Nicotine Polacr 4mg Orig Gum 50'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
D
FDA Approved
Jan 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine gum is a type of nicotine replacement therapy (NRT) that helps you quit smoking by providing your body with a small, controlled amount of nicotine. This helps reduce the cravings and withdrawal symptoms you feel when you stop smoking. You chew the gum slowly until you feel a tingle, then 'park' it between your cheek and gum to allow the nicotine to be absorbed.
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
- Stop smoking completely when you start using nicotine gum.
- Do not eat or drink anything (except water) for 15 minutes before and during chewing the gum.
- Chew the gum slowly until a tingle or peppery taste is felt, then 'park' it between your cheek and gum. When the tingle fades, chew again and repeat the process.
- Do not chew the gum too fast or swallow it, as this can lead to stomach upset or hiccups.
- Follow the recommended dosing schedule to gradually reduce your nicotine intake over 12 weeks.
Available Forms & Alternatives
Available Strengths:
- Nicotine Gum 2mg Mint Refill 50's
- Nicotine Gum 4mg Starter Kit 110's
- Nicotine Polacr 4mg Mint Gum 40's
- Nicotine Polacr 4mg Mintgum 100s
- Nicotine Polacr 2mg Gum 40's
- Nicotine Pol 2mg Mint Gum 100s
- Nicotine Polacr 4mg Cinn Gum 100's
- Nicotine Polacr 4mg Orig Gum 50's
- Nicotine Polacr 2mg Gum Orig 50s
- Nicotine Pol 2mg Original Gum
- Nicotine Polacr 4mg Mint Loz 72's
- Nicotine Polacrilex 4mg Gum 100's
- Nicotine Pol 4mg Orig Gum
- Nicotine TD 7mg/24h Patch 14s
- Nicotine Polacrilex 4mg Chewing Gum
- Nicotine Polacrilex 2mg Chewing Gum
- Nicotine 14mg/24h Patch 14s
- Nicotine 21mg/24h Patch 28s
- Nicotine 21mg/24h Patch 14s
- Nicotine TD 21mg/24h Patch 7s
- Nicotine TD 14mg/24h Patch 7s
- Nicotine SF 2mg Cinn Gum 100's
- Nicotine Lozenge 4mg Mint
- Nicotine 2mg Original Gum 20s
- Nicotine 2mg Mint Lozenge 81s
- Nicotine 4mg Mint Gum 110s
- Nicotine 4mg Mint Gum 20s
- Nicotine TD 7mg/24h Patch 7s
- Nicotine 2mg SF Fruit Gum 100s
- Nicotine TD 21mg/24h Patch 14s
- Nicotine Pol 4mg Mint Lozenges
- Nicotine TD 14mg/24h Patch 28's
- Nicotine Pol 2mg Mint Loz 72s
- Nicotine Polacr 4mg Mint Loz 72s
- Nicotine Pol 2mg Mint Gum 110s
- Nicotine 2mg Mini Mint Loz 72s
- Nicotine 4mg Mini Mint Loz 72s
- Nicotine Pol 4mg Mint Gum
- Nicotine Mini Mint 2mg Loz 81s
Dosing & Administration
Adult Dosing
Standard Dose:
For individuals smoking their first cigarette within 30 minutes of waking: 4 mg gum. For individuals smoking their first cigarette more than 30 minutes after waking: 2 mg gum. Chew one piece every 1-2 hours for the first 6 weeks, then one piece every 2-4 hours for weeks 7-9, then one piece every 4-8 hours for weeks 10-12. Do not exceed 24 pieces per day.
Condition-Specific Dosing:
initial_therapy_duration:
12 weeks
maximum_daily_dose:
24 pieces
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.
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 gum provides nicotine to the body, reducing withdrawal symptoms associated with smoking cessation. Nicotine acts as an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems, mimicking the effects of nicotine from tobacco.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-70% (buccal absorption, highly variable)
Tmax:
Approximately 15-30 minutes (buccal absorption)
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:
Approximately 2.6 L/kg
ProteinBinding:
Less than 5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2 hours (nicotine), 18-20 hours (cotinine)
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (primarily)
Unchanged:
Approximately 10-20% (nicotine, pH dependent)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of chewing)
PeakEffect:
Approximately 15-30 minutes
DurationOfAction:
Effects related to nicotine levels last for the duration of absorption and distribution, but craving relief can extend beyond peak levels.
Safety & Warnings
Side Effects
Serious 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. However, many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Trouble sleeping
Bad dreams
Feeling nervous and 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 not mentioned here. 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 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. However, many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Trouble sleeping
Bad dreams
Feeling nervous and 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 not mentioned here. 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:
- Symptoms of nicotine overdose: severe nausea, vomiting, dizziness, weakness, rapid heartbeat, cold sweat, confusion, fainting, seizures.
- Signs of allergic reaction: rash, itching, swelling (especially of 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 to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as the symptoms that occurred.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
If you currently use tobacco products, such as smoking or chewing tobacco, or use 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 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 drugs 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 to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as the symptoms that occurred.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
If you currently use tobacco products, such as smoking or chewing tobacco, or use 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 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 drugs 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 may lead to unsafe side effects. If you are using another medication to aid in smoking cessation, be sure to notify your doctor.
