Contractubex (Gel) Instructions for Use

Marketing Authorization Holder

Merz Pharma, GmbH & Co. KGaA (Germany)

Contact Information

Merz Pharma LLC (Russia)

ATC Code

D03AX (Other drugs that promote normal scarring)

Active Substances

Heparin sodium (Rec.INN registered by WHO)

Onion (BP British Pharmacopoeia)

Allantoin (USAN adopted for use in the USA)

Dosage Form

Contractubex

Gel for external use 100 mg+50 IU+10 mg/1 g: tubes 20 g or 50 g

Dosage Form, Packaging, and Composition

Gel for external use matte, from light beige to light brown in color, with a characteristic odor.

Excipients: sorbic acid, methylparahydroxybenzoate, xanthan gum, polyethylene glycol 200, flavored oil (flavor 30263773 Rosae), purified water.

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

Clinical-Pharmacological Group

Drug with proteolytic activity promoting the resorption of keloid scars, for external use

Pharmacotherapeutic Group

Hyper scarring treatment agent

Pharmacological Action

The drug has an antiproliferative, anti-inflammatory, loosening and smoothing effect on scar tissue.

Onion extract acts as an anti-inflammatory agent by suppressing the release of inflammatory mediators and also has an antiallergic effect. Onion extract inhibits the growth of fibroblasts of various origins and, in particular, keloid fibroblasts.

In addition to the inhibitory effect on mitogens, a reduction in the formation of extracellular matrix components from fibroblasts (e.g., proteoglycans) has been demonstrated.

Onion extract also has a bactericidal effect. These properties stimulate primary wound healing and prevent the formation of non-physiological scars.

Heparin has anti-inflammatory, antiallergic, antiproliferative effects and increases tissue hydration. It also has a loosening effect on the collagen structure.

In the treatment of scars, the anti-inflammatory effect of heparin and its influence on the components of the connective tissue matrix are more important than its well-known antithrombotic effect.

Allantoin stimulates wound healing; it promotes epithelialization and increases the tissue’s ability to bind water. Furthermore, its keratolytic properties and ability to enhance skin permeability increase the effectiveness of the other active substances in the composition of Contractubex.

Allantoin also has a soothing effect, relieving the itching often associated with scar formation.

The synergistic effect of this combination of active substances lies in the superadditive inhibition of fibroblast proliferation and, in particular, the pathologically increased synthesis of collagen.

Pharmacokinetics

Not applicable.

Indications

Adults and children over 1 year of age

• Hypertrophic and keloid scars occurring after surgical operations, amputations, burns, and injuries;
• Joint ankyloses (contractures);
• Dupuytren’s contracture;
• Traumatic tendon contractures;
• Stretch marks after pregnancy;
• Atrophic scars (in particular, those occurring after acne or furunculosis);
• Prevention of pathological scar formation in the postoperative period or after an accident.

ICD codes

Dosage Regimen

Externally.

The drug consumption per single application is on average 0.5 cm of gel for a scar surface area of 20-25 cm².

For adults apply 2-3 times/day, for children over 1 year – 1-2 times/day. The gel is applied in a thin layer and gently rubbed into the scar tissue.

The course of treatment for fresh scars (including joint ankyloses (contractures), traumatic tendon contractures, stretch marks after pregnancy) is on average 4 weeks.

For old, dense scars (including joint ankyloses (contractures), traumatic tendon contractures, stretch marks after pregnancy) an occlusive dressing with the gel is applied overnight. The course of treatment is on average 3-6 months.

For Dupuytren’s contracture the course of treatment is on average 12 months.

For prevention use the phase after wound epithelialization (do not apply to granulations).

Adverse Reactions

Adverse reactions are classified by frequency of occurrence

The most frequently reported adverse reactions are local reactions at the application site.

Skin and subcutaneous tissue disorders common – itching, erythema, telangiectasia, scar atrophy; uncommon – skin hyperpigmentation, skin atrophy.

The following adverse reactions have been reported in spontaneous reports

Infections and infestations frequency unknown – pustular rash.

Immune system disorders frequency unknown – hypersensitivity (allergic reactions).

Nervous system disorders frequency unknown – paresthesia.

Skin and subcutaneous tissue disorders frequency unknown – urticaria, rash, itching, erythema, skin irritation, papules, skin inflammation, burning sensation of the skin, skin tightness sensation, contact dermatitis.

General disorders and administration site conditions frequency unknown – edema, pain at the application site, skin peeling at the application site.

If any of the adverse reactions mentioned in the instructions worsen or the patient notices any other adverse reactions not listed in the instructions, they should inform their doctor.

Overall, Contractubex is very well tolerated even with long-term use. Itching, which is rarely observed during treatment with Contractubex, is a manifestation of the desired change in the scar and usually does not require discontinuation of treatment.

Contraindications

• Hypersensitivity to the active substances: onion extract, heparin sodium, allantoin; to citronellol, geraniol, benzyl alcohol, citral and linalool or to other components of the drug;
• Children under 1 year of age (due to insufficient data on efficacy and safety).

Use in Pregnancy and Lactation

There are currently no data on the risks of use during pregnancy and breastfeeding. Use during pregnancy and breastfeeding is not recommended.

Pediatric Use

Contraindicated for use in children under 1 year of age (due to insufficient data on efficacy and safety).

Special Precautions

When treating fresh scars, ultraviolet radiation, exposure to cold, and intensive massage should be avoided.

Contractubex contains methylparahydroxybenzoate, which may cause allergic reactions (including delayed ones).

Contractubex contains sorbic acid, which may cause local skin reactions, such as contact dermatitis.

The flavored oil contained in Contractubex contains citronellol, geraniol, benzyl alcohol, citral and linalool, which may cause allergic reactions.

The onion extract contained in Contractubex contains ethanol. The concentration is 13.4 mg of ethanol/1 g of gel (1.34% w/w). Alcohol may cause a burning sensation on damaged skin.

Effect on ability to drive vehicles and operate machinery

No effect.

Overdose

Overdose of Contractubex has not been described.

Drug Interactions

Drug interactions of Contractubex have not been described.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Shelf life after opening the tube – 6 months. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.