Nicotine Polacr 4mg Mintgum 100s
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
D (historical); use with caution and medical supervision, benefits vs risks of continued smoking should be weighed.
FDA Approved
Jan 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine gum is a medicine that helps you quit smoking by giving your body a small amount of nicotine, which reduces the unpleasant feelings and cravings you get when you stop smoking. It helps manage withdrawal symptoms so you can focus on quitting.
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 Reminders
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 Reminders
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 until the tingling stops. Repeat this chew-and-park method for about 30 minutes.
- Do not chew the gum too fast or swallow it, as this can lead to hiccups, indigestion, or too much nicotine too quickly.
- Avoid eating or drinking anything (especially acidic beverages like coffee, soda, or fruit juice) for 15 minutes before and during the use of the gum, as this can reduce nicotine absorption.
- Use the gum on a fixed schedule initially, rather than just when cravings occur, to maintain steady nicotine levels.
- Combine gum use with behavioral support programs for best results.
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: 4 mg gum. Chew one piece every 1 to 2 hours for the first 6 weeks. Then, one piece every 2 to 4 hours for weeks 7-9. Finally, one piece every 4 to 8 hours for weeks 10-12. Do not use more than 24 pieces per day.
Condition-Specific Dosing:
initialPhase:
1 piece every 1-2 hours for 6 weeks
taperingPhase1:
1 piece every 2-4 hours for weeks 7-9
taperingPhase2:
1 piece every 4-8 hours for weeks 10-12
maximumDose:
24 pieces per day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for smoking cessation; generally not recommended.
Adolescent:
Not established for smoking cessation; use only under medical supervision if considered.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution due to potential for altered clearance.
Dialysis:
Considerations: Nicotine is dialyzable, but clinical significance for gum is low due to slow absorption. Use with caution.
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution due to potential for altered clearance.
Pharmacology
Mechanism of Action
Nicotine, an agonist at nicotinic acetylcholine receptors, replaces the nicotine from cigarettes, thereby reducing the severity of nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, restlessness, increased appetite, cravings) experienced during smoking cessation.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, approximately 50-80% of the nicotine released from the gum is absorbed buccally.
Tmax:
15-30 minutes (buccal absorption)
FoodEffect:
Acidic beverages (e.g., coffee, soda, fruit juice) can significantly reduce buccal absorption of nicotine. Patients should avoid eating or drinking acidic beverages 15 minutes before and during chewing the gum.
Distribution:
Vd:
Approximately 2.6 L/kg
ProteinBinding:
<5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Nicotine: 1-2 hours; Cotinine: Approximately 19 hours
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (pH-dependent, increased with acidic urine)
Unchanged:
10-20% (increased with acidic urine)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of proper chewing)
PeakEffect:
15-30 minutes
DurationOfAction:
Relief of withdrawal symptoms can last for the duration of elevated nicotine levels, typically 1-2 hours, but the overall effect on cravings can be more sustained.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience 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
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
Abnormal sensations, such as burning, numbness, or tingling
Dizziness, tiredness, or weakness
Diarrhea, stomach upset, 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:
Sleep disturbances
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Mouth tingling
* Gum changes
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience 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
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
Abnormal sensations, such as burning, numbness, or tingling
Dizziness, tiredness, or weakness
Diarrhea, stomach upset, 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:
Sleep disturbances
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Mouth tingling
* Gum changes
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of too much nicotine (overdose): severe nausea, vomiting, dizziness, cold sweat, confusion, weakness, fainting, seizures, rapid or irregular heartbeat.
- Severe mouth or throat irritation, jaw pain that doesn't go away.
- Allergic reaction symptoms: 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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your use of tobacco products, such as smoking or chewing tobacco, or other 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 under 18 without consulting a doctor
This list is not exhaustive, and it is crucial to discuss all your medications (prescription and over-the-counter), natural products, 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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your use of tobacco products, such as smoking or chewing tobacco, or other 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 under 18 without consulting a doctor
This list is not exhaustive, and it is crucial to discuss all your medications (prescription and over-the-counter), natural products, 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 driving and engaging in other activities that require alertness. 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 on a low-sodium or sodium-free diet, consult with your doctor, as some products contain sodium.
This medication can be hazardous or even fatal if ingested by children or pets, so it is vital to keep it out of their reach. If a child uses this medication or ingests it, immediately contact a doctor or poison control center.
If you are 65 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 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 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 driving and engaging in other activities that require alertness. 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 on a low-sodium or sodium-free diet, consult with your doctor, as some products contain sodium.
This medication can be hazardous or even fatal if ingested by children or pets, so it is vital to keep it out of their reach. If a child uses this medication or ingests it, immediately contact a doctor or poison control center.
