Consumer medicine information

1 Name of Medicine

Nicotine.

2 Qualitative and Quantitative Composition

Nicorette 16hr Invisipatch patch is a transdermal delivery system for topical application, available in sizes of 22.5, 13.5 and 9 cm² each containing 1.75 mg/cm² of nicotine, releasing 25 mg, 15 mg and 10 mg respectively over 16 hours.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Transdermal patch. Nicorette 16hr Invisipatch are semi-transparent, beige, imprinted, rectangular Transdermal Therapeutic System (TTS) with rounded corners, centrally located on a rectangular, aluminised and siliconised release liner.

4 Clinical Particulars

4.9 Overdose

Excessive use of nicotine from either NRT and/or smoking might cause symptoms of an overdose.
Symptoms of overdosage are those of acute nicotine poisoning and include nausea, salivation, vomiting, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. At high doses these symptoms may be followed by hypotension, weak and irregular pulse, breathing difficulties, prostration, circulatory collapse and general convulsions.
Overdosage with nicotine can occur if the patient has a very low pre-treatment nicotine intake and uses other forms of nicotine. The acute minimum lethal oral dose of nicotine in non-smokers is believed to be 40-60 mg.
Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small children and may prove fatal. The lethal dose of nicotine in a small child is approximately 10-15 mg. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.
Management of overdosage. In view of the lack of actual experience in the treatment of Nicorette 16hr Invisipatch patch overdose, the procedures recommended are those that have been suggested for the treatment of acute nicotine poisoning.
Overdose from topical exposure. In case of intoxication, immediately remove all nicotine patches. The skin may be flushed with water and dried. Soap should not be used since it may increase nicotine absorption. The patient may deteriorate during the following hours, due to the slow distribution of nicotine from the patch area. The patient should therefore be carefully supervised for a prolonged period.
Overdose from ingestion of the patch. If a patch is ingested, activated charcoal should be given as soon as possible. Contact the Poisons Information Centre (13 11 26) for advice on treatment. The administration of nicotine from any other source must be stopped immediately and the patient should be treated symptomatically. Activated charcoal reduces gastrointestinal absorption of nicotine. Repeated doses of activated charcoal should be administered as long as the patch remains in the gastrointestinal tract as it will continue to release nicotine for many hours.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Neither nicotine nor cotinine was mutagenic in the Ames Salmonella test.
Carcinogenicity. Literature reports indicate that nicotine is neither an initiator nor a tumour-promoter in mice. There is inconclusive evidence to suggest that cotinine, an oxidised metabolite of nicotine, may be carcinogenic in rats.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSNICOTI.gif CAS number. 54-11-5.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/NICINVST.gif