Drugs List

Therapeutic Indications

Uses

Treatment of Rosacea (topical)

Treatment of inflammatory lesions of rosacea (papulopustular).

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Severe hepatic impairment

Contains cetyl alcohol - may cause local skin reactions
Contains hydroxybenzoate
Contains propylene glycol: may cause irritation
Advise patient to wash hands after use
Avoid contact with eyes, lips or mouth
Discontinue if an adequate response not achieved within 3 months

Pregnancy and Lactation

Pregnancy

Ivermectin is contraindicated in pregnancy.

At the time of writing there is limited data on the use of ivermectin in pregnant women.

Oral reproductive toxicity studies have shown that ivermectin is teratogenic in rats and rabbits, however due to the low systemic exposure following topical administration of the product at the proposed posology, there is a low safety concern for a human foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Ivermectin is contraindicated in breastfeeding.

At the time of writing there is limited data on the use of ivermectin in breastfeeding women.

Following oral administration, ivermectin is excreted in human milk in low concentrations. Excretion in human milk following topical administration has not been evaluated. Available data in animals have also shown excretion of ivermectin in milk. A risk to a suckling child cannot be excluded.

A decision must be made whether to discontinue breastfeeding or to discontinue from ivermectin therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic dermatitis
Burning sensation (local)
Dry skin
Erythema
Facial swelling
Irritant dermatitis
Pruritus
Skin irritation

Drugs List

Therapeutic Indications

Uses

Treatment of Rosacea (topical)

Treatment of inflammatory lesions of rosacea (papulopustular).

Dosage

Adults

Additional Dosage Information

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Severe hepatic impairment

Contains cetyl alcohol - may cause local skin reactions
Contains hydroxybenzoate
Contains propylene glycol: may cause irritation
Advise patient to wash hands after use
Avoid contact with eyes, lips or mouth
Discontinue if an adequate response not achieved within 3 months

Pregnancy and Lactation

Pregnancy

Ivermectin is contraindicated in pregnancy.

At the time of writing there is limited data on the use of ivermectin in pregnant women.

Oral reproductive toxicity studies have shown that ivermectin is teratogenic in rats and rabbits, however due to the low systemic exposure following topical administration of the product at the proposed posology, there is a low safety concern for a human foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Ivermectin is contraindicated in breastfeeding.

At the time of writing there is limited data on the use of ivermectin in breastfeeding women.

Following oral administration, ivermectin is excreted in human milk in low concentrations. Excretion in human milk following topical administration has not been evaluated. Available data in animals have also shown excretion of ivermectin in milk. A risk to a suckling child cannot be excluded.

A decision must be made whether to discontinue breastfeeding or to discontinue from ivermectin therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic dermatitis
Burning sensation (local)
Dry skin
Erythema
Facial swelling
Irritant dermatitis
Pruritus
Skin irritation

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: May 2018

Reference Sources

Summary of Product Characteristics: Soolantra 10mg/g cream. Galderma (UK) Ltd. Revised April 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 09 May 2018

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ivermectin Last revised: 05 May 2015
Last accessed: 09 May 2018