Nicotine Gum 2mg Mint Refill 50's
It is used to treat nicotine withdrawal.It is used to curb the craving to smoke.
Drug Class
Smoking cessation aid
Pharmacologic Class
Nicotinic acetylcholine receptor agonist
Pregnancy Category
Category D
FDA Approved
Jan 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine gum is a type of medicine that helps you quit smoking by giving your body a small amount of nicotine, which reduces the strong cravings and withdrawal symptoms 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 through your mouth.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all the information provided. This product is available in two different doses, which are determined by 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.
Important Reminders
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 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.
Important Reminders
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
- Set a quit date and stick to it.
- Use the gum regularly as directed, even if you don't feel a strong craving initially.
- Avoid acidic drinks (like coffee, soda, or juice) 15 minutes before and during gum use, as they can reduce nicotine absorption.
- Develop coping strategies for cravings (e.g., deep breathing, distraction, exercise).
- Seek support from family, friends, or smoking cessation programs.
- Identify and avoid triggers that make you want to smoke.
- Combine with behavioral support for best results.
Available Forms & Alternatives
Available Strengths:
- Nicotine Gum 2mg Mint Refill 50's
- Nicotine Gum 4mg Starter Kit 110's
- Nicotine Polacr 4mg Mint Gum 40's
- Nicotine Polacr 4mg Mintgum 100s
- Nicotine Polacr 2mg Gum 40's
- Nicotine Pol 2mg Mint Gum 100s
- Nicotine Polacr 4mg Cinn Gum 100's
- Nicotine Polacr 4mg Orig Gum 50's
- Nicotine Polacr 2mg Gum Orig 50s
- Nicotine Pol 2mg Original Gum
- Nicotine Polacr 4mg Mint Loz 72's
- Nicotine Polacrilex 4mg Gum 100's
- Nicotine Pol 4mg Orig Gum
- Nicotine TD 7mg/24h Patch 14s
- Nicotine Polacrilex 4mg Chewing Gum
- Nicotine Polacrilex 2mg Chewing Gum
- Nicotine 14mg/24h Patch 14s
- Nicotine 21mg/24h Patch 28s
- Nicotine 21mg/24h Patch 14s
- Nicotine TD 21mg/24h Patch 7s
- Nicotine TD 14mg/24h Patch 7s
- Nicotine SF 2mg Cinn Gum 100's
- Nicotine Lozenge 4mg Mint
- Nicotine 2mg Original Gum 20s
- Nicotine 2mg Mint Lozenge 81s
- Nicotine 4mg Mint Gum 110s
- Nicotine 4mg Mint Gum 20s
- Nicotine TD 7mg/24h Patch 7s
- Nicotine 2mg SF Fruit Gum 100s
- Nicotine TD 21mg/24h Patch 14s
- Nicotine Pol 4mg Mint Lozenges
- Nicotine TD 14mg/24h Patch 28's
- Nicotine Pol 2mg Mint Loz 72s
- Nicotine Polacr 4mg Mint Loz 72s
- Nicotine Pol 2mg Mint Gum 110s
- Nicotine 2mg Mini Mint Loz 72s
- Nicotine 4mg Mini Mint Loz 72s
- Nicotine Pol 4mg Mint Gum
- Nicotine Mini Mint 2mg Loz 81s
Dosing & Administration
Adult Dosing
Standard Dose:
For those who smoke their first cigarette more than 30 minutes after waking: 2 mg gum. Chew one piece every 1-2 hours for the first 6 weeks, then one piece every 2-4 hours for weeks 7-9, then one piece every 4-8 hours for weeks 10-12. Do not exceed 24 pieces per day.
Condition-Specific Dosing:
heavySmokers:
For those who smoke their first cigarette within 30 minutes of waking: 4 mg gum (not this product).
maximumDailyDose:
Do not use more than 24 pieces of gum per day. Do not use for more than 12 weeks without consulting a doctor.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (contraindicated for use in persons under 18 years of age without medical advice)
Adolescent:
Not established (contraindicated for use in persons under 18 years of age without medical advice)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required, but use with caution.
Moderate:
No specific dose adjustment generally required, but use with caution.
Severe:
No specific dose adjustment generally required, but use with caution. Monitor for increased side effects.
Dialysis:
Consideration for reduced clearance; monitor for increased side effects.
Hepatic Impairment:
Mild:
No specific dose adjustment generally required, but use with caution.
Moderate:
No specific dose adjustment generally required, but use with caution.
Severe:
No specific dose adjustment generally required, but use with caution. Monitor for increased side effects.
