Methyluracil

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT METHYLURACIL

Composition:

Active substance: methyluracil;

1 g of ointment contains methyluracil – 100 mg;

Excipients: macrogol 400, macrogol 1500.

Pharmaceutical form. Ointment.

Main physicochemical properties: homogeneous mass of white or almost white color.

Pharmacotherapeutic group. Medicinal products for the treatment of wounds and ulcers.

ATC code D03A X.

Pharmacological properties.

Pharmacodynamics.

The drug has anabolic and anticatabolic properties. Methyloauracil accelerates regeneration, wound healing, stimulates cellular and humoral immunity, and exerts anti-inflammatory effects. A specific property of the drug is its stimulatory effect on erythropoiesis and, particularly, leukopoiesis.

The medicinal product provides photoprotective action in patients with photodermatoses.

Pharmacokinetics.

Due to the properties of the ointment base to retain the active substance on the surface of the application site, it is not significantly absorbed into the systemic circulation and usually does not cause systemic effects.

Clinical characteristics.

Indications.

Wounds; burns; ulcers and other skin injuries.

Contraindications.

Hypersensitivity to the active substance or to any of the other components of the medicinal product; acute and chronic forms of leukemia; lymphogranulomatosis; malignant diseases of the bone marrow.

Interaction with other medicinal products and other forms of interaction.

The preparation is compatible with topical applications of antibacterial and antiseptic agents.

When methyluracil is used concomitantly with strophanthin, antibiotics, and sulfonamide drugs, an increase in their effectiveness is observed, while concomitant use with pentoxyl leads to enhanced toxic effects.

When the medicinal product is used simultaneously with topical glucocorticosteroids, its effectiveness is reduced.

Special precautions.

Use the medicinal product with caution in patients with neoplasms undergoing radiation and chemotherapy.

The efficacy of the medicinal product increases if it is applied to a wound surface previously cleaned with an antiseptic solution. The presence of purulent-necrotic material in the wound may require additional amounts of the ointment.

In cases of deep infection localization in soft tissues, the medicinal product may be used in combination with systemic antibiotics.

Use during pregnancy or breastfeeding.

Due to the lack of controlled studies on the safety and efficacy of the medicinal product, it should not be used during pregnancy or breastfeeding.

Ability to affect reaction rate while driving or operating machinery.

There are no data regarding the ability of the medicinal product to affect reaction speed while driving or operating machinery.

Administration and Dosage.

Apply the medicinal product topically. After standard wound or burn treatment, apply the ointment directly to the affected surface, then cover with a sterile gauze dressing, or apply the oint游戏副本 to the dressing material and then place it on the wound.

Alternatively, use swabs soaked in the medicinal product to carefully fill the cavities of purulent wounds after surgical debridement, or use gauze tampons impregnated with the ointment, inserting them into fistulous tracts.

Apply a thin layer of ointment to affected areas in amounts of 5–20 g daily for 15–30 days. The dosage depends on the wound surface area and the degree of purulent exudation. The duration of treatment is determined by the dynamics of wound cleansing and healing. Discontinue treatment with the medicinal product when granulation tissue appears and wounds are cleared of exudate.

Children.

Due to insufficient experience of use, the medicinal product should not be prescribed in pediatric practice.

Overdose.

Cases of overdose have not been observed. However, when applying the medicinal product to large areas of damaged skin, partial absorption of the active components into the systemic circulation cannot be excluded, although in quantities insufficient to cause acute poisoning. Systemic effects of methyluracil may include headache, dizziness, and hypersensitivity reactions. With overdose caused by prolonged use of large amounts of ointment, changes in blood composition may occur due to the effect of methyluracil on hematopoietic processes.

Treatment: reduce the dose or discontinue the medicinal product, symptomatic therapy.

Adverse reactions.

Immune system, skin and subcutaneous tissue disorders: hypersensitivity reactions, including hyperemia, itching, skin rashes, urticaria.

Central nervous system disorders: headache, dizziness.

Application site reactions: transient burning sensation, itching at the site of application may occasionally occur.

If any adverse reactions occur, use of the medicinal product should be discontinued and medical advice should be sought.

Reporting of suspected adverse reactions

Reporting of adverse reactions following registration of the medicinal product is important. It allows continued 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 through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

15 g, 25 g or 40 g in tubes; 1 tube per cardboard box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and location of its business activity.

16 Barvinkova Street, Lubny, Poltava region, 37500, Ukraine.