to 1 tube) to completely cover dry scalp and hair; for single-dose use only.

Rosacea

Rosacea: Topical: Cream: Apply to each affected area (eg, forehead, chin, nose, each cheek) once daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Ivermectin (topical): Pediatric drug information")

Head lice

Head lice: Topical: Lotion 0.5%: Infants ≥6 months, Children, and Adolescents: Apply sufficient amount (up to 1 tube) to completely cover dry hair and scalp; for single use only; discard any remaining product.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Central nervous system: Localized burning (≤1%)

Dermatologic: Skin irritation (≤1%)

<1%, postmarketing, and/or case reports: Allergic dermatitis, conjunctivitis, contact dermatitis, eye irritation, ocular hyperemia, seborrheic dermatitis of scalp, xeroderma

Contraindications

There are no contraindications listed in the US manufacturer's labeling.

Canadian labeling: Hypersensitivity to ivermectin or any component of the formulation.

Warnings/Precautions

Other warnings/precautions:

• Appropriate use:

Topical lotion: For topical use on scalp and scalp hair only; treatment of lice on eyebrows or eyelashes should only be done under the guidance of a health care provider. Avoid contact with eyes and do not use inside the nose, ears, or mouth. Wash hands after application.

Topical cream: Not for oral, ophthalmic, or vaginal use; avoid contact with eyes and lips. Wash hands after application.

Warnings: Additional Pediatric Considerations

In infants <6 months, systemic absorption may be increased due to higher skin surface area to body mass ratio and immature skin barrier; risk for ivermectin toxicity potentially increased; avoid use in these patients (Sklice prescribing information 2017).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Soolantra: 1% (30 g [DSC], 45 g) [contains cetyl alcohol, edetate (edta) disodium, methylparaben, propylene glycol, propylparaben]

Generic: 1% (45 g)

Lotion, External:

Sklice: 0.5% (117 g [DSC]) [contains methylparaben, propylparaben]

Generic: 0.5% (117 g)

Generic Equivalent Available: US

Yes

Pricing: US

Cream (Ivermectin External)

1% (per gram): $14.55 - $16.00

Cream (Soolantra External)

1% (per gram): $18.54

Lotion (Ivermectin External)

0.5% (per gram): $1.68

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Rosiver: 1% (2 g, 15 g, 30 g, 45 g, 60 g) [contains cetyl alcohol, edetate (edta) disodium, methylparaben, propylene glycol, propylparaben]

Administration: Adult

Topical lotion: For external use only. Apply to dry scalp and hair closest to scalp first, then apply outward towards ends of hair; completely covering scalp and hair. Leave on for 10 minutes (start timing treatment after the scalp and hair have been completely covered). The hair should then be rinsed thoroughly with water; wait 24 hours before shampooing. Wash hands after applying product. Avoid contact with the eyes. Nit combing is not required, although a fine-tooth comb may be used to remove treated lice and nits. Lotion is for one-time use; discard any unused portion. Ivermectin should be a portion of a whole lice removal program, which should include washing or dry cleaning all clothing, hats, bedding, and towels recently worn or used by the patient and washing combs, brushes, and hair accessories in hot soapy water.

Topical cream: For external use only. Not for use in the eye, mouth or vagina. Wash hands with soap and water prior to application and after application. Apply a pea-size amount as a thin layer on each affected area (eg, forehead, chin, nose, each cheek).

Administration: Pediatric

For external use only. Not for use in the eye, mouth, or vagina.

Head lice: Topical lotion 0.5%: Apply to dry scalp and hair closest to scalp first, then apply outward towards ends of hair, completely covering scalp and hair. Leave on for 10 minutes (start timing treatment after the scalp and hair have been completely covered). The hair should then be rinsed thoroughly with water alone. Wait 24 hours after application before applying shampoo. Avoid contact with the eyes; do not use on lice in eyebrows or eyelashes, or inside the nose, ear, mouth, or vagina. Nit combing is not required, although a fine-tooth comb may be used to remove treated lice and nits. Lotion is for one-time use; discard any unused portion.

Ivermectin should be a component of a comprehensive lice removal program, which should include washing or dry cleaning all clothing, hats, bedding, and towels recently worn or used by the patient and washing combs, brushes, and hair accessories in hot, soapy water.

Use: Labeled Indications

Head lice (Pediculus capitis) (lotion): Treatment of head lice infestations in patients 6 months and older.

Rosacea (cream): Treatment of inflammatory lesions of rosacea in adult patients.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Although use in pregnancy is likely low risk, agents other than ivermectin are currently recommended for the treatment of pediculosis pubis or scabies in pregnant patients (CDC [Workowski 2021]). Agents other than ivermectin may also be preferred for the treatment of rosacea during pregnancy (Gomolin 2021; Murase 2014).

