AdultPediatricDosage Forms & Strengths gum 2mg 4mg Smoking Cessation Weeks 1-6: 1 piece of gum q1-2hr; ches at least 9 pieces per day during the first 6 weeks to increase chances of quiting Weeks 7-9: 1 piece of gum q2-4hr Weeks 10-12: 1 piece of gum q4-8hr <25 cigarettes/day: Initiate with 2 mg ≥25 cigarettes/day: Initiate with 4 mg For strong/frequent cravings, may use second piece within 1 hourSafety and efficacy not established Frequency Not Defined Increased blood pressure Tachycardia Dizziness Insomnia Irritability Anorexia Dyspepsia Hiccups Increased salivation Indigestion Nausea Vomiting Cough Dental May loosen inlays/fillings Stick to dentures Damage to oral mucosa & teeth Temporal mandibular joint dysfunction and pain with excessive chewing Contraindications Hypersensitivity drug or excipients, including soya Cautions Weigh benefits versus risk in patients with cardiovascular or peripheral vascular disease, including angina pectoris, vasospastic disease, or serious cardiac arrhythmias, hypertension; discontinue use if irregular heartbeat or palpitations occur Monitor for adverse effects and consider dose reduction in hepatic or renal impairment as clearance may be reduced Patient should discontinue use and contact healthcare professional if symptoms of nicotine overdose occur, including dizziness, nausea, vomiting, diarrhea, or rapid heartbeat Poisoning/fatality may occur in children if inhaled, ingested, or buccally absorbed Continuously chewing gum increases nicotine release leading to increased adverse effects (see administration instructions) Stop use if oral blistering occurs If teeth, mouth, or jaw problems occur, discontinue use and talk to healthcare provider May delay healing of esophagitis or active gastric or peptic ulcer disease Use caution in patients with insulin-dependent diabetes Use caution in patients on sodium restricted diet or with history of seizures Use caution in hyperthyroidism or pheochromocytoma Stop use and ask a doctor if symptoms of an allergic reaction occur, such as, difficulty breathing or rash Pregnancy category: D; tobacco smoke known to cause low birth weight, spontaneous abortion, increased perinatal mortality, decreased placental perfusion; however, nicotine replacement is believed to be safer during pregnancy than smoking Lactation: nicotine and metabolite (cotinine) pass into breast milk up to hr after maternal smoking; risk of exposure of infant to 2nd hand smoke may be more detrimental than nicotine replacement; nicotine may increase infant heart rate Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugsPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Transdermal nicotine systemically absorbed; binds to nicotine receptors; reduces withdrawal symptoms, including nicotine craving, associated with smoking cessation Pharmacokinetics Peak Plasma Level: Dependent on chewing vigor and duration Trough Plasma Level: trough serum level 1 hr after smoking 1 cigarette/hr about 2x that of 2 mg gum Elimination Half-Life: 30-120 min Metabolism: Liver via oxidation Excretion: (renal; pH dependent, increased with acidic urine) 10-20% Administration There are no significant safety concerns associated with using more than 1 nonprescription nicotine replacement therapies (OTC NRT) at the same time or at the same time as another nicotine-containing product—including a cigarette Patients using an OTC NRT while trying to quit smoking but slip up and have a cigarette, should not stop using the NRT, but keep using the OTC NRT and keep trying to quit NRT users should still pick a day to quit smoking, and begin using the OTC NRT product on their "quit" day, even if they aren't immediately able to stop smoking It is important for patients to complete the full program, but some patients may need to use the NRT for a longer period of time to keep from smoking Nicotine is bound to an ion exchange resin (polacrilex) and released only during chewing Delay use until at least 15 minutes after consuming food or liquids Concurrent consumption of acidic beverages (eg, coffee, cola) significantly decreases nicotine absorption Instruct patient to not chew nicotine gum as regular gum; begin chewing slowly until feels tingling or peppery taste in mouth; THEN Move gum between to inside cheek (ie, between patient’s teeth & cheek) until tingling subsides Repeat chewing until tingling appears & subsides until tingling doesn’t come back (then that piece of gum is finished) Before using this product, instruct the patient to read the enclosed user's guide for complete directions and other important information To improve the chances of quitting, chew at least 9 pieces/day for the first 6 weeks BRAND FORM. UNIT PRICE PILL IMAGE Nicotrol inhalation- 10 mg solutionNicoderm CQ transdermal- 21 mg/24 hr transdermal systemNicoderm CQ transdermal- 14 mg/24 hr transdermal systemNicoderm CQ transdermal- 21 mg/24 hr transdermal systemNicoderm CQ transdermal- 7 mg/24 hr transdermal systemNicoderm CQ transdermal- 7 mg/24 hr transdermal systemNicoderm CQ transdermal- 21 mg/24 hr transdermal systemnicotine transdermal- 21 mg/24 hr transdermal systemnicotine transdermal- 21 mg/24 hr transdermal systemnicotine transdermal- 21 mg/24 hr transdermal systemnicotine transdermal- 7 mg/24 hr transdermal systemnicotine transdermal- 14 mg/24 hr transdermal systemnicotine transdermal- 21 mg/24 hr transdermal systemnicotine transdermal- 21 mg/24 hr transdermal systemnicotine transdermal- 14 mg/24 hr transdermal systemnicotine transdermal- 21-14-7 mg/24 