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Silver Nitrate & Caustic Product
Information


(download Caustic Pencil Summary Characteristics as Adobe Acrobat .pdf)

SUMMARY OF PRODUCT CHARACTERISTICS
Caustic Pencil 95 % Silver Nitrate

1. Trade Name of Medicinal Product
Caustic Pencil 95 % Silver Nitrate

2. Qualitative and Quantitative Composition
Silver Nitrate BP/PhEur 95 % w/w

3. Pharmaceutical Form
Solid caustic tip

4. Clinical Particulars
4.1. Therapeutic Indications
For the removal of warts (including verrucae) and granulation tissue, for cautery and as a caustic, on skin and mucous membranes. For patients’ own use only for the treatment of warts / verrucae, strictly according to instructions.
4.2. Posology and Method of Administration
For topical (external) use only. For multiple-use on a single patient. Surrounding areas of healthy skin should be protected with a wart pad or petroleum jelly prior to use. The tip is moistened with suitably clean water and applied topically to area to be treated for up to 2 minutes. The operation may be repeated after 24 hours up to a total of 3 daily applications for a wart, 6 for a plantar verruca. Must be used strictly according to the instructions supplied with the product in view of its caustic / staining nature.
4.3. Contraindications
Caustics are not suitable for use near eyes or other sensitive areas. Not for genital warts.
4.4. Special Warnings and Precautions for Use
For single-patient use only. Must be used strictly according to instructions.
4.5. Interactions with other Medicaments and Other Forms of Interaction
None known.
4.6. Pregnancy and Lactation
No known effects.
4.7. Effects on Ability to Drive and Use Machinery
None.
4.8. Undesirable Effects
Chronic application of silver nitrate or its products to conjunctiva, mucous membranes or open wounds may lead to a condition known as argyria, an accumulation of silver metal or compounds in the connective tissues resulting in a local or general greyish or blackish-blue appearance. This is thought to be a harmless cosmetic effect only, but it may persist indefinitely or disappear only very slowly. Absorption of nitrite following reduction of nitrate by certain bacteria in some wounds may cause methaemoglobinaemia. Cases of argyria or methaemoglobinaemia are likely to arise only after prolonged use of large quantities of silver nitrate.
4.9. Overdose
Excessive quantities or incorrect use in topical application may give rise to burning or staining. Accidental poisoning by ingestion is unlikely with the small quantities involved, but symptoms that do arise are due to the caustic nature of silver nitrate. There may be pain in the mouth, sialorrhoea, diarrhoea, nausea, vomiting, coma or convulsions. Tissues and vomit may be stained pages black. Treatment for poisoning by ingestion should be commenced without delay, by washing out the stomach repeatedly with 1 % sodium chloride solution. After this lavage a purgative should be given, such as 30 g of sodium sulphate in 250 ml of water, to be allowed to remain in the stomach. Demulcents such as egg-white, milk or liquid paraffin may be administered, with pethidine or morphine if necessary. Close attention must be paid to renal function and fluid balance.
4.10. Other Information
None.

5. Pharmacological Properties
5.1. Pharmacodynamic Properties
Silver nitrate acts as a caustic to remove unwanted tissue and destroy warts, verrucae and other small skin growths.
5.2. Pharmacokinetic Properties
The caustic activity of silver nitrate remains local to the area of topical application, where it is converted to more inert silver and other compounds, and eventually shed by desquamation. Gastrointestinal absorption is more efficient, and when ingested or applied chronically in large quantities silver later redistributes about the various organs of the body, and especially the skin and mucous membranes, as deposits of the metal and other insoluble compounds, principally within the connective tissues. Systemic excretion is very slow and reported to be almost exclusively faecal.
5.3. Preclinical Safety Data
None.

6. Pharmaceutical Particulars
6.1. List of Excipients
Potassium Nitrate BP 5 % w/w.
6.2. Incompatibilities
Externally, silver nitrate forms insoluble precipitates with some anions such as chloride, which may be present in tap water, for example, and so lose part or all of its activity. Silver nitrate may react dangerously when mixed with certain organic and inorganic chemicals.
6.3. Shelf Life
5 years (unopened).
6.4. Special Precautions for Storage
Protect from moisture and light.
6.5. Nature and Contents of Container
Tip of solid caustic mixture mounted into the end of a plastic handle, with replaceable plastic cap.
6.6. Instructions for Use / Handling
Must be used strictly according to the instructions supplied with the product due to its caustic / staining nature.

7. Marketing Authorisation Holder
Bray Group Ltd, Olive House, Regal Way, Faringdon, Oxfordshire, SN7 7BX, UK.

8. Marketing Authorisation Number
(UK) PL 4286 / 0005

9. Authorisation Date
Date of first authorization 29th October 1982. Date of renewal 1st February 2007.

10. Date of (Partial) Revision of Text
10th December 2003

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