Nicorette

Nicorette is a drug intended for the treatment of nicotine addiction.

Release form and composition

• Sublingual tablets: round, flat, with beveled edges, white, on one side of the inscription "NIC", and on the other - the number "2" (10 pieces in a blister, in a carton 2, 3, 9 or 10 blisters);
• Lemon sublingual tablets: round, flat, with beveled edges, white, “N2” inscription is squeezed out on one side (10 pieces in a blister, in a carton pack of 2, 3, 9 or 10 blisters);
• Chewing gums: square (14 × 14 × 5 mm), white (2 mg) or yellow (4 mg), with a characteristic odor (15 pieces in blisters, in a carton pack of 1, 2 or 7 blisters);
• Mint chewing gum: square (14 × 14 × 5 mm), light beige (2 mg) or light yellow (4 mg) colors, characteristic mint flavor (15 pieces in blisters, in a carton pack 1, 2, 7 or 14 blisters);
• Fresh Mint chewing gum: square (15 × 15 × 6 mm), with a shell of white (2 mg) or from pale brown to pale yellow with a greenish tint (4 mg), with a smell of mint (6 pcs. in a blister, in a carton pack 1 blister; 15 pieces in a blister, in a carton pack 1, 2 or 7 blisters);
• “Frosty mint” chewing gum: square (15 × 15 × 6 mm), slight irregularities of white (2 mg) or light yellow with brown or greenish tint (4 mg) colors (15 pieces in blisters, a carton of 2 blisters);
• Chewing mint chewing gum: square (15 × 15 × 6 mm), slight unevenness on the sides, white (2 mg) or light yellow with brown or greenish tint (4 mg) colors (15 pieces in blisters, in a carton pack of 1, 2 or 7 blisters);
• Fresh fruit chewing gum: square (15 × 15 × 6 mm), small irregularities are possible on the sides, white (2 mg) or light yellow with brown or greenish tint (4 mg) (6 pcs in a blister, in a carton pack 1 blister; 15 pieces in a blister, in a carton pack 1, 2 or 7 blisters);
• Inhalation solution: in the cartridge (white or slightly colored porous cylinder, sealed in a transparent plastic cartridge, with the specified serial number and the inscription "NICORETTE") (6 inhalers in a blister, in a cardboard box 1 or 3 blisters complete with 1 mouthpiece) ;
• Spray dosed for topical use: clear solution, from light yellow to colorless, transparent or slightly opalescent, with a mint smell (13.2 ml each (150 doses) in polyethylene terephthalate bottles, in a contour plastic container 1 or 2 bottles in protective polypropylene case complete with dispenser);
• Transdermal therapeutic system (TTS): a rectangular patch with rounded edges with a contact surface area of ​​10, 20 or 30 cm ² , one side of a light brown color with the words “nicorette”, the second one is silver-white with an adhesive surface that is covered with a protective synthetic transparent foil (1 piece in a sachet, in a carton pack of 7 or 14 sachets);
• Transdermal patch: rectangular with rounded corners, translucent, on a detachable siliconized, aluminized substrate; 10 mg / 16 h - with an area of ​​9 cm² ± 2% and a size of 27.7 × 33.2 mm, 15 mg / 16 h with an area of ​​13.5 cm² ± 2% and a size of 33.2 × 41.3 mm; 25 mg / 16 h - with an area of ​​22.5 cm² ± 2% and a size of 43 × 53 mm (1 pc. Each in a sachet, in a carton pack of 7, 14, or 28 sachets);

The composition of 1 tablet sublingual:

• Active ingredient: nicotine (in the form of a nicotine-β-cyclodextrin complex) - 2 mg;
• Additional substances: colloidal silicon dioxide, crospovidone, magnesium stearate, Betadex (β-cyclodextrin).

The composition of 1 tablet sublingual lemon:

• Active ingredient: nicotine (in the form of nicotine ditartrate dihydrate) - 2 mg;
• Excipients: ProSolv (microcrystalline cellulose and colloidal silicon dioxide), magnesium stearate, microcrystalline cellulose, methylcellulose, povidone K90, mannitol, aspartame, flavors 501438 AP1051 and Lemon 501163 TP0551.

