Nicotine Polacrilex 4mg Gum 100's
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 your cravings and withdrawal symptoms. It's chewed like regular gum, but with a special technique to release the nicotine slowly.
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 doses, which are determined by when you have 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 are 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. When the taste or tingling sensation disappears, 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.
6. Avoid eating or drinking within 15 minutes before using the gum or while you are 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
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. However, if it is 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 doses, which are determined by when you have 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 are 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. When the taste or tingling sensation disappears, 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.
6. Avoid eating or drinking within 15 minutes before using the gum or while you are 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
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. However, if it is 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
- Set a quit date and stop smoking completely on that day.
- Use the gum regularly as directed, even if you don't feel a strong craving.
- Avoid acidic beverages (like coffee, soda, juice) 15 minutes before and during chewing, as they can reduce nicotine absorption.
- Do not eat or drink while chewing the gum.
- Proper chewing technique: Chew slowly until you feel a tingle or peppery taste, then 'park' the gum between your cheek and gum. When the tingle fades, chew again and repeat. Continue for about 30 minutes.
- Do not chew too fast or swallow the gum, as this can lead to hiccups, heartburn, or upset stomach.
- Combine with behavioral support programs 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:
For individuals who smoke their first cigarette within 30 minutes of waking: 4 mg gum. Weeks 1-6: 1 piece every 1-2 hours. Weeks 7-9: 1 piece every 2-4 hours. Weeks 10-12: 1 piece every 4-8 hours. Do not exceed 20 pieces per day.
Condition-Specific Dosing:
initial_therapy:
1 piece every 1-2 hours for 6 weeks
tapering_phase_1:
1 piece every 2-4 hours for 3 weeks
tapering_phase_2:
1 piece every 4-8 hours for 3 weeks
maximum_daily_dose:
20 pieces per day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (contraindicated for individuals under 18 years of age)
Adolescent:
Not established (contraindicated for individuals under 18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution due to potential for increased nicotine levels.
Dialysis:
Use with caution; nicotine and its metabolites are dialyzable, but clinical data on dosing adjustment are limited.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
Use with caution; nicotine clearance may be reduced, leading to higher nicotine levels.
Severe:
Use with caution; nicotine clearance may be significantly reduced, leading to higher nicotine levels and increased risk of adverse effects.
Confidence:
Medium
Pharmacology
Mechanism of Action
Nicotine gum provides therapeutic nicotine to reduce withdrawal symptoms associated with smoking cessation. Nicotine acts as an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems, mimicking the effects of nicotine from tobacco and alleviating cravings and withdrawal symptoms.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (approximately 30-60% due to buccal absorption and first-pass metabolism of swallowed nicotine)
Tmax:
15-30 minutes (from buccal absorption)
FoodEffect:
Acidic beverages (e.g., coffee, juices, soft drinks) can decrease buccal absorption of nicotine; avoid consumption 15 minutes before or during chewing.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
Less than 5%
CnssPenetration:
Yes
Elimination:
HalfLife:
2-3 hours (nicotine), 15-20 hours (cotinine)
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (primarily as metabolites, small amount as unchanged nicotine)
Unchanged:
10-20% (urine, pH dependent)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Dependent on chewing duration and frequency, but effects on cravings can last for hours.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when 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
Feeling confused
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. Although 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 and 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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
Feeling confused
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. Although 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 and 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:
- Signs of nicotine overdose: severe nausea, vomiting, dizziness, headache, cold sweat, confusion, blurred vision, hearing difficulties, weakness, rapid heartbeat, seizures.
- Signs of allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble 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 symptoms you experienced.
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 symptoms you experienced.
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 your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To increase your chances of 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 prescribed may lead to unsafe side effects. If you are using another medication to aid in smoking cessation, be sure to inform 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 alertness. Additionally, be aware that quitting smoking may impact the effectiveness of other medications you are taking, so consult with your doctor.
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 on 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 hazardous or even fatal if ingested by children or pets. 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, exercise caution when using this medication, 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 immediately, as it may harm the unborn baby. Breastfeeding women should also consult with their doctor to weigh the benefits and risks of continuing treatment.
To minimize the risk of adverse effects, do not exceed the recommended dosage. Taking more than prescribed may lead to unsafe side effects. If you are using another medication to aid in smoking cessation, be sure to inform 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 alertness. Additionally, be aware that quitting smoking may impact the effectiveness of other medications you are taking, so consult with your doctor.
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 on 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 hazardous or even fatal if ingested by children or pets. 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, exercise caution when using this medication, 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 immediately, as it may harm the unborn baby. Breastfeeding women should also consult with their doctor to weigh the benefits and risks of continuing treatment.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Cold sweat
- Confusion
- Blurred vision
- Hearing difficulties
- Weakness
- Fainting
- Rapid or irregular heartbeat
- Seizures
- Difficulty breathing
What to Do:
Immediately stop using the gum. Seek emergency medical attention or call a Poison Control Center (1-800-222-1222). Remove any remaining gum from the mouth. Provide supportive care for symptoms.
