Nicorette Icy Mint Gum

Nicorette Icy Mint Gum

nicotine

Manufacturer:

Johnson & Johnson

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Nicotine.
Description
Excipients/Inactive Ingredients: Nicorette Icy Mint 2 mg Gum Nicotine (as Resinate): Chewing gum base, levomenthol, acesulfame potassium, talc, magnesium oxide (light), xylitol, peppermint oil, sodium carbonate anhydrous, sodium hydrogen carbonate.
Nicorette Icy Mint 4 mg Gum Nicotine (as Resinate): Chewing gum base, xylitol, levomenthol, quinolone yellow E104 Al-lake, acesulfame potassium, magnesium oxide (light), peppermint oil, sodium carbonate anhydrous, and talc.
Action
Pharmacotherapeutic Group: Drug used in nicotine dependence. ATC Code: N07BA01.
Pharmacology: Pharmacodynamics: Abruptly interrupted use of tobacco products after a long period of daily use may give characteristic withdrawal symptoms comprising four or more of the following: Dysphoria or depressed mood; insomnia; irritability, frustration or aggression; anxiety; difficulty concentrating, restlessness or impatience; decreased heart rate, increased appetite or increase weight. Urge to smoke is recognized as a clinically relevant symptom, and is an important part of the withdrawal symptoms when giving up smoking.
Clinical studies have shown that nicotine replacement products can help smokers abstain from or reduce their smoking by relieving these withdrawals symptoms.
Pharmacokinetics: The amount of nicotine absorbed from a piece of nicotine chewing gum depends on the quantity of nicotine that is released into the oral cavity and the amount that is lost via swallowing. The greater part of nicotine that is released is absorbed through the oral mucosa. The systemic bioavailability of swallowed nicotine is lower because of first-passage elimination. The high and rapidly rising nicotine concentrations that are seen with smoking are seldom reached with treatment with chewing gum.
In normal case, approximately nicotine 1.4 mg is released from a 2 mg piece of chewing gum and approximately nicotine 3.4 mg from a 4 mg piece of chewing gum. Maximum blood concentration is achieved after 30 minutes of chewing and is then comparable to the concentration 20-30 min after smoking a cigarette of medium strength. The volume of distribution after intravenous administration of nicotine is around 2 to 3 L/kg and the half-life is approximately 2-3 hours. Nicotine is metabolized in the liver, kidney and lungs. More than 20 metabolites have been identified, of which all are believed to be less active than nicotine. The main metabolite is cotinine, which has a half-life of 14-20 hours and concentrations that exceed nicotine by 10-fold. The plasma protein-binding of nicotine is less than 5%.
Other diseases or concomitant use of other drugs which affect the level of plasma proteins are not expected to have a significant effect on the nicotine kinetics. The main metabolites in urine are cotinine (10-12% of the dose) and trans-3-hydroxy cotinine (28-37% of the dose). Approximately 10-15% of the nicotine is excreted unchanged with the urine. Up to 23% may be excreted with the urine via increased diuresis and acidification of the urine below pH 5.
Greatly impaired renal function is assumed to affect total clearance of nicotine. Elevated nicotine levels have been seen in smoking subjects undergoing haemodialysis.
The pharmacokinetics of nicotine are unaffected in liver cirrhosis patients with mild impairment of liver function (Child-Pugh score 5) and reduced by about 40-50% in liver cirrhosis patients with moderate impairment of liver function (Child-Pugh score 7).
A smaller reduction in total clearance of nicotine has been shown in healthy elderly users, however, not justifying adjustment of the dose.
No difference in nicotine kinetics has been observed between men and women.
Indications/Uses
Nicorette is used for the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms. Facilitating smoking cessation in smokers motivated to quit.
As an aid to reduce smoking [Nicotine Assisted Reduction to Stop (NARS)].
Dosage/Direction for Use
Stop smoking completely at the same time in order to increase your chances of success.
Regular use beyond 12 months is generally not recommended.
Adults: The initial dosage should be individualized on the basis of the smoker's nicotine dependence. The Nicorette chewing gum 4 mg is recommended for smokers who are highly dependent (for example smoking 20 cigarettes or more per day or smoking the first cigarette in the morning 30 minutes or less after waking up). Other smokers should begin treatment with the 2 mg dosage strength.
The Nicorette chewing gum should be used when cigarettes normally would have been smoked or if cravings emerge. Sufficient Nicorette chewing gum should be used each day. In order to maximize the chances of success it is important not to under dose. The dosage should be individualized on the basis of the smoker's nicotine dependence.
Dosing Regime: 8 to 12 Nicorette chewing gum per day, for at least 3 months. Do not exceed 24 gums per day. Smokers should stop smoking completely during the course of treatment with Nicorette chewing gum.
Gradual tapering from the Nicorette chewing gum should then be initiated. Treatment should be stopped when the dose is reduced to Nicorette 1 to 2 Nicorette chewing gum per day.
Each piece of Nicorette chewing gum should be chewed slowly for approximately 30 mins, with pauses. The gum should be chewed until a strong taste or mild burning sensation is experienced, then rested between the cheek and gums until the taste and/or sensation have disappeared, then chew again slowly and repeat.
Children and Adolecents: Nicorette chewing gum should not be administered to a person under 18 years of age with recommendation from healthcare professional.
Combination Therapy: Highly dependent smokers, smokers who experience "breakthrough" cravings or those who have failed with single NRT treatment, can use a flexible smoking cessation format in combination with the patch for fast relief of cravings.
Overdosage
Symptoms of overdosage with nicotine may occur if patient has low nicotine consumption before the treatment or uses other sources of nicotine at the same time.
The symptoms of overdosage are the same as the symptoms of acute nicotine poisoning such as nausea, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, disturbed hearing and prostration. At high doses, these symptoms may be accompanied by low blood pressure, weak and irregular pulse, breathing difficulties, exhaustion, circulatory collapse and general convulsions.
Nicotine doses that are tolerated by adult smokers during treatment may cause serious symptoms of poisoning in young children which may have fatal outcome. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.
Treatment: All administration of nicotine is stopped immediately and the patient should be treated for the symptoms. If excessive amount of nicotine is swallowed, activated charcoal reduces the absorption of nicotine in the gastrointestinal canal.
Contraindications
Hypersensitivity to nicotine or any excipients in the chewing gum.
Special Precautions
The chewing gum may adhere to and in rare cases damage, dentures and dental bridges.
Nicorette chewing gum should only be used after consulting a physician by certain cardiovascular patient groups: Those who have experienced a serious cardiovascular event, or hospitalization for a cardiovascular complaint, in the previous 4 weeks (e.g. stroke, myocardial infarction, unstable angina, cardiac arrhythmia, coronary artery by-pass graft and angioplasty) or where they suffer with uncontrolled hypertension.
Nicorette chewing gum should be used with caution in patients with severe/moderate hepatic impairment, severe renal impairment, active duodenal and gastric ulcer, inflammation of the stomach and inflammation of the esophagus.
Nicotine, both from nicotine medications and from smoking, causes release of catecholamines from the adrenal medulla. Therefore, Nicorette chewing gum should also be used with caution by patients with hyperthyroidism or phaeochromocytoma.
Patients with diabetes mellitus may need lower level doses of insulin as a result of smoking cessation.
Nicotine dependence may continue but at a lower level. However, use of pure nicotine is less harmful than tobacco.
Use In Pregnancy & Lactation
Use in Pregnancy: Nicotine passes to the fetus and affects its breathing movements and circulation. The effect on the circulation is dose-dependent. Pregnant smoker should therefore always be recommended to give up smoking without using nicotine substitute at all. The risk of continued smoking may however constitute a greater hazard to the fetus than use of nicotine substitution preparations within the framework of a smoking cessation program. Nicorette chewing gum should not be used by pregnant patients other than where there is a high level of nicotine dependence and on physician's advice.
Use in Lactation: Nicotine passes into breastmilk in small quantities that may affect the infant, even at therapeutic doses. Nicorette chewing gum should therefore be avoided when breastfeeding.
Side Effects
Most of the undesirable effects reported by the subjects occur during the early phase of treatment and are mainly dose-dependent.
Irritation in the mouth and throat may be experienced, however most subjects adapt to this with ongoing use.
Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of Nicorette chewing gum.
As would be expected, the types of adverse reactions seen for the chewing gum in clinical trials are similar to those associated with nicotine administered by other means.
Clinical Trial Data: The safety of nicotine from clinical trial data is based on data on a meta-analysis of randomized clinical trials (RCTs) for the treatment of smoking cessation.
ADRs with oral formulations identified from clinical trials are presented in Table 1. (See Table 1).

