Nicorette spray for local use 1 mg/dose 150 doses (Johnson)

For application to the oral mucosa. The patient should do everything possible to permanently quit smoking while being treated with Nicorette® spray. Adults over 18 years of age Nicorette® Spray should be used at the moment when an irresistible urge to smoke occurs. After preparing the spray for use (see below for Instructions for Use when using the spray for the first time), place the tip of the spray as close to your open mouth as possible. Press the dispenser from above, thus releasing one dose of the drug into the oral cavity; Avoid getting the spray on your lips. To prevent the substance from entering the respiratory tract, do not inhale when pressing the dispenser. For best results, do not swallow saliva for several seconds after injection. While using the spray, eating and drinking is not recommended. If symptoms of overdose appear (see section “Overdose”), use of the drug must be stopped immediately. Complete smoking cessation Nicorette® Spray should be used in all cases of craving for smoking or to prevent cravings in situations that may provoke it. Smokers 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. If you completely quit smoking, take 1 or 2 injections during the period of time when you usually smoked a cigarette, as well as if you have 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 made. If two doses are required, subsequent application of the spray may consist of 2 consecutive injections. Every hour you are allowed to take no more than 4 dosed injections of the spray. Do not inject more than 2 doses of spray at a time or use more than 64 doses per day (or 4 doses per hour for 16 hours). Each bottle contains at least 150 doses. The average course of use 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 the average number of doses per day received in the first 6 weeks, and during the 12th week - no more than 4 doses per day. When the daily dose drops to 2-4 injections, use of the spray should be discontinued. After completion of therapy, to prevent a return to smoking, patients can use Nicorette® spray if they have an irresistible urge to smoke. In such situations, you can make 1 injection, and if after a single injection the craving for smoking does not decrease within a few minutes, you should make a second injection. In this case, you should not exceed 4 dosed injections per day. Regular use of the spray for more than 6 months is usually not recommended, but some patients may require longer therapy to avoid relapse into smoking. Reducing the number of cigarettes smoked Smokers who want to reduce the number of cigarettes they smoke should use the spray as needed between smoking episodes to increase the amount of time between smoking and to reduce smoking as much as possible. Once readiness is felt, smokers should aim to quit completely. After quitting smoking, you should follow the recommendations for therapy and gradual dose reduction indicated above for complete smoking cessation. Behavioral therapy and psychological support usually increase treatment success. Those who have managed to quit smoking but find it difficult to give up the spray are advised to consult a doctor for medical help. Temporary smoking cessation The spray can be used during periods when it is necessary to abstain from smoking, for example, when in places where smoking is prohibited, or in other situations when it is necessary to abstain from smoking. The maximum daily dose for temporary smoking cessation is 64 doses. In combination with a transdermal patch For smokers with a severe nicotine addiction (more than 20 cigarettes per day) or experiencing an irresistible craving for smoking, or smokers who have not been able to quit smoking using only one type of nicotine replacement therapy, it is possible to use a spray for the mucous membrane Nicorette® oral membranes in combination with Nicorette® transdermal patch for rapid relief of smoking cravings. The patch is applied to an intact area of skin immediately after waking up in the morning and removed before going to bed. The patch should be applied to dry, clean, intact, hair-free skin, such as the thighs, upper limbs or chest. It is necessary to change the application site every day: do not use the same area for two consecutive days. After applying the patch, wash your hands thoroughly to avoid eye irritation from possible nicotine contact. Initial therapy: Treatment should begin with a 25 mg/16 hour patch (stage 1) in combination with a 1 mg/dose spray. Usually 13 doses of spray per day are sufficient. The maximum daily dose of the spray is 32 doses. Patients should completely stop smoking during therapy. Usually the general course of treatment lasts for 8 weeks. After this, the dose of nicotine should be gradually reduced. Withdrawal of combination therapy: There are two ways to discontinue combination therapy. Method 1: Over the next 2 weeks, switch from the 25 mg/16 hour patch (Stage 1) to the 15 mg/16 hour patch (Stage 2), and then, over the next 2 weeks, to the 10 mg/16 hour patch ( stage 3), while maintaining, if necessary, the number of doses of Nicorette® spray used, as with Initial therapy. Next, the number of doses of the spray is gradually reduced until complete withdrawal for the time that the patient needs depending on his needs, but no later than 12 months after the start of combination therapy. Method 2: involves completely removing the patch immediately after completing the Initial Therapy phase. Next, gradually reduce the number of doses of Nicorette® spray until complete withdrawal during the time that the patient needs depending on his needs, but no later than 12 months after the start of combination therapy. Children and adolescents under 18 years of age The drug is not recommended for use by persons under 18 years of age. There is no experience in treating adolescents under 18 years of age with the spray.

