Nicorette spray spray d / local. apply. 1 mg / dose 150 doses

Release form, composition and packaging

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Spray for the oral mucosa, dosed [mint] from colorless to light yellow, transparent or slightly opalescent solution with a mint odor.

1 dose 1 ml

nicotine 1 mg 13.6 mg

propylene glycol - 150 mg, ethanol - 97 mg, trometamol - 40.5 mg, poloxamer - 40 mg, glycerol - 25 mg, sodium bicarbonate - 14.3 mg, levomenthol - 10 mg, mint flavor QL24245 - 4 mg, Cooler 2 flavor SN046680 - 3 mg , sucralose - 1.5 mg, acesulfame potassium - 1.5 mg, hydrochloric acid 10% - a sufficient amount up to pH 9, purified water - a sufficient amount up to 1 ml.

13.2 ml (150 doses) - bottles made of polyethylene terephthalate with a dispenser (1) - protective cases made of polypropylene (1) - plastic contoured container with a cardboard base.

13.2 ml (150 doses) - bottles made of polyethylene terephthalate with a dispenser (2) - protective cases made of polypropylene (2) - plastic contoured container with a cardboard base.

pharmachologic effect

Nicotine is an agonist of nicotinic receptors in the peripheral and central nervous system, has a pronounced effect on the central nervous system and the cardiovascular system. Abrupt smoking cessation causes the development of a characteristic withdrawal syndrome, including cravings for smoking. Clinical studies have shown that nicotine replacement therapy drugs allow smokers to abstain from smoking, alleviating withdrawal symptoms. A single dose study in 200 healthy smokers showed that when using 2 doses of 1 mg spray, the urge to smoke was reduced from the first minute after using the spray and to a significantly greater extent than when using lozenges containing nicotine. Compared to nicotine gum chewing gum or lozenges,the absorption of nicotine from the topical spray is more rapid and, based on past experience with nicotine replacement therapy, this results in a more rapid reduction in cravings and other symptoms. Increased appetite is a well-known symptom of nicotine withdrawal, often after smoking cessation, weight gain occurs. The desire to smoke is also an important withdrawal symptom.

Pharmacokinetics

The pharmacokinetics of nicotine has been comprehensively studied it was found that the method of delivery of a substance to the body has a significant effect on the rate and degree of absorption. The pharmacokinetics of a topical spray was studied in 4 studies with 141 volunteers. Absorption The dosage form of the drug assumes that the dose of nicotine is delivered immediately and, as a result, its absorption from the oral cavity is fast. After the introduction of nicotine at a dose of 2 mg, Cmax is reached within 13 minutes and is 5.3 ng / ml. 10 minutes after spray application at doses of 1 and 2 mg, AUC exceeded those obtained in studies of chewing gum and tablets containing 4 mg nicotine (0.48 and 0.64 h ng / ml versus 0.33 and 0.33 h ng / ml) ... AUC values? testifythat the bioavailability of nicotine when using the spray is similar to the bioavailability when using tablets and slightly higher than when using nicotine chewing gum. AUC? for a spray with a dosage of 2 mg it was 14 h ng / ml compared to 23 h ng / ml for chewing gum with a dosage of 4 mg and 26.7 h ng / ml for tablets with a dosage of 4 mg. The mean Css of nicotine in blood plasma achieved after the maximum dose (i.e. 2 injections of the drug at a dose of 1 mg every 30 minutes) was approximately 28.8 ng / ml, compared with 23.3 ng / ml when using chewing gum at a dosage of 4 mg ( 1 pad every hour) and 25.5 ng / ml for 4 mg nicotine tablets (1 tablet every hour). Considering the rapid absorption and similarly high relative bioavailability, most of the nicotine released from the spray is apparently absorbedthrough the mucous membrane of the cheeks. Vd distribution after intravenous injection of nicotine composition

Name ENG

NICORETTE

Clinical and pharmacological group

Drug for the treatment of nicotine addiction

ATX code

Nicotine

Dosage

1mg / dose x 13.2ml

Structure

Active ingredient: Nicotine.