Ingredients 1 chewing gum:

• Active ingredient: nicotine (in the form of a nicotine-polymer complex) - 2 or 4 mg;
• Additional substances: chewing gum base *, sodium bicarbonate, sodium carbonate, sorbitol solution (crystallizing), glycerol solution 85%, powdered sorbitol, perfume 84.6422 and Haverstroo ZD49284.

Ingredients 1 mint chewing gum:

• Active ingredient: nicotine (in the form of a nicotine-polymer complex) - 2 or 4 mg;
• Excipients: chewing gum base *, sodium bicarbonate, magnesium oxide, anhydrous sodium carbonate, talc, xylitol, nitrogen, levomenthol, peppermint oil, quinoline yellow dye.

Ingredients 1 fresh mint chewing gum:

• Active ingredient: nicotine (in the form of a nicotine-polymer complex) - 2 or 4 mg;
• Additional substances: chewing gum base *, sodium carbonate, acesulfame potassium, xylitol, magnesium oxide, sodium bicarbonate, levomenthol, peppermint oil;
• Chewing gum shell: gum arabic, peppermint oil, titanium dioxide, carnauba wax, xylitol.

Ingredients 1 Frosty mint chewing gum:

• Active ingredient: nicotine (in the form of a nicotine-polymer complex) - 2 or 4 mg;
• Excipients: chewing gum base *, sodium carbonate, acesulfame potassium, xylitol, magnesium oxide, sodium bicarbonate, levomenthol, peppermint oil;
• Outer shell: titanium dioxide, pregelatinized starch, carnauba wax, xylitol and Winterfresh flavoring;
• Inner casing: hypromellose, sucralose, polysorbate 80 and Winterfresh.

Ingredients of 1 Spicy Mint chewing gum:

• Active ingredient: nicotine (in the form of a nicotine-polymer complex) - 2 or 4 mg;
• Additional substances: chewing gum base *, sodium carbonate, acesulfame potassium, xylitol, magnesium oxide, sodium bicarbonate, levomenthol, peppermint oil;
• Outer shell: titanium dioxide, carnauba wax, gum arabic (acacia gum), xylitol and Burning Spicy Mint flavoring SN679712;
• Inner casing: hypromellose, sucralose, polysorbate 80, and Burning spicy mint flavoring SN679712.

Ingredients 1 fresh fruit chewing gum:

• Active ingredient: nicotine (in the form of a nicotine-polymer complex) - 2 or 4 mg;
• Excipients: chewing gum base *, sodium carbonate, acesulfame potassium, xylitol, magnesium oxide, sodium bicarbonate, levomenthol, peppermint oil;
• Outer shell: acacia, xylitol, carnauba wax, titanium dioxide, tutti-frutti flavoring CuEl44441;
• Inner shell: hypromellose, sucralose, polysorbate 80 and tutti-frutti flavoring CuEl444441.

* The composition of the basis of all chewing gum Nikorette: a mixture of calcium carbonate (no more than 40%) and various types of wax, resin and other hydrocarbons (no more than 60%).

Ingredients 1 inhaler (cartridge):

• Active ingredient: nicotine - 10 mg;
• Additional substances: levomenthol, nitrogen, ethanol evaporating during the production process.

The composition of 1 ml spray for local use:

• Active ingredient: nicotine - 10 mg;
• Excipients: sodium bicarbonate, levomenthol, poloxamer, trometamol, glycerol, ethanol, propylene glycol, water, sucralose, hydrochloric acid 10%, flavors Cooler 2 SN046680 and mint QL24245.

Composition 1 cm² transdermal therapeutic system:

• Active ingredient: nicotine - 0.83 mg (dose given out over 16 hours - 5, 10 or 15 mg);
• Additional components: non-woven polyester, polybutene, low molecular weight polyisobutylene, siliconized polyester, medium molecular weight polyisobutylene, substrate film.

