Nicotine Polacrilex 2mg Chewing Gum
It is used to treat nicotine withdrawal.It is used to curb the craving to smoke.
Drug Class
Smoking Cessation Aid
Pharmacologic Class
Nicotinic Acetylcholine Receptor Agonist
Pregnancy Category
Category D
FDA Approved
Jan 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine gum is a medicine that helps you quit smoking by giving your body a small amount of nicotine, which reduces cravings and withdrawal symptoms. It's designed to be chewed slowly and parked between your cheek and gum, allowing the nicotine to be absorbed through your mouth.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all the information provided. This product is available in two different doses, which are determined by how soon you smoke your first cigarette after waking up. If you're unsure about which dose to use, consult your pharmacist or doctor.
Using the Gum
1. Use the gum immediately after opening the package.
2. Do not swallow the gum. Instead, chew it slowly until you experience a tingling or peppery taste in your mouth.
3. Once you feel the tingling sensation, place the gum between your cheek and gum.
4. After the taste or tingling sensation subsides, chew the gum again slowly.
5. Move the gum to a different location between your cheek and gum when the taste or tingling returns. Repeat this process for about 30 minutes or until the taste or tingling is gone.
6. Avoid eating or drinking within 15 minutes before using the gum or while you're using it.
7. If needed, you can use a second piece of gum within an hour. However, do not use two pieces of gum back-to-back.
Storing and Disposing of Your Medication
1. Store the gum at room temperature, protected from light.
2. After using the gum, wrap it in paper before disposing of it.
What to Do If You Miss a Dose
1. If you miss a dose, use it as soon as you remember.
2. If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
3. Do not use two doses at the same time or take extra doses.
To use this medication effectively, follow your doctor's instructions and read all the information provided. This product is available in two different doses, which are determined by how soon you smoke your first cigarette after waking up. If you're unsure about which dose to use, consult your pharmacist or doctor.
Using the Gum
1. Use the gum immediately after opening the package.
2. Do not swallow the gum. Instead, chew it slowly until you experience a tingling or peppery taste in your mouth.
3. Once you feel the tingling sensation, place the gum between your cheek and gum.
4. After the taste or tingling sensation subsides, chew the gum again slowly.
5. Move the gum to a different location between your cheek and gum when the taste or tingling returns. Repeat this process for about 30 minutes or until the taste or tingling is gone.
6. Avoid eating or drinking within 15 minutes before using the gum or while you're using it.
7. If needed, you can use a second piece of gum within an hour. However, do not use two pieces of gum back-to-back.
Storing and Disposing of Your Medication
1. Store the gum at room temperature, protected from light.
2. After using the gum, wrap it in paper before disposing of it.
What to Do If You Miss a Dose
1. If you miss a dose, use it as soon as you remember.
2. If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
3. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Set a quit date and stick to it.
- Identify and avoid smoking triggers (e.g., certain places, people, activities).
- Develop coping strategies for cravings (e.g., deep breathing, distraction, exercise).
- Seek behavioral support (e.g., counseling, support groups, quitlines) to increase your chances of success.
- Avoid eating or drinking anything (except water) for 15 minutes before and during chewing the gum, as acidic beverages can reduce nicotine absorption.
- Do not chew the gum like regular chewing gum; chew slowly until you feel a tingle, then 'park' it between your cheek and gum until the tingle fades, then repeat. This allows for proper nicotine absorption and reduces side effects.
