Nicotine Pol 2mg Original 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 type of medicine that helps you quit smoking by giving your body a small, controlled amount of nicotine. This helps reduce the strong cravings and uncomfortable feelings you get when you stop smoking. It's designed to be chewed slowly and 'parked' in your cheek 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 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 sensation in your mouth.
3. Once you feel the tingling sensation, place the gum between your cheek and gum.
4. After the sensation has subsided, chew the gum again slowly and place it between your cheek and gum at a different site.
5. Repeat this process for about 30 minutes or until the tingling sensation is gone.
Important Instructions
Avoid eating or drinking within 15 minutes before using the gum or while you're using it.
If needed, you can use a second piece of gum within an hour, but do not use two pieces 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.
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 sensation in your mouth.
3. Once you feel the tingling sensation, place the gum between your cheek and gum.
4. After the sensation has subsided, chew the gum again slowly and place it between your cheek and gum at a different site.
5. Repeat this process for about 30 minutes or until the tingling sensation is gone.
Important Instructions
Avoid eating or drinking within 15 minutes before using the gum or while you're using it.
If needed, you can use a second piece of gum within an hour, but do not use two pieces 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.
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.
- Chew the gum slowly until you feel a tingling sensation, then 'park' it between your cheek and gum. When the tingling stops, chew again until it tingles, then park it in a different spot. Repeat this for about 30 minutes.
- 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.
- Follow the dosing schedule carefully and gradually reduce the number of pieces you chew over 12 weeks.
- Keep out of reach of children and pets, as nicotine can be toxic if ingested.
- Combine with behavioral support and counseling for best results in quitting smoking.
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 more than 30 minutes after waking: Chew one 2 mg piece of gum 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 exceed 24 pieces per day.
Dose Range:
9 - 24 mg
Condition-Specific Dosing:
heavySmokers:
For individuals who smoke their first cigarette within 30 minutes of waking, the 4 mg gum is typically recommended, but 2 mg can be used if preferred, with careful monitoring of withdrawal symptoms.
lightSmokers:
2 mg gum is appropriate for those smoking less than 25 cigarettes per day or smoking their first cigarette more than 30 minutes after waking.
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 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 reduced clearance.
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 due to potential for reduced clearance.
Pharmacology
Mechanism of Action
Nicotine gum provides therapeutic nicotine to the body, which binds to nicotinic acetylcholine receptors in the brain, particularly the ι4β2 subtype. This binding stimulates dopamine release in the mesolimbic system, mimicking the effects of nicotine from tobacco. By providing a controlled dose of nicotine, it reduces the severity of nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) experienced during smoking cessation, thereby aiding in the cessation process.
Pharmacokinetics
Absorption:
Bioavailability:
50-70% (buccal absorption, highly variable)
Tmax:
15-30 minutes (for a single piece)
FoodEffect:
Acidic beverages (e.g., coffee, soda, fruit juice) can decrease buccal absorption of nicotine, so avoid consuming them 15 minutes before or during chewing.
Distribution:
Vd:
2-3 L/kg
ProteinBinding:
Less than 5%
CnssPenetration:
Yes
Elimination:
HalfLife:
2-3 hours (nicotine); 15-19 hours (cotinine)
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (pH-dependent; acidic urine increases excretion)
Unchanged:
10-20% (dependent on urine pH)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Varies, but effects of a single piece last for about 1-2 hours, with sustained levels if chewed regularly.
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
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
Unusual burning, numbness, or tingling sensations
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. 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 symptoms that bother you or persist, 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 not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
Unusual burning, numbness, or tingling sensations
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. 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 symptoms that bother you or persist, 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 not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe nausea or vomiting
- Dizziness or lightheadedness
- Weakness
- Cold sweat
- Confusion
- Blurred vision
- Hearing difficulties
- Trouble breathing
- 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. 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
If you currently use tobacco products, such as smoking or chewing tobacco, or use other 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
If you currently use tobacco products, such as smoking or chewing tobacco, or use other 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 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 alertness. 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 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. Pregnant women or those who become pregnant while taking this medication should notify their doctor promptly, as it may pose a risk to the unborn baby. Breastfeeding mothers should also consult with their doctor to discuss any potential risks to their baby.
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 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 alertness. 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 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. Pregnant women or those who become pregnant while taking this medication should notify their doctor promptly, as it may pose a risk to the unborn baby. Breastfeeding mothers should also consult with their doctor to discuss any potential risks to their baby.
Overdose Information
Overdose Symptoms:
- Severe nausea and vomiting
- Diarrhea
- Abdominal pain
- Excessive salivation
- Sweating
- Headache
- Dizziness
- Confusion
- Weakness
- Palpitations
- Hypotension
- Rapid, shallow breathing
- Convulsions
- Coma
What to Do:
If you suspect an overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222 in the US). 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 may increase levels of some beta-blockers due to reduced enzyme induction)
- Insulin (smoking cessation may increase insulin absorption or reduce insulin resistance, requiring dose adjustment)
- Theophylline (smoking cessation may increase theophylline levels due to reduced enzyme induction)
- Caffeine (smoking cessation may increase caffeine levels due to reduced enzyme induction)
- Imipramine (smoking cessation may increase imipramine levels due to reduced enzyme induction)
- Pentazocine (smoking cessation may increase pentazocine levels due to reduced enzyme induction)
Monitoring
Baseline Monitoring
Smoking history (cigarettes per day, time to first cigarette)
Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and initial dosing strategy.
