Nicotine Polacr 2mg Gum Orig 50s
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
Aug 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine gum is a medicine that helps people quit smoking by providing nicotine to the body without the harmful chemicals found in cigarettes. It helps reduce the cravings and withdrawal symptoms you feel when you stop smoking.
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 sensation in your mouth.
3. Once you feel the tingling sensation, place the gum between your cheek and gum.
4. When the sensation disappears, chew the gum slowly again and place it between your cheek and gum at a different site.
5. Repeat this process for about 30 minutes or until the tingling sensation is gone.
Important Instructions
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 sensation in your mouth.
3. Once you feel the tingling sensation, place the gum between your cheek and gum.
4. When the sensation disappears, chew the gum slowly again and place it between your cheek and gum at a different site.
5. Repeat this process for about 30 minutes or until the tingling sensation is gone.
Important Instructions
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
- Use the 'chew and park' method: Chew the gum slowly until you feel a tingling sensation or a peppery taste, then 'park' it between your cheek and gum. When the tingling fades, chew again and repeat. This allows nicotine to be absorbed through the lining of your mouth.
- Do not chew too fast or swallow the gum, as this can lead to stomach upset (hiccups, heartburn, nausea).
- Avoid eating or drinking anything (especially acidic beverages like coffee, soda, or fruit juice) for 15 minutes before and during chewing, as they can reduce nicotine absorption.
- Gradually reduce the number of pieces of gum used over 12 weeks as directed by the product instructions or your doctor.
- Do not smoke or use other nicotine products while using nicotine 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:
For those smoking their first cigarette more than 30 minutes after waking: 2 mg gum. For those smoking their first cigarette within 30 minutes of waking: 4 mg gum. Initial phase (Weeks 1-6): 1 piece every 1-2 hours. Reduction phase (Weeks 7-9): 1 piece every 2-4 hours. Further reduction (Weeks 10-12): 1 piece every 4-8 hours.
Condition-Specific Dosing:
maximum_daily_dose:
Do not use more than 24 pieces 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 (Not recommended for individuals under 18 years of age without medical supervision)
Adolescent:
Not established (Not recommended for individuals under 18 years of age without medical supervision)
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:
Considerations: Nicotine is dialyzable, but clinical significance for NRT gum is low due to slow absorption and short half-life. Use with caution.
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. It binds to alpha4beta2 nicotinic receptors in the brain's reward pathways, leading to dopamine release.
Pharmacokinetics
Absorption:
Bioavailability:
30-60% (highly variable, dependent on chewing technique)
Tmax:
15-30 minutes
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 chewing.
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
ExcretionRoute:
Renal (pH-dependent, increased in acidic urine)
Unchanged:
10-30% (dependent on urine pH)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Effects persist as long as nicotine levels are elevated, but the acute craving relief is typically within 30 minutes.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Mood changes
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
Burning, numbness, or tingling sensations that are not normal
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
Drooling
Shakiness
Sore throat
Mouth, teeth, or jaw problems
Cold sweats
Blurred vision
Changes in hearing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you're bothered by any of the following:
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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Mood changes
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
Burning, numbness, or tingling sensations that are not normal
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
Drooling
Shakiness
Sore throat
Mouth, teeth, or jaw problems
Cold sweats
Blurred vision
Changes in hearing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you're bothered by any of the following:
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, headache, cold sweat, confusion, weakness, fainting, seizures, blurred vision, hearing difficulties, rapid or irregular heartbeat.
- Signs of 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your tobacco use, including smoking, chewing tobacco, or using nicotine products, as these may interact with this medication
If you have temporomandibular joint (TMJ) disease
* 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 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 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your tobacco use, including smoking, chewing tobacco, or using nicotine products, as these may interact with this medication
If you have temporomandibular joint (TMJ) disease
* 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 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 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, 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 can 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 can potentially cause problems 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. 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.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
For pregnant women, this medication may pose a risk to the unborn baby. If you become pregnant or are already pregnant while taking this medication, notify your doctor promptly. 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, 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 can 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 can potentially cause problems 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. 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.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
For pregnant women, this medication may pose a risk to the unborn baby. If you become pregnant or are already pregnant while taking this medication, notify your doctor promptly. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Cold sweat
- Confusion
- Weakness
- Fainting
- Blurred vision
- Hearing difficulties
- Rapid or irregular heartbeat
- Seizures
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 remaining gum from the mouth. Provide supportive care as needed.
