Nicotine Gum 4mg Starter Kit 110'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 medicine that helps people quit smoking by giving them a small, controlled amount of nicotine. This helps reduce the strong cravings and other uncomfortable feelings you get when you stop smoking, making it easier to quit.
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 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 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.
6. 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 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 throwing it away.
What to Do If You Miss a Dose
If you miss a dose, use it as soon as you remember.
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 how soon you smoke your first cigarette after waking up. 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 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.
6. 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 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 throwing it away.
What to Do If You Miss a Dose
If you miss a dose, use it as soon as you remember.
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.
- Follow the chewing instructions carefully: chew slowly until you feel a tingle or taste, then 'park' the gum between your cheek and gum. Chew again when the taste fades. This ensures proper absorption and reduces side effects.
- Avoid eating or drinking anything (except water) for 15 minutes before and during chewing the gum, as acidic beverages can reduce nicotine absorption.
- Gradually reduce the number of pieces of gum used per day over the 12-week treatment period as directed.
- Set a quit date and commit to it. Nicotine gum is a tool to help, but your commitment is key.
- Consider behavioral support or counseling to increase your chances of success.
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 25 or more cigarettes per day: 4 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 use more than 24 pieces per day.
Condition-Specific Dosing:
light_smokers:
For individuals smoking less than 25 cigarettes per day, 2 mg gum is typically recommended, but 4 mg may be used if 2 mg is insufficient.
chewing_technique:
Chew slowly until a tingle or peppery taste is felt, then 'park' the gum between the cheek and gum. When the taste fades, chew again. Repeat for about 30 minutes.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (contraindicated for individuals under 18 years of age)
Adolescent:
Not established (contraindicated for individuals under 18 years of age without medical supervision)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for increased side effects.
Moderate:
No specific adjustment recommended, monitor for increased side effects.
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, monitor for increased side effects.
Moderate:
Use with caution; nicotine clearance may be reduced. Monitor for increased side effects.
Severe:
Use with caution; nicotine clearance may be significantly reduced. Monitor for increased side effects. Consult physician.
Pharmacology
Mechanism of Action
Nicotine acts as an agonist at nicotinic acetylcholine receptors (nAChRs) in the central and peripheral nervous systems. By binding to these receptors, it stimulates the release of neurotransmitters such as dopamine, norepinephrine, acetylcholine, serotonin, GABA, and glutamate. In the context of smoking cessation, nicotine gum provides a controlled dose of nicotine to reduce withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) associated with abrupt cessation of tobacco use, thereby helping individuals manage their nicotine dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-60% (of the absorbed dose, overall absorption from gum is variable depending on chewing technique and pH of the mouth)
Tmax:
15-30 minutes
FoodEffect:
Acidic beverages (e.g., coffee, soda, fruit juice) can significantly reduce the absorption of nicotine from the oral cavity. Patients should avoid eating or drinking anything except water for 15 minutes before and during chewing the gum.
Distribution:
Vd:
2-3 L/kg
ProteinBinding:
<5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Nicotine: 2-3 hours; Cotinine: 15-20 hours
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
10-20% (nicotine), <5% (cotinine)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of proper chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Acute effects last for the duration of absorption (approx. 30 minutes per piece), but overall effect on withdrawal symptoms is sustained by regular dosing.
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
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. 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 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 about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek 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
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. 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 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 about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of nicotine overdose: severe nausea, vomiting, dizziness, weakness, cold sweat, pale skin, rapid or irregular heartbeat, confusion, seizures.
- Severe mouth, jaw, or throat pain.
- Allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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 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 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 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 may lead to unsafe side effects. If you are using another medication to aid in smoking cessation, be sure to notify your doctor.
When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary, so it is crucial to report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, be aware that quitting smoking may impact 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, such as nicotine gum, may cause problems with dental work, so this should be discussed with your dentist.
If you are on a low-sodium or sodium-free diet, consult with your doctor before using this medication, as some products may contain sodium. It is also critical to keep this medication out of reach of children and pets, as it can be harmful or even fatal if ingested. If a child uses this medication or if it is swallowed by a child or pet, immediately contact a doctor or poison control center.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Furthermore, if you are pregnant or become pregnant while taking this medication, notify 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 may lead to unsafe side effects. If you are using another medication to aid in smoking cessation, be sure to notify your doctor.
When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary, so it is crucial to report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, be aware that quitting smoking may impact 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, such as nicotine gum, may cause problems with dental work, so this should be discussed with your dentist.
If you are on a low-sodium or sodium-free diet, consult with your doctor before using this medication, as some products may contain sodium. It is also critical to keep this medication out of reach of children and pets, as it can be harmful or even fatal if ingested. If a child uses this medication or if it is swallowed by a child or pet, immediately contact a doctor or poison control center.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Furthermore, if you are pregnant or become pregnant while taking this medication, notify 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:
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Weakness
- Cold sweat
- Pale skin
- Abdominal pain
- Salivation
- Confusion
- Hearing and vision disturbances
- Rapid or irregular heartbeat (tachycardia, arrhythmias)
- Hypotension (low blood pressure)
- Respiratory depression
- Seizures
- Coma
What to Do:
If you suspect an overdose, seek immediate medical attention. Call 911 or your local emergency number. You can also contact a poison control center at 1-800-222-1222. Remove any remaining gum from the mouth. Provide supportive care, including respiratory and cardiovascular support as needed. Activated charcoal may be considered if ingestion was recent.
