Nicotine Pol 4mg Mint 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 nicotine replacement therapy (NRT) that helps you quit smoking by providing nicotine to your body without the harmful chemicals found in cigarettes. It helps reduce cravings and withdrawal symptoms, making it easier to stop smoking.
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 again slowly.
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, 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 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 again slowly.
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, 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
- Chew the gum slowly until you feel a tingling sensation or a peppery taste, then 'park' it between your cheek and gum. Let the nicotine absorb. When the tingling fades, chew again and repeat the process. This 'chew and park' method is crucial for proper absorption.
- Do not chew the gum continuously or too quickly, as this can lead to excessive nicotine release, causing side effects like hiccups, heartburn, or nausea.
- Avoid eating or drinking anything (except water) for 15 minutes before and during chewing the gum, especially acidic beverages (e.g., coffee, soda, juice), as they can reduce nicotine absorption.
- Use the gum on a fixed schedule, not just when cravings hit, especially during the initial weeks, to maintain steady nicotine levels.
- Combine nicotine gum with behavioral support programs or counseling for the best chance of quitting successfully.
- Gradually reduce the number of pieces used per day over the 12-week treatment period as directed.
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 smoking their first cigarette within 30 minutes of waking or smoking more than 25 cigarettes per day: 4 mg gum. Chew one piece every 1-2 hours for the first 6 weeks, then every 2-4 hours for weeks 7-9, then every 4-8 hours for weeks 10-12. Do not exceed 20 pieces per day.
Condition-Specific Dosing:
initialPhase:
1 piece every 1-2 hours for 6 weeks
taperingPhase1:
1 piece every 2-4 hours for weeks 7-9
taperingPhase2:
1 piece every 4-8 hours for weeks 10-12
maximumDailyDose:
20 pieces (4mg) per day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (contraindicated for individuals under 18 years of age without medical supervision)
Adolescent:
Not established (contraindicated for individuals under 18 years of age without medical supervision)
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 and increased nicotine exposure.
Dialysis:
Considerations: Nicotine is dialyzable, but clinical significance for gum is low due to slow absorption. Use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution due to potential for reduced clearance and increased nicotine exposure.
Severe:
No specific dose adjustment recommended, use with caution due to potential for reduced clearance and increased nicotine exposure.
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. It also stimulates dopamine release in the brain's reward pathways, mimicking the effects of smoking.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-70% (buccal absorption, highly variable depending on chewing technique and pH)
Tmax:
Approximately 15-30 minutes (buccal absorption)
FoodEffect:
Acidic beverages (e.g., coffee, soda, fruit juice) can decrease buccal absorption of nicotine by lowering the pH of the oral cavity. Patients should avoid eating or drinking (except water) for 15 minutes before and during chewing.
Distribution:
Vd:
Approximately 2.5 L/kg
ProteinBinding:
Less than 5%
CnssPenetration:
Yes (readily crosses the blood-brain barrier)
Elimination:
HalfLife:
Approximately 2 hours (nicotine); 15-20 hours (cotinine)
Clearance:
Approximately 1.2 L/min (nicotine)
ExcretionRoute:
Renal (primarily as metabolites, small amount as unchanged nicotine)
Unchanged:
Approximately 10-20% (nicotine, dependent on urinary pH)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of proper chewing)
PeakEffect:
Approximately 15-30 minutes
DurationOfAction:
Relief of withdrawal symptoms can last for 1-2 hours per piece, but the pharmacological effects of nicotine are shorter.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 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
Feeling confused
Chest pain or pressure
Fast heartbeat 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 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 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 list is not exhaustive, and you may experience other 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 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
Feeling confused
Chest pain or pressure
Fast heartbeat 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 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 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 list is not exhaustive, and you may experience other 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, weakness, rapid heartbeat, cold sweats, confusion, seizures. Seek immediate medical attention.
- Persistent or severe jaw pain, mouth sores, or dental problems.
- Severe indigestion or heartburn that does not improve.
- Chest pain or irregular heartbeat.
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 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 instructed can lead to unsafe side effects. If you are using another medication to aid in smoking cessation, notify your doctor to ensure safe and effective treatment.
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 understand how this medication affects you, avoid operating vehicles or engaging in activities that require alertness. Additionally, be aware that quitting smoking can alter the effectiveness of other medications you are taking. Consult 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, particularly if you have dental work such as fillings, crowns, or dentures, may cause problems.
If you are following a low-sodium or sodium-free diet, consult 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. In the event of accidental ingestion, 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 promptly. Breastfeeding women should also consult 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 instructed can lead to unsafe side effects. If you are using another medication to aid in smoking cessation, notify your doctor to ensure safe and effective treatment.
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 understand how this medication affects you, avoid operating vehicles or engaging in activities that require alertness. Additionally, be aware that quitting smoking can alter the effectiveness of other medications you are taking. Consult 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, particularly if you have dental work such as fillings, crowns, or dentures, may cause problems.
If you are following a low-sodium or sodium-free diet, consult 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. In the event of accidental ingestion, 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 promptly. Breastfeeding women should also consult their doctor to weigh the benefits and risks of continuing treatment.
Overdose Information
Overdose Symptoms:
- Severe nausea and vomiting
- Diarrhea
- Dizziness
- Weakness
- Cold sweats
- Pallor
- Headache
- Hearing and vision disturbances
- Confusion
- Fainting
- Rapid or irregular heartbeat (tachycardia, arrhythmias)
- Hypotension (low blood pressure)
- Shortness of breath
- Seizures
- Respiratory depression or arrest (in severe cases)
What to Do:
If you suspect an overdose, immediately stop using the gum and call a poison control center (1-800-222-1222) or emergency medical services (911). Management is supportive, including removal of unabsorbed nicotine, activated charcoal, and symptomatic treatment for cardiovascular and respiratory effects.