Pharmacology
Mechanism of Action
Nicotine gum provides therapeutic nicotine to the body, replacing the nicotine obtained from tobacco products. This helps to reduce nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, restlessness, increased appetite, cravings) experienced during smoking cessation. Nicotine acts as an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (approx. 50-70% of the nicotine released from the gum is absorbed buccally, depending on chewing technique and saliva pH)
Tmax:
15-30 minutes (after chewing 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 gum use.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
Less than 5%
CnssPenetration:
Yes
Elimination:
HalfLife:
2-3 hours (nicotine); 15-20 hours (cotinine)
Clearance:
Approx. 1.2 L/min
ExcretionRoute:
Renal (pH-dependent, increased with acidic urine)
Unchanged:
Approx. 10-30% (nicotine, depending on urine pH)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Relief of withdrawal symptoms for 1-2 hours per piece
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 medical attention immediately:
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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 attention immediately:
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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent nausea, vomiting, or diarrhea
- Dizziness or lightheadedness
- Fast or irregular heartbeat
- Chest pain
- Difficulty breathing
- Severe headache
- Signs of allergic reaction (rash, itching, swelling, 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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your use of tobacco products, including 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 essential 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 crucial to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your use of tobacco products, including 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 essential 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 the addiction.
Do not exceed the recommended dosage, as this may lead to severe and potentially harmful side effects. If you are currently taking another medication to aid in smoking cessation, be sure to notify your doctor.
When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary, so it is crucial to report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in activities that require your full attention. Additionally, be aware that quitting smoking may impact the effectiveness of other medications you are taking, so consult with your doctor to discuss any necessary adjustments.
If you have been using this medication for the recommended duration and have not been able to quit smoking, inform your doctor. It is also important to note that chewing gum, a common form of nicotine replacement therapy, may cause issues 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 before using this medication, as some products 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 accidentally ingests this medication or if a child or pet swallows it, 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.
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, as it may harm the unborn baby. Breastfeeding women should also consult with their doctor to weigh the benefits and risks of continuing to take this medication.
Do not exceed the recommended dosage, as this may lead to severe and potentially harmful side effects. If you are currently taking another medication to aid in smoking cessation, be sure to notify your doctor.
When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary, so it is crucial to report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in activities that require your full attention. Additionally, be aware that quitting smoking may impact the effectiveness of other medications you are taking, so consult with your doctor to discuss any necessary adjustments.
If you have been using this medication for the recommended duration and have not been able to quit smoking, inform your doctor. It is also important to note that chewing gum, a common form of nicotine replacement therapy, may cause issues 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 before using this medication, as some products 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 accidentally ingests this medication or if a child or pet swallows it, 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.
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, as it may harm the unborn baby. Breastfeeding women should also consult with their doctor to weigh the benefits and risks of continuing to take this medication.
Overdose Information
Overdose Symptoms:
- Severe nausea and vomiting
- Excessive salivation
- Abdominal pain
- Diarrhea
- Sweating
- Headache
- Dizziness
- Confusion
- Weakness
- Fainting
- Hearing and vision disturbances
- Rapid or irregular heartbeat
- Low blood pressure
- Seizures
- Respiratory depression (slow, shallow breathing)
What to Do:
If you suspect an overdose, seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). 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 (smoking cessation can increase levels of some beta-blockers due to reduced induction of hepatic enzymes)
- Insulin (smoking cessation can increase insulin absorption and sensitivity, potentially requiring dose reduction)
- Theophylline (smoking cessation can increase theophylline levels due to reduced induction of hepatic enzymes)
- Caffeine (smoking cessation can increase caffeine levels due to reduced induction of hepatic enzymes)
- Adrenergic agonists/antagonists (nicotine can affect cardiovascular parameters, potentially altering response to these agents)
Monitoring
Baseline Monitoring
Smoking history (number of cigarettes per day, time to first cigarette)
Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and initial dosing.
Timing: Before initiation of therapy
Cardiovascular status (history of heart attack, stroke, arrhythmias, uncontrolled hypertension)
Rationale: Nicotine can affect the cardiovascular system; caution is advised in patients with pre-existing conditions.
Timing: Before initiation of therapy
Dental/oral health
Rationale: Gum can stick to dentures or dental work, and some oral irritation may occur.
Timing: Before initiation of therapy
Routine Monitoring
Adherence to dosing schedule and proper chewing technique
Frequency: Regularly during therapy (e.g., weekly during initial phase)
Target: Consistent use as directed, proper 'chew and park' method
Action Threshold: Inconsistent use or improper technique may lead to inadequate nicotine delivery or side effects; provide re-education.