Timing: Prior to initiation of therapy
Cardiovascular status (history of MI, angina, arrhythmias, hypertension)
Rationale: Nicotine can have cardiovascular effects; caution is advised in patients with pre-existing cardiovascular disease.
Timing: Prior to initiation of therapy
Dental/oral health assessment
Rationale: Gum can stick to dentures or dental work, and proper chewing technique is important.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to chewing instructions
Frequency: At each follow-up visit (e.g., weekly for first few weeks, then bi-weekly)
Target: Proper 'chew and park' technique, avoiding acidic beverages
Action Threshold: Incorrect use may lead to inadequate nicotine delivery or excessive side effects; re-educate patient.
Assessment of withdrawal symptoms (e.g., cravings, irritability, anxiety)
Frequency: At each follow-up visit
Target: Reduction in severity of symptoms
Action Threshold: Persistent severe symptoms may indicate need for dose adjustment (e.g., increase frequency, consider 4mg gum) or combination NRT.
Assessment of side effects (e.g., nausea, jaw soreness, hiccups, dyspepsia)
Frequency: At each follow-up visit
Target: Minimal to no side effects
Action Threshold: Persistent or severe side effects may indicate improper chewing technique or need for dose reduction/alternative NRT.
Smoking status (abstinence, slips, relapses)
Frequency: At each follow-up visit
Target: Sustained abstinence
Action Threshold: Relapse requires re-evaluation of treatment plan and support.
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Jaw soreness
- Hiccups
- Dyspepsia
- Throat irritation
- Palpitations
- Insomnia
Special Patient Groups
Pregnancy
Category D. Smoking during pregnancy poses significant risks to the fetus. While nicotine itself is harmful, the risks of continued smoking generally outweigh the risks of nicotine replacement therapy (NRT) when used under medical supervision. NRT should be considered only if the pregnant woman is unable to quit smoking without it and the benefits outweigh the risks. Intermittent NRTs like gum may be preferred over continuous forms like patches to allow for nicotine-free periods.
Trimester-Specific Risks:
First Trimester:
Nicotine is teratogenic in animal studies. Human data suggest potential for adverse pregnancy outcomes (e.g., preterm birth, low birth weight, stillbirth) with nicotine exposure, but it's difficult to separate from smoking effects.
Second Trimester:
Continued exposure to nicotine can affect fetal growth and development, potentially leading to low birth weight and other complications.
Third Trimester:
Nicotine exposure in late pregnancy is associated with increased risk of preterm birth, stillbirth, and potential long-term neurodevelopmental effects.
Lactation
L3 (Moderately safe). Nicotine and its metabolites (e.g., cotinine) are excreted into breast milk. While breastfeeding is generally encouraged, nicotine exposure to the infant should be minimized. If NRT is used, the lowest effective dose should be chosen, and the gum should be used immediately after breastfeeding to allow for maximum clearance before the next feeding. Intermittent NRTs are generally preferred over continuous ones.
Infant Risk:
Potential for infant exposure to nicotine, which can cause irritability, sleep disturbances, and gastrointestinal upset. Long-term effects are not fully known.
Pediatric Use
Not recommended for individuals under 18 years of age. Safety and efficacy have not been established in this population. Nicotine can be toxic to children.
Geriatric Use
Use with caution in elderly patients, especially those with cardiovascular disease, due to potential for increased sensitivity to nicotine's effects. No specific dose adjustment is generally required, but close monitoring for adverse effects is recommended.
Clinical Information
Clinical Pearls
- Proper chewing technique ('chew and park') is crucial for effective nicotine delivery and to minimize side effects like hiccups or dyspepsia.
- Advise patients to avoid acidic beverages (e.g., coffee, soda, juice) 15 minutes before and during gum use, as they can impair nicotine absorption.
- Nicotine gum can be used as a 'rescue' dose for sudden, intense cravings, even if the patient is also using a nicotine patch.
- Encourage patients to set a quit date and start using the gum on that date. It's not meant to be used while still smoking.
- The 2mg gum is typically for those who smoke their first cigarette more than 30 minutes after waking, while the 4mg gum is for those who smoke within 30 minutes of waking.
- Tapering the dose over 12 weeks is important to gradually reduce nicotine dependence and prevent relapse.
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, cognitive behavioral therapy (CBT).
Cost & Coverage
Average Cost:
$20 - $60 per 100-110 pieces
Generic Available:
Yes
Insurance Coverage:
Often covered by most prescription drug plans, especially for smoking cessation programs. May be covered as a preventive benefit.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.