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 due to reduced CYP1A2 induction; monitor for increased bradycardia/hypotension)
- Caffeine (smoking cessation can increase caffeine levels due to reduced CYP1A2 induction; monitor for increased caffeine-related side effects)
- Insulin (smoking cessation can increase insulin absorption and sensitivity; monitor blood glucose and adjust insulin dose)
- Theophylline (smoking cessation can increase theophylline levels due to reduced CYP1A2 induction; monitor theophylline levels)
- Adrenergic agonists (e.g., phenylephrine, isoproterenol) (nicotine may potentiate cardiovascular effects)
- Adrenergic antagonists (e.g., prazosin, labetalol) (nicotine may reduce their hypotensive effects)
Monitoring
Baseline Monitoring
Smoking history (number of cigarettes/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, arrhythmia, 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, fillings, or cause jaw pain.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to dosing regimen
Frequency: Weekly during initial phase, then as needed
Target: Consistent use as directed
Action Threshold: Inconsistent use or overuse; counsel on proper technique and schedule.
Withdrawal symptoms (e.g., cravings, irritability, anxiety, difficulty concentrating)
Frequency: Weekly during initial phase, then as needed
Target: Reduction or absence of severe symptoms
Action Threshold: Persistent or severe withdrawal symptoms; consider dose adjustment, combination NRT, or behavioral support.
Side effects (e.g., nausea, hiccups, jaw pain, dyspepsia, dizziness, palpitations)
Frequency: Weekly during initial phase, then as needed
Target: Minimal or manageable side effects
Action Threshold: Persistent or severe side effects; counsel on proper chewing technique, consider dose reduction or alternative NRT.
Smoking status (abstinence)
Frequency: Weekly, then monthly
Target: Complete abstinence from smoking
Action Threshold: Relapse to smoking; re-evaluate treatment plan, provide additional support.
Symptom Monitoring
- Nausea
- Hiccups
- Jaw pain
- Dyspepsia (heartburn, indigestion)
- Dizziness
- Headache
- Palpitations
- Sore throat
- Mouth irritation
- Sleep disturbances
Special Patient Groups
Pregnancy
Category D. Smoking during pregnancy poses significant risks to both mother and fetus (e.g., low birth weight, premature birth, stillbirth, SIDS). 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 behavioral interventions alone are unsuccessful and the benefits of quitting smoking outweigh the potential risks of nicotine exposure from NRT. Intermittent NRT (like gum) may be preferred over continuous forms to allow for nicotine-free periods.
Trimester-Specific Risks:
First Trimester:
Nicotine is a known teratogen and can affect organogenesis. Use with extreme caution and only if essential.
Second Trimester:
Continued nicotine exposure can affect fetal growth and development, including lung development and neurodevelopment.
Third Trimester:
Increased risk of premature birth, low birth weight, and potential for neonatal nicotine withdrawal.
Lactation
L3. Nicotine and its metabolites (e.g., cotinine) are excreted into breast milk. Nicotine levels in breast milk are higher than in maternal plasma. While breastfeeding is generally encouraged, the risks of nicotine exposure to the infant should be weighed against the benefits of breastfeeding and the risks of continued maternal smoking. If NRT is used, intermittent forms like gum are preferred, and mothers should use the gum immediately after breastfeeding and avoid use for at least 2-3 hours before the next feeding to minimize infant exposure.
Infant Risk:
Potential for infant exposure to nicotine, leading to irritability, sleep disturbances, increased heart rate, and gastrointestinal upset. Long-term effects on infant neurodevelopment are not fully established but are a concern.
Pediatric Use
Nicotine gum is not indicated for use in individuals under 18 years of age. Safety and efficacy have not been established in this population. Nicotine can be highly toxic to children, and accidental ingestion can be life-threatening.
Geriatric Use
No specific dose adjustments are generally required for elderly patients. However, older adults may be more susceptible to the cardiovascular effects of nicotine. Use with caution in patients with pre-existing cardiovascular disease. Monitor for side effects and adjust dose as tolerated.
Clinical Information
Clinical Pearls
- Proper chewing technique ('chew and park') is critical for effective nicotine absorption and to minimize side effects like hiccups and indigestion.
- Patients should be encouraged to use the gum on a regular schedule, especially during the initial weeks, rather than only when cravings occur, to maintain consistent nicotine levels and prevent withdrawal.
- Acidic beverages (e.g., coffee, soda, juice) should be avoided 15 minutes before and during gum use, as they can significantly impair nicotine absorption.
- Nicotine gum can be combined with other forms of NRT (e.g., patch) for patients with high nicotine dependence or severe withdrawal symptoms, under medical supervision.
- Behavioral counseling and support are essential components of successful smoking cessation and should be offered in conjunction with nicotine gum therapy.
- The 4mg strength is typically recommended for individuals who smoke their first cigarette within 30 minutes of waking or smoke more than 25 cigarettes per day, indicating higher nicotine dependence.
Alternative Therapies
- Nicotine patch (transdermal)
- Nicotine lozenge (buccal)
- Nicotine inhaler (oral)
- Nicotine nasal spray (nasal)
- Bupropion SR (Zyban, Wellbutrin SR)
- Varenicline (Chantix)
- Cytisine (not FDA approved in US, but used elsewhere)
Cost & Coverage
Average Cost:
$20 - $60 per 100-110 pieces (4mg)
Generic Available:
Yes
Insurance Coverage:
Often covered by most prescription drug plans, sometimes as a preferred generic or over-the-counter benefit. Coverage may vary by plan and state (e.g., Medicaid smoking cessation benefits).
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 details about the overdose, including the medication taken, the amount, and the time it occurred.