Composition
1 g of the cream contains:
Active ingredient: ivermectin 10.0 mg.
Excipients: Glycerol 40.0 mg, isopropyl palmitate 40.0 mg, carbomer copolymer type B 2.0 mg, dimethicone 20 Cst 5.0 mg, edetate disodium 0.5 mg, citric acid monohydrate 0.5 mg, cetyl alcohol 35.0 mg, stearic alcohol 25.0 mg, macrogoal cetosterol ester 30, 0 mg, sorbitan stearate 20.0 mg, methyl parahydroxybenzoate 2.0 mg, propyl parahydroxybenzoate 1.0 mg, phenoxyethanol 10.0 mg, propylene glycol 20.0 mg, oleyl alcohol 20.0 mg, sodium hydroxide solution 10% to pH 6.3±0.3, purified water 1000 mg.
Pharmacotherapeutic group
antimicrobial and antiprotozoal agent
Indications
Treatment of inflammatory skin lesions in rosacea (papulopustular form) in adult patients.
Contraindications
- Hypersensitivity to the active ingredient or any other component of the drug;
- pregnancy;
- Breast-feeding period;
- Childhood under 18 years of age (safety and efficacy of the drug in this age group has not been studied).
Caution:
Impaired liver function.
Pregnancy and lactation:
Pregnancy
There are limited or no data on the use of ivermectin in pregnant women. Studies of reproductive toxicity in oral ivermectin have shown teratogenic potential in rats and rabbits, but because of the low systemic effects, the drug has a low risk of fetotoxicity in humans when administered externally at the recommended dose. The use of Solantra during pregnancy is not recommended.
Breast-feeding period
Low concentrations of ivermectin are excreted into breast milk after oral administration. Excretion of ivermectin in breast milk has not been studied during external administration. Pharmacokinetic and toxicological data from animal studies also indicate excretion of ivermectin in breast milk. A risk to the infant cannot be excluded. If application of the drug is necessary, the attending physician should be consulted in order to decide whether to stop breastfeeding.
Directions for use and dosages
For external use only.
Apply Solantra cream once a day every day for the duration of treatment - up to 4 months. If necessary, the treatment course may be repeated.
If there is no improvement after 3 months of use, treatment should be discontinued.
Apply a small amount of cream (about the size of a pea) to each of the five areas of the face: forehead, chin, nose and cheeks. Spread the product in a thin layer all over the face, avoiding contact with eyes, lips and mucous membranes.
Solantra should only be applied to the face.
Dosage adjustment is not necessary in patients with impaired renal function or in elderly patients.
Side effects
The most frequent undesired reactions, such as burning sensation, skin irritation, itching and dry skin have been reported in less than 1% of patients treated with the drug in clinical trials.
As a rule, these reactions are mild to moderate and usually subside with continued therapy.
No significant differences in the safety profile have been observed between patients aged 18 to 65 years and patients over 65 years.
The adverse reactions reported in clinical trials of Solantra are shown in Table 1. These reactions are classified by organ system and frequency of occurrence as follows: very common (? 1/10), common (? 1/100 to < 1/10), infrequent (? 1/1 000 to < 1/100), rare (? 1/10 000 to < 1/1 000), very rare (< 1/10 000), unknown (cannot be estimated based on available data).
Skin and subcutaneous tissue disorders
Frequently Burning sensation in the skin
Infrequent Skin irritation, itching, dry skin
Not known Contact dermatitis and allergic reactions
Overdose
No cases of overdose of Solantra have been reported.
When accidental or significant exposure of humans to unknown amounts of veterinary dosage forms of ivermectin (ingestion, inhalation, parenteral administration or body surface contact), the following symptoms have been reported most frequently: skin rash, facial swelling, eyelid swelling, headache, dizziness, asthenia, nausea, vomiting and diarrhoea. Other reported adverse reactions include: seizures, ataxia, dyspnea, abdominal pain, paraesthesia, urticaria and contact dermatitis.
In case of accidental ingestion, symptomatic therapy including parenteral administration of fluids and electrolytes, respiratory support (provision of oxygen supply and, if necessary, artificial ventilation) and vasopressors (if there is a marked decrease in blood pressure) are applied. Induction of vomiting and/or emergency gastric lavage may be indicated to prevent absorption of the ingested preparation, with
Drug interaction
Studies to study drug interactions with other drugs have not been conducted.
Concomitant use of Solantra cream with other topical and systemic products for the treatment of rosacea has not been studied.
Caution should be exercised when coadministering ivermectin with potent CYP3A4 inhibitors, because plasma concentrations of the drug may increase significantly.
Special precautions
The medicinal product contains:
- cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis),
- methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (including delayed-type),
- propylene glycol, which may cause skin irritation.
Wash your hands after applying the medicinal product.
After the drug has dried, cosmetic products may be applied.
Effect on the ability to drive motor vehicles and vehicles:
Solantra has no or negligible effect on the ability to drive vehicles and operate machinery.