Available Forms & Alternatives
Available Strengths:
- Nicotine Gum 2mg Mint Refill 50's
- Nicotine Gum 4mg Starter Kit 110's
- Nicotine Polacr 4mg Mint Gum 40's
- Nicotine Polacr 4mg Mintgum 100s
- Nicotine Polacr 2mg Gum 40's
- Nicotine Pol 2mg Mint Gum 100s
- Nicotine Polacr 4mg Cinn Gum 100's
- Nicotine Polacr 4mg Orig Gum 50's
- Nicotine Polacr 2mg Gum Orig 50s
- Nicotine Pol 2mg Original Gum
- Nicotine Polacr 4mg Mint Loz 72's
- Nicotine Polacrilex 4mg Gum 100's
- Nicotine Pol 4mg Orig Gum
- Nicotine TD 7mg/24h Patch 14s
- Nicotine Polacrilex 4mg Chewing Gum
- Nicotine Polacrilex 2mg Chewing Gum
- Nicotine 14mg/24h Patch 14s
- Nicotine 21mg/24h Patch 28s
- Nicotine 21mg/24h Patch 14s
- Nicotine TD 21mg/24h Patch 7s
- Nicotine TD 14mg/24h Patch 7s
- Nicotine SF 2mg Cinn Gum 100's
- Nicotine Lozenge 4mg Mint
- Nicotine 2mg Original Gum 20s
- Nicotine 2mg Mint Lozenge 81s
- Nicotine 4mg Mint Gum 110s
- Nicotine 4mg Mint Gum 20s
- Nicotine TD 7mg/24h Patch 7s
- Nicotine 2mg SF Fruit Gum 100s
- Nicotine TD 21mg/24h Patch 14s
- Nicotine Pol 4mg Mint Lozenges
- Nicotine TD 14mg/24h Patch 28's
- Nicotine Pol 2mg Mint Loz 72s
- Nicotine Polacr 4mg Mint Loz 72s
- Nicotine Pol 2mg Mint Gum 110s
- Nicotine 2mg Mini Mint Loz 72s
- Nicotine 4mg Mini Mint Loz 72s
- Nicotine Pol 4mg Mint Gum
- Nicotine Mini Mint 2mg Loz 81s
Dosing & Administration
Adult Dosing
Standard Dose:
For those who smoke their first cigarette more than 30 minutes after waking: 2 mg gum. Chew one piece every 1 to 2 hours for the first 6 weeks, then one piece every 2 to 4 hours for weeks 7-9, then one piece every 4 to 8 hours for weeks 10-12. Do not exceed 24 pieces per day.
Condition-Specific Dosing:
heavySmokers:
For those who smoke their first cigarette within 30 minutes of waking, the 4 mg gum is typically recommended. However, if using 2 mg, the frequency might be at the higher end of the range.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Not for use in individuals under 18 years of age)
Adolescent:
Not established (Not for use in individuals under 18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution. Monitor for increased side effects.
Severe:
No specific dose adjustment recommended, but use with caution. Monitor for increased side effects.
Dialysis:
Use with caution. Nicotine is dialyzable, but clinical significance for gum is low due to slow absorption.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution. Monitor for increased side effects.
Severe:
No specific dose adjustment recommended, but use with caution. Monitor for increased side effects.
Pharmacology
Mechanism of Action
Nicotine, an agonist at nicotinic acetylcholine receptors, replaces the nicotine from tobacco products, thereby reducing the severity of nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) and the urge to smoke. It acts on the central nervous system to produce its reinforcing effects.
Pharmacokinetics
Absorption:
Bioavailability:
50-70% (buccal absorption, highly variable)
Tmax:
15-30 minutes (after chewing a single piece)
FoodEffect:
Acidic beverages (e.g., coffee, soda, fruit juice) can decrease buccal absorption of nicotine. Avoid eating or drinking (except water) for 15 minutes before and during chewing.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
Less than 5%
CnssPenetration:
Yes
Elimination:
HalfLife:
1-2 hours (nicotine); 15-20 hours (cotinine)
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (primarily), also via bile and saliva
Unchanged:
10-20% (nicotine)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Effects on withdrawal symptoms can last for several hours, but the pharmacokinetic half-life is short.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Mood changes
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
Burning, numbness, or tingling sensations that are not normal
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
Drooling
Shakiness
Sore throat
Mouth, teeth, or jaw problems
Cold sweats
Blurred vision
Changes in hearing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Trouble sleeping
Bad dreams
Feeling nervous and excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Mouth tingling
* Gum changes
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Mood changes
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
Burning, numbness, or tingling sensations that are not normal
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
Drooling
Shakiness
Sore throat
Mouth, teeth, or jaw problems
Cold sweats
Blurred vision
Changes in hearing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Trouble sleeping
Bad dreams
Feeling nervous and excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Mouth tingling
* Gum changes
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe nausea or vomiting
- Dizziness or lightheadedness
- Weakness
- Rapid or irregular heartbeat
- Seizures
- Difficulty breathing
- Chest pain
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your tobacco use, including smoking, chewing tobacco, or using nicotine products, as these may interact with this medication.
If you have temporomandibular joint (TMJ) disease.
* If you are under 18 years of age, as this medication is not recommended for children without consulting a doctor.
This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
It is crucial to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your tobacco use, including smoking, chewing tobacco, or using nicotine products, as these may interact with this medication.
If you have temporomandibular joint (TMJ) disease.
* If you are under 18 years of age, as this medication is not recommended for children without consulting a doctor.
