Nicotine Polacr 2mg Gum 40'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 you quit smoking by giving you a small, controlled amount of nicotine. This helps reduce the strong cravings and withdrawal symptoms you feel 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'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. When the taste or tingling sensation disappears, chew the gum again slowly and place it between your cheek and gum at a different site.
5. Repeat this process for about 30 minutes or until the taste or tingling sensation is gone.
6. Avoid eating or drinking within 15 minutes before using the gum or while you're using it.
7. 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. 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 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. When the taste or tingling sensation disappears, chew the gum again slowly and place it between your cheek and gum at a different site.
5. Repeat this process for about 30 minutes or until the taste or tingling sensation is gone.
6. Avoid eating or drinking within 15 minutes before using the gum or while you're using it.
7. 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. 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.
- Avoid situations or triggers that make you want to smoke.
- Seek behavioral support or counseling to increase your chances of success.
- Do not smoke or use other nicotine products while using nicotine gum.
- Avoid eating or drinking anything (except water) for 15 minutes before and during gum use, as it can reduce nicotine absorption.
- Proper chewing technique is crucial: chew slowly until you feel a tingle, then 'park' the gum between your cheek and gum until the tingle fades, then repeat. Do not chew continuously like regular gum.
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:
Chew one 2mg piece of gum slowly until a peppery taste or tingle is felt, then 'park' it between the cheek and gum. When the taste or tingle fades, chew again and repeat the process. Continue for about 30 minutes. Use 1 piece every 1-2 hours for the first 6 weeks, then gradually reduce frequency over 12 weeks. Max 24 pieces/day.
Condition-Specific Dosing:
initial_use:
For individuals who smoke their first cigarette more than 30 minutes after waking.
max_daily_dose:
Do not exceed 24 pieces per day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Not recommended for individuals under 18 years of age)
Adolescent:
Not established (Not recommended for individuals under 18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution.
Dialysis:
Consideration for reduced clearance; use with caution and monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution.
Pharmacology
Mechanism of Action
Nicotine acts as an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems. In smoking cessation, it replaces the nicotine from cigarettes, reducing withdrawal symptoms and cravings associated with nicotine dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-70% of the nicotine released from the gum is absorbed buccally.
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 (except water) for 15 minutes before and during gum use.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
Less than 5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2 hours (nicotine), 15-19 hours (cotinine)
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (pH-dependent, increased with acidic urine)
Unchanged:
Approximately 10-20% (dependent on urine pH)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Effects persist as long as nicotine is absorbed from the gum (approx. 30 minutes per piece), with sustained relief of cravings for longer periods.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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. 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 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.
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 attention 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. 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 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:
- Severe nausea or vomiting
- Dizziness or lightheadedness
- Weakness
- Rapid or irregular heartbeat (palpitations)
- Seizures
- Difficulty 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 to this medication, its components, or other substances, including foods and drugs. Be sure to describe the allergic reaction you experienced.
If you have a history of chest pain or pressure, an irregular heartbeat, or have recently had a heart attack.
If you currently use nicotine products, such as smoking, chewing tobacco, or using other nicotine-containing products, while taking this medication.
If you have temporomandibibular joint (TMJ) disease.
* If you are under 18 years of age. 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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health issues. 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 to this medication, its components, or other substances, including foods and drugs. Be sure to describe the allergic reaction you experienced.
If you have a history of chest pain or pressure, an irregular heartbeat, or have recently had a heart attack.
If you currently use nicotine products, such as smoking, chewing tobacco, or using other nicotine-containing products, while taking this medication.
If you have temporomandibibular joint (TMJ) disease.
* If you are under 18 years of age. 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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health issues. 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, notify your doctor to avoid potential interactions.
When attempting to quit smoking, even with the assistance of this medication, you may experience symptoms of nicotine withdrawal. These symptoms can vary, so it is crucial to report any adverse effects to your doctor.
Until you understand how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, be aware that quitting smoking may alter the effectiveness of other medications you are taking, so consult your doctor to discuss potential adjustments.
If you have not been able to quit smoking after using this medication for the recommended duration, inform your doctor. It is also important to note that chewing gum, particularly if you have dental work such as crowns or bridges, may cause problems.
If you are on a low-sodium or sodium-free diet, consult your doctor before using this medication, as some products contain sodium.
This medication can be hazardous or even fatal if ingested by children or pets. 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 harm 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, notify your doctor to avoid potential interactions.
When attempting to quit smoking, even with the assistance of this medication, you may experience symptoms of nicotine withdrawal. These symptoms can vary, so it is crucial to report any adverse effects to your doctor.
Until you understand how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, be aware that quitting smoking may alter the effectiveness of other medications you are taking, so consult your doctor to discuss potential adjustments.
If you have not been able to quit smoking after using this medication for the recommended duration, inform your doctor. It is also important to note that chewing gum, particularly if you have dental work such as crowns or bridges, may cause problems.
If you are on a low-sodium or sodium-free diet, consult your doctor before using this medication, as some products contain sodium.
This medication can be hazardous or even fatal if ingested by children or pets. 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 harm 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 or irregular heartbeat
- Cold sweat
- Confusion
- Fainting
- Seizures
- Difficulty breathing
What to Do:
If you suspect an overdose, stop using the gum immediately and seek emergency medical attention or call a Poison Control Center (1-800-222-1222). Remove any gum from the mouth. Keep out of reach of children and pets.