hr transdermal systemnicotine transdermal- 7 mg/24 hr transdermal systemnicotine transdermal- 7 mg/24 hr transdermal systemnicotine transdermal- 14 mg/24 hr transdermal systemnicotine transdermal- 14 mg/24 hr transdermal systemnicotine transdermal- 21 mg/24 hr transdermal systemnicotine transdermal- 21 mg/24 hr transdermal systemnicotine transdermal- 14 mg/24 hr transdermal systemnicotine transdermal- 7 mg/24 hr transdermal systemnicotine transdermal- 21 mg/24 hr transdermal systemnicotine transdermal- 14 mg/24 hr transdermal systemnicotine transdermal- 7 mg/24 hr transdermal systemnicotine transdermal- 21 mg/24 hr transdermal systemnicotine transdermal- 21 mg/24 hr transdermal systemnicotine transdermal- 14 mg/24 hr transdermal systemnicotine transdermal- 7 mg/24 hr transdermal systemnicotine transdermal- 21 mg/24 hr transdermal systemnicotine transdermal- 21 mg/24 hr transdermal systemNicotrol NS nasal- 10 mg/mL liquidCopyright © 2010 First DataBank, Inc.Select a drug:nicotine inhalationnicotine transdermalnicotine nasalPrint Patient Educationnicotine inhalation NICOTINE INHALER - ORAL INHALATION (NICK-oh-teen) COMMON BRAND NAME(S): Nicotrol USES: This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Using the inhaler can replace the hand-to-mouth habit of smoking.Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer. HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using your nicotine inhaler and each time you get a refill. Follow all the directions for use carefully. If you have any questions, consult your doctor or pharmacist.It is very important to stop smoking completely while using this nicotine product. Insert a cartridge into the mouthpiece and inhale the medication by quickly puffing on the mouthpiece for four 5-minute sessions or continually for about 20 minutes. Although using the inhaler is like smoking a cigarette, you do not need to inhale deeply as you would a cigarette for the medicine to work. The medicine works in the mouth and throat, not in the lungs.Avoid acidic food and drink (such as citrus fruit, coffee, juices, carbonated drinks) for 15 minutes before inhaling this medication.After using the inhaler for a total of 20 minutes, remove the used cartridge and throw it away out of reach of children and pets. The mouthpiece is reusable. Clean with soap and water.When you quit smoking, start using a nicotine cartridge whenever you crave a cigarette. Usually, you will use at least 6 cartridges each day for the first 3 to 6 weeks or as directed by your doctor. Do not use more than 16 cartridges in a day. Your doctor may direct you to use this product on a regular schedule as well as at times when you have the urge to smoke. Regular use can help your body get used to the medication and decrease side effects such as sore throat. The best dose for you is the dose that decreases the urge to smoke without side effects from too much nicotine. Follow your doctor's orders carefully. Your dose will need to be adjusted to your needs, including smoking history and medical condition.After you have stopped smoking and you have reached the best dose and schedule for you, continue at that dose. Usually, after about 3 months, your doctor will help you gradually reduce your dose until you are no longer smoking and no longer need nicotine replacement.If you suddenly stop using this medication, you may have withdrawal symptoms (such as tobacco cravings, nervousness, irritability, headache). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used nicotine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.Tell your doctor if you have not been able to quit smoking after using this product for 4 weeks. Some smokers are unsuccessful the first time they try to quit. You may need to stop using this product and try again later. Many people who cannot quit the first time are successful the next time. SIDE EFFECTS: Headache, nausea, mouth/tooth/throat pain, cough, runny/stuffy nose, change in taste, heartburn, hiccups, sweating, or diarrhea may occur. Common nicotine withdrawal symptoms can occur when you stop smoking and include dizziness, anxiety, depression, or trouble sleeping, among others. If any of these withdrawal symptoms or side effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Serious side effects are more likely if you continue to smoke while using this product. Do not smoke while you are using this medication.Stop using this medication and tell your doctor right away if you have any serious side effects, including: severe dizziness, mental/mood changes (such as irritability, trouble sleeping, vivid dreams), numbness/tingling in hands/feet, swelling hands/ankles/feet.Stop using this medication and get medical help right away if you have any very serious side effects, including: chest pain, confusion, severe headache, fast/irregular/pounding heartbeat, trouble speaking, weakness on one side of the body.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as menthol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel disease (such as Raynaud's disease, stroke), breathing problems (such as asthma, emphysema), diabetes, heart disease (such as chest pain, heart attack, irregular heartbeat), high blood pressure, liver disease, kidney disease, esophagus problems (such as esophagitis), stomach/intestinal sores (peptic ulcers), certain adrenal problem (pheochromocytoma), overactive thyroid (hyperthyroidism), seizures.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Nicotine and smoking may harm an unborn baby. If you