When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary, so it is crucial to discuss any adverse effects with 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 may impact the effectiveness of other medications you are taking, so consult with your doctor.
If you have not been able to quit smoking after using this medication for the recommended duration, inform your doctor. It is also important to note that chewing gum, such as nicotine gum, may cause problems with dental work, such as loose dentures or other oral appliances.
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 swallowed by a child or pet, immediately contact a doctor or a 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, 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 discuss any adverse effects with 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 may impact the effectiveness of other medications you are taking, so consult with your doctor.
If you have not been able to quit smoking after using this medication for the recommended duration, inform your doctor. It is also important to note that chewing gum, such as nicotine gum, may cause problems with dental work, such as loose dentures or other oral appliances.
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 swallowed by a child or pet, immediately contact a doctor or a 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
- Vomiting
- Diarrhea
- Dizziness
- Weakness
- Rapid or irregular heartbeat
- Cold sweat
- Confusion
- Fainting
- Seizures
- Difficulty breathing
What to Do:
If you suspect an overdose, seek immediate 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 (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Beta-blockers (nicotine may reduce hypotensive effects)
- Insulin (nicotine may decrease subcutaneous absorption of insulin, requiring dose adjustment)
- Adrenergic agonists (e.g., phenylephrine, isoproterenol) (nicotine may potentiate cardiovascular effects)
- Adrenergic antagonists (e.g., prazosin, labetalol) (nicotine may reduce hypotensive effects)
Monitoring
Baseline Monitoring
Smoking history and current smoking status
Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and assess baseline nicotine dependence.
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
Adherence to dosing regimen
Frequency: At each follow-up visit (e.g., weekly initially, then bi-weekly/monthly)
Target: As prescribed (e.g., 1 piece every 1-2 hours)
Action Threshold: Non-adherence may lead to treatment failure or withdrawal symptoms; provide counseling.
Side effects (e.g., nausea, dyspepsia, jaw soreness, headache, dizziness)
Frequency: At each follow-up visit
Target: Minimal to tolerable
Action Threshold: Persistent or severe side effects may require dose adjustment, change in administration technique, or discontinuation.
Smoking cessation progress (e.g., number of cigarettes smoked, cravings)
Frequency: At each follow-up visit
Target: Progressive reduction in smoking leading to abstinence
Action Threshold: Lack of progress may indicate need for higher dose, combination therapy, or behavioral support.
Symptom Monitoring
- Nausea
- Vomiting
- Dyspepsia
- Jaw soreness
- Headache
- Dizziness
- Insomnia
- Palpitations
- Mouth/throat irritation
Special Patient Groups
Pregnancy
Category D. Nicotine crosses the placenta and can cause fetal harm. Smoking cessation is critical during pregnancy. If behavioral counseling alone is insufficient, NRT may be considered, but the risks of NRT must be weighed against the risks of continued smoking. Intermittent dosing (like gum) may be preferred over continuous dosing (like patch) to allow for nicotine-free periods.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects.
Second Trimester:
Potential for adverse developmental effects, including reduced fetal breathing movements.
Third Trimester:
Potential for adverse developmental effects, including reduced fetal breathing movements, premature birth, low birth weight.
Lactation
L3. Nicotine is excreted into breast milk. The amount of nicotine transferred is less than from smoking. If NRT is used, it should be used immediately after breastfeeding to minimize infant exposure. Intermittent NRT (gum) may be preferred over continuous NRT (patch). Breastfeeding is still preferred over formula feeding, even with NRT use, as the risks of smoking are much higher.
Infant Risk:
Potential for infant exposure to nicotine, leading to irritability, sleep disturbances, or increased heart rate. Risk is lower than from active smoking.
Pediatric Use
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.
Geriatric Use
No specific dose adjustment is typically required. However, older adults may be more sensitive to the cardiovascular effects of nicotine. Use with caution in patients with underlying cardiovascular disease.
Clinical Information
Clinical Pearls
- Proper chewing technique is crucial: 'Chew, Chew, Park' to maximize buccal absorption and minimize side effects.
- Avoid acidic beverages (coffee, soda, juice) 15 minutes before and during gum use, as they can significantly reduce nicotine absorption.
- Nicotine gum can be used on an 'as needed' basis for sudden cravings, but a regular schedule is often more effective for sustained cessation.
- Combining nicotine gum with a nicotine patch (combination NRT) can be more effective for highly dependent smokers.
- Counseling and behavioral support significantly improve the success rates of nicotine gum therapy.
Alternative Therapies
- Other Nicotine Replacement Therapies (NRTs): Nicotine patch, lozenge, inhaler, nasal spray.
- Non-nicotine pharmacotherapies: Bupropion SR (Zyban, Wellbutrin), Varenicline (Chantix).
- Behavioral therapies: Counseling, support groups, quitlines.
Cost & Coverage
Average Cost:
$30 - $70 per 100 pieces (generic)
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, sometimes OTC benefit. Tier 1 or 2 for generics.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the medication taken, the amount consumed, and the time it occurred.