Nicotine 2mg Original Gum 20s
It is used to treat nicotine withdrawal.It is used to curb the craving to smoke.
Drug Class
Smoking cessation aids
Pharmacologic Class
Nicotinic acetylcholine receptor agonists
Pregnancy Category
Category D
FDA Approved
Jan 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine gum is a medicine that helps you quit smoking by giving your body a small, controlled amount of nicotine. This helps reduce the strong cravings and uncomfortable feelings you get when you stop smoking, making it easier to break free from cigarettes without the harmful chemicals found in tobacco smoke.
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 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 use one dose; if you smoke your first cigarette more than 30 minutes after waking up, you will use the other dose. 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 or peppery taste, place the gum between your cheek and gum.
4. After the taste or tingling sensation has disappeared, 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 Usage Guidelines
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. However, do not use two pieces of gum back-to-back.
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'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 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 use one dose; if you smoke your first cigarette more than 30 minutes after waking up, you will use the other dose. 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 or peppery taste, place the gum between your cheek and gum.
4. After the taste or tingling sensation has disappeared, 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 Usage Guidelines
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. However, do not use two pieces of gum back-to-back.
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'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.
- Identify and avoid smoking triggers (e.g., certain places, people, activities).
- Develop coping strategies for cravings (e.g., deep breathing, distraction, physical activity).
- Combine gum use with behavioral support programs or counseling for best results.
- Inform family and friends about your quit attempt for support.
- Avoid acidic beverages (e.g., coffee, soda, juice) for 15 minutes before and during gum use, as they can reduce nicotine absorption.
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 smoking less than 25 cigarettes/day: 2 mg gum. Weeks 1-6: 1 piece every 1-2 hours. Weeks 7-9: 1 piece every 2-4 hours. Weeks 10-12: 1 piece every 4-8 hours. Max 24 pieces/day. Chew slowly until a peppery taste or tingle is felt, then 'park' between cheek and gum. When taste fades, chew again. Continue for about 30 minutes.
Dose Range:
1 - 24 mg
Condition-Specific Dosing:
initial_phase:
1 piece every 1-2 hours for 6 weeks
tapering_phase_1:
1 piece every 2-4 hours for 3 weeks
tapering_phase_2:
1 piece every 4-8 hours for 3 weeks
max_daily_dose:
24 pieces/day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
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:
Use with caution; nicotine clearance may be reduced. Monitor for increased side effects.
Dialysis:
Use with caution; monitor for increased side effects. Consult physician.
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
Use with caution; nicotine clearance may be reduced. Monitor for increased side effects.
Confidence:
Medium
Pharmacology
Mechanism of Action
Nicotine acts as an agonist at nicotinic acetylcholine receptors (nAChRs) in the central and peripheral nervous systems. In the brain, particularly in the ventral tegmental area, nicotine stimulates the release of dopamine, which is associated with the rewarding effects of smoking. By providing a controlled dose of nicotine, the gum helps to alleviate nicotine withdrawal symptoms (e.g., cravings, irritability, anxiety, difficulty concentrating) experienced during smoking cessation, thereby reducing the urge to smoke.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-70% of the nicotine released from the gum is absorbed buccally, but overall bioavailability is variable (around 50% of the dose released).
Tmax:
15-30 minutes (buccal absorption)
FoodEffect:
Acidic beverages (e.g., coffee, soda, juice) can significantly reduce buccal absorption of nicotine. Advise patients to avoid eating or drinking (except water) for 15 minutes before and during gum use.
Distribution:
Vd:
2-3 L/kg
ProteinBinding:
<5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Nicotine: Approximately 2 hours; Cotinine: Approximately 18-20 hours
Clearance:
Approximately 1.2 L/min (nicotine)
ExcretionRoute:
Renal (pH-dependent, increased with acidic urine)
Unchanged:
Approximately 10-20% (nicotine, highly variable based on urine pH)
Pharmacodynamics
OnsetOfAction:
5-10 minutes (for relief of withdrawal symptoms)
PeakEffect:
15-30 minutes
DurationOfAction:
Relief of withdrawal symptoms can last for several hours due to sustained nicotine levels and the longer half-life of cotinine.