Assessment of withdrawal symptoms and cravings
Frequency: Regularly during therapy
Target: Reduction in severity and frequency of symptoms
Action Threshold: Persistent severe withdrawal symptoms may indicate need for dose adjustment (e.g., higher strength gum, combination NRT) or alternative therapy.
Side effects (e.g., nausea, jaw pain, hiccups, heartburn, dizziness)
Frequency: Regularly during therapy
Target: Minimal or tolerable side effects
Action Threshold: Intolerable side effects may require dose reduction, change in chewing technique, or discontinuation.
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Jaw muscle soreness/pain
- Hiccups
- Heartburn
- Throat irritation
- Increased salivation
- Sleep disturbances
- Irritability (if withdrawal symptoms are not adequately controlled)
Special Patient Groups
Pregnancy
Nicotine gum is classified as Pregnancy Category D. While smoking during pregnancy poses significant risks to the fetus, nicotine itself is also harmful. It crosses the placenta and can cause fetal harm, including reduced birth weight, premature birth, and adverse neurodevelopmental effects. However, the risks of NRT are generally considered less than the risks of continued smoking. Use should only be considered if the pregnant woman is unable to quit smoking without NRT and the benefits outweigh the potential risks to the fetus, under strict medical supervision.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though less studied for NRT than for smoking. Nicotine is a vasoconstrictor and can reduce uteroplacental blood flow.
Second Trimester:
Continued exposure to nicotine can impair fetal growth and development, affecting lung and brain development.
Third Trimester:
Increased risk of premature birth, low birth weight, and potential for long-term neurobehavioral problems in the child.
Lactation
Nicotine is excreted into breast milk and can be harmful to the nursing infant. It can cause symptoms such as restlessness, irritability, vomiting, and diarrhea in the infant. The L3 (Moderately Safe) lactation risk rating suggests that while nicotine is present, the benefits of the mother quitting smoking may outweigh the risks of nicotine exposure via breast milk, especially if the mother is unable to quit by other means. If used, mothers should try to use the gum immediately after breastfeeding and avoid using it just before feeding to minimize infant exposure. Pumping and discarding milk during peak nicotine levels may also be considered.
Infant Risk:
Risk of infant exposure to nicotine and its metabolites, potentially causing adverse effects.
Pediatric Use
Not recommended for use in individuals under 18 years of age for smoking cessation without medical supervision. Safety and efficacy have not been established in this population. Nicotine is toxic to children.
Geriatric Use
No specific dose adjustments are generally required for elderly patients. However, caution is advised due to potential for increased sensitivity to nicotine's effects, especially cardiovascular effects. Monitor for side effects and adjust dose as tolerated.
Clinical Information
Clinical Pearls
- Proper chewing technique is crucial: Chew slowly until a peppery taste or tingle is felt, then 'park' the gum between the cheek and gum. When the taste fades, chew again and re-park. This 'chew and park' method allows for buccal absorption and prevents rapid release of nicotine, which can cause side effects like hiccups or heartburn.
- Do not chew the gum like regular chewing gum, as this can lead to swallowing nicotine, causing stomach upset.
- Avoid eating or drinking anything (especially acidic beverages) for 15 minutes before and during gum use to maximize absorption.
- The 2mg strength is typically for those who smoke their first cigarette more than 30 minutes after waking. The 4mg strength is for those who smoke within 30 minutes of waking.
- Nicotine gum can be used on an 'as needed' basis for cravings, but consistent use as directed (e.g., every 1-2 hours) is often more effective for managing withdrawal.
- Combining nicotine gum with a long-acting NRT (like a patch) can be more effective for heavy smokers or those with severe cravings.
- Patients should be encouraged to set a quit date and use the gum as part of a comprehensive smoking cessation plan that includes behavioral support.
Alternative Therapies
- Other Nicotine Replacement Therapies (NRTs): Nicotine patch, nicotine lozenge, nicotine inhaler, nicotine nasal spray.
- Prescription medications: Bupropion (Zyban, Wellbutrin SR), Varenicline (Chantix).
- Behavioral therapies: Counseling, support groups, cognitive behavioral therapy (CBT), quitlines.
Cost & Coverage
Average Cost:
$20 - $50 per 100-110 pieces
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, sometimes OTC benefit or FSA/HSA eligible. Coverage tier varies (e.g., Tier 1 or 2 for generics).
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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.