Drug Interactions
Moderate Interactions
- Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Beta-blockers (smoking cessation can increase levels of some beta-blockers, e.g., propranolol, labetalol)
- Insulin (smoking cessation can increase subcutaneous insulin absorption, requiring dose adjustment)
- Theophylline (smoking cessation can increase theophylline levels due to reduced CYP1A2 induction)
- Caffeine (smoking cessation can increase caffeine levels due to reduced CYP1A2 induction)
- Fluvoxamine (smoking cessation can increase fluvoxamine levels due to reduced CYP1A2 induction)
- Clozapine (smoking cessation can increase clozapine levels due to reduced CYP1A2 induction)
- Olanzapine (smoking cessation can increase olanzapine levels due to reduced CYP1A2 induction)
Monitoring
Baseline Monitoring
Smoking history (cigarettes per day, time to first cigarette)
Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and guide dosing.
Timing: Prior to initiation of therapy
Cardiovascular history (e.g., recent MI, unstable angina, severe arrhythmias)
Rationale: Nicotine can exacerbate cardiovascular conditions; NRT should be used with caution or under medical supervision in these patients.
Timing: Prior to initiation of therapy
Dental/oral health assessment
Rationale: Gum can stick to dentures, dental work, or cause jaw pain.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to dosing schedule and proper chewing technique
Frequency: At each follow-up visit (e.g., weekly initially, then bi-weekly)
Target: As prescribed
Action Threshold: Poor adherence or improper use may lead to treatment failure or side effects; provide re-education.
Assessment of withdrawal symptoms and cravings
Frequency: At each follow-up visit
Target: Reduction in severity
Action Threshold: Persistent severe cravings or withdrawal may indicate need for dose adjustment, combination NRT, or alternative therapy.
Monitoring for adverse effects (e.g., nausea, jaw pain, hiccups, dyspepsia, mouth irritation)
Frequency: At each follow-up visit
Target: Absence or mild/tolerable
Action Threshold: Persistent or severe side effects may require dose adjustment, change in chewing technique, or discontinuation.
Symptom Monitoring
- Nausea
- Vomiting
- Hiccups
- Dyspepsia
- Jaw muscle ache
- Mouth or throat irritation
- Dizziness
- Headache
- Insomnia
Special Patient Groups
Pregnancy
Category D. Nicotine crosses the placenta and is associated with adverse pregnancy outcomes including low birth weight, premature birth, stillbirth, and increased risk of SIDS. While quitting smoking without NRT is preferred, if a pregnant woman cannot quit, NRT may be considered under medical supervision if the benefits of quitting smoking outweigh the risks of nicotine exposure. Gum provides intermittent nicotine exposure, which may be preferable to continuous exposure from patches.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data are mixed. Nicotine is a vasoconstrictor and can reduce uteroplacental blood flow.
Second Trimester:
Continued risk of fetal growth restriction, premature birth, and adverse neurodevelopmental effects.
Third Trimester:
Increased risk of premature birth, low birth weight, and potential for fetal nicotine withdrawal after birth.
Lactation
Nicotine is excreted into breast milk. While nicotine levels from NRT are lower than from smoking, it can still pose risks to the infant (e.g., irritability, sleep disturbances, increased heart rate). If NRT is used, it should be done under medical supervision, and the mother should breastfeed just before using the gum to minimize infant exposure.
Infant Risk:
L3 (Moderate risk). Potential for infant exposure and adverse effects. Monitor infant for irritability, poor feeding, or changes in sleep patterns.
Pediatric Use
Contraindicated for individuals under 18 years of age. Safety and efficacy have not been established in pediatric populations. Nicotine can be toxic to children, and accidental ingestion can be life-threatening.
Geriatric Use
No specific dose adjustment is generally required. However, elderly patients may be more susceptible to the cardiovascular effects of nicotine. Use with caution in elderly patients with pre-existing cardiovascular disease.
Clinical Information
Clinical Pearls
- Proper chewing technique is crucial for efficacy and to minimize side effects. Advise patients to 'chew and park' rather than continuous chewing.
- Acidic beverages can significantly reduce nicotine absorption; instruct patients to avoid them 15 minutes before and during gum use.
- Nicotine gum can be combined with other forms of NRT (e.g., patch) for patients with severe cravings or high nicotine dependence, under medical supervision.
- Patients should be encouraged to use the gum on a fixed schedule initially, rather than only when cravings occur, to maintain consistent nicotine levels.
- The 4mg strength is typically for individuals who smoke their first cigarette within 30 minutes of waking, indicating higher nicotine dependence.
- Jaw pain or soreness is a common side effect, often due to improper chewing or overuse. Advise slower chewing and proper parking.
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:
$30 - $60 per 100 pieces (4mg)
Generic Available:
Yes
Insurance Coverage:
Often covered by most prescription drug plans, especially for smoking cessation programs. May be Tier 1 or 2.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.