Safety & Warnings
Side Effects
Urgent 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
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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they 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 a comprehensive list of all possible 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.
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
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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they 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 a comprehensive list of all possible 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 nausea or vomiting
- Dizziness or lightheadedness
- Cold sweat
- Palpitations or irregular heartbeat
- Weakness
- Confusion
- Seizures
- Difficulty breathing
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your use of tobacco or nicotine products, such as smoking or chewing tobacco, 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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
It is crucial to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your use of tobacco or nicotine products, such as smoking or chewing tobacco, 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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To increase your chances of 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 widely, so it is crucial to report any adverse effects to your doctor.
Until you understand how this medication affects you, exercise caution when engaging in activities that require alertness, such as driving. 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 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 can potentially cause problems with dental work, so this should be discussed with your dentist.
If you are following a low-sodium or sodium-free diet, consult with 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, so it is vital to keep it out of their reach. If a child uses this medication or if it is accidentally ingested by a child or pet, immediately contact a doctor or a poison control center.
Individuals aged 65 and older should use this medication with caution, as they may be more susceptible to side effects. If you are pregnant or become pregnant while taking this medication, contact your doctor promptly, as it may pose a risk to the unborn baby. Furthermore, 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 notify your doctor.
When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary widely, so it is crucial to report any adverse effects to your doctor.
Until you understand how this medication affects you, exercise caution when engaging in activities that require alertness, such as driving. 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 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 can potentially cause problems with dental work, so this should be discussed with your dentist.
If you are following a low-sodium or sodium-free diet, consult with 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, so it is vital to keep it out of their reach. If a child uses this medication or if it is accidentally ingested by a child or pet, immediately contact a doctor or a poison control center.
Individuals aged 65 and older should use this medication with caution, as they may be more susceptible to side effects. If you are pregnant or become pregnant while taking this medication, contact your doctor promptly, as it may pose a risk to the unborn baby. Furthermore, if you are breastfeeding, discuss the potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Severe nausea and vomiting
- Diarrhea
- Abdominal pain
- Excessive salivation
- Sweating
- Dizziness
- Headache
- Confusion
- Weakness
- Fainting
- Rapid or irregular heartbeat
- Low blood pressure
- Difficulty breathing
- Seizures
What to Do:
If you suspect an overdose, seek immediate medical attention. Call emergency services (e.g., 911 in the US) or a poison control center (e.g., 1-800-222-1222 in the US) right away. Remove any remaining gum from the mouth. Provide supportive care as needed.
Drug Interactions
Moderate Interactions
- Adenosine (nicotine may block adenosine-induced vasodilation)
- Beta-blockers (e.g., propranolol, labetalol - smoking cessation may increase levels due to reduced metabolism)
- Caffeine (smoking cessation may increase caffeine levels due to reduced metabolism)
- Fluvoxamine (smoking cessation may increase fluvoxamine levels)
- Imipramine (smoking cessation may increase imipramine levels)
- Insulin (smoking cessation may increase insulin absorption or effectiveness, requiring dose adjustment)
- Olanzapine (smoking cessation may increase olanzapine levels)
- Pentazocine (smoking cessation may increase pentazocine levels)
- Ropinirole (smoking cessation may increase ropinirole levels)
- Theophylline (smoking cessation may increase theophylline levels due to reduced metabolism)
Monitoring
Baseline Monitoring
Smoking history (number of cigarettes/day, duration)
Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and overall treatment plan.
Timing: Prior to initiation of therapy
Cardiovascular status (e.g., history of MI, angina, arrhythmias)
Rationale: Nicotine can have cardiovascular effects; caution is advised in patients with pre-existing cardiovascular disease.
Timing: Prior to initiation of therapy
Dental health/oral conditions
Rationale: Gum can stick to dentures or dental work, and can exacerbate existing oral conditions.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to dosing regimen
Frequency: At each follow-up visit (e.g., weekly initially, then bi-weekly/monthly)
Target: Consistent use as directed
Action Threshold: Inconsistent use or overuse may indicate need for counseling or dose adjustment.
Smoking cessation progress
Frequency: At each follow-up visit
Target: Reduction or cessation of smoking
Action Threshold: Continued smoking or relapse requires re-evaluation of treatment plan and behavioral support.
