Iruxol Ointment For The Enzymatic Wounds And Burn Debridement

Iruxol Ointment is indicated for:

  • the enzymatic debridement of necrotizing wounds, including leg and decubital ulcers.
  • In ulcerations & necroses, such as leg ulcer, decumbitus, gangrene of the extremities, especially diabetic gangrene, frostbite.
  • in poorly healing wounds i.e in wounds after operations, radiotherapy, accidents.
  • In all type of bums & before skin grafting.

Dosage And Administration

For topical administration: If not otherwise prescribed by physician:

A layer of approximately 2 mm of ointment should be applied to the dressing or directly to the slightly moistened area to be treated once daily. Close contact to the wound surface should be assured. Occasionally, twice daily use may be required.

It is unnecessary to apply too great amount of the product to the wound. With this, the cleaning process is not improved.

In general, it will suffice to change the dressing once daily. An increase of activity may possibly be obtained by applying the ointment twice daily.

The treatment of varicose ulcers with collagenase ointment will be usefully supplemented by a pressure bandage and in arterial circulatory disorders, ulcers of diabetic or neurologic etiology, by appropriate drug treatment.

Necrotic material which has separated should be removed when dressing is changed.

To ensure successful enzymatic wound treatment with Iruxol ointment,, sufficient moisture must be present in the wound area during therapy. In dry wounds, the wound base must therefore be moistened with normal saline (0.9% NaCl) or other solutions which are well tolerated by the tissue (e.g. 5% glucose). Dry and hard crusts should first be softened by applying a moist dressing.

Treatment with Iruxol ointment should be discontinued when the whole surface of the wound is clean.

Whenever infection is present, an appropriate antibiotic treatment should be considered. Chloramphenicol, neomycin, framycetin, bacitracin, gentamycin, polymyxin B and macrolides, e.g., erythromycin, have been shown to be compatible with Iruxol ointment.

As is common clinical practice, the wound edges and healthy skin should be protected in order to avoid irritation. If no improvement is seen in the wound after 14 days, treatment with Iruxol ointment should be discontinued.

composition

Each 1 gm of Ointment contains: 0.6 units of clostridiopeptidase A (EC3.4.24.3) in a lipophilic anhydrous ointment base.

Product Description

Iruxol Ointment contains: Collagenase is a lyophilizate from the purified culture filtrate of Clostridium histolyticum The active constituent is the collagenase clostridiopeptidase A (EC3.4.24.3) with associated proteases. Collagenase is a proteolytic enzyme with a high specifity for native and denatured collagen used as a debriding agent.

Iruxol Ointment, is a brown, lipophilic ointment with a faint characteristic odor. Containing clostridiopeptidase A and associated proteases as an active ingredient.

Contraindications

Hypersensitivity to the active substance(s) or to any of the inactive ingredients. It is also contraindicated in patients with major burns.

Warnings And Precautions

Contact with eyes and mucosa should be avoided. In diabetic patients, dry gangrenes should be moistened with caution in order to avoid conversion to moist gangrene.

If no improvement is seen in the wound after 14 days, treatment with Iruxol ointment should be discontinued. Collagenase should be used coutiously in debilitated patients because of the increased risk of bacteremia and /or bacterial sepsis. Collagenase is optimally effective at a pH of 6 to 8.

Drug Interactions

Iruxol ointment should not be used in the presence of antiseptics, heavy metals, detergents and soaps because the activity of collagenase will be inhibited. Tyrothricin, gramicidin and tetracyclines should not be used locally with Iruxol  ointment.

Pregnancy And Lactation

Although no evidence of any teratogenic effect has been reported, since studies have not been performed in pregnant women, Iruxol ointment, should only be administered during the first three months of pregnancy when strictly indicated.

Nursing Mothers Since Iruxol ointment, does not enter the systemic circulation, excretion into breast milk is unlikely.

Adverse Reactions

Common: Nervous System Disorders, General disorders.

Overdose

Accidental ingestion of the drug is unlikely.

Clinical Pharmacology

Pharmacodynamic Properties

The wound healing is speeded up if the wound base is free from necrotic tissue. There are different methods of wound cleaning.

The topical application of hydrolytic enzymes is an atraumatic method. Iruxol ointment is indicated for the debridement of wounds, where necrotic tissue is to be digested and removed, thus promoting the wound-healing process.

Necrotic tissue is anchored to the wound surface by strands of native collagen, and it can only be removed enzymatically after the native collagen strands have been digested. Collagenases are the only proteolytic enzymes capable of digesting strands of native collagen. They attack the apolar region of the collagen fibers which consist of several successive tripeptides with the specific amino acid sequence, glycine, proline and hydroxyproline or another amino acid.

By splitting the apolar region, the collagen fiber is broken down into high molecular weight peptides, which can then be completely digested by collagen peptidases and non-specific proteases.

Due to its substrate specificit, the effect of collagenase alone is not sufficient for the debridement of wounds, since it does not affect fibrous or globular proteins The combined action of collagenase and its associated proteases ensures the digestion of all protein components of the wound, thus intensifying the wound cleansing effect.

Toxicology

From the toxicological point of view, collagenase is well tolerated. There is hardly any acute toxicity; healthy mucosa or skin are not significantly affected. No signs of allergic potential or systemic intolerability reactions were observed after topical application to intact or scarified skin.

According to the results of immunological studies, there is no evidence of systemic absorption of collagenase after application either to intact skin or areas of ulceration. As a result, extensive toxicological studies, e.g., reproduction, mutagenicity, carcinogenicity studies have not been performed.

إيروكسول مرهم للجروح و الحروق
إيروكسول مرهم للجروح و الحروق
اسم الدواء إيروكسول مرهم للجروح و الحروق
المكون النشط مستحضر إنزيمى من كلوستريديم هيستوليتيكم
دواعى الاستعمال علاج إنزيمى للجروح و الحروق
الشركة المنتجة شركة القاهرة للادوية و الصناعات الكيماوية

إيروكسول مرهم – النشرة الداخلية

IRUXOL OINTMENT – PATIENT INFORMATION LEAFLET