Dose: 1 mg / dose

Indications

Nicorette spray relieves and / or prevents smoking cravings and withdrawal symptoms associated with tobacco dependence and is indicated for:

as a support for patients who intend to quit smoking or reduce the number of cigarettes they smoke before quitting

in order to assist smoking patients who do not want to smoke, or in the absence of such an opportunity

as a safer alternative to smoking.

Contraindications

children and adolescents up to 18 years old

hypersensitivity to nicotine or other components of the drug.

INN / Active ingredient

nicotine

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

Specifications

Category

Smoking

Scope of the medicinal product

Neurology, psychiatry

Release form

Spray

Manufacturer country

Sweden

Package quantity, pcs

one

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Nicorette

The amount of the dosage form in the primary package

13.2 ml

Primary packaging type

Bottle

Type of consumer packaging

Container

Pharmaco-therapeutic group

Nicotine addiction treatment

Anatomical and therapeutic characteristics

N07BA01 Nicotine

Dosage (volume) of the substance in the preparation

Nicotine - 1 mg / dose.

Expiration date in days

730

Package weight, g

one

Mode of application

:

The drug is intended for application to the oral mucosa. < br> The patient should do everything possible to finally quit smoking while treating with Nicorette spray. < br> Adults and adolescents over 18 years old spray Nicorette® should be used at the moment when an irresistible desire arises light a cigarette. After preparing the spray for use, bring the spray tip as close to your open mouth as possible. Press the dispenser from above, thus releasing 1 dose of the drug into the oral cavity you should avoid getting the spray on the lips. To prevent the substance from entering the respiratory tract, do not inhale at the time of pressing the dispenser. For best results, do not swallow saliva for a few seconds after injecting. < br> While using the spray, food and liquid intake is not recommended. < br> If symptoms of an overdose appear, the drug should be stopped immediately. < br> Complete cessation of smoking < br> Nicorette spray should be used in all cases of cravings for smoking or to prevent cravings in situations that can provoke it. < br> Patients who want or are able to quit smoking immediately, should immediately replace smoking cigarettes with Nicorette spray and, as soon as possible, reduce the number of injections until they stop completely. < br> With complete cessation of smoking make 1 or 2 sprays during the period of time when the patient usually smoked a cigarette, as well as in the case of a craving for smoking.If after a single injection the craving for smoking does not decrease within a few minutes, a second injection should be performed. If 2 doses are required, the subsequent application of the spray can consist of 2 consecutive injections. < br> No more than 4 metered injections of the spray are allowed every hour. You should not inject more than 2 doses of the spray at one time or use more than 64 doses / day (or 4 doses per hour for 16 hours). < br> Each bottle contains at least 150 doses. < br> The average rate of application of the spray at the indicated dose is 6 weeks. Then, you should begin to reduce the number of injections so that by the end of the 9th week the number of doses is half of the average number of doses per day received in the first 6 weeks, and during the 12th week - no more than 4 doses / day. When the daily dose drops to 2-4 injections,the use of the spray should be discontinued. < br> After the end of therapy, to prevent a return to smoking, patients can use the Nicorette® spray if they have an irresistible desire to smoke. In such situations, you can make 1 injection, and if, after a single injection, the craving for smoking does not decrease for several minutes, a second injection should be made. In this case, do not exceed 4 metered injections per day. < br> Regular use of the spray for more than 6 months is usually not recommended, however, some patients may require longer therapy in order not to resume smoking. < br> Reducing the number of cigarettes smoked < br> Patients, those who want to reduce the number of cigarettes they smoke,spray should be applied as needed between smoking episodes in order to increase the time between smoking and to reduce smoking as much as possible. < br> Once ready, the patient should aim for complete smoking cessation. < br> After smoking cessation, observe the recommendations for therapy and gradual dose reduction indicated above for complete smoking cessation. < br> Behavioral therapy and psychological support usually increase treatment success. Those who have successfully quit smoking but find it difficult to quit the spray are advised to seek medical advice from a doctor. < br> Temporary smoking cessation < br> The spray can be used during periods when it is necessary to refrain from smoking, for example, when being in places, where smoking is prohibited, or in other situations,when you need to refrain from smoking. The maximum daily dose for temporary cessation of smoking is 64 doses. < br>

Dosage form

:

Spray for the oral mucosa, metered dose [mint]

Information on technical characteristics, delivery set, country of manufacture