Side effects (e.g., mouth/throat irritation, jaw pain, GI upset, headache, dizziness)
Frequency: At each follow-up visit
Target: Minimal or tolerable side effects
Action Threshold: Persistent or severe side effects may require dose adjustment, change in administration technique, or discontinuation.
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Heartburn
- Indigestion
- Jaw muscle ache
- Mouth or throat irritation
- Hiccups
- Palpitations (rare)
- Signs of nicotine overdose (e.g., severe nausea/vomiting, sweating, weakness, confusion, seizures)
Special Patient Groups
Pregnancy
Nicotine gum is classified as Pregnancy Category D. While nicotine itself can cause fetal harm, the risks associated with continued smoking during pregnancy are significantly higher than the risks of nicotine replacement therapy (NRT). NRT should only be used in pregnant women if the benefits of quitting smoking outweigh the potential risks to the fetus, and under the guidance of a healthcare professional. Non-pharmacological interventions should be tried first.
Trimester-Specific Risks:
First Trimester:
Nicotine exposure in the first trimester is associated with increased risks of congenital malformations, although the direct causal link is complex due to confounding factors of smoking.
Second Trimester:
Nicotine can affect fetal growth and development, potentially leading to preterm birth, low birth weight, and adverse neurodevelopmental outcomes.
Third Trimester:
Continued nicotine exposure can lead to reduced fetal breathing movements, altered fetal heart rate, and increased risk of stillbirth and sudden infant death syndrome (SIDS) post-delivery.
Lactation
Nicotine and its metabolites (e.g., cotinine) are excreted into breast milk. While NRT delivers less nicotine than smoking, it is still present. If NRT is used, advise the lowest effective dose immediately after breastfeeding to minimize infant exposure. Consider alternative feeding methods if possible, or discuss with a healthcare provider to weigh risks vs. benefits.
Infant Risk:
L3 (Moderately safe). Potential risks to the infant include irritability, sleep disturbances, and changes in heart rate. The risks of continued maternal smoking are much greater than NRT use during lactation.
Pediatric Use
Nicotine gum is not recommended for individuals under 18 years of age for smoking cessation without specific medical supervision. Safety and efficacy have not been established in this population. Accidental ingestion by children can lead to serious nicotine poisoning.
Geriatric Use
No specific dose adjustments are typically required for elderly patients. However, geriatric patients may be more susceptible to the cardiovascular effects of nicotine. Monitor closely for side effects, especially in those with pre-existing cardiovascular conditions.
Clinical Information
Clinical Pearls
- Proper 'chew and park' technique is essential for effective buccal absorption and to minimize side effects like hiccups or heartburn. Do not chew continuously like regular gum.
- Avoid eating or drinking anything (except water) for 15 minutes before and during gum use, as acidic beverages can significantly reduce nicotine absorption.
- The 2mg strength is generally recommended for individuals who smoke their first cigarette more than 30 minutes after waking up, or who smoke less than 25 cigarettes per day.
- Encourage patients to use the gum on a fixed schedule initially (e.g., every 1-2 hours) rather than waiting for cravings, to maintain consistent nicotine levels and prevent withdrawal.
- Treatment duration is typically 12 weeks. Long-term use beyond this period should be discussed with a healthcare professional.
- Combining nicotine gum with behavioral counseling or support programs significantly increases the chances of successful smoking cessation.
Alternative Therapies
- Other Nicotine Replacement Therapies (NRTs): Nicotine patch, nicotine lozenge, nicotine inhaler, nicotine nasal spray.
- Non-nicotine pharmacotherapies: Bupropion (Zyban, Wellbutrin), Varenicline (Chantix).
- Behavioral therapies: Counseling, support groups, cognitive behavioral therapy (CBT), motivational interviewing.
Cost & Coverage
Average Cost:
$10 - $25 per 20 pieces (2mg)
Generic Available:
Yes
Insurance Coverage:
Often available over-the-counter (OTC). Some insurance plans may cover NRTs, sometimes requiring a prescription or specific program enrollment. Coverage tier varies (e.g., Tier 1 or 2 if covered).
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 your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.