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Helping Patients Quit Smoking With Nicotine Replacement Products

W. Steven Pray, PhD, DPh
Bernhardt Professor, Nonprescription Products and Devices
College of Pharmacy
Southwestern Oklahoma State University
Weatherford, Oklahoma
 

Gabriel E. Pray, PharmD Candidate
College of Pharmacy
Southwestern Oklahoma State University

Weatherford, Oklahoma



2/17/2012


US Pharm
. 2012;37(2):12-15. 

Pharmacists often have the chance to counsel patients who wish to quit smoking and ask about the use of nonprescription products. These products are known to be safe, and with judicious pharmacist counseling, can be used effectively.1-3 

Role of Nonprescription Products

The long-term consequences of smoking are crippling at best and deadly at worst. Non-prescription nicotine replacement products provide a nicotine blood level to minimize withdrawal symptoms while the patient attempts to quit smoking.1 When they are used, patients will not smoke at the usual times (e.g., after meals, following sexual activity). The habit of grabbing a cigarette at the customary times gradually fades, and the absence of withdrawal symptoms facilitates the process. Then when the patient undergoes the recommended tapering regimen, nicotine blood levels also fall until nicotine is cleared from the system. 

The products are only labeled for stopping cigarette smoking.1 They do not carry labeling for other forms of nicotine abuse, such as snuff or smokeless tobacco. Furthermore, these products are only indicated for smoking withdrawal. Patients may ask about use in other situations. The author counseled two such patients. One needed to conduct an 8-hour presentation in a nonsmoking building. Another had a day-long series of flights that would not allow the time to duck into the smoking area due to tight connections. When questioned, both stressed that they planned to continue smoking when their ordeal was over. The author explained that these products are only labeled for those who wish to stop smoking, and advised against their use in those two situations. 

Dosage Forms Available

At the present time, pharmacists can recommend oral products such as nicotine gum (e.g., Nicorette Gum 2 and 4 mg) and lozenges (once trade-named Commit Lozenges, but now known as Nicorette Lozenges and Nicorette Mini Lozenges [2 and 4 mg]), or topical patches (e.g., NicoDerm CQ Steps 1, 2, and 3 or Nicotine Transdermal System Steps 1, 2, and 3).2-4 All are proven safe and effective when used as directed. 

Choosing a Product and Methods of Use

Gum: If the patient wishes to use Nicorette Gum, the initial decision is which strength to purchase. Those smoking more than 25 cigarettes daily should choose the 4-mg Nicorette product, and those smoking less than 25 daily should choose the 2-mg product.2 Products must be used correctly. If patients chew continuously as though it were regular gum, blood levels of nicotine can become excessive. Rather, patients must use a chew-park method. Chew the gum slowly until it tingles, then stop chewing and “park” the gum between the cheek and gingiva. When the tingle abates, chew a few times until it reappears and park the gum again. Repeat the process until you cannot obtain the tingle, which usually occurs in about 30 minutes. Patients should use at least nine pieces per day for the first 6 weeks, but should not use more than 24 pieces daily in any consecutive 24-hour period. If patients have strong cravings, they may use another piece of gum within an hour. However, using one piece after another in rapid succession can cause hiccups, heartburn, nausea, or other problems. 

Lozenge: The appropriate Nicorette Lozenge strength is chosen on the basis of how long a patient can endure before smoking after awakening in the morning.2 If the time period is within 30 minutes, the patient is more heavily addicted and should choose the 4-mg strength to maximize the chances of success. If the person is able to wait more than 30 minutes, success may be possible with the 2-mg product. 

Patients should allow a lozenge to slowly dissolve in the mouth over a 20- to 30-minute period (standard lozenge) or a 10-minute period (mini lozenge). During this time, they should occasionally move the lozenge from side to side, refrain from swallowing saliva, and not chew or swallow the lozenge. They may feel a warm or tingling sensation. Patients are also advised to  
use 8 mini lozenges or 9 standard lozenges daily for the first 6 weeks. They should not use more than 5 lozenges in 6 hours or more than  
20 lozenges in any consecutive 24-hour period. Using more than one lozenge at a time or one after another can cause hiccups, heartburn, nausea, or other problems. 

Patch: The beginning strength of both patches is chosen based on the number of cigarettes smoked. Patients smoking more than 10 cigarettes daily begin with Step 1, and those smoking 10 or fewer daily begin with Step 2.3,4 Patches should be applied to dry, clean, hairless skin, using a different site each day, at the same time each day. Patients should remove the backing from the patch, and immediately press it onto the targeted skin area, holding it in place for 10 seconds to increase adhesion. Patients should wash their hands after applying or removing a patch. They should only wear one patch at a time and should not cut the patch into two or more pieces.

