NIKORETTE (The solution for inhalations)

Active material: Nicotine
When ATH: N07BA01
CCF: Drug for the treatment of nicotine addiction
ICD-10 codes (testimony): F17
When CSF: 02.17
Manufacturer: JOHNSON & JOHNSON LTD (Russia)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

◊ The solution for inhalations [absorbed] In the inhaler (White or slightly painted porous cylinder in a clogged transparent plastic cartridge with an inscription “NICORETTE” and the indicated number number, with a protective coating of aluminum foil from both ends). Before use, the cartridge is inserted into the mouthpiece, In this case, the protective coating is automatically opened.

Excipients: levomenthol, ethanol (evaporates during manufacture), nitrogen.

Inhalers (6) – blisters (1) complete with a mouthpiece (1 PC.) – cardboard boxes.
Inhalers (6) – blisters (3) complete with a mouthpiece (1 PC.) – cardboard boxes.
Inhalers (6) – blisters (7) complete with a mouthpiece (1 PC.) – cardboard boxes.

◊ The solution for inhalations [absorbed] In the cartridge (White or slightly painted porous cylinder in a clogged, Transparent, plastic cartridge with the inscription “NICORETTE” and the indicated number number, with a protective coating of aluminum foil from both ends). Before use, the cartridge is inserted into the mouthpiece, In this case, the protective coating is automatically opened.

Excipients: levomenthol, ethanol (evaporates during manufacture), nitrogen.

Spare packaging:

Cartridges (6) – blisters (3) – cardboard boxes.

Pharmacological action

Drug for the treatment of nicotine addiction. Nikorette avoids the development of cancellation syndrome (irritability, malaise and desire to smoke), which develops with the rejection of smoking, reduction in the number of cigarettes and temporary refusal in situations, when you can’t smoke.

When using the drug, the intake of nicotine is ensured in the body; At the same time, such ingredients of tobacco smoke, the resin, carcinogens, carbon monoxide, Do not enter the body.

It must be borne in mind, that the patient himself decides to abandon smoking, And the drug Nikrette only helps him in this, reducing physiological dependence on nicotine.

In cases where it is not possible to immediately refuse smoking, a decrease in the number of cigarettes smoked is also a positive result. Success, associated with a decrease in the number of cigarettes smoked, can stimulate a complete rejection of smoking.

Pharmacokinetics

When air inhaling through the inhaler, inhalation solution, nicotine evaporates and sucks in the oral cavity.

Testimony

Removing symptoms of cancellation, caused by a decrease in tobacco use (In the treatment of tobacco dependence):

- with a complete rejection of smoking,, who decided to quit smoking;

- with a decrease in the number of cigarettes smoked in those, who can not or does not want to completely give up smoking;

- In temporary smoking cessation.

Dosage regimen

Inhalation solution should be used at that moment, when an irresistible desire to smoke arises. The dose is selected individually, taking into account the degree of severity in the patient nicotine dependence. However, you should not use more 12 cartridges in day. Such a maximum daily dose can be used during 6-12 weeks, After which it should be reduced.

The more often the inhaler is used, It is easier to give up smoking for a long time.

The recommended dose for Adult (incl. elderly patients) is 6-12 cartridges in day. 1 The cartridge replaces 4 cigarettes. If the patient smoked 20 cigarettes in days, then he should use 6 cartridges in day. Each cartridge can be used approximately in 4 admission, Each lasting about 20 m.

At full smoking cessation The course is carried out for at least 3 Months. Then you should begin a gradual decrease in the number of cartridges used. It is recommended to have several additional cartridges with you, tk. an unexpected desire to smoke may arise.

At reducing the number of cigarettes smoked The inhaler should be used in between smoking to increase their duration and to the maximum possible reduction in the number of smoked cigarettes. Patients should be warned, that if through 6 weeks the number of cigarettes smoked daily did not decrease, you should consult your doctor.

Usually, It is not recommended to use an inhaler more 6 Months. Some patients, dropped out smoking, a longer use of the inhaler is required to prevent a return to smoking.

The patient must try to quit smoking when he will be ready for this, but no later than 6 months after initiation of treatment. If during the 9 months after initiation of therapy was unable to quit smoking, should consult a specialist.

Professional consultation and psychological support contribute to the effectiveness of therapy.

