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 of:

Swelling after surgery, contusions, dislocations, sprains.
Rheumatic lesions of soft tissues: tenosynovitis, bursitis, fibrositis, periarthritis.
Symptoms of chronic venous insufficiency (to relieve swelling, heaviness and pain in the legs).
Superficial thrombophlebitis, phlebitis; postphlebitic conditions.

Pharmacological effect

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory and antirheumatic drug

ATX code: M01AV51

Pharmacological properties

Pharmacodynamics

Indovazin® gel is a combination drug that contains indomethacin and troxerutin.

Indomethacin has a pronounced anti-inflammatory, analgesic and anti-edematous effect. This leads to pain relief, reduced swelling and reduced recovery time for damaged vessels and tissues. The main mechanism of action is associated with the suppression of prostaglandin synthesis through reversible blockade of cyclooxygenase.

Troxerutin (trihydroxyethylrutinoside) is a bioflavonoid. It belongs to angioprotective agents. Reduces capillary permeability and has a venotonic effect. Blocks the venodilating effect of histamine, bradykinin and acetylcholine. It has an anti-inflammatory effect on perivenous tissue, reduces capillary fragility and has some antiplatelet effect. Reduces swelling, improves trophism in pathological changes associated with venous insufficiency.

When applied to the skin, Indovazin® gel suppresses the inflammatory edematous reaction, relieves pain and temperature in areas of inflammation located on the surface and in the depths, reaching the blood vessels located there. It has a venotonic, capillary-tonic and hemostatic effect.

Pharmacokinetics

Absorption

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

Distribution and biotransformation

Indomethacin binds to plasma proteins by more than 90% and undergoes intensive biotransformation in the liver through 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.

Removal

Indomethacin is excreted in urine (60%), bile and feces (30%). Penetrates into breast milk, so it is not recommended to use the drug during breastfeeding.

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

Special instructions

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

The drug should be applied only to intact areas of the skin, avoid contact with the eyes and mucous membranes.

In case of contact with the eyes, mucous membranes or open wound surfaces, local irritation is observed – tearing, redness, burning, pain. The necessary measures in this case are washing the affected area with copious amounts of distilled water or saline until the complaints disappear or decrease.

It is not recommended to apply the drug based on the combination of indomethacin and troxerutin in persons with increased food and drug sensitivity, bronchial asthma, allergic rhinitis or a predisposition to other allergic reactions.

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

With a duration of therapy of more than 10 days, laboratory monitoring of the number of leukocytes and platelets is required.

Use in children

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

After applying the drug, you should not apply an occlusive dressing.

Indovazin® gel contains sodium benzoate and dimethyl sulfoxide as excipients, which may be irritating to the skin.

If you experience any side effects or unusual reactions, you should consult your doctor.

Impact on the ability to drive vehicles and machinery

Does not affect the speed of psychomotor reactions when driving and working with machinery.

Active ingredient

Indomethacin, Troxerutin

Composition

100 g of gel contain:

Active ingredients:

Indomethacin 3.00 g,

Troxerutin 2.00 g;

Excipients:

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

Pregnancy

There is no clinical experience confirming the safety of using the product during pregnancy or breastfeeding. The use of the drug is possible only after a thorough assessment of the clinical situation by the attending physician, if the expected benefit to the mother outweighs the possible risks to the fetus.

Contraindications

Hypersensitivity to indomethacin, troxerutin or auxiliary components of the drug.
Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs).
Should not be applied to open wounds, mucous membranes, oral cavity, or conjunctiva of the eyes.
III trimester of pregnancy and breastfeeding and children under 14 years of age (due to lack of clinical experience with use).

With caution

Concomitant use of the drug with other NSAIDs, bronchial asthma, allergic rhinitis, polyps of the nasal mucosa or a predisposition to other allergic reactions; use in patients with active ulcers, severe liver and kidney failure.

Side Effects

The drug is usually well tolerated.

Adverse reactions are systematized in accordance with the World Health Organization (WHO) Classification: very common (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (< 1/10000); frequency unknown (cannot be determined from available data).

Systemic reactions

Very rarely, with prolonged use over large areas of the body, undesirable effects may occur:

Immune system disorders:

Frequency unknown – symptoms of hypersensitivity (acute anaphylaxis, bronchial asthma, angioedema).

Gastrointestinal disorders:

Frequency unknown – nausea, dyspepsia, abdominal pain.

Laboratory and instrumental data:

Frequency unknown – increased concentration of liver enzymes.

Local reactions

Disorders of the skin and subcutaneous tissues:

Frequency unknown – contact dermatitis, itching, redness, rash, feeling of warmth and burning at the site of application.

Interaction

Concomitant use with corticosteroids is not recommended due to the high risk of developing gastrointestinal ulcers.
No clinically significant interactions with other drugs have been identified.

Overdose

There is no information about cases of overdose with topical use of the drug Indovazin®gel.

With prolonged use (more than 10 days), monitoring of the patient is recommended, because the development of systemic effects in the form of hemorrhagic manifestations is possible. Regular monitoring of the concentration of leukocytes and platelets in peripheral blood is required.

If large quantities are accidentally ingested, a burning sensation in the mouth, salivation, nausea, and vomiting may occur. The measures that need to be taken in this case are lavage of the oral cavity and stomach, and, if necessary, symptomatic treatment.

Local irritation – if the drug accidentally gets into the eyes, other mucous membranes or open wound surfaces, signs of local tissue irritation appear, including lacrimation, redness, burning sensation, pain. Measures: Rinse the affected area generously with distilled water or saline until the severity of symptoms decreases or disappears.

Storage conditions

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

Shelf life

2 years. Do not use after expiration date.

Manufacturer

Balkanpharma-Troyan AD, Bulgaria