Nicorette

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

即購入

ダウンロード 製品の特徴 (SPC)
17-12-2010

有効成分:

Nicotine 16.6mg (20cm² patch delivers 10mg/16hours.);  

から入手可能:

Johnson & Johnson (New Zealand) Limited

INN(国際名):

Nicotine 16.6 mg (20cm² patch delivers 10mg/16hours.)

投薬量:

10mg/16hours

医薬品形態:

Transdermal patch

構図:

Active: Nicotine 16.6mg (20cm² patch delivers 10mg/16hours.)  

パッケージ内のユニット:

Individual wrap, 7x20cm� patches, 7 patches

クラス:

General sale

処方タイプ:

General sale

製:

Siegfried Ltd

製品概要:

Package - Contents - Shelf Life: Individual wrap, 7x20cm? patches - 7 patches - 36 months from date of manufacture stored at or below 25°C

承認日:

1991-06-28

製品の特徴

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DATA SHEET 
NICORETTE
®
 PATCH 
5MG/16H, 10MG/16H, 15MG/16H 
PRESENTATION 
Nicorette Patch is a transdermal delivery system for topical
application, 
available in sizes of 30, 20 and 10 cm
2
 each containing 0.83 mg/cm
2
 of 
nicotine, releasing 15 mg, 10 mg and 5 mg respectively over 16 hours.
Each 
patch is rectangular in shape and comprises 3 distinct layers; an
outer beige 
matt finish backing layer, a patterned silvery middle layer and an
inner clear 
release liner, which is removed prior to use. Each patch is packaged
in a heat 
sealed multilaminate sachet. 
USES 
ACTIONS 
Pharmacotherapeutic group: Drug for treatment of addiction. 
 
ATC code: N07B A01 
 
Abrupt cessation of the use of tobacco-containing products following
a 
prolonged period of daily use results in a characteristic withdrawal
syndrome 
that includes four or more of the following: dysphoria or depressed
mood; 
insomnia; irritability, frustration or anger; anxiety; difficulty
concentrating, 
restlessness or impatience; decreased heart rate; and increased
appetite or 
weight gain. Nicotine craving, which is recognised as a clinically
relevant 
symptom, is also an important element in nicotine withdrawal. 
 
Clinical studies have shown that nicotine replacement products can
help 
smokers abstain from smoking. 
PHARMACOKINETICS 
GENERAL PHARMACOKINETIC PROPERTIES OF NICOTINE 
The volume of distribution following i.v. administration of nicotine
is about 2 to 
3 L/kg. Plasma protein binding of nicotine is <5%. Therefore, changes
in 
nicotine binding from use of concomitant drugs or alterations of
plasma 
proteins by disease states would not be expected to have significant
effects 
on nicotine kinetics. 
 
The average plasma clearance following intravenous administration
of 
nicotine is about 70 L/hour and the terminal half-life approximately
2 hours. 
The major eliminat
                                
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