Drug Interactions
Moderate Interactions
- Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Beta-blockers (nicotine cessation may lead to increased beta-blocker effects due to reduced sympathetic tone)
- Insulin (nicotine cessation may lead to increased insulin absorption/effects due to improved subcutaneous blood flow)
- Theophylline (nicotine cessation may lead to increased theophylline levels due to reduced metabolism)
- Caffeine (nicotine cessation may lead to increased caffeine levels due to reduced metabolism)
- Adrenergic agonists (e.g., phenylephrine, isoproterenol - nicotine may potentiate their effects)
- Adrenergic antagonists (e.g., prazosin, labetalol - nicotine may reduce their effects)
Monitoring
Baseline Monitoring
Smoking history and dependence level
Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and dosing schedule.
Timing: Prior to initiation of therapy
Cardiovascular status (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
Dental/oral health assessment
Rationale: Gum can stick to dentures or dental work, and may exacerbate existing oral conditions.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in cravings, smoking cessation)
Frequency: Regularly throughout therapy (e.g., weekly for first few weeks, then monthly)
Target: Progressive reduction in nicotine cravings and cigarette consumption, leading to complete cessation.
Action Threshold: If no significant reduction in cravings or continued smoking, consider dose adjustment, combination NRT, or alternative therapies.
Adverse effects (e.g., nausea, hiccups, jaw soreness, dyspepsia, dizziness)
Frequency: Regularly throughout therapy
Target: Minimal to tolerable side effects
Action Threshold: If severe or persistent side effects, consider dose reduction, alternative NRT, or discontinuation.
Adherence to proper chewing technique
Frequency: Periodically, especially early in therapy
Target: Correct 'chew and park' method
Action Threshold: Incorrect use can lead to rapid nicotine release, causing side effects (e.g., hiccups, heartburn) or reduced efficacy.
Symptom Monitoring
- Nausea
- Hiccups
- Jaw soreness
- Dyspepsia (heartburn, indigestion)
- Dizziness
- Headache
- Throat irritation
- Palpitations
- Insomnia
Special Patient Groups
Pregnancy
Nicotine gum is classified as Pregnancy Category D. While nicotine itself is harmful to the fetus, the risks of continued smoking during pregnancy generally outweigh the risks of nicotine replacement therapy (NRT). NRT should be used in pregnant women only after careful consideration and under medical supervision, with the goal of complete smoking cessation.
Trimester-Specific Risks:
First Trimester:
Nicotine exposure can lead to vasoconstriction and reduced placental blood flow, potentially affecting fetal development. However, the risks of smoking (e.g., carbon monoxide, thousands of toxins) are far greater.
Second Trimester:
Continued nicotine exposure can impact fetal lung development and increase risks of preterm birth and low birth weight.
Third Trimester:
Increased risk of preterm birth, low birth weight, and potential long-term neurodevelopmental effects. NRT should be used at the lowest effective dose for the shortest duration.
Lactation
Nicotine is excreted into breast milk and can be harmful to the nursing infant. While NRT is generally preferred over continued smoking, the infant will still be exposed to nicotine. If NRT is used, it should be at the lowest effective dose, and the mother should consider using the gum immediately after breastfeeding to minimize infant exposure.
Infant Risk:
Risk level L3 (Moderate hazard). Potential effects include irritability, sleep disturbances, and increased heart rate in the infant. Cotinine, an active metabolite, also passes into breast milk.
Pediatric Use
Nicotine gum is not recommended for individuals under 18 years of age. Safety and efficacy have not been established in this population. Nicotine can be toxic to children, and even small amounts can cause serious harm.
Geriatric Use
No specific dose adjustments are generally required for elderly patients. However, caution should be exercised due to potential age-related decreases in renal or hepatic function and increased sensitivity to nicotine's cardiovascular effects. Monitor for adverse effects.
Clinical Information
Clinical Pearls
- The 'chew and park' method is essential for proper nicotine absorption and to minimize side effects like hiccups and heartburn. Do not chew continuously like regular gum.
- Patients should be encouraged to use the gum regularly, not just when cravings are intense, especially during the initial weeks of quitting.
- Combination NRT (e.g., nicotine patch for continuous nicotine delivery plus gum for acute cravings) can be more effective for highly dependent smokers.
- Behavioral support and counseling significantly improve the success rates of smoking cessation with NRT.
- Acidic beverages can significantly reduce nicotine absorption from the gum; advise patients to avoid them 15 minutes before and during use.
- Nicotine gum can stick to dentures or dental work; advise patients to be aware of this.
Alternative Therapies
- Nicotine patch
- Nicotine lozenge
- Nicotine inhaler
- Nicotine nasal spray
- Bupropion SR (Zyban, Wellbutrin SR)
- Varenicline (Chantix)
- Cytisine (Tabex - not FDA approved in US)
Cost & Coverage
Average Cost:
$20 - $40 per 40 pieces
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans (even though OTC) or health savings accounts (HSAs)/flexible spending accounts (FSAs) for smoking cessation. Coverage varies by plan.
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 this 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 taken, the amount, and the time it happened.