Indovasin, gel 45 g

Pharmacotherapeutic group

Non-steroidal anti-inflammatory and anti-rheumatic drug

ATC code: M01AB51

Pharmacological properties

Pharmacodynamics

Indovazine

sup>® gel is a combination drug consisting of indomethacin and troxerutin.

Indomethacin has pronounced anti-inflammatory, analgesic and anti-edema effects. This leads to relief of pain, reduction of edema and reduction of the recovery time of damaged vessels and tissues. The main mechanism of action is associated with inhibition of prostaglandin synthesis by reversible blockade of cyclooxygenase.

Troxerutin (trihydroxyethylrutinoside) is a bioflavonoid. It belongs to the angioprotective agents. It reduces capillary permeability and shows venotonic effect. It blocks the venodilator effect of histamine, bradykinin and acetylcholine. It has anti-inflammatory effect on the periovenous tissue, reduces capillary fragility and has some anti-aggregant effect. It reduces swelling, improves trophism in pathological changes associated with venous insufficiency.

When applied to the skin Indovasin ^® gel suppresses the inflammatory edema reaction, relieves pain and fever in inflammation foci located on the surface and in depth, reaching the blood vessels located there. It has venotonic, capillarotonic and hemostatic action.

Pharmacokinetics

Absorption

The ointment base used provides complete solubility and maximum release of active ingredients. The gel dosage form with indomethacin and troxerutin ensures good absorption from the surface of the skin and the therapeutic effect at different levels by forming the necessary concentrations in the adjacent tissues and synovial fluid.

Distribution and biotransformation

Indomethacin binds to plasma proteins by more than 90% and undergoes intense biotransformation in the liver by O-demethylation and N-deacetylation to inactive compounds.

Troxerutin is a mixture of hydroxyethyl derivatives of the bioflavonoid rutin (O-(β-hydroxyethyl)rutosides) in which trihydroxyethylrutin predominates.

Evolution

Indomethacin is excreted with urine (60%), bile and feces (30%). It penetrates into the breast milk, so it is not recommended to use the drug while breastfeeding.

Most of the resorbed tri-, di- and monohydroxyethylrutosides are excreted in the bile, a much smaller part – in the kidneys. Tetrahydroxyethylrutoside is excreted mainly with the urine.

Indications

The drug is used for symptomatic treatment:

Active ingredient

Composition

100 g of the gel contain:

The active ingredients:

Indomethacin 3.00 g,

Troxerutin 2.00 g;

Ancillary substances:

Carbomer 2.00 g, diatrium edetate 0.05 g, sodium benzoate 0.25 g, macrogol 400 40.00 g, isopropanol 20.00 g, dimethyl sulfoxide 15.00 g, fragrance Fresco BM&GD R.08.0932.1 0.20 g, purified water to 100 g.

How to take, the dosage

Interaction

Special Instructions

Do not apply to open wounds, mucous membranes, the oral cavity, eyes.

The product should be applied only to intact skin, avoid contact with eyes and mucous membranes.

In case of contact with eyes, mucous membranes or open wound surfaces, local irritation – lacrimation, redness, burning, pain. Necessary measures in this case – washing the affected area with copious amounts of distilled water or saline solution until the disappearance or reduction of complaints.

Application of the drug based on the combination of indomethacin and troxerutin is not recommended in people with hypersensitivity to food and drugs, bronchial asthma, allergic rhinitis or predisposition to other allergic reactions.

In patients with acute peptic ulcer disease, severe liver or kidney disease, long-term use of the drug and application to large areas of the body should be limited due to possible high systemic absorption.

Laboratory monitoring of leukocyte and platelet counts is required if therapy is prolonged over 10 days.

Use in children

The use of the drug in children under 14 years of age is not recommended.

After application, an occlusive dressing should not be applied.

Indovasin® Gel contains sodium benzoate and dimethyl sulfoxide as excipients which may have an irritating effect on the skin.

If you experience any side effects or unusual reactions, your physician should be consulted.

Influence on driving, operating machinery

There is no effect on the speed of psychomotor reactions when driving and operating machinery.

Synopsis

Contraindications

Cautions

Simultaneous use with other NSAIDs, bronchial asthma, allergic rhinitis, nasal polyps or predisposition to other allergic reactions; use in patients with active ulcer, severe hepatic and renal impairment.

Side effects

Tolerability of the drug is generally good.

The adverse reactions are systematized according to the World Health Organization (WHO) Classification: Very common (≥1/10); common (≥1/100, < 1/10); infrequent (≥1/1000, < 1/100); rare (≥1/10000, < 1/1000); very rare (< 1/10000); frequency unknown (cannot be determined from available data).

Systemic reactions

Very rare, with prolonged use on large areas of the body, adverse effects may occur:

Immune system disorders:

Prevalence unknown – symptoms of hypersensitivity (acute anaphylaxis, bronchial asthma, angiodystrophy).

Gastrointestinal tract disorders:

Prevalence unknown – nausea, dyspepsia, abdominal pain.

Laboratory and instrumental findings:

Prevalence unknown – increased concentration of liver enzymes.

Local reactions

Skin and subcutaneous tissue disorders:

Prevalence unknown – contact dermatitis, itching, redness, rash, feeling of heat and burning at application site.

Overdose

There are no reports of overdose during topical administration of Indovasin® gel.

In case of prolonged use (more than 10 days) monitoring of the patient is recommended, since the development of systemic effects in the form of hemorrhagic manifestations is possible. Regular monitoring of leukocyte and platelet concentrations in peripheral blood is required.

In case of accidental ingestion of large amounts a burning sensation in the mouth, salivation, nausea, vomiting are possible. The measures to be taken in this case are rinsing the mouth and stomach, and symptomatic treatment if necessary.

Local irritation – in case of accidental contact of the drug in the eyes, on other mucous membranes or open wound surfaces, signs of local tissue irritation were observed, including lacrimation, redness, burning sensation, pain. Measures – rinse the affected area abundantly with distilled water or saline until symptoms are reduced or disappear.

Pregnancy use

Similarities