Tapering Regimens

Some patients latch onto these products because they can no longer smoke in their workplace and never taper them, using these replacements indefinitely in lieu of cigarettes. Long-term safety of the products cannot be assured. Instead, patients must follow the labeled directions for tapering their use. Nicorette Gum and Lozenges suggest identical tapering schedules. Patients use one lozenge or piece of gum every 1 to 2 hours during weeks 1 to 6, tapering to one every 2 to 4 hours during weeks 7 to 9, and one every 4 to 8 hours during weeks 10 to 12.2 At the end of 12 weeks, if patients are unable to stop using the lozenge, they should see a physician to explore their options. 

The NicoDerm CQ patch is tapered according to the number of cigarettes the patient smokes. Those who smoke more than 10 cigarettes daily begin with NicoDerm CQ Step 1 (21 mg of nicotine), using it daily during weeks 1 to 6, stepping down to Step 2 (14 mg) during weeks 7 and 8, and ending with Step 3 (7 mg) during weeks 9 and 10.3 Patients who smoke 10 or fewer cigarettes daily begin with Step 2, applying it daily during weeks 1 to 6, and tapering to Step 3 during weeks 7 and 8. 

The Nicotine Transdermal System is tapered in a similar manner to the NicoDerm CQ patch. Patients smoking more than 10 cigarettes daily use Step 1 during weeks 1 to 4, Step 2 during weeks 5 and 6, and Step 3 during weeks 7 and 8.4 Those smoking 10 or less daily use Step 2 during weeks 1 to 6 and Step 3 during weeks 7 and 8. 

General Precautions for All Products

Certain warnings are required on all dosage forms. For instance, labels of all three caution pregnant and breastfeeding women not to use the products unless their health care provider has suggested that they do so.2-4 Some labels explain that smoking can harm the child (one specifically mentions the risk of tachycardia), and that patients should attempt to stop smoking using willpower alone. Some labels also mention that these products are believed to be safer than smoking, but that the risks to the child from use are not fully known. 

All products warn against use if the patient has heart disease, a history of recent heart attack, or irregular heartbeat, explaining that nicotine can increase the heart rate.2-4 They also warn against use by patients with hypertension not controlled by medication, as the products can raise blood pressure. Patients are cautioned to stop use and speak to a physician if they experience irregular heartbeat, palpitations, or symptoms of nicotine overdose (e.g., nausea, vomiting, dizziness, weakness, tachycardia). Products are not to be sold or used by those under the age of 18 years and are not to be placed in a vending machine or offered in any other sales situation where proof of age cannot be verified. Proof of age is required before sale. 

Product-Specific Instructions and Warnings

Nicorette Gum and Lozenges carry labels warning against use if the patient is on a sodium-restricted diet, a warning not found on the mini lozenge or patches.2 Lozenges, mini lozenges, and gum also warn against use if the patient has gastric ulcers or diabetes. Both patches carry a precaution against use if patients are allergic to adhesive tape or have “skin problems,” explaining that those patients are more likely to “get rashes” (i.e., contact dermatitis).3,4 

Both lozenges and gum caution patients not to eat or drink for 15 minutes before use and during use.2 They also advise stopping use and consulting a physician if the patient experiences diarrhea or mouth problems, warnings not found on either patch. Lozenges also advise cessation of use and a physician appointment if the patient experiences persistent headache or severe sore throat, while the gum advises patients to do the same if they experiences problems with the teeth or jaw. Patches advise ceasing use and seeing a physician if patients experience a rash, skin inflammation, or redness caused by the patch that does not abate after 4 days.3,4 

NicoDerm CQ advises patients that they may wear the patch for the entire 24 hours if they awaken with a craving for cigarettes. However, nicotine used during sleep can cause bizarre dreams.3 Both product labels advise users to remove the patch at bedtime if they have vivid dreams or any other sleep disturbances.3,4 

Drug Interaction Warnings

Nicotine replacement products warn the patient either to not use them or to consult with a physician or pharmacist if the purchaser wishes to continue to smoke, chew tobacco, or use any other smoking cessation product at the same time.2-4 Patients should be cautioned against these practices. The label of the Nicotine Transdermal System explains that smoking is prohibited even when not wearing a patch, as nicotine continues to enter the skin for several hours after a patch is removed.4 Both patches also warn against use if the patient is using an antismoking medication that does not contain nicotine (e.g., Chantix [varenicline]). 

