Troximetacin (Gel) Instructions for Use

Marketing Authorization Holder

Danson-BG (Bulgaria)

Manufactured By

Vetprom, AD (Bulgaria)

ATC Code

M01AB51 (Indomethacin in combination with other drugs)

Active Substances

Troxerutin (Rec.INN registered by WHO)

Indometacin (Rec.INN registered by WHO)

Dosage Form

Troximetacin

Gel for external use 30 mg+20 mg/1 g: tubes 40 g or 50 g

Dosage Form, Packaging, and Composition

Gel for external use from yellow to yellow-brown in color, homogeneous, transparent.

Excipients: carbomer – 15 mg, disodium edetate – 0.5 mg, sodium benzoate – 2.5 mg, macrogol 400 – 522 mg, isopropanol – 150 mg, dimethyl sulfoxide – 150 mg, purified water – 110 mg.

40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs

Clinical-Pharmacological Group

Drug with anti-inflammatory and angioprotective action for external use

Pharmacotherapeutic Group

Topical anti-inflammatory agent

Pharmacological Action

A combined drug containing Indomethacin and Troxerutin.

Indomethacin has a pronounced anti-inflammatory, analgesic, and anti-edematous action. This leads to pain relief, reduction of swelling, and shortening of the recovery time for damaged tissues. The main mechanism of action is associated with the suppression of prostaglandin synthesis through reversible blockade of COX-1 and COX-2.

Troxerutin (trihydroxyethylrutoside) is a bioflavonoid that has an angioprotective effect. It reduces capillary permeability and exhibits a venotonic action. It blocks the venodilatory action of histamine, bradykinin, and acetylcholine. It acts anti-inflammatory on perivenous tissue, reduces capillary fragility, and has some antiplatelet action. It reduces swelling, improves trophism in pathological changes associated with venous insufficiency.

Pharmacokinetics

The gel base used ensures the solubility and release of indomethacin and troxerutin.

The gel dosage form containing Indomethacin and Troxerutin is well absorbed from the skin surface and provides the therapeutic effect of the drug.

When applied to the skin, concentrations close to therapeutic levels are achieved in the subcutaneous tissue and periarticular tissues. The penetration of the active components of the drug into the systemic circulation is clinically insignificant.

Indications

As part of complex therapy for chronic venous insufficiency of the lower extremities (varicose veins) – to relieve edema, feeling of heaviness and pain in the legs; superficial thrombophlebitis, phlebitis; postphlebitic conditions; rheumatic soft tissue lesions (tenosynovitis, bursitis, fibrositis, periarthritis); postoperative edema, contusions, dislocations, sprains.

ICD codes

Dosage Regimen

The drug is intended for external use only.

Apply a thin layer of gel to the affected skin area.

Use gentle, rubbing movements until fully absorbed.

Apply the gel three to four times daily.

The maximum duration of continuous treatment is 10 days.

Do not exceed the recommended application frequency or treatment duration.

Wash hands thoroughly before and after each application.

Avoid applying the gel to open wounds, abraded skin, or mucous membranes.

Do not use an occlusive dressing over the application site.

Discontinue use and consult a physician if symptoms persist or skin irritation occurs.

For chronic venous insufficiency, apply along the affected vein, typically from the ankle upward.

For rheumatic soft tissue conditions, apply directly over the painful or swollen area.

For post-traumatic injuries like contusions or sprains, apply to the site of injury.

Ensure the skin is intact and dry prior to application.

Do not allow the gel to contact the eyes or mouth.

Adverse Reactions

Drug tolerance is generally good.

Local reactions: possible appearance of hypersensitivity symptoms from the skin – contact dermatitis, itching, redness, rash, feeling of warmth and burning at the application site.

Contraindications

Impaired integrity of the skin; third trimester of pregnancy; lactation period; children under 14 years of age (no clinical experience of use); hypersensitivity to the components of the drug and NSAIDs.

With caution simultaneous use of the drug with other NSAIDs, bronchial asthma, allergic rhinitis, polyps of the nasal mucosa.

Use in Pregnancy and Lactation

The use of the drug is contraindicated in the third trimester of pregnancy and during lactation.

Pediatric Use

The use of the drug is contraindicated in children under 14 years of age (no clinical experience of use).

Special Precautions

The drug should not be applied to open wounds, mucous membranes, into the oral cavity, or into the eyes. If it gets into the eyes, on mucous membranes, or on open wound surfaces, local irritation may occur – lacrimation, redness, burning, pain. Necessary measures – rinsing the affected area with plenty of distilled water or physiological saline until complaints disappear or decrease.

After applying the drug, an occlusive dressing should not be applied.

Sodium benzoate, dimethyl sulfoxide, or propylene glycol contained in the drug as excipients may have an irritating effect on the skin.

Effect on ability to drive vehicles and mechanisms

The drug does not affect the ability to perform potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).

Drug Interactions

The drug may enhance the effect of drugs causing photosensitization.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.