Nicorette Fresh Fruit Chewing Gum, 2 mg 30pcs

Pharmacodynamics:

After abrupt smoking cessation in patients who have used tobacco-containing products daily for a long time, withdrawal syndrome may develop, which includes: dysphoria, insomnia, increased irritability, anxiety, impaired concentration, reduced heart rate, increased appetite or weight gain. An important symptom of withdrawal syndrome is also a desire to smoke.

In the treatment of tobacco addiction nicotine replacement therapy reduces the number of cigarettes smoked, reduces the severity of withdrawal symptoms arising from complete cessation of smoking in those who decided to quit smoking; facilitates temporary abstinence from smoking and also helps to reduce the number of cigarettes smoked by those who can not or do not want to give up smoking completely.

Pharmacokinetics:

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

The distribution volume of nicotine during intravenous administration is about 2-3 liters/kg, and the half-life is about 2 hours. Nicotine is mainly excreted by the liver, its average plasma clearance is about 70 l/h. Nicotine is also metabolized in the kidneys and lungs. More than 20 nicotine metabolites have been identified that are inferior to it in activity.

The binding of nicotine to plasma proteins is less than 5%.
Primary metabolite of nicotine in plasma – cotinine – has a half-life of 15-20 hours, and its concentration is 10 times higher than that of nicotine.

Urinary excretion is primarily cotinine (15% of the dose) and trans-3-hydroxy-cotinine (45% of the dose). Between 10% and 30% of the dose of nicotine is excreted unchanged in the urine.

Progressive deterioration of renal function is accompanied by a decrease in total clearance of nicotine. Its pharmacokinetics does not change in cirrhotic patients with mild impairment of liver function (Child-Pugh index 5) and decreases in cirrhotic patients with moderate impairment of liver function (Child-Pugh index 7). Smokers treated with hemodialysis have increased plasma nicotine concentrations.

Elderly patients have a slight decrease in total nicotine clearance, which does not require dose adjustment.

Indications

Active ingredient

Composition

1 medicinal chewing gum contains:

The active ingredient:

nicotine-polymer complex – 11 mg (the indicated amount is equivalent to 2.2 mg of nicotine, including 10% excess).

Excipients:

Chewing gum medicinal core: chewing gum (base)* – 560 mg, xylitol – 314 mg, peppermint oil – 30 mg, sodium carbonate – 20 mg, sodium hydrocarbonate – 10 mg, acesulfame potassium – 2 mg, levomenthol – 2 mg, magnesium oxide – 1 mg;

Chewing gum shell: xylitol – 294 mg, peppermint oil – 9 mg, Arabian gum – 9 mg, titanium dioxide – 7 mg, carnauba wax – 1 mg.

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

How to take, the dosage

Interaction

Special Instructions

Synopsis

Contraindications

Side effects

Overdose

Pregnancy use

Smoking during pregnancy is associated with risks such as delayed intrauterine development, premature birth or stillbirth. Quitting smoking is the single most effective intervention to improve the health of both the pregnant woman and her baby.

Early smoking cessation is the best option.

Nicotine penetrates the placenta and is excreted with the woman’s milk, so its use may pose a risk to the fetus or baby.

Patients should be informed to attempt smoking cessation without nicotine replacement therapy. If such attempts are unsuccessful, the decision to undergo therapy is made after weighing the possible positive effect on the mother against the potential harm to the fetus.

Nicotine passes in small amounts into breast milk even when taken in therapeutic doses, which may have adverse effects on the baby when the drug is taken by a nursing mother. That is why you should refrain from using Nicorette® chewing gum while breastfeeding.

If you can not give up smoking, the drug should be started only after consulting your doctor. In order to reduce the negative effects of nicotine on the baby nicorette® chewing gum should be used immediately after feeding.

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