Active substanceNicotineNicotine
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  • Dosage form: & nbspchewing gums
    Composition:

    Active substance: nicotine-polymer complex 10 mg or 20 mg (corresponding to 2 mg or 4 mg of nicotine);

    Excipients: chewing gum (base) *, sorbitol powdered, sorbitol solution (crystallizing), glycerol solution 85%, sodium carbonate, sodium hydrogen carbonate (for dosage 2 mg), perfume 84.6422, perfume Haverstroo ZD49284, certified FDA quinoline yellow dye D & C №10 (for a dosage of 4 mg).

    * Chewing gum base is a mixture of different types of wax, resin and other hydrocarbons (about 60%) and calcium carbonate (up to 40%).

    Description:For a dosage of 2 mg: square beige color cushion with a characteristic odor of approximately 14x14x5 mm, for a dosage of 4 mg: A square yellow colored cushion with a characteristic odor of approximately 14x14x5 mm. . For both dosages, a rough surface and slight unevenness on the sides are allowed.
    Pharmacotherapeutic group:a remedy for the treatment of nicotine addiction.
    ATX: & nbsp

    N.07.B.A   Drugs used in nicotine addiction

    N.07.B.A.01   Nicotine

    Pharmacodynamics:

    After a sharp quitting in patients who have used tobacco products for a long time, a withdrawal syndrome may develop, which includes: dysphoria, insomnia, increased irritability, anxiety, impaired concentration, decreased heart rate, increased appetite, or an increase in appetite weight.An important symptom of withdrawal syndrome is also the desire to smoke.

    In the treatment of tobacco dependence, nicotine replacement therapy reduces the need for the number of cigarettes smoked, reduces the severity of withdrawal symptoms that occur with complete quitting in those who choose to quit smoking, facilitates temporary abstinence from smoking, and also reduces the number of smoked cigarettes in those who can not or does not want to completely give up smoking.

    Pharmacokinetics:

    Nicotine, coming from the chewing gum, is quickly absorbed through the mucous membrane of the cheek and is found in the blood after 5-7 minutes. The maximum concentration of nicotine is reached 30 minutes after the beginning of chewing.

    The volume of nicotine distribution for intravenous administration is about 2-3 l / kg, and the elimination half-life is approximately 2 h. Nicotine basically is excreted by the liver, its average plasma clearance is about 70 l / h. Nicotine it is also metabolized in the kidneys and lungs. Identified more than 20 metabolites of nicotine, which are inferior to him in terms of activity.

    The connection of nicotine with plasma proteins is less than 5%.In this regard, violations of the binding of nicotine with the simultaneous use of other drugs or changes in plasma protein levels in various diseases should not have a significant effect on the kinetics of nicotine.

    The primary metabolite of nicotine in plasma - cotinine - has a half-life of 15-20 hours, and its concentration exceeds that of nicotine by a factor of 10.

    Urine is excreted mainly cotinine (15% dose) and trans-3-hydroxy-cotinine (45% dose). From 10% to 30% of the dose of nicotine is excreted in the urine unchanged.

    Progressive deterioration of kidney function is accompanied by a decrease in overall nicotine clearance. Its pharmacokinetics does not change in patients with cirrhosis of the liver with negligible hepatic impairment (index 5 in Child-Pyo) and decreases in patients with cirrhosis of the liver with moderate impaired hepatic function (Child-Pugh index 7). Smokers who received hemodialysis treatment had an increase in the concentration of nicotine in the blood plasma.

    In elderly patients there is a slight decrease in total nicotine clearance, which does not require dose adjustment.

    Indications:

    Treatment of tobacco dependence by reducing the need for nicotine in the following cases:

    - reduction of withdrawal symptoms occurring with complete rejection of

    smoking in patients who decided to quit smoking;

    - with a temporary cessation of smoking

    - reduction in the number of smoked cigarettes in those who can not or not wants to completely reject

    Contraindications:

    Hypersensitivity to nicotine or other components of the chewing gum.

    Carefully:

    Chewing gum "Nicorette" should be used only after

    consulting a physician for patients with cardiovascular disorders, in particular having suffered serious cardiovascular diseases for 1 month before the start of the application (such as stroke, unstable angina, arrhythmia, myocardial infarction, shunting or angioplasty) or with uncontrolled hypertension.

    Chewing gum "Nicoretge®" should be administered with caution to patients with moderate or severe impairment of liver function, severe renal failure, exacerbation of duodenal ulcer and stomach ulcer.

    Nicotine, entering the human body with replacement therapy or smoking, causes the release of catecholamines from the adrenal medulla. In connection with this chewing gum."Nicoretge®" should be used with caution in patients with uncontrolled hyperthyroidism, pheochromocytoma, and also with diabetes mellitus.

    The use of chewing gum "Nicoretge®" is accompanied by a lower risk than smoking.