Breastfeeding Considerations

It is not known if ivermectin is present in breast milk following topical application.

Ivermectin is present in breast milk following oral administration. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Use of topical ivermectin for the treatment of pediculosis pubis or scabies is likely compatible with breastfeeding (CDC [Workowski 2021]).

Monitoring Parameters

Lotion: Monitor scalp for live lice.

Mechanism of Action

In pediculosis capitus treatment, ivermectin is a semisynthetic anthelminthic agent; it binds selectively and with strong affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to increased permeability of cell membranes to chloride ions then hyperpolarization of the nerve or muscle cell, and death of the parasite.

In rosacea treatment, the mechanism of action is unknown.

Pharmacokinetics (Adult Data Unless Noted)

Protein binding: >99%.

Metabolism: Metabolized hepatically by CYP3A4.

Half-life elimination: 1% cream: ~6.5 days.

Time to peak: 1% cream: ~10 hours post application.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Soolantra;
  • (AR) Argentina: Evanix | Ivercrem | Licend | Soolantra;
  • (AT) Austria: Soolantra;
  • (AU) Australia: Soolantra;
  • (BD) Bangladesh: Alice;
  • (BE) Belgium: Soolantra;
  • (BR) Brazil: Soolantra;
  • (CL) Chile: Ivercrem | Soolantra;
  • (CO) Colombia: Quanox | Soolantra;
  • (CZ) Czech Republic: Soolantra;
  • (DE) Germany: Soolantra;
  • (DO) Dominican Republic: Soolantra;
  • (EC) Ecuador: Soolantra;
  • (EE) Estonia: Soolantra;
  • (EG) Egypt: Iverzine;
  • (ES) Spain: Soolantra;
  • (FI) Finland: Soolantra;
  • (FR) France: Soolantra;
  • (GB) United Kingdom: Soolantra;
  • (GR) Greece: Soolantra;
  • (HK) Hong Kong: Soolantra;
  • (HU) Hungary: Soolantra;
  • (IE) Ireland: Soolantra;
  • (IN) India: Ivrea | Scabover;
  • (IT) Italy: Efacti;
  • (KR) Korea, Republic of: Soolantra;
  • (KW) Kuwait: Soolantra;
  • (LB) Lebanon: Soolantra;
  • (LT) Lithuania: Soolantra;
  • (LU) Luxembourg: Soolantra;
  • (LV) Latvia: Soolantra;
  • (MX) Mexico: Presteme;
  • (NL) Netherlands: Soolantra;
  • (NO) Norway: Soolantra;
  • (NZ) New Zealand: Soolantra;
  • (PE) Peru: Ivercrem | Quanox fast | Soolantra;
  • (PL) Poland: Soolantra;
  • (PR) Puerto Rico: Sklice | Soolantra;
  • (PT) Portugal: Soolantra;
  • (PY) Paraguay: Licend | Soolantra;
  • (RO) Romania: Soolantra;
  • (RU) Russian Federation: Solantra;
  • (SA) Saudi Arabia: Soolantra;
  • (SE) Sweden: Soolantra;
  • (SG) Singapore: Soolantra;
  • (SK) Slovakia: Soolantra;
  • (TW) Taiwan: Soolantra;
  • (UA) Ukraine: Soolantra;
  • (UY) Uruguay: Ivercrem | Soolantra | X Pel;
  • (ZA) South Africa: Soolantra
  1. Frankowski BL and Bocchini JA Jr, “Head Lice,” Pediatrics, 2010, 126(2):392-403. [PubMed 20660553]
  2. Gomolin T, Cline A, Pereira F. Treatment of rosacea during pregnancy. Dermatol Online J. 2021;27(7). doi:10.5070/D327754360 [PubMed 34391325]
  3. Ivermectin 0.5% lotion [prescribing information]. Hawthorne, NY: Taro Pharmaceuticals USA Inc; November 2020.
  4. Murase JE, Heller MM, Butler DC. Safety of dermatologic medications in pregnancy and lactation: part I. Pregnancy. J Am Acad Dermatol. 2014;70(3):401.e1-e14;quiz 415. doi:10.1016/j.jaad.2013.09.010 [PubMed 24528911]
  5. Rosiver (ivermectin) [product monograph]. Thornhill, Ontario, Canada: Galderma Canada Inc; May 2020.
  6. Sklice (ivermectin) [prescribing information]. Atlanta, GA: Arbor Pharmaceuticals; June 2017.
  7. Sklice (ivermectin) [prescribing information]. Atlanta, GA: Arbor Pharmaceuticals; May 2021.
  8. Soolantra (ivermectin) [prescribing information]. Dallas, TX: Galderma Laboratories LP; October 2022.
  9. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1 [PubMed 34292926]
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