This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To increase your chances of successfully quitting smoking, consider seeking counseling to help you overcome nicotine addiction.
Do not exceed the recommended dosage, as this may lead to severe and potentially life-threatening side effects. If you are currently taking another medication to aid in smoking cessation, be sure to notify your doctor.
When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary widely, so it is crucial to report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in any activities that require your full attention. Additionally, be aware that quitting smoking may alter the effectiveness of other medications you are taking, so consult with your doctor to discuss any potential interactions.
If you have not been able to quit smoking after using this medication for the recommended duration, inform your doctor. It is also important to note that chewing gum, such as nicotine gum, may cause problems with dental work, so this should be discussed with your dentist.
If you are following a low-sodium or sodium-free diet, consult with your doctor before using this medication, as some products may contain sodium.
This medication can be highly toxic and even fatal if ingested by children or pets, so it is vital to keep it out of their reach. If a child uses this medication or if it is swallowed by a child or pet, immediately contact a doctor or poison control center.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
For pregnant or breastfeeding women, it is essential to discuss the potential risks with your doctor. If you become pregnant while taking this medication, notify your doctor right away. Breastfeeding women should also consult with their doctor to weigh the benefits and risks of continuing treatment.
Do not exceed the recommended dosage, as this may lead to severe and potentially life-threatening side effects. If you are currently taking another medication to aid in smoking cessation, be sure to notify your doctor.
When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary widely, so it is crucial to report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in any activities that require your full attention. Additionally, be aware that quitting smoking may alter the effectiveness of other medications you are taking, so consult with your doctor to discuss any potential interactions.
If you have not been able to quit smoking after using this medication for the recommended duration, inform your doctor. It is also important to note that chewing gum, such as nicotine gum, may cause problems with dental work, so this should be discussed with your dentist.
If you are following a low-sodium or sodium-free diet, consult with your doctor before using this medication, as some products may contain sodium.
This medication can be highly toxic and even fatal if ingested by children or pets, so it is vital to keep it out of their reach. If a child uses this medication or if it is swallowed by a child or pet, immediately contact a doctor or poison control center.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
For pregnant or breastfeeding women, it is essential to discuss the potential risks with your doctor. If you become pregnant while taking this medication, notify your doctor right away. Breastfeeding women should also consult with their doctor to weigh the benefits and risks of continuing treatment.
Overdose Information
Overdose Symptoms:
- Severe nausea and vomiting
- Diarrhea
- Dizziness
- Weakness
- Cold sweat
- Pale skin
- Headache
- Hearing and vision disturbances
- Confusion
- Fainting
- Rapid or irregular heartbeat
- Low blood pressure
- Seizures
- Respiratory depression
What to Do:
If you suspect an overdose, seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US). Remove any remaining gum from the mouth. Provide supportive care as needed.
Drug Interactions
Moderate Interactions
- Adenosine (increased risk of cardiovascular effects)
- Beta-blockers (may require dose adjustment due to smoking cessation)
- Insulin (may require dose adjustment due to smoking cessation)
- Theophylline (may require dose adjustment due to smoking cessation)
- Caffeine (may require dose adjustment due to smoking cessation)
- Opioid analgesics (e.g., propoxyphene, pentazocine - smoking cessation may alter metabolism)
Monitoring
Baseline Monitoring
Smoking history (number of cigarettes/day, time to first cigarette)
Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and initial dosing schedule.
Timing: Prior to initiation of therapy
Cardiovascular status (history of MI, angina, arrhythmias)
Rationale: Nicotine can have cardiovascular effects; caution is advised in patients with pre-existing cardiovascular disease.
Timing: Prior to initiation of therapy
Dental/oral health assessment
Rationale: Gum can stick to dentures, fillings, or cause jaw pain.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to dosing schedule
Frequency: At each follow-up visit (e.g., weekly for first month, then monthly)
Target: As prescribed, gradually tapering
Action Threshold: Inconsistent use may lead to withdrawal symptoms or treatment failure; counsel on proper use.
Nicotine withdrawal symptoms (e.g., cravings, irritability, anxiety, difficulty concentrating)
Frequency: Daily (patient self-monitoring), at each follow-up visit
Target: Reduction in severity
Action Threshold: Persistent severe symptoms may indicate need for dose adjustment (e.g., higher strength, more frequent use) or adjunctive therapy.
Side effects (e.g., jaw soreness, dyspepsia, nausea, hiccups, headache, dizziness)
Frequency: Daily (patient self-monitoring), at each follow-up visit
Target: Minimal to tolerable
Action Threshold: Persistent or severe side effects may require dose adjustment, change in administration technique, or discontinuation.