    Pregnancy and lactation:

    Nicotine penetrates the placenta and is excreted with human milk, and therefore its use may pose a risk to the fetus or child. Patients should be informed about the need to attempt to quit without nicotine-substituting therapy. In case of failure of such attempts, the decision to conduct therapy is taken after comparing the possible positive effect and potential harm.

    Nicotine is absorbed in small amounts in breast milk even when taken in therapeutic doses, which can negatively affect the health of the child when taking the drug by the nursing mother. In order to reduce the negative influence of nicotine on the baby chewing gum "Nicorette®" should be used immediately after feeding.

    Dosing and Administration:

    The dose is selected individually depending on the intensity of smoking.

    Usually:

    - chewing gum Nicorette with a dosage of 2 mg should be used if you smoke less than 20 cigarettes a day or smoke your first cigarette after 30 minutes. after waking up,

    - chewing gum Nicorette dosage of 4 mg should be used if you smoke more than 20 cigarettes a day.

    How to apply a chewing gum to Nicorette

    Chewing gum Nicorette should be used in all cases when there is an irresistible desire to smoke, in accordance with the following scheme:

    1. slowly chew the chewing gum until the appearance of a sharp taste of nicotine,

    2. stop chewing and leave an elastic band between the inside of the cheek and the gum,

    3. when the taste disappears, start chewing the chewing gum again.

    Full cessation of smoking

    At one time, chew only one chewing gum, stopping smoking.

    With complete cessation of smoking, the amount of chewing gum per day is determined by the degree of dependence on nicotine and is usually 8-12 pieces per day, but should not exceed 15 pieces per day. Use chewing gum in the indicated amount should be up to 3 months, after which the daily number of gum should be gradually reduced to a complete cancellation.Chewing gum is canceled when its daily dose is 1-2 pieces per day.

    Regular use of chewing gum for more than 12 months is usually not recommended, but some people require longer therapy to not resume smoking.

    Reducing the number of cigarettes smoked

    Chewing gum Nicorette should be used when you want to smoke, gradually reducing the number of cigarettes smoked per day.

    If within 6 weeks it was not possible to achieve decrease in daily consumption of cigarettes, it is necessary to address for the help to the expert.

    Try to completely abandon cigarettes should be taken as soon as you feel ready for it, but no later than 6 months after the start of therapy. If you could not make a serious attempt to quit smoking within 9 months after the start of therapy, you should contact a specialist.

    Regular use of chewing gum for more than 12 months is usually not recommended, but some people require longer therapy to not resume smoking or return to previous levels of tobacco use.

    Medical counseling and providing psychological support at the same time with the Nicorette chewing gum therapy usually increase the effectiveness of therapy.

    Temporary cessation of smoking

    Chewing gum Nicorette can be used during periods when it is necessary to refrain from smoking, for example, when staying in places where smoking is prohibited, or in other situations when it is necessary to refrain from smoking (air travel, hospitalization, etc.).

    In combination with a plaster (a transdermal therapeutic system with nicotine)

    Chewing gum Nicorette with a dosage of 2 mg can also be used in conjunction with a band-aid in situations where,

    plaster, a person continues to periodically experience irresistible urge to smoke, or if you can not quit using only chewing gums or just a patch. In combination with the band-aid, the Nicorette chewing gum with a dosage of 2 mg allows you to quickly remove strong urges to smoke when necessary.

    Initial therapy:

    Treatment should begin with a 15 mg / 16 hour patch (Stage 1) in combination with a 2 mg gum. Patch 15 mg / 16 hours apply for 6-12 weeks, applying it every morning to a clean, intact, hair-free area of ​​the skin of the shoulder or thigh and taking off before bed. At the same time apply at least 4 chewing gum 2 mg per day; usually enough 5-6 chewing gums. The number of chewing gums should not exceed 15 pieces per day.

    Abolition of combination therapy:

    You can cancel combination therapy in two ways.

    Method 1: over the next 3-6 weeks, you need to switch from a 15 mg / 16 hour patch (1 stage) to a 10 mg / 16 hour patch (Stage 2), and then for a further 3-6 weeks on a 5 mg / 16 hour patch (Stage 3), while maintaining the amount of chewing gum Nicorette used with a dosage of 2 mg, as in Initial therapy. Further, the amount of chewing gum is gradually reduced to a complete cancellation for the time that is necessary for a person, depending on his needs, but no later than 9 months after the start of the combination therapy.

    Method 2: is to completely remove the patch immediately after the end of the step Initial therapy. Then gradually reduce the amount of chewing gum Nicorette with a dosage of 2 mg until complete cancellation over a period of time,which is necessary for a person depending on his needs, but no later than 9 months after the start of the combination therapy.

