Drugs List

Therapeutic Indications

Uses

Removal of eschar in thermal burns

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Cardiopulmonary disorder
Elderly
Predisposition to haemorrhage
Coagulopathy
Hepatic impairment
Pulmonary disease
Renal impairment
Thrombocytopenia

Hypersensitivity reactions in patients allergic to papain may occur
Hypersensitivity reactions in patients allergic to pineapple may occur
Avoid using where medical devices/vital structures may become exposed
Not recommended for use on chemical wounds
Not recommended for wounds contaminated with hazardous substances
Premedication with analgesic recommended
Treatment to be initiated and supervised by a specialist
Avoid application to more than 15% body surface area
Avoid contact with eyes
If accidental contact with the eyes occurs, rinse thoroughly with water
Investigate signs and symptoms suggesting an infection
Monitor coagulation values
Monitor fluid and electrolyte status
Monitor for signs and symptoms of allergic reaction
Monitor for signs or symptoms of uncontrolled inflammatory reactions
Monitor hepatic enzymes
Monitor pulse, blood pressure and temperature regularly
Repeated contact may cause sensitisation

General principles of proper burn wound care must be adhered.

Must be used with caution in patients with perineal and genital burns, electrical burns and facial burns.

Patients should be monitored for a rise in body temperature, signs of local and systemic inflammatory and infectious processes, conditions that could be precipitated or worsened by analgesic premedication or antibiotic prophylaxis as well as the routine monitoring for burns patients including for potential effects on haemostasis.

All topically applied antibacterial medical products must be removed before the application of bromelains.

Bromelains is not recommended for use on chemical burn wounds, vital structures such as larger vessels or the eyes that are, or could be, exposed during debridement, burn wounds where foreign materials such as implants, pacemakers and shunts are penetrating, as well as wounds contaminated with hazardous or radioactive substances to avoid reactions that could cause an increased risk of spreading the noxious substances.

Pregnancy and Lactation

Pregnancy

Bromelain proteolytic enzymes is contraindicated during pregnancy.

The manufacturer does not recommend the use of bromelain proteolytic enzymes during pregnancy.

At the time of writing there is limited published information regarding the use of bromelain proteolytic enzymes during pregnancy.

Animal studies are insufficient to properly assess the potential risk of bromelain proteolytic enzymes with embryonal and foetal development.

Lactation

Bromelain proteolytic enzymes is contraindicated during breastfeeding.

The manufacturer does not recommend the use of bromelain proteolytic enzymes during breastfeeding and that breastfeeding should be discontinued for at least 4 days after application of bromelain proteolytic enzymes.

At the time of writing there is limited published information regarding the use of bromelain proteolytic enzymes during breastfeeding. It is not known whether proteolytic enzymes enriched in bromelain or its metabolites are excreted in human breast milk.

Side Effects

Anaphylactic reaction
Anaphylaxis
Erythema
Hyperthermia
Hypotension
Impaired platelet function
Local pain
Prothrombin time increased
Pyrexia
Rash
Sensitisation
Tachycardia
Urinary tract infections
Viral infection
Wound infection

Presentation

Topical formulation of proteolytic enzymes enriched in bromelain.

Drugs List

Therapeutic Indications

Uses

Removal of eschar in thermal burns

Dosage

Adults

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Cardiopulmonary disorder
Elderly
Predisposition to haemorrhage
Coagulopathy
Hepatic impairment
Pulmonary disease
Renal impairment
Thrombocytopenia

Hypersensitivity reactions in patients allergic to papain may occur
Hypersensitivity reactions in patients allergic to pineapple may occur
Avoid using where medical devices/vital structures may become exposed
Not recommended for use on chemical wounds
Not recommended for wounds contaminated with hazardous substances
Premedication with analgesic recommended
Treatment to be initiated and supervised by a specialist
Avoid application to more than 15% body surface area
Avoid contact with eyes
If accidental contact with the eyes occurs, rinse thoroughly with water
Investigate signs and symptoms suggesting an infection
Monitor coagulation values
Monitor fluid and electrolyte status
Monitor for signs and symptoms of allergic reaction
Monitor for signs or symptoms of uncontrolled inflammatory reactions
Monitor hepatic enzymes
Monitor pulse, blood pressure and temperature regularly
Repeated contact may cause sensitisation

General principles of proper burn wound care must be adhered.

Must be used with caution in patients with perineal and genital burns, electrical burns and facial burns.

Patients should be monitored for a rise in body temperature, signs of local and systemic inflammatory and infectious processes, conditions that could be precipitated or worsened by analgesic premedication or antibiotic prophylaxis as well as the routine monitoring for burns patients including for potential effects on haemostasis.

All topically applied antibacterial medical products must be removed before the application of bromelains.

Bromelains is not recommended for use on chemical burn wounds, vital structures such as larger vessels or the eyes that are, or could be, exposed during debridement, burn wounds where foreign materials such as implants, pacemakers and shunts are penetrating, as well as wounds contaminated with hazardous or radioactive substances to avoid reactions that could cause an increased risk of spreading the noxious substances.

Pregnancy and Lactation

Pregnancy

Bromelain proteolytic enzymes is contraindicated during pregnancy.

The manufacturer does not recommend the use of bromelain proteolytic enzymes during pregnancy.

At the time of writing there is limited published information regarding the use of bromelain proteolytic enzymes during pregnancy.

Animal studies are insufficient to properly assess the potential risk of bromelain proteolytic enzymes with embryonal and foetal development.

Lactation

Bromelain proteolytic enzymes is contraindicated during breastfeeding.

The manufacturer does not recommend the use of bromelain proteolytic enzymes during breastfeeding and that breastfeeding should be discontinued for at least 4 days after application of bromelain proteolytic enzymes.

At the time of writing there is limited published information regarding the use of bromelain proteolytic enzymes during breastfeeding. It is not known whether proteolytic enzymes enriched in bromelain or its metabolites are excreted in human breast milk.

Side Effects

Anaphylactic reaction
Anaphylaxis
Erythema
Hyperthermia
Hypotension
Impaired platelet function
Local pain
Prothrombin time increased
Pyrexia
Rash
Sensitisation
Tachycardia
Urinary tract infections
Viral infection
Wound infection

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: July 2020

Reference Sources

Summary of Product Characteristics: NexoBrid 2g powder and gel for gel. MediWound Germany GmbH. Revised July 2019.

Summary of Product Characteristics: NexoBrid 5g powder and gel for gel. MediWound Germany GmbH. Revised July 2019.