Nicotine replacement products also warn against use if the patient is taking medications for depression or asthma, mentioning that the medication may require a dosage adjustment.2-4 

Disposing of Nicotine Replacement Products

All products strongly advise users to take care with disposal. Patients eventually must dispose of used Nicorette Gum and may wish to dispose of Nicorette Lozenges before they are completely dissolved.2 These items may contain sufficient nicotine to make children and pets ill, so manufacturers advise users to wrap the used products in paper and dispose of them in the trash. Patch users are cautioned to fold the sticky ends of the patch together before disposing of them in the disposal tray that is molded into the box.3,4 Products also warn patients to contact a poison control center immediately if unintended ingestion of any dosage form occurs. 

Assistance Programs

Users of the Nicotine Transdermal System are encouraged to enroll in the Habitrol Take Control Support Program.4 Users of lozenges, gum, and NicoDerm CQ can enroll  
in the Committed Quitters program.2,3 Pharmacists should point out the availability of the programs and suggest that patients enroll to take advantage of the professional assistance they can receive. 

PATIENT INFORMATION

The decision to start smoking cigarettes may have been made in response to peer pressure when you were young. Later in life, you may wish to quit for any number of reasons. For instance, your workplace may be smoke free, your family may no longer tolerate smoking in the house, or you may have a serious illness due to smoking (e.g., emphysema, lung cancer). However, you are now fully addicted to nicotine. This addiction is the same type of process as counselors see in those who are addicted to cocaine, heroin, meth, and alcohol. 

You are to be congratulated for trying to stop this addiction. Smoking has no health benefits. It can only harm you, leading to illness and early death if you continue. Stopping smoking can allow your body to cleanse itself of the dangerous toxins you inhale with every cigarette. Quitting “cold turkey” is often doomed to failure unless your willpower is extremely strong. Fortunately, there are nonprescription products that are proven to be safe and effective in helping you stop smoking. 

How Do the Products Work?

All smoking cessation products available without a prescription contain nicotine, available as gum (Nicorette Gum), lozenges (Nicorette Lozenges, Nicorette Mini Lozenges), and patches (NicoDerm CQ, Nicotine Transdermal System). When used as directed, they get some nicotine into your bloodstream. While you use them, you should lose the old habits such as reaching for a cigarette after meals or at other usual times. All of the products are to be tapered and stopped after a period of a few weeks. Many users find that they can then stop smoking. 

Can I Use More Than One Product at a Time?

It may be tempting to try to increase your chances of success by chewing gum or using lozenges while also wearing a nicotine patch. However, this practice can produce nicotine blood levels that are dangerous and must be avoided. For the same reason, you cannot use any form of nicotine while using them, including cigarettes, cigars, and snuff. You should also tell your physician if you are using any of these OTC smoking cessation products because they should not be used along with prescription antismoking medications (e.g., Chantix, nicotine inhaler or nasal spray). 

Use During Pregnancy

Smoking is incredibly dangerous during pregnancy since nicotine can damage the baby and cause problems for the mother as well. It is also potentially harmful if you are breastfeeding, as nicotine can enter breast milk and hurt the child. Thus, you must stop smoking during these periods. However, smoking cessation products are also dangerous at these times. For this reason, you must try to stop smoking using willpower (going cold turkey) or see your physician to explore safer alternatives. 

Read the Labels

You should always read the labels of every OTC product you purchase. However, nicotine is more dangerous than most nonprescription ingredients. For this reason, it is critically important to read and follow every single label on smoking cessation products. If you have any question about safe use of these products, be sure to Consult Your Pharmacist

REFERENCES

1. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
2. Nicorette. GlaxoSmithKline. www.nicorette.com. Accessed December 26, 2011.
3. NicoDerm CQ. GlaxoSmithKline. www.nicodermcq.com. Accessed December 26, 2011.
4. Habitrol Take Control Support Program. Novartis Consumer Health Inc. www.habitrol.com/index.html. Accessed December 26, 2011.
5. Alpert HR, Connolly GN, Biener L. A prospective cohort study challenging the effectiveness of population-based medical intervention for smoking cessation. Tob Control. 2012 Jan 10; Epub ahead of print. http://tobaccocontrol.bmj.com/
content/early/2012/01/03/ tobaccocontrol-2011-050129. abstract. Accessed January 26, 2012. 

To comment on this article, contact rdavidson@uspharmacist.com.

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