Troxerutin

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

Composition:

Active substance: troxerutin;

1 capsule contains troxerutin 300 mg;

Excipients: macrogol 6000, lactose monohydrate, magnesium stearate; capsule shell: quinoline yellow (E 104), yellow FCF (E 110), titanium dioxide (E 171), gelatin.

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules of yellow color. The capsule contents are granules, granule aggregates, or compressed mass conforming to the shape of the capsule, ranging in color from yellow to yellow-brown or yellow-green.

Pharmacotherapeutic group. Angioprotectors. Capillary-stabilizing agents. Bioflavonoids. Troxerutin.

ATC code C05CA04.

Pharmacological properties.

Pharmacodynamics.

Troxerutin is a mixture of bioflavonoids containing not less than 95% of the active substance troxerutin; it is a capillary- and venotonic agent. It exhibits anti-inflammatory and antioxidant effects and inhibits hyaluronidase. It prevents oxidation of hyaluronic acid, ascorbic acid, and adrenaline, and inhibits lipid peroxidation. Troxerutin reduces increased capillary permeability and fragility and prevents damage to the endothelial cell basement membrane by various factors. In addition, it possesses antioxidant, membrane-stabilizing, antihemorrhagic, anti-inflammatory, and venotonic effects. It reduces edema, improves trophism, enhances microcirculation and microvascular perfusion, and reduces symptoms associated with venous insufficiency or impaired lymphatic drainage.

Pharmacokinetics.

Maximum plasma concentrations are reached between 1 and 9 hours after oral administration. Plasma concentration decline is biexponential. Plasma protein binding ranges from 27% to 29%. It accumulates predominantly in endothelial tissue. It does not cross the blood-brain barrier, crosses the placental barrier in insignificant amounts, and passes into breast milk in minimal quantities. It is metabolized in the liver via glucuronidation. It is primarily excreted from the body with bile, and to a minor extent, via urine.

Clinical characteristics.

Indications.

Symptomatic treatment of the following conditions:

• prevaricose and varicose syndrome, varicose ulcers;
• superficial thrombophlebitis, phlebitis, and postphlebitic conditions;
• chronic venous insufficiency;
• hemorrhoids;
• diabetic retinopathy, as part of combination therapy;
• edema and pain following trauma and in varicose veins; varicose dermatitis;
• contusions, sprains, dislocations, symptoms of muscle cramps (calf muscle cramping) – combined treatment.

Contraindications.

Hypersensitivity to the active substance troxerutin or to any of the excipients; peptic ulcer disease of the stomach and duodenum, chronic gastritis (in the phase of exacerbation).

Interaction with other medicinal products and other forms of interaction.

The drug enhances the effect of ascorbic acid, strengthening the structure and reducing the permeability of the vascular wall.

Special precautions for use.

The drug Troxerutin is ineffective in treating edema of the lower limbs caused by liver, kidney or cardiovascular diseases.

The drug should be administered with caution in patients with severe liver or gallbladder diseases.

The drug may irritate the gastric mucosa; therefore, it should be taken during meals.

If a patient has known sugar intolerances, medical advice must be sought before taking this medicinal product. The drug contains lactose and therefore should not be administered to patients with lactase deficiency, galactosemia, or glucose-galactose malabsorption syndrome.

Due to the presence of a dye (E 110), treatment with this drug may cause allergic reactions, including asthma. The risk of allergy is higher in patients with hypersensitivity to acetylsalicylic acid.

Use during pregnancy or breastfeeding.

Pregnancy.

There are no data indicating a negative effect of troxerutin in pregnant women or women who are breastfeeding. Nevertheless, its use during the first trimester of pregnancy is not recommended.

Breastfeeding.

The drug passes into breast milk in minimal amounts, but there is no evidence that these amounts cause clinically significant reactions in newborns. The decision on whether to use the drug in this category of women should be made by a physician, based on the benefit of treatment to the mother versus the potential risk to the fetus or infant.

Ability to influence reaction rate while driving or operating machinery.

Troxerutin does not affect the ability to drive vehicles or operate other machinery.

Method of Administration and Dosage

Troxe Rutin, capsules, should be taken orally during meals. The dosage and duration of treatment are determined by a physician depending on the severity and nature of the disease course.

The usual dose is 2 capsules per day. For maintenance therapy – 1 capsule per day for 3–4 weeks. This treatment may be combined with concomitant use of Troxe Rutin gel. The efficacy of Troxe Rutin treatment depends on regular administration, correct dosage, and treatment duration. Clinical experience shows that the desired effect may sometimes be achieved with doses exceeding 600 mg (2 capsules) per day.

Children. Experience with the use of the drug for treatment of children (under 18 years of age) is limited; therefore, the use of this medicinal product in children is not recommended.

Overdose.

Symptoms. The manifestations of adverse reactions may intensify.

Treatment. The administration of the drug should be discontinued. Induction of vomiting or gastric lavage is recommended, along with symptomatic treatment. If necessary, peritoneal dialysis may be administered.

Adverse reactions.

Unwanted reactions occur rarely during treatment with Troxerutin capsules.

Adverse reactions are categorized by frequency as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated from available data).

Immune system disorders: very rare – anaphylactic shock, anaphylactoid reactions, hypersensitivity reactions.

Skin and subcutaneous tissue disorders: rare – rash; frequency not known – allergic dermatitis (itching, urticaria).

Psychiatric disorders: frequency not known – sleep disturbances.

Nervous system disorders: very rare – dizziness, headache.

Vascular disorders: very rare – ecchymosis.

Gastrointestinal disorders: rare – stomach pain, epigastric discomfort, dyspepsia, meteorism, diarrhea; frequency not known – nausea, vomiting.

General disorders: very rare – increased fatigue.

Shelf life. 2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

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

Packaging. 10 capsules in a blister; 3 or 6 blisters in a cardboard box.

Classification. Over-the-counter.

Manufacturer.

JSC "CHIMFARMZAVOD "CHERVONA ZIRKA".

Manufacturer's address and place of business.

1 Gordienkovskaya Street, Kharkiv, Kharkiv Region, 61010, Ukraine.