Nicotine Polacr 4mg Mint Gum 40'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 type of medicine that helps you stop smoking by giving your body a small, controlled amount of nicotine. This helps reduce the strong cravings and withdrawal symptoms you get when you try to quit. It's designed to be chewed slowly and 'parked' in your cheek to allow 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 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. 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 Instructions
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 at the same time.
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 different 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. 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 Instructions
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 at the same time.
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
- Use the 'chew and park' method: Chew the gum slowly until you feel a tingling sensation or a peppery taste, then 'park' it between your cheek and gum. When the tingling fades, chew it again a few times and re-park it. Repeat for about 30 minutes.
- Do not chew the gum too fast or swallow it, as this can lead to hiccups, heartburn, or stomach upset.
- Avoid eating or drinking anything (except water) for 15 minutes before and during chewing the gum, especially acidic beverages like coffee, soda, or fruit juice, as they can reduce nicotine absorption.
- Gradually reduce the number of pieces of gum you use each day over the course of 12 weeks, as directed by the product instructions or your healthcare provider.
- 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, or smoke more than 25 cigarettes per day: Chew one 4mg piece of gum every 1 to 2 hours for the first 6 weeks. Then, one piece every 2 to 4 hours for weeks 7 to 9. Finally, one piece every 4 to 8 hours for weeks 10 to 12. Do not use more than 20 pieces per day.
Condition-Specific Dosing:
initialPhase:
1 piece every 1-2 hours (weeks 1-6)
taperingPhase1:
1 piece every 2-4 hours (weeks 7-9)
taperingPhase2:
1 piece every 4-8 hours (weeks 10-12)
maxDailyDose:
20 pieces/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.
Dialysis:
Considerations: Nicotine is dialyzable, but clinical significance for gum is low due to slow absorption. Use with caution and monitor for adverse effects.
Hepatic 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.
Pharmacology
Mechanism of Action
Nicotine acts as an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems. In smoking cessation, it replaces the nicotine from cigarettes, reducing withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) and the urge to smoke.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 60-70% of the nicotine released from the gum is absorbed buccally.
Tmax:
15-30 minutes (for buccal absorption)
FoodEffect:
Acidic beverages (e.g., coffee, soda, fruit juice) can decrease buccal absorption of nicotine. Patients should avoid eating or drinking (except water) for 15 minutes before and during chewing the gum.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
Less than 5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2 hours (nicotine); 15-20 hours (cotinine)
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (primarily as metabolites, with a small percentage of unchanged nicotine)
Unchanged:
Approximately 10-20% (renal excretion, pH-dependent)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Effects on cravings can last for 1-2 hours, but the pharmacokinetic half-life is shorter.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
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 medical help 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
Abnormal sensations, such as burning, numbness, or tingling
Dizziness, tiredness, or weakness
Diarrhea, stomach upset, 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:
Sleep disturbances
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Mouth tingling
* Gum changes
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact 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 medical help 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
Abnormal sensations, such as burning, numbness, or tingling
Dizziness, tiredness, or weakness
Diarrhea, stomach upset, 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:
Sleep disturbances
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Mouth tingling
* Gum changes
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact 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:
- Nausea, vomiting, or diarrhea (signs of too much nicotine)
- Dizziness or lightheadedness
- Headache
- Cold sweats
- Confusion
- Weakness
- Blurred vision
- Hearing disturbances
- Rapid or irregular heartbeat
- Seizures
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. Describe the allergic reaction you experienced, including the 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 younger than 18 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. Describe the allergic reaction you experienced, including the 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 younger than 18 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 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 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 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 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 product, as some formulations may contain sodium.
This medication can be hazardous or even fatal if ingested by children or pets. If a child accidentally uses this medication or if it is swallowed by a child or pet, immediately contact a doctor or a 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. 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 the 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 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 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 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 product, as some formulations may contain sodium.
This medication can be hazardous or even fatal if ingested by children or pets. If a child accidentally uses this medication or if it is swallowed by a child or pet, immediately contact a doctor or a 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. 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 the potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Severe nausea and vomiting
- Diarrhea
- Abdominal pain
- Dizziness, confusion, weakness
- Cold sweats
- Pallor
- Salivation
- Headache
- Hearing and vision disturbances
- Rapid or irregular heartbeat
- Hypotension (low blood pressure)
- Respiratory depression
- Convulsions
What to Do:
If you suspect an overdose, stop using the gum immediately and call your local poison control center (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Remove any remaining gum from the mouth. Treatment is supportive, focusing on maintaining vital signs.