Drug Interactions
Moderate Interactions
- Adenosine (potential for increased cardiovascular effects)
- Beta-blockers (e.g., propranolol, labetalol - smoking cessation may increase their effects due to reduced metabolism)
- Caffeine (smoking cessation may increase caffeine levels due to reduced metabolism)
- Insulin (smoking cessation may increase insulin absorption/effect, requiring dose adjustment)
- Theophylline (smoking cessation may increase theophylline levels due to reduced metabolism)
- Fluvoxamine (smoking cessation may increase fluvoxamine levels)
- Clozapine, Olanzapine, Ropinirole (smoking cessation may increase levels of these drugs)
Monitoring
Baseline Monitoring
Smoking history (number of cigarettes/day, time to first cigarette)
Rationale: To determine appropriate starting dose (2mg vs 4mg) and assess dependence level.
Timing: Prior to initiation of therapy
Cardiovascular history (e.g., recent MI, unstable angina, severe arrhythmias)
Rationale: Nicotine can have cardiovascular effects; caution is advised in patients with pre-existing cardiovascular disease.
Timing: Prior to initiation of therapy
Routine Monitoring
Smoking status
Frequency: Weekly initially, then periodically
Target: Complete abstinence from smoking
Action Threshold: Continued smoking while using NRT may lead to nicotine toxicity; reassess therapy.
Adherence to chewing instructions
Frequency: At follow-up visits
Target: Proper 'chew and park' technique, avoiding acidic beverages
Action Threshold: Improper use can lead to reduced efficacy or increased side effects (e.g., dyspepsia, jaw ache).
Side effects (e.g., nausea, dyspepsia, jaw ache, mouth/throat irritation, dizziness)
Frequency: At follow-up visits
Target: Minimal to tolerable side effects
Action Threshold: Severe or persistent side effects may require dose adjustment, change in NRT formulation, or discontinuation.
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Palpitations
- Mouth/throat irritation
- Jaw ache
- Dyspepsia
- Hiccups
Special Patient Groups
Pregnancy
Category D. Nicotine can harm the fetus. While quitting smoking is crucial during pregnancy, NRT should only be used if the benefits outweigh the risks and under medical supervision. Behavioral counseling is preferred first-line. If NRT is used, intermittent dosing forms (like gum) may be preferred over continuous forms (like patches) to allow for nicotine-free periods.
Trimester-Specific Risks:
First Trimester:
Increased risk of birth defects, premature birth, low birth weight.
Second Trimester:
Increased risk of premature birth, low birth weight, respiratory problems.
Third Trimester:
Increased risk of premature birth, low birth weight, stillbirth, sudden infant death syndrome (SIDS).
Lactation
Nicotine passes into breast milk and can harm a nursing infant. While NRT is safer than smoking, it's still advisable to minimize infant exposure. If used, advise the mother to use the lowest effective dose, use the gum immediately after breastfeeding, and avoid using it for at least 2-3 hours before the next feeding to allow nicotine levels to decrease.
Infant Risk:
Risk of infant exposure to nicotine, which can cause irritability, sleep disturbances, and potentially long-term developmental effects. Cotinine, an active metabolite, also passes into breast milk.
Pediatric Use
Not recommended for individuals under 18 years of age without medical supervision. Safety and efficacy have not been established in this population for smoking cessation.
Geriatric Use
Use with caution in elderly patients, especially those with pre-existing cardiovascular disease, due to potential cardiovascular effects of nicotine. No specific dose adjustment is typically required based on age alone, but monitor for side effects.
Clinical Information
Clinical Pearls
- Emphasize the 'chew and park' method to patients to maximize absorption and minimize side effects like hiccups and stomach upset.
- Advise patients to avoid acidic beverages (coffee, soda, juice) 15 minutes before and during gum use, as they can significantly reduce nicotine absorption.
- Nicotine gum can help manage acute cravings quickly due to its rapid onset 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.
- Combine NRT with behavioral support for the best quitting outcomes.
Alternative Therapies
- Other Nicotine Replacement Therapies (NRTs): Nicotine patch, nicotine lozenge, nicotine inhaler, nicotine nasal spray.
- Non-nicotine pharmacotherapies: Bupropion SR (Zyban, Wellbutrin SR), Varenicline (Chantix).
- Behavioral therapies: Counseling, support groups, quitlines.
Cost & Coverage
Average Cost:
$20 - $40 per 50 pieces (2mg)
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans (even if OTC) or health savings accounts (HSAs/FSAs). Some state Medicaid programs or employer wellness programs may cover it.
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 overdose, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.