Storage temperature
2℃ to 25℃
1 g of the cream contains:
Active ingredient: ivermectin 10.0 mg.
Excipients: Glycerol 40.0 mg, isopropyl palmitate 40.0 mg, carbomer copolymer type B 2.0 mg, dimethicone 20 Cst 5.0 mg, edetate disodium 0.5 mg, citric acid monohydrate 0.5 mg, cetyl alcohol 35.0 mg, stearic alcohol 25.0 mg, macrogoal cetosterol ester 30, 0 mg, sorbitan stearate 20.0 mg, methyl parahydroxybenzoate 2.0 mg, propyl parahydroxybenzoate 1.0 mg, phenoxyethanol 10.0 mg, propylene glycol 20.0 mg, oleyl alcohol 20.0 mg, sodium hydroxide solution 10% to pH 6.3±0.3, purified water 1000 mg.
Pharmacotherapeutic group
antimicrobial and antiprotozoal agent
Indications
Treatment of inflammatory skin lesions in rosacea (papulopustular form) in adult patients.
Contraindications
- Hypersensitivity to the active ingredient or any other component of the drug;
- pregnancy;
- Breast-feeding period;
- Childhood under 18 years of age (safety and efficacy of the drug in this age group has not been studied).
Caution:
Impaired liver function.
Pregnancy and lactation:
Pregnancy
There are limited or no data on the use of ivermectin in pregnant women. Studies of reproductive toxicity in oral ivermectin have shown teratogenic potential in rats and rabbits, but because of the low systemic effects, the drug has a low risk of fetotoxicity in humans when administered externally at the recommended dose. The use of Solantra during pregnancy is not recommended.
Breast-feeding period
Low concentrations of ivermectin are excreted into breast milk after oral administration. Excretion of ivermectin in breast milk has not been studied during external administration. Pharmacokinetic and toxicological data from animal studies also indicate excretion of ivermectin in breast milk. A risk to the infant cannot be excluded. If application of the drug is necessary, the attending physician should be consulted in order to decide whether to stop breastfeeding.
Directions for use and dosages
For external use only.
Apply Solantra cream once a day every day for the duration of treatment - up to 4 months. If necessary, the treatment course may be repeated.
If there is no improvement after 3 months of use, treatment should be discontinued.
Apply a small amount of cream (about the size of a pea) to each of the five areas of the face: forehead, chin, nose and cheeks. Spread the product in a thin layer all over the face, avoiding contact with eyes, lips and mucous membranes.
Solantra should only be applied to the face.
Dosage adjustment is not necessary in patients with impaired renal function or in elderly patients.
Side effects
The most frequent undesired reactions, such as burning sensation, skin irritation, itching and dry skin have been reported in less than 1% of patients treated with the drug in clinical trials.
As a rule, these reactions are mild to moderate and usually subside with continued therapy.
No significant differences in the safety profile have been observed between patients aged 18 to 65 years and patients over 65 years.
The adverse reactions reported in clinical trials of Solantra are shown in Table 1. These reactions are classified by organ system and frequency of occurrence as follows: very common (? 1/10), common (? 1/100 to < 1/10), infrequent (? 1/1 000 to < 1/100), rare (? 1/10 000 to < 1/1 000), very rare (< 1/10 000), unknown (cannot be estimated based on available data).
Skin and subcutaneous tissue disorders
Frequently Burning sensation in the skin
Infrequent Skin irritation, itching, dry skin
Not known Contact dermatitis and allergic reactions
Overdose
No cases of overdose of Solantra have been reported.
When accidental or significant exposure of humans to unknown amounts of veterinary dosage forms of ivermectin (ingestion, inhalation, parenteral administration or body surface contact), the following symptoms have been reported most frequently: skin rash, facial swelling, eyelid swelling, headache, dizziness, asthenia, nausea, vomiting and diarrhoea. Other reported adverse reactions include: seizures, ataxia, dyspnea, abdominal pain, paraesthesia, urticaria and contact dermatitis.
In case of accidental ingestion, symptomatic therapy including parenteral administration of fluids and electrolytes, respiratory support (provision of oxygen supply and, if necessary, artificial ventilation) and vasopressors (if there is a marked decrease in blood pressure) are applied. Induction of vomiting and/or emergency gastric lavage may be indicated to prevent absorption of the ingested preparation, with
Drug interaction
Studies to study drug interactions with other drugs have not been conducted.
Concomitant use of Solantra cream with other topical and systemic products for the treatment of rosacea has not been studied.
Caution should be exercised when coadministering ivermectin with potent CYP3A4 inhibitors, because plasma concentrations of the drug may increase significantly.
Special precautions
The medicinal product contains:
- cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis),
- methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (including delayed-type),
- propylene glycol, which may cause skin irritation.
Wash your hands after applying the medicinal product.
After the drug has dried, cosmetic products may be applied.
Effect on the ability to drive motor vehicles and vehicles:
Solantra has no or negligible effect on the ability to drive vehicles and operate machinery.
Storage temperature
2℃ to 25℃