Nicotine Pol 4mg Orig Gum
It is used to treat nicotine withdrawal.It is used to curb the craving to smoke.
Drug Class
Smoking Cessation Aids
Pharmacologic Class
Nicotinic 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 you a small, controlled amount of nicotine. This helps reduce the cravings and withdrawal symptoms you feel when you stop smoking, making it easier to quit.
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 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'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 the 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'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 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 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'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 the 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'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 eat or drink anything (except water) for 15 minutes before or while using the gum, as acidic beverages can reduce nicotine absorption.
- Follow the 'chew and park' method: chew slowly until you feel a tingle or peppery taste, then park the gum between your cheek and gum. When the taste fades, chew again and re-park. Repeat for about 30 minutes.
- Do not chew the gum too fast or continuously, as this can release too much nicotine too quickly, leading to side effects like hiccups, heartburn, or nausea.
- Do not swallow the gum.
- Use the gum on a fixed schedule, not just when cravings occur, especially during the initial weeks.
- Combine gum use with behavioral support programs for the best chance of quitting successfully.
- Keep out of reach of children and pets, as even small amounts of nicotine can be toxic.
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. 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, and one piece every 4 to 8 hours for weeks 10-12. Do not use more than 20 pieces per day.
Condition-Specific Dosing:
initial_therapy:
Use for 12 weeks with gradual reduction. Complete the full 12-week program.
chewing_technique:
Chew slowly until a tingle or peppery taste is felt, then 'park' the gum between the cheek and gum. When the taste fades, chew again and re-park. Repeat for about 30 minutes. Do not chew continuously or swallow.
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 adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution. Monitor for increased side effects due to potential accumulation.
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 adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution. Monitor for increased side effects due to potential accumulation.
Confidence:
Medium
Pharmacology
Mechanism of Action
Nicotine acts as an agonist at nicotinic acetylcholine receptors (nAChRs) in the central and peripheral nervous systems. In the brain, binding to nAChRs, particularly the ι4β2 subtype, leads to the release of neurotransmitters such as dopamine, norepinephrine, acetylcholine, serotonin, GABA, and glutamate. This action helps to alleviate nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating) and reduce the urge to smoke by partially replacing the nicotine from cigarettes.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-70% (variable due to chewing technique and swallowing)
Tmax:
Approximately 15-30 minutes (from gum)
FoodEffect:
Acidic beverages (e.g., coffee, soda, juice) can decrease the absorption of nicotine from the buccal mucosa. Avoid eating or drinking (except water) for 15 minutes before and during gum use.
Distribution:
Vd:
Approximately 2.6 L/kg
ProteinBinding:
Less than 5% (low)
CnssPenetration:
Yes
Elimination:
HalfLife:
Nicotine: Approximately 2 hours; Cotinine: Approximately 18-20 hours
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (pH-dependent, acidic urine increases excretion)
Unchanged:
Approximately 10-20% (nicotine)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
Approximately 15-30 minutes
DurationOfAction:
Effects persist as long as nicotine levels are maintained, typically for the duration of gum use and subsequent absorption.
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
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. Although many people may not experience any side effects or only have mild 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, 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.
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
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. Although many people may not experience any side effects or only have mild 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, 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:
- Signs of nicotine overdose: severe nausea, vomiting, dizziness, headache, cold sweat, confusion, weakness, fainting, rapid or irregular heartbeat, seizures.
- Persistent or severe jaw pain, mouth sores, or throat irritation.
- Allergic reaction symptoms: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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
If you currently use tobacco products, such as smoking or chewing tobacco, or use nicotine-containing products while taking this medication.
If you have temporomandibular joint (TMJ) disease.
* If you are under 18 years of age. This medication is not recommended for children under 18 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 drugs 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
If you currently use tobacco products, such as smoking or chewing tobacco, or use nicotine-containing products while taking this medication.
If you have temporomandibular joint (TMJ) disease.
* If you are under 18 years of age. This medication is not recommended for children under 18 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 drugs 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 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 prescribed 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 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 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 following a low-sodium or sodium-free diet, consult with your doctor, as some formulations of this medication 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 accidentally ingested 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 prescribed 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 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 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 following a low-sodium or sodium-free diet, consult with your doctor, as some formulations of this medication 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 accidentally ingested 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
- Dizziness, lightheadedness, fainting
- Headache
- Cold sweat
- Confusion
- Weakness
- Salivation
- Abdominal pain
- Rapid or irregular heartbeat (tachycardia, arrhythmias)
- Hypotension (low blood pressure)
- Seizures
- Respiratory depression or arrest
What to Do:
If you suspect an overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222) right away. Remove any remaining gum from the mouth. Provide supportive care as needed.
