Nicotine Polacr 4mg Cinn Gum 100'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
Aug 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine gum is a medicine that helps you stop smoking by giving your body nicotine without the harmful chemicals found in cigarettes. It helps reduce the cravings and withdrawal symptoms you feel when you try 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. After the taste or tingling sensation subsides, chew the gum again slowly.
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 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 taste in your mouth.
3. Once you feel the tingling sensation, place the gum between your cheek and gum.
4. After the taste or tingling sensation subsides, chew the gum again slowly.
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 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
- Chew the gum slowly until you feel a tingling sensation or a peppery taste. Then, 'park' the gum between your cheek and gum. When the tingling stops, chew again slowly until the tingling returns, then park it again. Repeat this process for about 30 minutes.
- Do not chew the gum too fast or swallow it, as this can lead to hiccups, heartburn, or stomach upset.
- Avoid eating or drinking anything (especially acidic beverages like coffee, soda, or juice) for 15 minutes before and during chewing the gum, as this can reduce nicotine absorption.
- Set a quit date and start using the gum on that day. Use the gum regularly as directed, not just when you have a craving.
- Gradually reduce the number of pieces of gum you use over 12 weeks as you become more comfortable without smoking.
- Combine gum use with behavioral support programs for the best chance of quitting successfully.
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 who smoke their first cigarette within 30 minutes of waking: 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 20 pieces/day.
Condition-Specific Dosing:
heavySmokers:
4mg strength is recommended for individuals who smoke their first cigarette within 30 minutes of waking.
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 dose adjustment, use with caution.
Moderate:
No specific dose adjustment, use with caution.
Severe:
No specific dose adjustment, use with caution; monitor for increased side effects due to reduced clearance.
Dialysis:
Use with caution; monitor for increased side effects.
Hepatic Impairment:
Mild:
No specific dose adjustment, use with caution.
Moderate:
No specific dose adjustment, use with caution.
Severe:
No specific dose adjustment, use with caution; monitor for increased side effects due to reduced clearance.
Pharmacology
Mechanism of Action
Nicotine polacrilex gum provides nicotine to the body, replacing the nicotine obtained from tobacco products. This helps to reduce nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, increased appetite) experienced during smoking cessation, thereby aiding in the cessation process. Nicotine acts as an agonist at nicotinic acetylcholine receptors (nAChRs) in the central and peripheral nervous systems.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-60% (buccal absorption, highly variable)
Tmax:
15-30 minutes (after chewing)
FoodEffect:
Acidic beverages (e.g., coffee, soda, juice) can significantly reduce buccal absorption of nicotine. Avoid eating or drinking for 15 minutes before and during chewing.
Distribution:
Vd:
2.6 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 in acidic urine)
Unchanged:
Approximately 10-20% (nicotine)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Effects related to nicotine levels persist as long as nicotine is absorbed and present, but the acute craving relief is typically within 30 minutes.
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. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual 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, 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. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual 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, 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:
- Signs of too much nicotine (overdose): Nausea, vomiting, dizziness, weakness, cold sweats, confusion, blurred vision, hearing problems, fast or irregular heartbeat, seizures. Seek immediate medical attention if these occur.
- Severe allergic reaction: Rash, itching/swelling (especially of face/tongue/throat), severe dizziness, trouble breathing. Seek immediate medical attention.
- Persistent jaw pain, mouth sores, or throat irritation.
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 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. 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 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 your full attention. 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 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. 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 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 your full attention. 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 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. 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
- Weakness
- Cold sweats
- Pallor (pale skin)
- Headache
- Hearing disturbances
- Confusion
- Faintness
- Palpitations
- Abnormal heart rhythm
- Seizures
What to Do:
If you suspect an overdose, stop using the gum immediately. Call your local poison control center (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Moderate Interactions
- Adrenergic agonists (e.g., phenylephrine, isoproterenol): Nicotine can potentiate their cardiovascular effects.
- Adrenergic antagonists (e.g., labetalol, prazosin): Nicotine can reduce their effects.
- Insulin: Smoking cessation can increase subcutaneous insulin absorption and/or sensitivity, potentially requiring a dose reduction.
- Caffeine, Theophylline, Imipramine, Pentazocine: Smoking cessation can decrease the metabolism/clearance of these drugs, potentially requiring dose reduction due to increased plasma levels.
