Nicotine Polacrilex 4mg 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 stop smoking by giving your body a small, controlled amount of nicotine. This helps reduce the cravings and withdrawal symptoms you get when you stop smoking. It's designed to be chewed slowly and 'parked' between your cheek and gum to allow the nicotine to be absorbed.
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 when you typically smoke your first cigarette of the day. If you smoke your first cigarette within 30 minutes of waking up, you will use one dose; if you smoke your first cigarette more than 30 minutes after waking up, you will use the other dose. 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 or peppery taste, place the gum between your cheek and gum.
4. After the taste or tingling sensation has disappeared, chew the gum slowly again.
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.
Important Usage Guidelines
Avoid eating or drinking within 15 minutes before using the gum or while you are using it.
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
Store the gum at room temperature, protected from light.
After using the gum, wrap it in paper before disposing of it.
Missing a Dose
If you miss a dose, use it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* 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 when you typically smoke your first cigarette of the day. If you smoke your first cigarette within 30 minutes of waking up, you will use one dose; if you smoke your first cigarette more than 30 minutes after waking up, you will use the other dose. 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 or peppery taste, place the gum between your cheek and gum.
4. After the taste or tingling sensation has disappeared, chew the gum slowly again.
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.
Important Usage Guidelines
Avoid eating or drinking within 15 minutes before using the gum or while you are using it.
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
Store the gum at room temperature, protected from light.
After using the gum, wrap it in paper before disposing of it.
Missing a Dose
If you miss a dose, use it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Do not smoke, chew tobacco, or use other nicotine products while using nicotine gum.
- Avoid eating or drinking anything (especially acidic beverages like coffee, soda, or juice) for 15 minutes before and during chewing the gum, as this can reduce nicotine absorption.
- Chew the gum slowly until you feel a tingling sensation, then 'park' it between your cheek and gum. When the tingling fades, chew again until it returns, then park it again. Repeat this for about 30 minutes.
- Follow the dosing schedule carefully and gradually reduce the number of pieces you use over time.
- Combine gum use with behavioral support and counseling for best results.
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:
One 4mg piece of gum every 1-2 hours for the first 6 weeks, then gradually reduce frequency.
Dose Range:
9 - 24 mg
Condition-Specific Dosing:
initial_use:
Use 4mg gum if you smoke your first cigarette within 30 minutes of waking.
maximum_dose:
Do not exceed 24 pieces of gum per day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (not recommended for individuals under 18 years of age)
Adolescent:
Not established (not recommended for individuals under 18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution due to potential for reduced clearance.
Dialysis:
Not available, use with caution.
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution due to potential for reduced clearance.
Confidence:
Medium
Pharmacology
Mechanism of Action
Nicotine acts as an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems. In the context of smoking cessation, it replaces the nicotine from tobacco, reducing withdrawal symptoms and cravings associated with nicotine dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-70% (buccal absorption, highly variable)
Tmax:
15-30 minutes (after chewing)
FoodEffect:
Acidic beverages (e.g., coffee, soda, fruit juice) can decrease buccal absorption of nicotine. Avoid eating or drinking for 15 minutes before and during chewing.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
Less than 5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2 hours (nicotine), 15-19 hours (cotinine)
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (pH-dependent, increased with acidic urine)
Unchanged:
Approximately 10-20% (dependent on urine pH)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Varies, but effects diminish as nicotine is absorbed and metabolized.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Abnormal sensations, such as burning, numbness, or tingling
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, contact your doctor for advice:
Trouble sleeping
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Mouth tingling
* Gum changes
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to 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 notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Abnormal sensations, such as burning, numbness, or tingling
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, contact your doctor for advice:
Trouble sleeping
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Mouth tingling
* Gum changes
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to 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
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your use of tobacco products, such as smoking, chewing tobacco, or using nicotine-containing products, while taking 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 crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems 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 dose of any medication without first consulting your doctor.
It is essential 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your use of tobacco products, such as smoking, chewing tobacco, or using nicotine-containing products, while taking 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 crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems 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 dose 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.
To minimize the risk of adverse effects, do not exceed the recommended dosage. Taking more than the prescribed amount can lead to unsafe side effects. If you are currently using 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, 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 activities that require your full attention. Additionally, be aware that quitting smoking can impact 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 can potentially cause problems with dental work, such as loose teeth or dental implants.
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. It is also critical to keep this medication out of reach of children and pets, as it can be harmful or even fatal if ingested. 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. Furthermore, if you are pregnant or become pregnant while taking this medication, notify your doctor promptly, as it may pose a risk to the unborn baby. If you are breastfeeding, discuss any potential risks to your baby with your doctor.
To minimize the risk of adverse effects, do not exceed the recommended dosage. Taking more than the prescribed amount can lead to unsafe side effects. If you are currently using 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, 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 activities that require your full attention. Additionally, be aware that quitting smoking can impact 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 can potentially cause problems with dental work, such as loose teeth or dental implants.