Smoking status (abstinence, slips, relapses)
Frequency: At each follow-up visit
Target: Complete abstinence
Action Threshold: Continued smoking while on NRT increases nicotine exposure and risk of adverse effects; counsel on cessation strategies.
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Hiccups
- Jaw soreness
- Dyspepsia
- Throat irritation
- Palpitations
- Insomnia
- Anxiety
Special Patient Groups
Pregnancy
Nicotine is classified as Pregnancy Category D. While nicotine itself is harmful to the fetus (associated with low birth weight, preterm birth, and other adverse outcomes), the risks of continued smoking during pregnancy are significantly higher. Nicotine replacement therapy (NRT) is generally considered a safer alternative to smoking for pregnant women who are unable to quit without pharmacologic aid. The decision to use NRT should be made in consultation with a healthcare provider, weighing the risks of NRT against the risks of continued smoking. Intermittent NRT forms like gum may be preferred over continuous forms like patches to allow for nicotine-free periods.
Trimester-Specific Risks:
First Trimester:
Nicotine exposure in the first trimester is associated with increased risk of congenital anomalies, though the evidence is mixed and often confounded by smoking itself.
Second Trimester:
Continued nicotine exposure can affect fetal growth and development, increasing risk of preterm birth and low birth weight.
Third Trimester:
Continued nicotine exposure can affect fetal lung development and increase the risk of stillbirth and sudden infant death syndrome (SIDS).
Lactation
Nicotine is excreted into breast milk. While NRT delivers less nicotine than smoking, it is still present. The American Academy of Pediatrics considers nicotine to be a drug for which there is evidence of risk to the infant. However, NRT is generally considered safer than continued smoking for the infant. If NRT is used, the lowest effective dose should be chosen, and the mother should breastfeed just before using the gum to minimize infant exposure. Monitoring the infant for signs of nicotine exposure (e.g., irritability, poor feeding, sleep disturbances) is advisable. Intermittent NRT forms like gum are preferred over continuous forms.
Infant Risk:
L3 (Moderately Safe) - Nicotine is present in breast milk, but the benefits of smoking cessation for the mother and infant generally outweigh the risks of NRT. Monitor infant for adverse effects.
Pediatric Use
Nicotine gum is not indicated for use in individuals under 18 years of age. The safety and efficacy have not been established in this population. Nicotine is highly toxic to children, and even small amounts can cause severe poisoning.
Geriatric Use
No specific dose adjustment is generally required for elderly patients. However, use with caution in elderly patients with significant cardiovascular disease or other comorbidities. Monitor for side effects, as elderly patients may be more sensitive to the effects of nicotine.
Clinical Information
Clinical Pearls
- Proper chewing technique is crucial: 'Chew and Park'. Chew slowly until a tingle is felt, then park the gum between the cheek and gum until the tingle fades, then repeat. This maximizes buccal absorption and minimizes gastrointestinal side effects.
- Avoid acidic beverages (e.g., coffee, soda, juice) 15 minutes before and during gum use, as they can significantly reduce nicotine absorption.
- Nicotine gum can stick to dentures or dental work; advise patients to be aware of this.
- The gum is not meant to be swallowed. If swallowed, nicotine absorption is reduced, but it can cause stomach upset.
- Encourage patients to use the gum on a fixed schedule initially (e.g., every 1-2 hours) rather than only when cravings occur, to maintain consistent nicotine levels and prevent withdrawal.
- Combine NRT with behavioral counseling or support programs for the best chance of successful smoking cessation.
- Patients should be advised not to smoke or use other nicotine-containing products while using nicotine gum, as this can lead to nicotine overdose.
Alternative Therapies
- Other Nicotine Replacement Therapies (NRTs): Nicotine patch, nicotine lozenge, nicotine inhaler, nicotine nasal spray.
- Bupropion (Zyban, Wellbutrin SR/XL) - antidepressant with smoking cessation indication.
- Varenicline (Chantix) - partial nicotinic acetylcholine receptor agonist.
- Behavioral counseling and support programs (e.g., quitlines, individual/group therapy) are essential components of any smoking cessation strategy, often used in conjunction with pharmacotherapy.
Cost & Coverage
Average Cost:
$20 - $60 per 100-110 pieces
Generic Available:
Yes
Insurance Coverage:
Often OTC, but some prescription drug plans and Medicaid programs may cover NRT products. Coverage varies by plan.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.