Monitoring
Baseline Monitoring
Smoking history (number of cigarettes/day, time to first cigarette)
Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and to assess baseline nicotine dependence.
Timing: Prior to initiation of therapy.
Cardiovascular status (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.
Current medications
Rationale: To identify potential drug interactions, especially with drugs whose metabolism may be affected by smoking cessation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Adherence to chewing instructions
Frequency: Regularly during therapy
Target: Proper slow chewing and 'park and chew' technique
Action Threshold: Improper technique can lead to reduced efficacy or increased side effects (e.g., GI upset, hiccups).
Side effects (e.g., jaw soreness, hiccups, nausea, dyspepsia, headache, dizziness)
Frequency: Regularly during therapy
Target: Minimal to tolerable
Action Threshold: Persistent or severe side effects may require dose adjustment, change in chewing technique, or discontinuation.
Progress towards smoking cessation and reduction of withdrawal symptoms
Frequency: Weekly or bi-weekly during initial phase, then as needed
Target: Gradual reduction in cigarette use, decreased cravings and withdrawal symptoms
Action Threshold: Lack of progress or persistent severe cravings/withdrawal may indicate need for higher dose, combination NRT, or alternative therapy.
Symptom Monitoring
- Symptoms of nicotine overdose: Nausea, vomiting, diarrhea, dizziness, weakness, cold sweats, pallor, headache, hearing disturbances, confusion, faintness, palpitations, abnormal heart rhythm, seizures.
- Symptoms of nicotine withdrawal: Irritability, frustration, anger, anxiety, difficulty concentrating, restlessness, depressed mood, insomnia, increased appetite, weight gain, cravings.
Special Patient Groups
Pregnancy
Category D. Nicotine can cause fetal harm (e.g., preterm birth, low birth weight, respiratory problems, neurodevelopmental effects). However, the risks of continued smoking during pregnancy are greater than the risks of NRT. Nicotine gum should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus, and only after behavioral counseling has failed. The lowest effective dose should be used.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on organogenesis and early fetal development.
Second Trimester:
Continued exposure can lead to growth restriction, premature rupture of membranes, and placental abnormalities.
Third Trimester:
Increased risk of preterm birth, low birth weight, and potential for neonatal nicotine withdrawal.
Lactation
Nicotine passes into breast milk. While NRT is generally preferred over continued smoking for breastfeeding mothers, nicotine levels in breast milk can be significant. To minimize infant exposure, use the gum immediately after breastfeeding, and consider using shorter-acting NRT forms (like gum) over longer-acting ones (like patches). Monitor the infant for signs of nicotine exposure (e.g., irritability, poor feeding, sleep disturbances).
Infant Risk:
Moderate risk (L3). Nicotine can cause adverse effects in the infant, but the benefits of breastfeeding generally outweigh the risks of NRT compared to continued maternal smoking.
Pediatric Use
Not recommended for individuals under 18 years of age without medical supervision. Safety and efficacy have not been established in this population. Accidental ingestion by children can be dangerous and potentially fatal.
Geriatric Use
No specific dose adjustment is required for elderly patients. However, use with caution and monitor for side effects, particularly cardiovascular effects, as elderly patients may be more susceptible to these effects.
Clinical Information
Clinical Pearls
- Proper chewing technique is paramount for efficacy and to minimize side effects. Advise patients to 'chew and park' rather than continuous chewing.
- Nicotine gum is not a 'magic bullet'; it is most effective when used as part of a comprehensive smoking cessation program that includes behavioral support.
- Patients should be encouraged to set a quit date and start using the gum on that day, rather than trying to cut down on cigarettes first.
- Emphasize the importance of avoiding acidic beverages 15 minutes before and during gum use to ensure optimal nicotine absorption.
- Advise patients not to exceed the maximum recommended daily dose (20 pieces for 4mg gum) to avoid nicotine overdose symptoms.
- The 12-week treatment course is a guideline; some patients may need to use the gum for a longer period to prevent relapse, but long-term use should be discussed with a healthcare provider.
Alternative Therapies
- Bupropion (Zyban, Wellbutrin SR)
- Varenicline (Chantix)
- Behavioral counseling and support programs (e.g., Quitline)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$60 per 100 pieces (4mg)
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, sometimes as a preferred generic or over-the-counter benefit. Coverage tier varies (e.g., Tier 1 or 2).
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 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.