Drug Interactions
Moderate Interactions
- Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Beta-blockers (nicotine may blunt the hypotensive effects of beta-blockers)
- Insulin (nicotine may increase blood glucose levels, potentially requiring increased insulin dosage)
- Theophylline (nicotine may increase the metabolism of theophylline, leading to decreased therapeutic effect)
- Caffeine (nicotine may increase the metabolism of caffeine, leading to decreased caffeine levels)
- Imipramine (nicotine may increase the metabolism of imipramine)
- Pentazocine (nicotine may increase the metabolism of pentazocine)
Monitoring
Baseline Monitoring
Smoking history and dependence level
Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and initial dosing schedule.
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 conditions.
Timing: Prior to initiation of therapy
Dental/oral health
Rationale: Gum can stick to dentures, bridges, or cause jaw pain/mouth irritation.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to dosing schedule and proper chewing technique
Frequency: Regularly during therapy (e.g., weekly)
Target: As prescribed/directed
Action Threshold: Poor adherence or incorrect technique may lead to treatment failure or increased side effects; provide re-education.
Assessment of nicotine withdrawal symptoms
Frequency: Regularly during therapy
Target: Reduction in severity of symptoms
Action Threshold: Persistent severe withdrawal symptoms may indicate need for dose adjustment or alternative therapy.
Assessment of nicotine overdose symptoms
Frequency: Regularly during therapy
Target: Absence of symptoms
Action Threshold: Presence of symptoms (nausea, vomiting, dizziness, weakness, rapid heartbeat) requires immediate intervention and dose reduction/cessation.
Oral/dental discomfort or irritation
Frequency: Regularly during therapy
Target: Absence or mild discomfort
Action Threshold: Persistent or severe discomfort may require discontinuation or change to another NRT.
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Jaw muscle ache
- Mouth or throat irritation
- Heartburn
- Indigestion
- Hiccups
- Insomnia
- Nervousness
- Irritability
Special Patient Groups
Pregnancy
Nicotine is harmful to the fetus and is classified as Pregnancy Category D. However, the risks of continued smoking during pregnancy are significantly higher than the risks associated with nicotine replacement therapy (NRT). NRT should be considered only if the pregnant woman is unable to quit smoking without it, and under strict medical supervision. The lowest effective dose should be used for the shortest possible duration.
Trimester-Specific Risks:
First Trimester:
Nicotine exposure can lead to congenital malformations, premature birth, and low birth weight.
Second Trimester:
Continued exposure increases risks of premature birth, low birth weight, and potential long-term neurodevelopmental effects.
Third Trimester:
Increased risk of premature birth, low birth weight, stillbirth, and potential for neonatal nicotine withdrawal.
Lactation
Nicotine and its metabolites (e.g., cotinine) are excreted into breast milk. While NRT delivers less nicotine than smoking, it still exposes the infant. If NRT is used, the mother should try to time doses to minimize infant exposure (e.g., use gum immediately after breastfeeding). The lowest effective dose should be used. Breastfeeding is generally preferred over formula feeding, even with NRT use, as the risks of formula feeding outweigh the risks of low-level nicotine exposure. Consult a healthcare provider.
Infant Risk:
L3 (Moderate risk). Potential for infant irritability, sleep disturbances, and increased heart rate. Long-term effects are not fully established but are considered less harmful than exposure to tobacco smoke.
Pediatric Use
Nicotine gum is contraindicated for individuals under 18 years of age without medical supervision. Safety and efficacy have not been established in pediatric populations for smoking cessation. Accidental ingestion by children can be dangerous and potentially fatal.
Geriatric Use
No specific dose adjustments are generally required for elderly patients. However, elderly patients 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 is paramount for effective nicotine absorption and to minimize side effects like hiccups or heartburn. Patients should be instructed to 'chew and park' rather than continuous chewing like regular gum.
- Acidic beverages (e.g., coffee, soda, juice) can significantly impair nicotine absorption from the gum. Advise patients to avoid these for 15 minutes before and during gum use.
- Nicotine gum is not a 'chewing gum' in the traditional sense; it's a medication. Over-chewing can lead to rapid nicotine release, causing side effects and reducing the duration of action.
- Encourage patients to use the gum on a fixed schedule initially (e.g., every 1-2 hours) rather than only when cravings occur, to maintain steady nicotine levels and prevent withdrawal symptoms.
- The 4mg strength is typically recommended for individuals who smoke their first cigarette within 30 minutes of waking up, indicating higher nicotine dependence.
- Combine NRT with behavioral support or counseling for the best chance of successful smoking cessation.
Alternative Therapies
- Other Nicotine Replacement Therapies (NRTs): Nicotine patch, nicotine lozenge, nicotine inhaler, nicotine nasal spray.
- Pharmacological agents: Bupropion (Zyban, Wellbutrin SR), Varenicline (Chantix).
- Non-pharmacological interventions: Behavioral counseling, cognitive behavioral therapy (CBT), motivational interviewing, support groups, acupuncture, hypnotherapy (evidence for efficacy varies).
Cost & Coverage
Average Cost:
$30 - $60 per 100-110 pieces
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans (Tier 1 or 2) or through OTC benefits. Some state Medicaid programs and employer plans cover NRTs.
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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information, including the name of the medication taken, the amount, and the time it occurred.