Pharmacokinetics

The pharmacokinetics of nicotine are comparable when the patch is applied to the skin of the arm or thigh. Absorption After applying a nicotine patch to the skin of the arm or thigh, approximately 95% of the released nicotine enters the systemic circulation. The remaining part evaporates at the edges of the patch. All patches indicate the average amount of nicotine that is absorbed by the average patient within 16 hours. The Cmax of nicotine in the blood plasma after applying the patch is reached after 6-10 hours and after applying the 15 mg/16 hour patch is 9-15 ng/ml. If the 15 mg/16 hour patch is left on for 24 hours (rather than 16 hours), the nicotine concentration during the last 8 hours decreases from an average of 7.2 to 5.6 ng/ml. When using smaller patches, similar changes in plasma nicotine concentrations can be expected. When three patch doses were used, plasma nicotine concentrations differed slightly from the proportional increase in dose: as patch size increased, the corresponding increase in concentration was slightly lower than expected. The distribution of Vd of nicotine with intravenous administration is about 2-3 l/kg. The binding of nicotine to blood plasma proteins is less than 5%. In this regard, disturbances in the binding of nicotine during the simultaneous use of other drugs or changes in the amount of protein in plasma in various diseases should not have a significant effect on the kinetics of nicotine. When the patch is applied repeatedly, the nicotine concentration does not significantly exceed that after its single application. Metabolism Nicotine is metabolized in the liver, kidneys and lungs. More than 20 metabolites have been identified that are inferior in activity to nicotine. The concentration of the primary metabolite, cotinine, is 10 times higher than the concentration of nicotine. Excretion Excreted mainly by the liver. The average plasma clearance is about 70 l/h. T1/2 - about 2 hours. Mainly cotinine (15% of the dose, T1/2 - 15-20 hours) and trans-3-hydroxy-cotinine (45% of the dose) are excreted in the urine. 10-30% of the nicotine dose is excreted unchanged in the urine. Pharmacokinetics in special clinical situations Progressive deterioration of renal function is accompanied by a decrease in the overall clearance of nicotine. The pharmacokinetics of nicotine does not change significantly in patients with liver cirrhosis with mildly severe liver dysfunction (5 points on the Child-Pugh scale) and decreases in patients with cirrhosis with moderately severe liver dysfunction (7 points on the Child-Pugh scale). In smokers undergoing hemodialysis, an increase in the concentration of nicotine in the blood plasma was noted. In elderly patients, there is a slight decrease in the total clearance of nicotine, which does not require dose adjustment.

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Many pregnant women who suffer from nicotine problems are offered Nicorette spray as an excellent alternative. There is no need to resort to complex medical procedures or expose yourself to new dangers.

Doctors note that almost any method of quitting smoking is effective - they can definitely have a positive effect on the development of the fetus. Why is it so important to get rid of nicotine addiction during pregnancy? If you use the Nicorette patch correctly, you can get the most positive effect:

Harmful substances do not accumulate in the human body. Despite the small dose of nicotine, other harmful compounds do not affect the pregnant woman’s body or the fetus;
Smoking has a detrimental effect on the breathing rate, the body experiences problems with oxygen, which can lead to hypoxia in the child; The risk of catching a cold is significantly reduced; “Withdrawal syndrome” is much easier to overcome; special means can significantly reduce sensitivity to quitting smoking. You can gradually reduce the dose of nicotine and completely give up such a harmful habit;
No problems with passive smoking.

If the spray or patch are not suitable, try using an alternative; chewing gum has a positive effect and allows you to solve smoking problems.

Special conditions

The use of Nicorette® is associated with less risk than smoking. Patients who wear removable dentures may have difficulty using Nicorette® chewing gum. Chewing gum can stick to dentures and, in rare cases, damage them. Patients with diabetes may need to reduce their insulin doses after stopping smoking. Minor digestive upsets that may occur with 4 mg nicotine gum can be managed by chewing the gum more slowly or by using 2 mg nicotine gum (at shorter intervals if necessary). The patient should be informed that he should carry Nicorette® chewing gum with him to use if he suddenly wants to smoke. Use in pediatrics The question of prescribing the drug to patients under the age of 18 years is decided by the doctor individually. Effect on the ability to drive vehicles and operate machinery. A negative effect on the ability to drive a vehicle and operate machinery has not been established.