Universal reference book for medicines
Product name: INDOVAZIN ® (INDOVASIN ® )

Active substance: indometacin, troxerutin

Type: The drug with anti-inflammatory and angioprotective action for external use

Manufacturer: BALKANPHARMA-TROYAN (Bulgaria)
Composition, form of production and packaging
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Gel for external use from yellow to yellow-brown color, with light opalescence.
1 g

indomethacin 30 mg

troxerutin 20 mg

Excipients: carbomer - 23 mg, macrogol 400 - 524.5 mg, sodium benzoate - 2.5 mg, propylene glycol - 100 mg, ethanol 96% - 300 mg.

45 g - aluminum tubes (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Indovazin ® gel is a combined medicinal product, which includes indomethacin and troxerutin.

Indomethacin has a pronounced anti-inflammatory, analgesic and anti-edematous effect.
This leads to the removal of pain, reducing edema and reducing the recovery time of damaged tissues. The main mechanism of action is associated with the suppression of prostaglandin synthesis through a reversible blockade of COX-1 and COX-2.
Troxerutin (trihydroxyethyl rutinoside ) is a bioflavonoid.
It refers to angioprotective agents. Reduces the permeability of capillaries and exhibits a venotonic effect. It blocks the venodilating effect of histamine, bradykinin and acetylcholine. It acts anti-inflammatory on perennial tissue, reduces the fragility of capillaries and has some anti-aggregative effect. Reduces puffiness, improves trophism with pathological changes associated with venous insufficiency.
When applied to the skin, Indovazin ® gel suppresses the inflammatory edematous reaction, relieves pain and temperature in the foci of inflammation, located on the surface and in the depth, reaching the blood vessels located there.
It exhibits venotonic and capillaroprotective action.
PHARMACOKINETICS

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

The gel dosage form, which includes indomethacin and troxerutin, is well absorbed from the surface of the skin and provides a therapeutic effect of the drug.

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

- in complex therapy of chronic venous insufficiency of the lower extremities (varicose veins) - to relieve edema, feelings of heaviness and pain in the legs;

- superficial thrombophlebitis, phlebitis, postphlebitic states;

- rheumatic damage of soft tissues: tendovaginitis, bursitis, fibrositis, periarthritis;

- with swelling after surgical interventions, contusions, dislocations, sprains.

DOSING MODE

The drug is intended for external use.

4-5 cm of the gel is applied 3-4 times / day with a thin layer on the affected area with light rubbing movements.
The total daily amount should not exceed 20 cm. The duration of treatment should not exceed 10 days.
SIDE EFFECT

Drug tolerance is usually good.

Local reactions: there may be symptoms of increased sensitivity from the skin - contact dermatitis, itching, redness, rash, a feeling of warmth and burning sensation at the site of application.

CONTRAINDICATIONS

- violation of the integrity of the skin;

- III trimester of pregnancy;

- the period of lactation (breastfeeding);

- Children's age till 14 years (there is no clinical experience of application);

- Hypersensitivity to the components of the drug and NSAIDs.

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

PREGNANCY AND LACTATION

Clinical experience, proving the safety of the drug when used during pregnancy and during lactation, is absent.
Its use is possible only if the expected benefit exceeds the potential risk to the fetus.
APPLICATION FOR CHILDREN

Contraindicated in children under 14 years.

SPECIAL INSTRUCTIONS

Do not apply to open wounds, mucous membranes, into the mouth, eyes.

In case of contact with eyes, mucous membranes or open wound surfaces, local irritation is observed - tearing, redness, burning, pain.

Necessary measures - washing the affected area with copious amounts of distilled water or saline until the complaints disappear or decrease.

Indovazin ® gel contains sodium benzoate and propylene glycol as auxiliary substances, which can have irritating effect on the skin.

Impact on the ability to drive vehicles and manage mechanisms

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

OVERDOSE

There is no information about cases of overdose with topical application.
If you accidentally swallow large amounts of possible burning sensation in the mouth, salivation, nausea, vomiting.
Treatment: washing the mouth and stomach, if necessary - symptomatic treatment.

DRUG INTERACTION

Ointment can enhance the effect of drugs that cause photosensitivity.

Clinically significant interaction with other drugs is not described.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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