Side effect

Most adverse reactions observed during the first 3-4 Week of the drug. Side effects are similar to those in the introduction of nicotine in other ways and are dose -dependent.

Often: 40% cases – cough, irritation of the upper respiratory tract; more 1% – headache, nausea, Ikotech, vomiting.

Rarely: 0.01-1% – эritema, hives, palpitations.

In some cases,: less 0.01% – Paroxysmal atrial fibrillation, allergic reactions (incl. angioedema).

Dizziness, headache, sleep disorders, Anxiety can be manifestations of cancellation syndrome, caused by quitting smoking. When quitting smoking may increase the incidence of canker sores. The connection of these phenomena with the use of the drug Nikrette is not obvious.

Contraindications

- recently transferred myocardial infarction (during the last 3 Months);

- unstable or progressive angina;

- Prinzmetal angina;

- severe heart rhythm disturbances;

- Acute phase of stroke;

- Hypersensitivity to nicotine and other ingredients.

Pregnancy and lactation

Nicotine penetrates through the placental barrier and affects respiratory activity and the blood circulation of the fetus. The effect on blood circulation is dose -dependent. Smoking can cause serious harm to the fetus, Therefore, smoking pregnant women should be recommended to completely abandon smoking without the use of replacement therapy with nicotine -containing drugs.

As shown by the results of research within the framework of the program to refuse smoking, Continuation of smoking is a greater danger to the fetus, than the use of nicotine -containing drugs for replacement therapy in case of rejection of smoking.

The patient should warn about, that the issue of the use of the drug Nikrette during pregnancy is solved only by a doctor.

Nicotine is released with breast milk in quantities, who can have an adverse effect on the child, even when used in therapeutic doses. Nikorette cannot be used during breastfeeding.

Cautions

With caution, the drug should be prescribed to patients with severe diseases of the cardiovascular system (occlusive peripheral arterial disease, brain vessels, stable angina, stagnant heart failure in the phase of decompensation), With vascular spasms, uncontrolled hypertension, with severe and medium severity of liver diseases, In severe kidney diseases, With peptic ulcer of the stomach and duodenum in the exacerbation phase.

With caution, the inhaler should be used for chronic diseases of the pharynx and bronchial asthma.

Nicotine causes the release of catecholamines in the brain substance of the adrenal glands, Therefore, Nikrette with caution is prescribed for patients with hyperthyroidism or pheochromocytoma.

Patients with diabetes mellitus as a result of smoking refusal may require a decrease in insulin doses.

When using the drug, a transition from tobacco dependence to nicotine, However, the use of pure nicotine causes less harm to health, than using tobacco.

It is recommended to use an inhaler at a temperature above 15 ° C, tk. At low temperatures, the efficiency of the inhaler decreases.

After rejection of smoking, an increase in the concentration of blood plasma of such drugs may occur, Like Theophylline, Takerin and Klosapin, as well as Imipramine, olanzapine, Klomipramine and Fluvovsamin, which are characterized by a narrow therapeutic range. Besides, There is some information, indicating the possible stimulating effect of smoking on the metabolism of flexinide and pentazocin.

Use in Pediatrics

Experience in the use of the drug Nikrette in children and adolescents under the age of 18 years missing, Therefore, the drug should not be used in this category of patients without prescribing a doctor.

Overdose

Symptoms: nausea, drooling, abdominal pains, diarrhea, Sweating, headache, dizziness, hearing loss and severe weakness; in severe cases – hypotension, weak pulse and spasmodic, labored breathing, Extreme weakness, vascular collapse and generalized seizures, ie. Symptoms of acute nicotine poisoning.

Treatment: stop taking nicotine and start symptomatic treatment. With tachycardia, beta-blockers are prescribed; when excited and convulsions – diazepam; if necessary – IVL.

When swallowing, chewing or sucking cartridge with nicotine (as used, and unused) Children have a risk of poisoning.

Doses of nicotine, which are well tolerated during treatment with adult smoking, can cause severe poisoning symptoms in young children, and even lead to death.

Drug Interactions

The drug interaction of the drug Nikrette is not described.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 3 year.

After opening the protective coating, the concentration of nicotine in the cartridge quickly decreases. Therefore, it should be used as quickly as possible. Open cartridges should not be used the next day.