Methyluracil

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT METHYLURACIL (METHYLURACIL)

Composition:

Active substance: methyluracil;

1 suppository contains 6-methyluracil 0.5 g (500 mg);

Excipients: polyethylene glycol 400, polyethylene glycol 1500.

Pharmaceutical form. Rectal suppositories.

Main physico-chemical properties: white-colored, bullet-shaped suppositories.

Pharmacotherapeutic group. Non-steroidal anabolic agents. ATC code A14B.

Pharmacological properties.

Pharmacodynamics.

The medicinal product has anabolic and anticatabolic effects. It accelerates regeneration and wound healing, stimulates cellular and humoral immune responses, and exerts anti-inflammatory action. A characteristic specific property of the drug is its stimulating effect on erythropoiesis and, particularly, leukopoiesis.

Pharmacokinetics.

After administration of the suppository into the rectum, the drug is well absorbed through the mucosa and appears in the blood within 20–30 minutes. Maximum blood concentration is reached within 1–2 hours. The drug is excreted from the body mainly by the kidneys in the form of metabolites and conjugates, and partially unchanged in feces.

Clinical characteristics.

Indications.

Inflammatory and ulcerative diseases of the lower parts of the large intestine: erosive and ulcerative colitis, proctosigmoiditis, anal fissures.

Contraindications.

Hypersensitivity to methyluracil or to other components of the drug. The drug is contraindicated in acute and chronic (usually myeloid) forms of leukemia, lymphogranulomatosis, and malignant diseases of the bone marrow.

Interaction with other medicinal products and other forms of interaction.

Methyluracil enhances the effect of strophanthin and increases the effectiveness of antibiotics and sulfonamide drugs.

Special precautions.

Methyluracil is advisable to prescribe in mild forms of leukopenia. In moderate severity conditions, the drug should be taken only after the elimination of blood cell regeneration disorders. Methyluracil should not be prescribed in severe cases of hematopoietic system impairment.

Use during pregnancy or breastfeeding.

The medicinal product should not be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Until the individual patient's response to the drug is established, caution should be exercised when driving or operating machinery, considering that treatment with methyluracil may cause such nervous system side effects as dizziness.

Method of administration and dosage.

Before using the suppository, it is necessary to:

• tear off one suppository in the primary packaging along the perforation line of the blister pack;
• pull the edges of the film apart in opposite directions and remove the suppository from the primary packaging.

The drug is intended for rectal administration.

Before insertion, moisten the suppository with water.

For adults and children aged 14 years and older: 1 suppository 1–4 times daily.

Duration of treatment: from 7 days to 4 months, depending on the nature of the disease.

Children.

The drug should not be used for the treatment of children under 14 years of age.

Overdose.

Not observed.

Adverse reactions.

Central nervous system: headache, dizziness.

Skin and subcutaneous tissue: allergic reactions, including hyperemia, itching, skin rash, urticaria.

Local reactions at site of administration: transient burning sensation, itching may occasionally occur after rectal administration of the suppository.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging, out of reach of children, at a temperature not exceeding 25 °C.

Packaging.

5 suppositories per blister; 1 or 2 blisters per carton.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

Private Joint-Stock Company "Lekhym-Kharkiv".

Manufacturer's address.

36 Severina Pototskoho Street, Kharkiv, Kharkiv Oblast, 61115, Ukraine.