Drug Interactions
Moderate Interactions
- Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Beta-blockers (nicotine can increase catecholamine release, potentially antagonizing beta-blocker effects)
- Insulin (smoking cessation with NRT may increase insulin sensitivity, potentially requiring a dose reduction of insulin)
- Theophylline (smoking cessation with NRT may increase theophylline levels due to reduced metabolism, requiring dose adjustment)
- Caffeine (smoking cessation with NRT may increase caffeine levels due to reduced metabolism, requiring dose adjustment)
- Imipramine (smoking cessation with NRT may increase imipramine levels due to reduced metabolism, requiring dose adjustment)
- Pentazocine (smoking cessation with NRT may increase pentazocine levels due to reduced metabolism, requiring dose adjustment)
Monitoring
Baseline Monitoring
Smoking history (cigarettes per day, time to first cigarette)
Rationale: To determine appropriate starting dose (2mg vs 4mg) and assess dependence level.
Timing: Prior to initiation of therapy
Cardiovascular status (history of MI, angina, arrhythmias)
Rationale: Nicotine can exacerbate cardiovascular conditions. Use with caution in patients with recent MI, severe angina, or serious arrhythmias.
Timing: Prior to initiation of therapy
Dental/oral health assessment
Rationale: Gum can stick to dentures, bridges, or fillings, and may cause jaw pain or mouth irritation.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to dosing schedule and chewing technique
Frequency: At each follow-up visit (weekly initially, then bi-weekly/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 nicotine withdrawal symptoms (e.g., cravings, irritability, anxiety, difficulty concentrating)
Frequency: At each follow-up visit
Target: Reduction or absence of symptoms
Action Threshold: Persistent or severe withdrawal symptoms may indicate need for dose adjustment, combination NRT, or alternative therapy.
Monitoring for side effects (e.g., nausea, hiccups, dyspepsia, jaw pain, mouth/throat irritation, dizziness)
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 chewing technique, or discontinuation.
Progress towards smoking cessation
Frequency: At each follow-up visit
Target: Reduction in cigarette consumption, eventual abstinence
Action Threshold: Lack of progress may indicate need for behavioral support, dose adjustment, or alternative therapy.
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Hiccups
- Dyspepsia (indigestion)
- Jaw muscle ache/pain
- Mouth or throat irritation
- Excessive salivation
- Palpitations
- Weakness
Special Patient Groups
Pregnancy
Nicotine gum is classified as Pregnancy Category D. While nicotine itself is harmful to the fetus (associated with low birth weight, premature birth, and other adverse outcomes), the risks of continued smoking during pregnancy generally outweigh the risks of nicotine replacement therapy (NRT). NRT should be considered only if the pregnant woman is unable to quit smoking without pharmacological intervention and under the guidance of a healthcare provider. The lowest effective dose should be used for the shortest duration possible.
Trimester-Specific Risks:
First Trimester:
Nicotine exposure in early pregnancy is associated with increased risk of congenital anomalies, though data are mixed. Smoking cessation is critical.
Second Trimester:
Continued nicotine exposure can impair fetal lung development and increase risk of premature birth and low birth weight.
Third Trimester:
Continued nicotine exposure can lead to fetal growth restriction, premature birth, and potential neurodevelopmental effects. Fetal heart rate changes may occur.
Lactation
Nicotine and its metabolites are excreted into breast milk. Nicotine gum provides a controlled dose, which is generally preferred over smoking for breastfeeding mothers who cannot quit without NRT. To minimize infant exposure, mothers should use the gum immediately after breastfeeding and avoid using it just before feeding. The lowest effective dose should be used. Monitor the infant for signs of nicotine exposure (e.g., irritability, poor feeding, sleep disturbances).
Infant Risk:
L3 (Moderately Safe) - Nicotine is present in breast milk, but the benefits of smoking cessation for the infant generally outweigh the risks of NRT. Risk to infant is lower than continued smoking.
Pediatric Use
Nicotine gum is contraindicated for individuals under 18 years of age. Safety and efficacy have not been established in pediatric populations for smoking cessation. Accidental ingestion by children can be dangerous and potentially fatal.
Geriatric Use
Use with caution in elderly patients, especially those with underlying cardiovascular disease or other comorbidities. While no specific dose adjustment is generally required based on age alone, elderly patients may be more sensitive to the effects of nicotine. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Nicotine gum is a behavioral aid, not a magic bullet. It works best when combined with a comprehensive smoking cessation program that includes behavioral counseling and support.
- Proper chewing technique ('chew and park') is crucial for effective nicotine absorption and to minimize side effects like hiccups and 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 significantly reduce nicotine absorption.
- The 4mg strength is typically recommended for heavy smokers (those who smoke their first cigarette within 30 minutes of waking).
- Encourage patients to use the gum on a fixed schedule, especially during the initial weeks, rather than only when cravings occur, to maintain consistent nicotine levels and prevent withdrawal.
- Patients should be educated on the signs of nicotine overdose and instructed to seek immediate medical attention if they occur.
- Nicotine gum can stick to dental work (fillings, crowns, bridges), which can be a concern for some patients.
Alternative Therapies
- Bupropion (Zyban, Wellbutrin SR)
- Varenicline (Chantix)
Cost & Coverage
Average Cost:
$20 - $60 per 100-110 pieces (4mg)
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans (Rx or OTC benefit), sometimes preferred or Tier 1/2. 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.