Nicotine 4mg Mint Gum 20s
It is used to treat nicotine withdrawal.It is used to curb the craving to smoke.
Drug Class
Smoking cessation aid
Pharmacologic Class
Nicotinic acetylcholine receptor agonist
Pregnancy Category
Category D
FDA Approved
Jan 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine gum is a medicine that helps people quit smoking by giving them a small, controlled amount of nicotine. This helps reduce cravings and withdrawal symptoms that happen when you stop smoking. It's chewed slowly to release nicotine into your mouth, which is then absorbed into your body.
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 need one dose, and if you smoke your first cigarette more than 30 minutes after waking up, you will need the other dose. If you are unsure about which dose to use, consult your pharmacist or doctor.
Using the Gum
1. Use the gum immediately after opening the package.
2. Do not swallow the gum. Instead, chew it slowly until you experience a tingling or peppery taste in your mouth.
3. Once you feel the tingling or peppery taste, place the gum between your cheek and gum.
4. When the taste or tingling sensation disappears, chew the gum slowly again.
5. Move the gum to a different location between your cheek and gum when the taste or tingling returns. Repeat this process for about 30 minutes or until the taste or tingling is gone.
Important Precautions
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 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 return to 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 need one dose, and if you smoke your first cigarette more than 30 minutes after waking up, you will need the other dose. If you are unsure about which dose to use, consult your pharmacist or doctor.
Using the Gum
1. Use the gum immediately after opening the package.
2. Do not swallow the gum. Instead, chew it slowly until you experience a tingling or peppery taste in your mouth.
3. Once you feel the tingling or peppery taste, place the gum between your cheek and gum.
4. When the taste or tingling sensation disappears, chew the gum slowly again.
5. Move the gum to a different location between your cheek and gum when the taste or tingling returns. Repeat this process for about 30 minutes or until the taste or tingling is gone.
Important Precautions
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 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 return to 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. Let the nicotine absorb. When the tingling fades, chew again until it tingles, then park it again. Repeat for about 30 minutes.
- Do not eat or drink anything (except water) for 15 minutes before or during chewing the gum, as acidic beverages can reduce nicotine absorption.
- Follow the dosing schedule carefully and gradually reduce the number of pieces used over 12 weeks.
- Combine with behavioral support and counseling 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:
4 mg gum: 1 piece every 1-2 hours for weeks 1-6, then 1 piece every 2-4 hours for weeks 7-9, then 1 piece every 4-8 hours for weeks 10-12. Max 24 pieces/day.
Condition-Specific Dosing:
heavySmokers:
4 mg gum is recommended for individuals who smoke their first cigarette within 30 minutes of waking.
lightSmokers:
2 mg gum is recommended for individuals who smoke their first cigarette more than 30 minutes after waking.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (generally not recommended for individuals under 18 years of age without medical supervision)
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.
Dialysis:
Use with caution; monitor for increased side effects due to potential accumulation.
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.
Pharmacology
Mechanism of Action
Nicotine acts as an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems, including the adrenal medulla and autonomic ganglia. In smoking cessation, it replaces the nicotine from tobacco, reducing withdrawal symptoms and cravings. It also stimulates dopamine release in the brain's reward pathways, mimicking the effects of smoking.
Pharmacokinetics
Absorption:
Bioavailability:
50-60% (from gum, due to buccal absorption and some first-pass metabolism of swallowed nicotine)
Tmax:
15-30 minutes (from gum)
FoodEffect:
Acidic beverages (e.g., coffee, soda, fruit juice) can decrease buccal absorption of nicotine. Avoid eating or drinking anything except water for 15 minutes before and during chewing.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
Less than 5%
CnssPenetration:
Yes
Elimination:
HalfLife:
2 hours (nicotine); 15-19 hours (cotinine)
Clearance:
70 L/hour (nicotine)
ExcretionRoute:
Renal (primarily as metabolites, some unchanged nicotine)
Unchanged:
10-20% (nicotine, dependent on urinary pH)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Variable, effects can last for hours due to sustained nicotine levels and cotinine.
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
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. 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 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.
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
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. 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 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:
- Severe nausea or vomiting
- Dizziness or lightheadedness
- Weakness
- Rapid or irregular heartbeat
- Seizures
- Difficulty breathing
- Cold sweats
- Confusion
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 tobacco use, including smoking, chewing tobacco, or using nicotine products, as these may interact with this medication.
If you have temporomandibular joint (TMJ) disease.
* Your age, particularly if you are under 18 years old, as this medication is not recommended for children under 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 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 adjust the dosage 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 tobacco use, including smoking, chewing tobacco, or using nicotine products, as these may interact with this medication.
If you have temporomandibular joint (TMJ) disease.
* Your age, particularly if you are under 18 years old, as this medication is not recommended for children under 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 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 adjust 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 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 inform your doctor.
When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary, so it is crucial to report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in activities that require 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, as some formulations of this medication may contain sodium.
This medication can be hazardous or even fatal if ingested by children or pets, so it is vital to keep it out of their reach. 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. Furthermore, if you are pregnant or become pregnant while taking this medication, inform 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 using another medication to aid in smoking cessation, be sure to inform your doctor.
