Ureotop®
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT UREOTOP®
Composition:
Active substance: urea;
1 g of ointment contains 120 mg of urea;
Excipients: white soft paraffin; propylene glycol; alpha-tocopherol acetate; sorbitan sesquioleate; glycerol 85%; retinol palmitate concentrate (oily form containing peanut oil); isopropyl myristate; polyethylene glycol castor oil, hydrogenated; wheat starch; microcrystalline wax; lactic acid, alpha-tocopherol.
Pharmaceutical form. Ointment.
Main physicochemical properties: homogeneous white ointment, free from particles.
Pharmacotherapeutic group. Agents for treatment of dermatological diseases. Keratolytics.
ATC code D02AE01.
Pharmacological Properties.
Pharmacodynamics
The use of highly concentrated urea preparations in the treatment of dermatological diseases is primarily based on the keratoplastic effect of urea. In addition, topical applications of concentrated urea preparations increase the water content in the stratum corneum of human epidermis. Urea is a natural moisturizing agent that enhances water binding in the upper layers of the skin and reduces its loss by the epidermis. The efficacy of such agents has been proven in the treatment of ichthyosis and psoriasis, as well as their beneficial effect in patients with dry and sensitive skin. Urea has a low molecular weight, allowing for rapid absorption. Along with its hydrating properties, urea also exhibits a keratolytic effect, resulting in rapid softening of the skin and shedding of hard scales.
Pharmacokinetics
The excipients contained in the ointment formulation retain the active substance (urea) at the site of application, thereby preventing its absorption into the systemic circulation. Absorbed urea is excreted in urine and, in insignificant amounts, in sweat.
Clinical characteristics.
Indications.
For the treatment of neurodermatitis (including in elderly patients), and as an adjunctive agent in the treatment of ichthyosis.
Contraindications.
Hypersensitivity to urea, peanut or soy, or to any of the excipients listed in the section "Composition".
UREOTOP® should not be used for the treatment of acute skin inflammations caused by excoriation, or in dermatoses with pronounced exudation.
Interaction with other medicinal products and other forms of interaction.
Increased skin absorption of other topically applied agents (especially corticosteroids) may occur. Concomitant use of other products containing urea and its derivatives is not recommended.
Special precautions for use.
Avoid contact with eyes and mucous membranes.
Do not apply to large areas in case of renal insufficiency.
The integrity of latex condoms may be impaired when in contact with the ointment.
Ureotop® contains propylene glycol, which may cause skin irritation.
Ureotop® contains polyoxylated castor oil, which may cause skin reactions.
Ureotop® contains peanut oil. If you are allergic to peanuts or soy, do not use this medicinal product.
Avoid contact with eyes and mucous membranes.
Do not apply to large areas in case of renal insufficiency.
Use during pregnancy or breastfeeding.
Pregnancy
The risks associated with the use of Ureotop® during pregnancy are unknown.
Breastfeeding
The risks associated with the use of Ureotop® during breastfeeding are unknown. Ureotop® must not be applied to the breast area during breastfeeding.
Fertility
There is no information available on reproductive toxicity.
Ability to affect reaction speed when driving or operating machinery.
There are no data on the influence of Ureotop® on the ability to drive or operate machinery.
Method of Administration and Dosage.
Method of Administration
Apply the ointment to clean, dry skin and rub in thoroughly. Use occlusive dressings only as directed by a physician.
Dosage
Apply 1–2 times daily until symptoms subside.
There is no clinical data available on the use of Ureotop**®** ointment for longer than 3 weeks.
The duration of treatment should be determined individually by a physician.
Children
There are no data available on the use of this medicinal product in children; therefore, it should not be used in pediatric practice.
Reports from the specialized literature indicate that the use of high-concentration urea-containing products in children may cause transient skin burning sensation.
Overdose
Skin irritation caused by overdose usually resolves quickly after discontinuation of the product.
Side effects.
Assessment of the frequency of occurrence of adverse reactions:
| Very common |
≥1/10 |
| Common |
from ≥1/100 to <1/10 |
| Uncommon |
from ≥1/1000 to <1/100 |
| Rare |
from ≥1/10000 to <1/1000 |
| Very rare |
<1/10000 |
| Not known |
Frequency cannot be estimated based on available data |
Allergic reactions to the components of the medicinal product, as well as skin irritation such as burning, redness, itching or peeling, tingling, and contact dermatitis may occur uncommonly.
Peanut oil may rarely cause severe allergic reactions.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after medicinal product authorization is of great importance. It allows ongoing monitoring of the benefit/risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at https://aisf.dec.gov.ua.
Shelf life. 3 years. After opening the tube – 6 months.
Storage conditions.
Store in a place inaccessible to children at a temperature not exceeding 25 °C.
Packaging. Tube containing 50 g or 100 g in a cardboard box with instructions for medical use.
Category of supply. Over-the-counter (without prescription).
Manufacturer.
mibe GmbH Arzneimittel.
Manufacturer's address and place of business.
Muenchener Strasse 15, Breuna, Saxony-Anhalt, 06796, Germany.