Ivermectin

Cream "Soolantra^®"Is used for topical treatment of inflammatory lesions caused by rosacea (papular-pustular form) in adult patients.

Structure

The active substance is ivermectin (1 g of cream contains 10 mg ivermectin).

Excipients: glycerin; isopropyl palmitate; carbomer copolymer type B; dimethicone 20 Cst; disodium edetate; citric acid monohydrate; cetyl alcohol; stearyl alcohol; macrogol cetostearyl ether; sorbitan stearate; methyl parahydroxybenzoate (E 218); propyl parahydroxybenzoate (E 216); phenoxyethanol; propylene glycol; oleyl alcohol; sodium hydroxide; purified water.

Contraindications

Hypersensitivity to the active substance or to any of the excipients of the drug.

Mode of application

Cream "Soolantra^®"Apply only to the skin of the face.

Apply a small amount of the drug (pea-sized) to the skin on each of the five areas of the face: forehead, chin, nose and both cheeks. Distribute the drug in a thin layer on the skin of the entire face, avoiding the area of ​​the eyes, lips and mucous membranes.

After applying the cream "Soolantra^®"Wash hands.

Makeup can be applied only after the cream has dried.

Dosage

Apply cream once a day daily for no more than 4 months. The course of treatment can be repeated.

If there is no improvement after 3 months, treatment should be discontinued.

Individual patient groups:

• impaired renal function - dose adjustment is not required;
• impaired liver function - use with caution in patients with severe hepatic insufficiency;
• elderly patients - dose adjustment is not required for the geriatric patient population.

Application features

Pregnant women

For local use of ivermectin for pregnant women, information is missing or limited. A study of the toxic effect on reproductive function during oral administration of ivermectin showed that ivermectin has a teratogenic effect in animals, however, due to the low systemic exposure of the substance after topical administration at the recommended dosage, the probability of damage to human embryos is low. Cream "Soolantra^®"Not recommended during pregnancy.

After oral administration, ivermectin in low concentration is excreted in breast milk. Excretions in breast milk after topical administration have not been studied. Available pharmacokinetic / toxicological data for animals also indicate the excretion of ivermectin in breast milk. The risk to the infant during breastfeeding cannot be excluded. A decision must be made to stop breastfeeding or to cancel / refuse treatment with Soolantra cream^®”By weighing the benefits of breastfeeding for the baby and the benefits of treatment for the woman.

Information on the effect of ivermectin on human reproductive function is not available. In animals, there is no effect on mating or fertility during treatment with ivermectin.

Children

Safety and efficacy of Soolantra cream^®"Children (under the age of 18) have not been studied. No data available.

Drivers

Cream "Soolantra^®"Does not affect or has a slight effect on the ability to drive vehicles and work with other mechanisms.

Overdose

About cases of overdose of cream "Soolantra^®"Not reported.

In case of accidental ingestion of the drug, maintenance therapy is carried out, which, according to indications, may include parenteral administration of fluid and electrolytes, respiratory support (if necessary, oxygen and mechanical ventilation), as well as pressor drugs in the presence of clinically significant hypotension. If necessary, to prevent the absorption of the swallowed substance, artificially induce vomiting and / or gastric lavage, apply laxatives and take other measures typical of poisoning.

Side effects

The most common adverse reactions include a burning sensation on the skin, skin irritation, and dry skin. These phenomena occurred in ≤ 1% of patients treated with this agent in clinical trials.

Storage conditions

It does not require special storage conditions. Keep out of the reach of children.

Shelf life is 2 years.

After the first opening of the tube, the drug is suitable for use for 6 months.