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. It is also critical to keep this medication out of reach of children and pets, as it can be harmful or even fatal if ingested. 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. Furthermore, if you are pregnant or become pregnant while taking this medication, notify your doctor promptly, as it may pose a risk to the unborn baby. If you are breastfeeding, discuss any potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Weakness
- Rapid heartbeat
- Sweating
- Salivation
- Headache
- Confusion
- Seizures (severe cases)
What to Do:
If you suspect an overdose, seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Beta-blockers (nicotine may reduce the hypotensive effects of beta-blockers)
- Insulin (smoking cessation with NRT may increase insulin absorption or reduce insulin resistance, requiring dose adjustment)
- Adrenergic agonists (e.g., phenylephrine, isoproterenol - nicotine may potentiate cardiovascular effects)
- Adrenergic antagonists (e.g., prazosin, labetalol - nicotine may reduce their effects)
Monitoring
Baseline Monitoring
Smoking status and history
Rationale: To determine appropriate nicotine gum strength and duration of therapy.
Timing: Prior to initiation of therapy.
Cardiovascular history (e.g., recent MI, unstable angina, severe arrhythmias)
Rationale: Nicotine can have cardiovascular effects; NRT should be used with caution or avoided in certain conditions.
Timing: Prior to initiation of therapy.
Dental health
Rationale: Gum can stick to dentures, bridges, or dental fillings.
Timing: Prior to initiation of therapy.
Routine Monitoring
Smoking cessation progress
Frequency: Regularly (e.g., weekly for first few weeks, then monthly)
Target: Complete abstinence from tobacco products
Action Threshold: Continued smoking or relapse may require re-evaluation of therapy or counseling.
Adherence to gum chewing instructions
Frequency: Regularly (e.g., at follow-up visits)
Target: Proper 'chew and park' technique, appropriate frequency
Action Threshold: Improper use can lead to inadequate nicotine delivery or excessive side effects.
Side effects (e.g., nausea, hiccups, jaw soreness, dyspepsia)
Frequency: Regularly (e.g., at follow-up visits)
Target: Minimal or tolerable side effects
Action Threshold: Persistent or severe side effects may require dose adjustment, change in product, or discontinuation.
Symptom Monitoring
- Nausea
- Hiccups
- Jaw soreness
- Dyspepsia
- Dizziness
- Headache
- Palpitations
- Throat irritation
- Mouth sores
Special Patient Groups
Pregnancy
Nicotine gum is Pregnancy Category D. While nicotine itself is harmful to the fetus, the risks of continued smoking during pregnancy are significantly higher than the risks of nicotine replacement therapy (NRT). NRT should be considered only if the pregnant woman is unable to quit smoking without it, and under medical supervision. Non-pharmacological methods are preferred first-line.
Trimester-Specific Risks:
First Trimester:
Nicotine exposure can lead to vasoconstriction, reduced placental blood flow, and potential for congenital anomalies.
Second Trimester:
Continued exposure can impact fetal growth and development, increasing risks of preterm birth and low birth weight.
Third Trimester:
Increased risk of preterm birth, stillbirth, and adverse neurodevelopmental outcomes. Nicotine can affect fetal breathing movements and heart rate.
Lactation
Nicotine passes into breast milk. While NRT delivers less nicotine than smoking, it's still present. If NRT is used, it's preferable to use short-acting forms like gum immediately after breastfeeding to minimize infant exposure. Pumping and discarding milk after NRT use is not practical. The decision to use NRT during lactation should weigh the benefits of smoking cessation for the mother and infant against the risks of nicotine exposure.
Infant Risk:
L3 (Moderate risk). Potential for infant irritability, sleep disturbances, and cardiovascular effects. However, the risks of maternal smoking to the infant are far greater than the risks of nicotine from NRT.
Pediatric Use
Not recommended for individuals under 18 years of age. Safety and efficacy have not been established in this population for smoking cessation.
Geriatric Use
Use with caution in elderly patients, especially those with underlying cardiovascular disease. No specific dose adjustment is typically required, but monitor for adverse effects.
Clinical Information
Clinical Pearls
- Nicotine gum is a short-acting NRT, providing rapid relief from cravings. It's particularly useful for managing acute cravings.
- Proper chewing technique ('chew and park') is crucial for effective nicotine absorption and to minimize side effects like hiccups or dyspepsia.
- Patients should be advised to avoid acidic beverages (e.g., coffee, soda, juice) for 15 minutes before and during gum use, as they can impair nicotine absorption.
- Encourage patients to use the gum regularly, not just when cravings are severe, especially during the initial weeks of quitting.
- Combining nicotine gum with a long-acting NRT (e.g., patch) can be more effective for some individuals with high nicotine dependence.
- The gum can stick to dental work (fillings, bridges, dentures); advise patients to be cautious.
Alternative Therapies
- Nicotine patch
- Nicotine lozenge
- Nicotine inhaler
- Nicotine nasal spray
- Bupropion SR (Zyban, Wellbutrin SR)
- Varenicline (Chantix)
- Behavioral counseling and support programs
Cost & Coverage
Average Cost:
$20 - $60 per 100-110 pieces
Generic Available:
Yes
Insurance Coverage:
Often OTC, may be covered by some prescription drug plans or health savings accounts (HSAs)/flexible spending accounts (FSAs).
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.