AVOCA CAUSTIC PENCIL 40% w/w Cutaneous stick Ref.[27580] Active ingredients: Silver nitrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Bray Group Ltd, 1 Regal Way, Faringdon, Oxfordshire, SN7 7BX

4.3. Contraindications

Hypersensitivity to the silver nitrate or to the excipient potassium nitrate.

Not for use near the eyes or other sensitive areas of the body, due to the corrosive/staining action of the product.

Should not be used for genital warts

4.4. Special warnings and precautions for use

For single patient use only.

Must be used under medical supervision. The instruction must be followed in view of the caustic/staining nature of the product.

Paediatric population

No data are available.

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6. Pregnancy and lactation

None.

4.7. Effects on ability to drive and use machines

None.

4.8. Undesirable effects

Skin and subcutaneous tissue disorders

Chronic application of silver nitrate or its products to conjunctive, mucous membranes or open wounds may lead to a condition known as argyria, an accumulation of silver metal or compounds in the connective tissues which gives rise to a local or general bluish-black appearance. This is thought to be a completely harmless cosmetic effect only, but it may persist indefinitely or disappear only very slowly.

Absorption of nitrate following reduction of nitrate by certain bacteria in some wounds may cause methaemoglobinaemia. There is a risk of electrolyte disturbances.

Cases of either argyria or methaemoglobinaemia are very rare (<1/10,000) and are likely to arise only under exceptional circumstances of prolonged use of large quantities of sliver nitrate.

Paediatric population

No data are available.

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 national reporting system: United Kingdom, Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

6.2. Incompatibilities

Silver nitrate is chemically incompatible with a number of substances such as certain organic chemicals, with which it may present a risk of fire or explosion due to its oxidising properties. Silver nitrate will also form insoluble precipitates with some anions, e.g. chloride, which may for example be present in tap water, and so lose part or all of its activity.

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