Click on icon to see table/diagram/image

Post-Marketing Data: Undesirable drug reactions first identified during post-marketing experience with nicotine are presented in Table 2 (see Table 2). Frequencies are provided according to the following convention: Very common ≥1/10; common ≥1/100 and <1/10; uncommon ≥1/1,000 and <1/100; rare ≥1/10,000 and <1/1,000; very rare <1/10,000; not known (cannot be estimated from the available data). (See Table 2).

Click on icon to see table/diagram/image
 
Undesirable effects that may arise from combination treatment (chewing gum and patch) differ from each treatment alone only with regards to local undesirable effects that may be attributed to pharmaceutical form. The frequency of these adverse effects is comparable with that given in the summary of product characteristics for the respective product.
Drug Interactions
Smoking (but not nicotine) is associated with increased activity of CYP1A2. After giving up smoking, clearance of certain medications which are metabolized via CYP1A2 may be reduced. This may lead to increased plasma levels of certain medications. The increase may be of clinical significance for products with narrow therapeutic windows e.g. theophylline, tacrine, clozapine or ropinirole.
Plasma level of other medications which are in part metabolized via CYP1A2 e.g. imipramine, olanzapine, clomipramine and fluvoxamine, might also rise after stop smoking. There are no data supporting this however, and the possible clinical significance of this effect on these medications is unknown.
Limited data indicates that the metabolism of flecainide and pentazocine might also be capable of being induced by smoking.
Storage
Do not store above 30°C. Protect from light.
ATC Classification
N07BA01 - nicotine ; Belongs to the class of drugs used in the management of nicotine dependence.
Presentation/Packing
Chewing gum 2 mg (white coloured coated square, with a size of about 15 x 15 x 6 mm) x 105's. 4 mg (creme coloured coated, sized of about 15 x 15 x 6 mm) x 105's.
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