Drug Interactions
Moderate Interactions
- Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Caffeine (smoking cessation can lead to increased caffeine levels due to reduced CYP1A2 induction; monitor for caffeine toxicity)
- Theophylline (smoking cessation can lead to increased theophylline levels due to reduced CYP1A2 induction; monitor for toxicity)
- Imipramine (smoking cessation can lead to increased imipramine levels due to reduced CYP1A2 induction; monitor for toxicity)
- Insulin (smoking cessation may increase subcutaneous insulin absorption; dose adjustment may be needed)
- Flecainide (smoking cessation can lead to increased flecainide levels due to reduced CYP1A2 induction; monitor for toxicity)
- Furosemide (nicotine may decrease diuretic effect)
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 status (history of MI, angina, arrhythmias)
Rationale: Nicotine can have cardiovascular effects; caution is advised in patients with pre-existing conditions.
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 and proper chewing technique
Frequency: At each follow-up visit (e.g., weekly for first month, then monthly)
Target: Consistent use as directed, proper 'chew and park' method
Action Threshold: Inconsistent use or improper technique 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 and frequency of symptoms
Action Threshold: Persistent severe symptoms may indicate need for dose adjustment, combination therapy, or alternative treatment.
Monitoring for adverse effects (e.g., nausea, hiccups, jaw pain, dyspepsia)
Frequency: At each follow-up visit
Target: Absence or mild, tolerable side effects
Action Threshold: Persistent or severe side effects may require dose reduction, change in product, or discontinuation.
Smoking status (abstinence)
Frequency: At each follow-up visit
Target: Complete abstinence from smoking
Action Threshold: Continued smoking while on NRT increases risk of nicotine toxicity; reinforce cessation goals or adjust treatment plan.
Symptom Monitoring
- Nausea
- Hiccups
- Jaw pain or soreness
- Dyspepsia (indigestion)
- Throat irritation
- Dizziness
- Headache
- Insomnia
- Heartburn
Special Patient Groups
Pregnancy
Nicotine gum is classified as Pregnancy Category D. While nicotine itself is harmful to the fetus, the risks of continued smoking during pregnancy are significantly higher than the risks associated with nicotine replacement therapy (NRT). NRT should be considered only if the pregnant woman is unable to quit smoking without it, and under the guidance of a healthcare professional. The lowest effective dose should be used for the shortest duration possible.
Trimester-Specific Risks:
First Trimester:
Nicotine exposure in the first trimester is associated with increased risk of congenital malformations (e.g., cleft lip/palate, limb defects) and adverse pregnancy outcomes.
Second Trimester:
Continued nicotine exposure can lead to fetal growth restriction, preterm birth, and adverse neurodevelopmental outcomes.
Third Trimester:
Continued nicotine exposure can lead to fetal growth restriction, preterm birth, and adverse neurodevelopmental outcomes. Nicotine can also affect fetal breathing movements and heart rate.
Lactation
Nicotine and its metabolites (e.g., cotinine) are excreted into breast milk. Nicotine gum is rated L3 (Moderate risk) for lactation. While NRT exposes the infant to less nicotine than smoking, it is still present. If NRT is used, the lowest effective dose should be chosen, and the mother should consider timing doses immediately after breastfeeding to minimize infant exposure.
Infant Risk:
Risk of infant exposure to nicotine, which can cause irritability, sleep disturbances, and potentially long-term neurodevelopmental effects. However, the risk is generally considered lower than continued maternal smoking.
Pediatric Use
Nicotine gum is not indicated for use in individuals under 18 years of age for smoking cessation. Safety and efficacy have not been established in this population. Nicotine can be toxic to children, and accidental ingestion can be dangerous.
Geriatric Use
No specific dose adjustment is generally required for elderly patients. However, use with caution in elderly patients with pre-existing cardiovascular disease or other comorbidities, as they may be more sensitive to the cardiovascular effects of nicotine. Monitor for adverse effects.
Clinical Information
Clinical Pearls
- Proper chewing technique ('chew and park') is crucial for effective absorption and to minimize side effects like hiccups and dyspepsia.
- Avoid acidic beverages 15 minutes before and during gum use, as they can significantly reduce nicotine absorption.
- Nicotine gum can be combined with a nicotine patch for more severe nicotine dependence (combination NRT) under medical supervision.
- Patients should be encouraged to set a quit date and use the gum consistently, rather than as needed, especially in the initial weeks.
- Jaw soreness or pain is a common side effect, especially with the 4mg strength; ensure proper chewing technique.
Alternative Therapies
- Other Nicotine Replacement Therapies (NRTs): Nicotine patch, nicotine lozenge, nicotine inhaler, nicotine nasal spray.
- Pharmacological agents: Bupropion (Zyban, Wellbutrin), Varenicline (Chantix).
- Behavioral therapies: Counseling, support groups, quitlines.
Cost & Coverage
Average Cost:
$15 - $30 per 40 pieces (generic 4mg gum)
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans (Tier 1 or 2), and sometimes available OTC with FSA/HSA eligibility. Some state Medicaid programs and employer plans may cover NRT.
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 this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.