If you are 65 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 harm 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
- Cold sweat
- Confusion
- Weakness
- Fainting
- Seizures
- Rapid or irregular heartbeat
- Trouble breathing
What to Do:
If you suspect an overdose, stop using the gum immediately and call your doctor or poison control center (1-800-222-1222) right away. Seek emergency medical attention if symptoms are severe.
Drug Interactions
Moderate Interactions
- Adrenergic agonists (e.g., phenylephrine, isoproterenol): Nicotine may decrease their effects.
- Adrenergic antagonists (e.g., labetalol, prazosin): Nicotine may increase their effects.
- Insulin: Nicotine may increase subcutaneous absorption of insulin.
- Caffeine, Theophylline, Imipramine, Pentazocine: Nicotine may increase their metabolism/clearance, potentially requiring dose adjustments upon smoking cessation.
Monitoring
Baseline Monitoring
Smoking history (number of cigarettes per day, time to first cigarette)
Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and initial dosing.
Timing: Prior to initiation of therapy
Cardiovascular history (e.g., recent MI, unstable angina, severe arrhythmias)
Rationale: Nicotine can exacerbate cardiovascular conditions; caution is advised.
Timing: Prior to initiation of therapy
Dental health assessment
Rationale: Gum can stick to dentures, fillings, or cause dental problems.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to chewing instructions and dosing schedule
Frequency: Regularly during therapy
Target: As prescribed
Action Threshold: Poor adherence may lead to treatment failure or side effects; reinforce proper technique.
Assessment of nicotine withdrawal symptoms
Frequency: Weekly during initial phase, then as needed
Target: Reduction in severity
Action Threshold: Persistent severe symptoms may indicate need for dose adjustment or combination therapy.
Monitoring for side effects (e.g., mouth/throat irritation, GI upset, jaw soreness)
Frequency: Regularly during therapy
Target: Minimal to tolerable
Action Threshold: Severe or persistent side effects may require dose reduction, change in product, or discontinuation.
Progress towards smoking cessation
Frequency: Weekly during initial phase, then monthly
Target: Complete abstinence
Action Threshold: Lack of progress may indicate need for additional support or alternative strategies.
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Palpitations
- Mouth or throat irritation
- Jaw soreness
- Indigestion
- Hiccups
- Excessive salivation
- Signs of nicotine overdose (e.g., cold sweat, confusion, weakness, seizures)
Special Patient Groups
Pregnancy
Nicotine crosses the placenta and can harm the fetus. While non-pharmacological methods are preferred for smoking cessation in pregnancy, if these are unsuccessful, nicotine replacement therapy (NRT) may be considered under strict medical supervision. The risks of NRT are generally considered less than the risks of continued smoking, but the lowest effective dose should be used for the shortest duration possible.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, though less than continued smoking.
Second Trimester:
Potential for adverse effects on fetal development and growth.
Third Trimester:
Potential for adverse effects on fetal development, growth, and respiratory function; may affect fetal breathing movements.
Lactation
Nicotine is excreted into breast milk. While NRT is generally considered safer than continued smoking for the infant, it's best to use the lowest effective dose and consider using the gum immediately after breastfeeding to minimize infant exposure. Pumping and discarding milk after use is another option. Consult with a healthcare provider.
Infant Risk:
Low to moderate risk. Nicotine can cause irritability, sleep disturbances, and gastrointestinal upset in the infant. Cotinine, an active metabolite, also passes into breast milk.
Pediatric Use
Nicotine gum is not indicated for smoking cessation in individuals under 18 years of age. 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 adjustments are generally required for elderly patients. However, use with caution in elderly patients with pre-existing cardiovascular disease, diabetes, or other significant comorbidities, as they may be more susceptible to adverse effects of nicotine.
Clinical Information
Clinical Pearls
- Proper chewing technique is paramount for effective nicotine delivery and to minimize side effects like hiccups or indigestion. Emphasize 'chew and park'.
- Nicotine gum is a tool to help manage withdrawal, not a magic bullet. It works best when combined with behavioral support and a strong commitment to quit.
- Patients should be advised to avoid acidic beverages (e.g., coffee, soda, juice) 15 minutes before and during gum use, as they can significantly impair nicotine absorption.
- The 4mg strength is typically recommended for individuals who smoke their first cigarette within 30 minutes of waking, indicating higher nicotine dependence.
- Encourage patients to gradually reduce the number of pieces used per day over the 12-week course to successfully taper off nicotine.
Alternative Therapies
- Bupropion (Zyban, Wellbutrin SR)
- Varenicline (Chantix)
- Non-pharmacological interventions (e.g., counseling, behavioral therapy, support groups)
Cost & Coverage
Average Cost:
$30 - $60 per 100 pieces (4mg)
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans (Tier 1 or 2) or as an over-the-counter benefit. Coverage varies by insurance 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 details. 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 information about the medication taken, the amount, and the time it happened.