Composition of 1 transdermal patch:

• Active ingredient: nicotine - 15.75 / 23.62 / 39.37 mg (the dose released in 16 hours is 10, 15 or 25 mg, respectively);
• Auxiliary substances: polyethylene terephthalate film 19 μm (on one side can be varnished) - carrier layer containing the active substance, triglycerides, butyl methacrylate basic copolymer;
• Acrylate base: 100 μm polyethylene terephthalate film, aluminum acetylacetonate, potassium hydroxide, acrylic adhesive solution, croscarmellose sodium, aluminized removable substrate on one side (carrier, which serves to protect the adhesive layer, discarded before use), siliconized removable substrate on both sides.

Indications for use

Nicorette is used to treat tobacco dependence (by reducing the need of the human body for nicotine) in the following cases:

• Relief of withdrawal symptoms occurring in people who have decided to quit smoking, with full refusal of smoking;
• Reducing the number of cigarettes smoked per day for people who are unable or unwilling to completely stop smoking;
• Relieving withdrawal symptoms while temporarily abstaining from smoking.

Contraindications

The use of Nicorette is contraindicated in case of hypersensitivity to its components.

With caution, the drug should be used in the following cases:

• Pheochromocytoma;
• Uncontrolled hyperthyroidism;
• Diabetes;
• Liver dysfunction (moderate and severe);
• Severe renal failure;
• Exacerbation of gastric ulcer and 12 duodenal ulcer;
• Patients in the group of cardiovascular risk (those who have suffered serious diseases of the cardiovascular system or hospitalization for cardiovascular disorders, for example, cardiac arrhythmias, unstable angina, angioplasty or coronary artery bypass surgery, myocardial infarction, stroke, as well as patients with non-coronary arteries, myocardial infarction, stroke, as well as patients with non-coronary arteries, myocardial infarction, stroke, as well as patients with non-coronary arteries, myocardial infarction, stroke and patients hypertension).

Dosing and Administration

Sublingual tablets

In this dosage form, Nicorette should be taken sublingually - keep under the tongue until completely dissolved (approximately 30 minutes).

The initial dose is selected by the doctor individually, depending on the degree of nicotine addiction and is 1-2 tablets per reception. At the beginning of treatment, the drug must be taken every 1-2 hours. Usually, 8-12 tablets per dose of 2 mg are sufficient per day. The maximum permissible daily dose is 30 tablets (at a dose of 2 mg).

To stop smoking completely, it is recommended to take the drug for at least 3 months, gradually reducing the daily number of pills taken. Treatment can be stopped when the daily dose of 1-2 tablets is reached.

To reduce the number of cigarettes smoked Nicorette should be taken between episodes of smoking, thus extending the intervals between smoking. If there is no result for 1.5 months, you should consult a doctor.

If it is necessary to temporarily give up smoking, tablets should be taken during these periods.

Chewing gums of all kinds

Take the drug in this dosage form should be every time there is a strong desire to smoke. Chewing gum should be slowly until a sharp taste appears, after which it should be placed between the gum and the inside of the cheek, and after the taste disappears, it should be resumed. For 1 reception you can use 1 chewing gum.

The dose is determined depending on the degree of tobacco addiction: if a person smokes less than 20 cigarettes a day, chewing gum is prescribed in a dose of 2 mg. In case of insufficient effect, the dose may be increased to 4 mg.

The average daily dose is 8-12 gum. Maximum allowable - 15 pcs.

Take the drug should be continuously for 3 months, then gradually reduce the dose.

To reduce the number of cigarettes smoked, chewing gum should be between episodes of smoking, thus extending the intervals between smoking cigarettes. If there is no effect for 1.5 months, it is necessary to consult a doctor.

Solution for inhalation

In the form of a solution, Nicorette should be taken in cases where there is an irresistible desire to smoke.

The daily amount of inhalation is determined by the doctor individually, depending on the degree of nicotine addiction. Each cartridge replaces 4 cigarettes. The maximum allowable daily intake is 12 cartridges.

The course of treatment is 1.5-3 months, after which the dose should be gradually reduced.

The inhaler can be used simultaneously with the Nikorette transdermal therapeutic system.