    Recommended dose:

    Initial therapy

    Period

    time

    Patch

    Chewing gum 2 mg

    The first

    6-12

    weeks

    1 plaster 15 mg / 16 hours (1 stage) daily

    When

    necessity. Recommended 5 - 6 chewing gum 2 mg per day

    Cancel - Method 1

    The next 3-6 weeks

    1 plaster 10 mg / 16 hours (2nd stage)

    Continue

    application of

    chewing

    daily

    Eliminate Nicorette with a dosage of 2 mg as needed

    The next 3-6 weeks

    1 plaster 5 mg / 16 hours (stage 3) daily

    Continue the use of Nicorette chewing gum with a dosage of 2 mg as needed

    Up to 9 months after the onset of combined therapy

    Gradual abolition of Nicorette gum with a dosage of 2 mg

    Cancel - method 2

    Up to 9 months after the onset of combined therapy

    Gradual abolition of Nicorette gum with a dosage of 2 mg

    At the age of 18, chewing gum can be used only on the recommendation of a doctor!

    Do not exceed the indicated dose!

    Carry the chewing gum Nicorette with you to take advantage of it, if you suddenly want to smoke.

    Side effects:

    In the recommended dose, the chewing gum "Nicorette®" does not cause serious adverse effects. At the beginning of treatment contained in the chewing gum nicotine can sometimes cause mild irritation of the throat and increased salivation. When swallowing excessive amounts of dissolved nicotine at the beginning of treatment, hiccups are possible.

    Excessive use of Nicorette® chewing gum by persons who do not have the habit of inhaling tobacco smoke can lead to nausea, weakness, or headaches (similar to those experienced in such patients by inhalation of tobacco smoke).

    Most adverse effects are dose-dependent and occur in the first 3-4 weeks of treatment.

    Some symptoms, such as dizziness, headache and sleep disturbances, may be associated with withdrawal symptoms arising from abstinence from smoking. After quitting smoking, aphthous ulcers may occur with increased frequency in patients.

    In persons with a predisposition to digestive disorders at the beginning of treatment with a chewing gum "Nicorete®" with a dosage of 4 mg, minor digestive or heartburn disorders are possible; usually this problem is eliminated at a slowerchewing gum or using a gum containing 2 mg of nicotine (if necessary with shorter intervals).

    Symptom frequency: very common (> 1/10), often occurring (> 1/100, <1/10), infrequent (> 1/1000, <1/100), rare (> 1/10000, <1 / 1000), very rare (<1/10000).

    Organs and organ systems

    Degree of occurrence of a symptom

    Symptom

    central nervous system

    Very common: Common:

    Headache Vertigo

    The cardiovascular system

    Uncommon: Very rare:

    Heart palpitations Atrial fibrillation

    Gastrointestinal tract

    Very common: Common:

    Gastrointestinal discomfort, hiccough, nausea

    Vomiting

    Leather:

    Uncommon:

    Erythema, urticaria

    Others:

    Very common: Rare:

    Sore throat or in the mouth, muscular jaw pains

    Allergic reactions, including angioedema

    Overdose:

    Excessive intake of nicotine with substitution therapy and / or smoking can cause symptoms of overdose.

    Overdose Symptoms are similar to those in acute nicotine poisoning and include nausea, salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing impairment and severe weakness.When applying high doses of nicotine can be noted: arterial hypotension, weak and irregular pulse, shortness of breath, circulatory collapse and generalized convulsions.

    Nicotine in adult-dose smokers doses can cause severe symptoms of intoxication in young children, including fatalities.

    Treatment of overdose: should immediately stop using nicotine and prescribe symptomatic treatment. Activated carbon reduces absorption nicotine in the gastrointestinal tract. If necessary, give artificial respiration and oxygen.

    Interaction:

    Smoking (but not nicotine) causes an increase in enzyme activity CYP1A2. After cessation of smoking, a decrease in the clearance of the substrates of this enzyme can be observed. This may lead to an increase in the level of some drugs in the blood plasma, which has potential clinical significance when using drugs with a small breadth of therapeutic effect, such as theophylline, Tacrine, clozapine and ropinirole.

    Limited evidence suggests that smoking can induce the metabolism of flecainide and pentazocine.

    Special instructions:

    Chewing gum can stick to the denture and in rare cases of damage to it.

    Patients with diabetes mellitus after smoking cessation lowering of insulin doses is required.

    If the medicine has become unusable or the expiration date has expired, do not throw it into sewage or into the street! Place the drug in a bag and put it in the trash. These measures will help protect the environment!

    Effect on the ability to drive transp. cf. and fur:

    Negative impact on the ability to drive and work with mechanisms is not established.

    Form release / dosage:

    Erasers chewing 2 mg or 4 mg. For 6 or 15 chewable Elastic bands in a blister, 1 (blister 6, 15 chewing gums), 2 (a blister on 15 chewing gums) or 7 (a blister on 15 chewing gum) blisters together with instructions for use in a cardboard bundle.

    Packaging:(15) - packings, cellular, planimetric (1) - packs cardboard
    (15) - packings, cellular, outline (2) - packs, cardboard
    (15) - packings cellular planimetric (7) - packs cardboard
    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2.5 years.

    Note:

    The marking of the expiry date (the period from the date of manufacture to the date specified in the item "Good before") may be less than 2.5 years for 1 month.

    Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N012505 / 01
    Date of registration:11.02.2008
    The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp13.08.2015
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