“The ultimate goal is permanent cessation of tobacco use. The use of Nicorettemist should preferably be combined with a behavioral support program.
Composition: One free spray of 1 mg nicotine in 0.07 ml of solution. 1 ml of solution contains 13.6 mg nicotine. Excipients with known action: ethanol (less than 100 mg ethanol per spray).
Excipients: Clinically significant interactions between nicotine replacement therapy and other drugs have not yet been confirmed. However, nicotine may enhance the hemodynamic effects of adenosine, i.e. an increase in blood pressure and heart rate, as well as an increase in the pain response (chest pain resembling angina), caused by the administration of adenosine.
Dosage
Patients must completely quit smoking while taking nicorettemist. Adults and the elderly. The following table shows the recommended times to use the oral mucosal spray during full treatment (Phase I) and the tapering phases (Phase II and Phase III). You may use up to 4 pumps per hour. Do not exceed 2 puffs for each dose and 64 puffs (4 puffs per hour over a 16-hour period) in any 24-hour period. Phase I: Weeks 1 through 6. Take 1 or 2 puffs whenever you are about to smoke a cigarette or feel the urge to smoke. If one puff does not control the urge for a few minutes, take a second puff. If 2 puffs are needed, 2 puffs in a row may be taken thereafter. Most smokers will need 1 or 2 puffs every 30 minutes to 1 hour. Phase II: Weeks 7 through 9. Begin decreasing the number of puffs per day. By the end of Week 9, subjects should HALF the average number of daily puffs used in Phase I. Phase III: Weeks 10 through 12 Continue to reduce the number of daily puffs so that by Week 12 subjects are using no more than 4 sprays per day. Once subjects have reduced the number of sprays per day to 2-4, use of the oral mucosal spray should be discontinued. Example: If you smoke an average of 15 cigarettes per day, you should take 1-2 puffs at least 15 times throughout the day. As an aid to continuing to quit after Phase III, people can continue to use the oral mucosal spray in situations where they have a strong urge to smoke. You can take one puff in situations where you feel the urge to smoke, and a second puff if the first does not have an effect within a few minutes. No more than four sprays per day should be used during this phase. In general, regular use of the oral spray for more than 6 months is not recommended. Some former smokers may require longer treatment with the oral spray to avoid relapse. Any remaining oral spray should be saved for use in case of sudden cravings. Children and adolescents: Do not give Nicorettemist to anyone under 18 years of age. There is no experience with the use of Nicorettemist in adolescents under 18 years of age. Directions for use: After preparation, point the spray nozzle as close to the mouth as possible. Press the top of the dispenser and release the spray into the mouth, avoiding the lips. Subjects should not inhale during dispensing to prevent the spray from entering the respiratory tract. For best results, do not swallow for several seconds after dispensing. Subjects should not eat or drink while taking the oral spray. Support and behavioural therapy usually increase the likelihood of success. Contraindications: Hypersensitivity to nicotine or any of the excipients. Children under 18 years of age. Subjects who have never smoked.
Warnings
Nicorettemist should not be used by non-smokers. Dependent smokers with a history of recent myocardial infarction, unstable or exacerbated angina including Prinzmetal’s angina, serious cardiac arrhythmias, uncontrolled hypertension or recent cerebrovascular accident should be advised to quit smoking using non-pharmacological interventions (e.g. counselling). If the latter is ineffective, an oromucosal spray may be considered, but as safety data in this patient group are limited, treatment should only be initiated under close medical supervision. Patients with diabetes mellitus should be advised to monitor their blood glucose levels more closely than usual if they stop smoking and start NRT, as the reduction in nicotine-induced catecholamine release may affect carbohydrate metabolism. Allergic reactions: predisposition to angioedema and urticaria.”
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