Indovazin-teva

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Indovasin-Teva (Indovasin-Teva)

Composition:

Active substances: indomethacin, troxerutin;

1 g of gel contains 30 mg of indomethacin, 20 mg of troxerutin;

Excipients: carbomers, disodium edetate, polyethylene glycol (macrogol 400), sodium benzoate (E 211), isopropyl alcohol, dimethyl sulfoxide, flavoring agent Fresco BM & GD R.08.0932.1, purified water.

Pharmaceutical form. Gel.

Main physicochemical characteristics: slightly opalescent homogeneous gel, color ranging from yellow to yellowish-brown.

Pharmacotherapeutic group. Angioprotectors. Capillary stabilizing agents. Troxerutin, combinations. ATC code C05CA54.

Pharmacological properties.

Pharmacodynamics.

Indovazin-Teva is a combined medicinal product containing indomethacin and troxerutin.

Indomethacin exerts a pronounced anti-inflammatory, analgesic, and anti-edematous effect. This leads to pain relief, reduction of swelling, and shortens the recovery time of damaged joints and tissues. The mechanism of action is associated with inhibition of prostaglandin synthesis through reversible blockade of cyclooxygenase. Indomethacin has a more pronounced anti-inflammatory effect compared to salicylates and phenylbutazone.

Troxerutin (trihydroxyethylrutinoside) is a bioflavonoid. It belongs to angioprotective agents. Troxerutin reduces capillary permeability and exerts a venotonic effect. It blocks the venodilating action of histamine, bradykinin, and acetylcholine. It exerts anti-inflammatory effects on perivenous tissues, reduces capillary fragility, and has a certain anti-aggregant effect. It reduces edema and improves trophism in pathological changes associated with venous insufficiency. When applied to the skin, Indovazin-Teva suppresses inflammatory and edematous reactions, eliminates pain and hyperthermia at inflammatory sites (both superficially and in deep tissues, reaching blood vessels located therein). It exerts venotonic, capillary-protective, and hemostatic effects.

Pharmacokinetics.

Absorption. The ointment base of the drug is selected in such a way as to ensure complete solubility of active substances and their maximum release. The gel dosage form containing indomethacin and troxerutin ensures good absorption through the skin surface and therapeutic effect at various levels, achieving necessary concentrations in adjacent tissues and synovial fluid.

Distribution and biotransformation. Indomethacin is more than 90% bound to plasma proteins and undergoes intensive biotransformation in the liver via O-demethylation and N-deacetylation into inactive compounds. Troxerutin is a mixture of hydroxyethyl derivatives of the bioflavonoid rutin, with trihydroxyethylrutinoside (troxerutin) being predominant.

Elimination. Indomethacin is excreted in urine (60%), bile, and feces (30%). Since indomethacin penetrates into breast milk, the drug is not recommended during breastfeeding.

The majority of absorbed tri-, di-, and monohydroxyethylrutinosides are excreted via bile, while a significantly smaller portion is excreted by the kidneys. Tetrahydroxyethylrutinoside is excreted predominantly in urine.

Clinical characteristics.

Indications.

Indovazin-Teva, gel, is indicated for symptomatic treatment of:

• manifestations of chronic venous insufficiency, including varicose veins (edema, sensation of heaviness and pain in the legs);
• superficial thrombophlebitis, phlebitis;
• post-phlebitic condition;
• in complex therapy of hemorrhoidal disease;
• soft tissue rheumatism: tenosynovitis, bursitis, fibrositis, periarthritis;
• edema following surgical interventions;
• contusions, dislocations, sprains.

Contraindications.

Hypersensitivity (allergy) to the active substance and/or to any of the excipients.

Hypersensitivity to nonsteroidal anti-inflammatory drugs.

Bronchial asthma.

The gel must not be applied to mucous membranes, open wounds, or into the eyes.

Interaction with other medicinal products and other forms of interaction.

The product should not be used concomitantly with corticosteroids due to the possibility of potentiating their ulcerogenic effect.

Special precautions for use.

Indovazin-Teva gel is intended for topical use only.

Do not exceed the recommended dose.

Apply the gel only to intact skin.

The medicinal product is not recommended for patients with a history or proven hypersensitivity to food products or drugs; in the presence of allergic rhinitis or other allergic reactions and predisposition to such.

If treatment duration exceeds 10 days, laboratory monitoring of leukocyte and platelet counts is required.

Long-term use of the drug, especially over large skin areas, should be limited in patients with severe hepatic or renal impairment, as well as in those with active peptic ulcer disease, due to the possibility of high systemic absorption.

Use during pregnancy or breastfeeding.

There is no clinical experience regarding the safety of using the drug during pregnancy or breastfeeding. The drug should not be used during pregnancy.

Since indomethacin penetrates into breast milk, the drug should not be used during breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Has no effect.

Method of Administration and Dosage

The medication is intended for external use in adults and children aged 14 years and older. Apply the gel 3–4 times daily in a thin layer to affected areas using gentle massaging motions. The amount per single dose is 4–5 cm of gel. The total daily dose should not exceed 20 cm.

The duration of treatment should not exceed 10 days.

Children.

Indovazin-Teva is not recommended for children under 14 years of age due to insufficient clinical experience.

Overdose.

Cases of overdose following topical application of the medication have not been reported.

During prolonged treatment (more than 10 days), monitoring for possible systemic effects—such as hepatotoxicity, severe headache, or hemorrhage—is required. Leukocyte and platelet counts should be monitored.

In case of accidental ingestion of the gel, symptoms such as burning sensation in the oral cavity, increased salivation, nausea, and vomiting may occur. In such cases, rinse the mouth and stomach; symptomatic treatment should be administered if necessary.

If the gel comes into contact with the eyes, mucous membranes, or open wounds, local irritation may occur—such as lacrimation, redness, burning, and pain. Measures to counteract these effects include thorough rinsing of the affected areas with a large amount of distilled water or 0.9% sodium chloride solution until symptoms are alleviated or reduced.

Adverse reactions.

The drug is usually well tolerated.

Local reactions: skin hypersensitivity symptoms may occur ― contact dermatitis, itching, redness, rash, sensation of warmth and burning at the site of application.

The product contains sodium benzoate, which has a moderate irritating effect on the skin, eyes and mucous membranes.

The product contains dimethyl sulfoxide, which may cause skin irritation.

Systemic reactions: very rarely, with prolonged use over large areas of the body, adverse effects may occur:

Gastrointestinal effects ― nausea, vomiting, dyspepsia, abdominal pain, increased levels of liver enzymes;

Immune system effects ― hypersensitivity reactions (anaphylaxis, asthmatic attack, angioedema).

If any adverse reactions occur, discontinue use of the product and consult a physician regarding further treatment!

Shelf life. 2 years.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach of children! After first opening of the tube, store for up to 6 months under the specified conditions!

Packaging. Gel in 45 g tubes, 1 tube per cardboard box.

Availability. Over-the-counter.

Manufacturer.

Balkanpharma-Troyan AD / Balkanpharma-Troyan AD.

Manufacturer's address and location of business activity.

1 Krayrechna Str., 5600 Troyan, Bulgaria / 1 Krayrechna Str., 5600 Troyan, Bulgaria.