Topical spray

In the form of a spray, the drug should be used at times when there is an irrepressible desire to smoke. At one time you can do 1-2 injections. If within a few minutes the thrust is not reduced, it is necessary to take another dose.

To prevent the drug from entering the respiratory tract, do not inhale while pressing the dispenser. After spraying for several seconds, it is not recommended to swallow saliva, while using the spray, to drink and eat food.

Most patients need 1-2 doses of spray every 30-60 minutes. You cannot take more than 2 doses at one time, more than 4 doses for 60 minutes, more than 64 doses during the day.

Transdermal therapeutic system

TTC should be applied to intact skin every morning immediately after waking up and removed immediately before bedtime.

At the beginning of treatment is recommended to use 1 patch 15 mg / 16 hours. The duration of the initial period is determined individually. Usually it is 3 months. Further, the dose is recommended to be gradually reduced: within 2-3 weeks to apply patches at a dose of 10 mg / 16 hours, the next 2-3 weeks at a dose of 5 mg / 16 hours.

Transdermal patch

This type of patch is applied in the same way as a transdermal therapeutic system.

For people who smoke 20 or more cigarettes per day, for the first 2 months of the day, a patch should be applied at a dose of 25 mg / 16 hours. Then gradually reduce the dose: within 2 weeks, apply 1 patch at a dose of 15 mg / 16 hours, the next 2 weeks at a dose of 10 mg / 16 hours.

For people who smoke 10–20 cigarettes per day, for the first 2 months, patches can be applied at a dose of 15 mg / 16 hours, over the next 2 months at a dose of 10 mg / 16 hours.

In case of insufficiency of the therapeutic effect, i.e. If the irresistible desire to smoke periodically continues to appear, the patch can be applied simultaneously with the nicotte's chewing gum at a dose of 2 mg.

In the initial period, use at least 4 gum per day, but not more than 15 pcs. After 2 months, the dose should be gradually reduced.

You can cancel the combination therapy in one of 2 ways:

1. Gradually reduce the dose of the patch (for 2 weeks, patches of 15 mg / 16 hours, over the next 2 weeks - 10 mg / 16 hours), without changing the number of chewing gums, and then gradually reduce the number of gums until completely canceled;
2. At the end of the initial stage of therapy, completely abolish the use of the patch, then gradually reduce the number of chewing gums, until the full abolition.

The total duration of treatment Nicorette should not exceed 1 year. The effectiveness of therapy increases medical counseling and psychological support.

Side effects

Side effects that occur when using different dosage forms of Nicorette are similar, dose-dependent in nature, most of them develop in the first 3-4 weeks of taking the drug.

The most frequently observed adverse reactions include:

• Central nervous system: dizziness and headache (may be symptoms of withdrawal caused by smoking cessation);
• Respiratory system: rhinitis and cough;
• Digestive system: hiccups, discomfort, nausea;
• Cardiovascular system: rapid heart beat;
• Other: irritation of the oral mucosa, dryness and sore throat.

With the external use of patches may be moderately severe itching and redness of the skin.

special instructions

Experience with Nicorette in children and adolescents under the age of 18 is absent, therefore, it is necessary to consult a doctor.

In patients with diabetes mellitus after quitting smoking, you may need to lower the dose of insulin taken.

Nicorette use is associated with lower health risks than smoking.

During the period of treatment, caution is recommended when driving vehicles and engaging in activities that require a reaction speed and an increased concentration of attention.

Drug interaction

Smoking (not using nicotine!) Causes an increase in the activity of the CYP1A2 isoenzyme. For this reason, after giving up cigarettes, it is possible:

• Decrease in the clearance of substrates of this enzyme, due to which it is possible to increase the concentration in the blood plasma of certain drugs (for example, tacrine, clozapine, ropinirole, theophylline);
• An increase in the concentration of other drugs that are partially metabolized under the influence of the CYP1A2 isoenzyme (for example, clomipramine, imipramine, fluvoxamine, olanzapine).

Terms and conditions of storage

Store at temperatures up to 25 ° C out of the reach of children.

Shelf life of chewing gum and spray for local use - 2 years, sublingual tablets, TTC, patch and solution for inhalation - 3 years.