Peroxygel

Overdose

Accidental ingestion may cause sore throat, gastric disturbances and vomiting. Sudden evolution of oxygen may cause injury by acute distension of the stomach and internal bleeding. Water may be given to drink. Ingestion of large volumes can lead to gas embolism following evolution of oxygen in the stomach.

Contraindications

Hypersensitivity to any of the ingredients

Not for use in closed body cavities or on surgical wounds due to the risk of oxygen released into the circulation causing gas embolism.

Not for use as a disinfection agent for surgical instruments (particularly endoscopes) and as an enema.

Incompatibilities

Incompatible with reducing agents including organic matter and oxidisable substances and with alkalis, iodides, permanganates and other stronger oxidising agents. Its decomposition is increased by metallic salts, light, agitation, heat and metals.

Undesirable effects

Cases of gas embolism, sometimes resulting in cardiac arrest, have been reported when Peroxygel has been instilled in closed body cavities or deep surgical wounds.

Strong solutions of Peroxygel produce irritating burns on the skin and mucous membranes with a white eschar. The pain disappears after about 1 hour. Continued use of the product as a mouthwash may cause reversible hypertrophy of the papillae of the tongue.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Preclinical safety data

No data of relevance which is additional to that already included in other sections of the SPC.

Therapeutic indications

1. As a mild disinfectant for minor cuts, wounds and skin ulcers.

2. As a mouthwash or gargle.

Pharmacodynamic properties

A01A B02 - Antiinfectives and antiseptics for local oral treatment.

Peroxygel is used as a disinfectant and deodorant. It releases oxygen when applied to tissues, the effect lasts only as long as the oxygen is being released and is of short duration. The antimicrobial effect of the liberated oxygen is reduced in the presence of organic matter. It is used to cleanse wounds and ulcers in concentrations of up to 6%. Adhering and blood-soaked dressings may be released by the application of a solution of Peroxygel. A l.5% solution has been used as a mouthwash in the treatment of acute stomatitis and as a deodorant gargle.

Pharmacokinetic properties

No further information available.

Name of the medicinal product

Peroxygel

Qualitative and quantitative composition

Hydrogen Peroxide

Special warnings and precautions for use

For external use only.

Keep all medicines away from children.

Not for use in closed body cavities or on surgical wounds due to risk of oxygen released into the circulation causing gas embolism.

Avoid normal skin.

Product bleaches fabric.

Effects on ability to drive and use machines

None known.

Dosage (Posology) and method of administration

Topical.

Recommended dose and dosage schedule

1. As a disinfectant use as required. Dress the wound with cotton wool soaked in the peroxide.

2. As a mouthwash or gargle dilute one part of the peroxide to two parts of water (e.g. 5ml of peroxide and 10ml of water). Rinse the mouth for two to three minutes. This may be repeated up to three times daily.

As a disinfectant this product is suitable for use by adults, children and the elderly.

As a mouthwash or gargle the product is suitable for use by adults, children over 12 years and the elderly. Due to the risk of swallowing it should only be used by younger children under the instruction of a doctor.

Special precautions for disposal and other handling

None.