When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary, so it is crucial to report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in activities that require 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, as some formulations of this medication may contain sodium.
This medication can be hazardous or even fatal if ingested by children or pets, so it is vital to keep it out of their reach. 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. Furthermore, if you are pregnant or become pregnant while taking this medication, inform 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
- Weakness
- Rapid heartbeat
- Sweating
- Confusion
- Fainting
- Seizures
- Respiratory depression
What to Do:
If you suspect an overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222. Remove any remaining gum from the mouth. Provide supportive care.
Drug Interactions
Moderate Interactions
- Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Adrenergic agonists (e.g., phenylephrine, isoproterenol - nicotine may potentiate cardiovascular effects)
- Adrenergic antagonists (e.g., labetalol, prazosin - nicotine may blunt the therapeutic effects)
- Insulin (smoking cessation with nicotine replacement may increase insulin absorption or decrease insulin requirements due to improved glucose metabolism)
- Theophylline (smoking cessation with nicotine replacement may increase theophylline levels due to reduced metabolism)
Monitoring
Baseline Monitoring
Smoking history (number of cigarettes/day, time to first cigarette)
Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and guide treatment duration.
Timing: Prior to initiation of therapy
Cardiovascular history (e.g., recent MI, unstable angina, severe arrhythmias)
Rationale: Nicotine can have cardiovascular effects; caution is advised in patients with pre-existing cardiovascular disease.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to chewing instructions
Frequency: Regularly during therapy
Target: Proper 'chew and park' technique
Action Threshold: Improper use can lead to reduced efficacy or increased side effects (e.g., GI upset).
Side effects (e.g., nausea, dizziness, mouth irritation, jaw soreness)
Frequency: Regularly during therapy
Target: Minimal to tolerable
Action Threshold: Persistent or severe side effects may require dose adjustment or discontinuation.
Progress in smoking cessation (e.g., reduction in cravings, number of cigarettes smoked)
Frequency: Weekly initially, then as needed
Target: Gradual reduction leading to complete cessation
Action Threshold: Lack of progress may indicate need for counseling, dose adjustment, or alternative therapy.
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Heartburn
- Mouth or throat irritation
- Jaw soreness
- Palpitations
- Increased heart rate
- Chest pain (seek immediate medical attention)
Special Patient Groups
Pregnancy
Category D. Nicotine can harm the fetus. However, the risks of continued smoking during pregnancy are significant and outweigh the risks of nicotine replacement therapy (NRT) in many cases. NRT should only be used if the pregnant woman is unable to quit smoking without it and under medical supervision, with the lowest effective dose and shortest duration.
Trimester-Specific Risks:
First Trimester:
Increased risk of miscarriage, congenital malformations (though less clear for NRT vs. smoking).
Second Trimester:
Increased risk of preterm birth, low birth weight.
Third Trimester:
Increased risk of preterm birth, low birth weight, stillbirth, and potential long-term neurodevelopmental effects.
Lactation
L3 (Moderate risk). Nicotine is excreted into breast milk. While NRT delivers less nicotine than smoking, it's still present. If NRT is used, advise using the lowest effective dose immediately after breastfeeding to minimize infant exposure. Non-nicotine methods are preferred if possible.
Infant Risk:
Potential for infant irritability, sleep disturbances, and cardiovascular effects. Risk is lower than continued smoking.
Pediatric Use
Not recommended for individuals under 18 years of age without medical supervision due to lack of established safety and efficacy data in this population. Nicotine is toxic to children.
Geriatric Use
No specific dose adjustment is generally required. However, older adults may be more susceptible to the cardiovascular effects of nicotine. Use with caution and monitor for adverse effects, especially in those with pre-existing cardiovascular conditions.
Clinical Information
Clinical Pearls
- Proper chewing technique ('chew and park') is crucial for effective nicotine absorption and to minimize side effects like heartburn or hiccups.
- Acidic beverages (e.g., coffee, soda, juice) can significantly reduce nicotine absorption from the gum; advise patients to avoid them 15 minutes before and during use.
- Nicotine gum is a behavioral aid; it works best when combined with a comprehensive smoking cessation program that includes counseling and support.
- Patients should be encouraged to use enough gum to control cravings, rather than trying to 'tough it out' with too few pieces, especially in the initial weeks.
- The 4mg strength is typically for heavy smokers (first cigarette within 30 minutes of waking), while 2mg is for lighter smokers.
- Gradual tapering of the gum over 12 weeks is important to prevent relapse and manage withdrawal.
Alternative Therapies
- Other Nicotine Replacement Therapies (NRTs): Nicotine patch, lozenge, inhaler, nasal spray.
- Non-nicotine pharmacotherapies: Bupropion (Zyban, Wellbutrin), Varenicline (Chantix).
- Behavioral therapies: Counseling, support groups, cognitive behavioral therapy (CBT).
Cost & Coverage
Average Cost:
$15 - $30 per 20 pieces (4mg)
Generic Available:
Yes
Insurance Coverage:
Often available over-the-counter (OTC). Some prescription drug plans or state Medicaid programs may cover NRT products.
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. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.