Nicotine Pol 4mg Mint Lozenges
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
Jul 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine lozenges are a type of medicine that helps you stop smoking. They work by giving your body a small, controlled amount of nicotine, which helps reduce the strong cravings and uncomfortable feelings you get when you quit smoking. This allows you to focus on breaking the habit of smoking without dealing with severe withdrawal.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. This product is available in two different doses, which are determined by how soon you smoke your first cigarette after waking up. If you smoke your first cigarette within 30 minutes of waking up, you will need one dose, while smoking after 30 minutes requires the other dose. If you are unsure about which dose to use, consult your pharmacist or doctor.
Using the Oral Lozenge
1. Use the lozenge immediately after opening.
2. Suck on the lozenge without chewing, breaking, or crushing it. Do not swallow it whole.
3. Periodically move the lozenge to the other side of your mouth as it dissolves, which may take about 20 to 30 minutes.
4. Try to minimize swallowing while sucking on the lozenge.
5. Avoid eating or drinking within 15 minutes before using the lozenge or while it is dissolving.
6. Do not use more than one lozenge at a time, and do not use a second lozenge immediately after the first one.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light. When disposing of unused portions, wrap them in paper before throwing them away.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. This product is available in two different doses, which are determined by how soon you smoke your first cigarette after waking up. If you smoke your first cigarette within 30 minutes of waking up, you will need one dose, while smoking after 30 minutes requires the other dose. If you are unsure about which dose to use, consult your pharmacist or doctor.
Using the Oral Lozenge
1. Use the lozenge immediately after opening.
2. Suck on the lozenge without chewing, breaking, or crushing it. Do not swallow it whole.
3. Periodically move the lozenge to the other side of your mouth as it dissolves, which may take about 20 to 30 minutes.
4. Try to minimize swallowing while sucking on the lozenge.
5. Avoid eating or drinking within 15 minutes before using the lozenge or while it is dissolving.
6. Do not use more than one lozenge at a time, and do not use a second lozenge immediately after the first one.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light. When disposing of unused portions, wrap them in paper before throwing them away.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Commit to quitting smoking completely before starting the lozenges.
- Avoid smoking or using any other nicotine products (e.g., e-cigarettes, patches, gum) while using the lozenges.
- Avoid eating or drinking (especially acidic beverages like coffee, soda, or juice) for 15 minutes before and during lozenge use, as this can reduce nicotine absorption.
- Combine lozenge use with behavioral support programs or counseling for best results.
- Identify and avoid triggers that make you want to smoke.
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:
1 lozenge every 1-2 hours for weeks 1-6, then every 2-4 hours for weeks 7-9, then every 4-8 hours for weeks 10-12. Max 5 lozenges in 6 hours or 20 lozenges per day.
Condition-Specific Dosing:
initial_dosing_4mg:
For those who smoke their first cigarette within 30 minutes of waking.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Contraindicated for individuals under 18 years of age)
Adolescent:
Not established (Contraindicated for individuals under 18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, use with caution.
Moderate:
No specific adjustment, use with caution.
Severe:
No specific adjustment, use with caution.
Dialysis:
Consideration for increased nicotine levels, monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment, use with caution.
Moderate:
No specific adjustment, use with caution.
Severe:
No specific adjustment, use with caution.
Pharmacology
Mechanism of Action
Nicotine binds stereoselectively to nicotinic acetylcholine receptors (nAChRs) in the central and peripheral nervous systems, including autonomic ganglia, the adrenal medulla, and neuromuscular junctions. This binding acts as an agonist, stimulating the release of various neurotransmitters (e.g., dopamine, norepinephrine, acetylcholine, serotonin, GABA, glutamate), which helps to alleviate nicotine withdrawal symptoms and cravings.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-70% of the released nicotine from the lozenge is absorbed buccally.
Tmax:
30-60 minutes
FoodEffect:
Eating or drinking acidic beverages (e.g., coffee, soda, juice) immediately before or during use can significantly decrease buccal absorption of nicotine.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
<5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Nicotine: 2-3 hours; Cotinine: 15-20 hours
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Primarily renal (pH-dependent)
Unchanged:
10-30% (pH-dependent)
Pharmacodynamics
OnsetOfAction:
Approximately 10-15 minutes (from lozenge)
PeakEffect:
Approximately 30-60 minutes
DurationOfAction:
Relief of cravings can last for several hours, though acute nicotine effects are shorter.
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 notice 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 unusual symptoms that bother you or persist, contact your doctor for advice:
Sleep disturbances
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Warmth or tingling in the mouth
* Hiccups
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention 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 unusual symptoms that bother you or persist, contact your doctor for advice:
Sleep disturbances
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Warmth or tingling in the mouth
* Hiccups
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe nausea or vomiting
- Severe dizziness or lightheadedness
- Weakness or fainting
- Rapid or irregular heartbeat (palpitations)
- Cold sweat
- Confusion
- Seizures
- Difficulty breathing
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial 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 or nicotine products, such as smoking or chewing tobacco, while taking this medication.
Your age, particularly if you are under 18 years old. This medication is not recommended for children under 18 without consulting a doctor.
This list is not exhaustive, and it is essential to discuss all your medications (including 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 crucial 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 or nicotine products, such as smoking or chewing tobacco, while taking this medication.
Your age, particularly if you are under 18 years old. This medication is not recommended for children under 18 without consulting a doctor.
This list is not exhaustive, and it is essential to discuss all your medications (including 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 successfully quitting smoking, consider seeking counseling.
Do not exceed the recommended dosage, as this may lead to unsafe side effects. If you are using another medication to help you stop smoking, be sure to inform your doctor. When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal, which can manifest in various ways. If you encounter any adverse effects, notify your doctor promptly.
Until you are familiar with how this medication affects you, it is advisable to avoid driving and other activities that require alertness. Quitting smoking can impact the effectiveness of other medications you are taking, so it is crucial to discuss this with your doctor.
If you have been unable to quit smoking after using this medication for the recommended duration, inform your doctor. Individuals with phenylketonuria (PKU) should consult their doctor before using this product, as some formulations contain phenylalanine. Similarly, if you are on a low-sodium or sodium-free diet, discuss this with your doctor, as some products contain sodium. If you have a soy allergy, consult your doctor, as some products may contain soy.
This medication can be harmful 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. Additionally, this medication may pose risks to an unborn baby if taken during pregnancy. If you become pregnant or are already pregnant while taking this medication, contact your doctor immediately.
Breastfeeding mothers should consult their doctor to discuss potential risks to their baby associated with this medication.
Do not exceed the recommended dosage, as this may lead to unsafe side effects. If you are using another medication to help you stop smoking, be sure to inform your doctor. When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal, which can manifest in various ways. If you encounter any adverse effects, notify your doctor promptly.
Until you are familiar with how this medication affects you, it is advisable to avoid driving and other activities that require alertness. Quitting smoking can impact the effectiveness of other medications you are taking, so it is crucial to discuss this with your doctor.
If you have been unable to quit smoking after using this medication for the recommended duration, inform your doctor. Individuals with phenylketonuria (PKU) should consult their doctor before using this product, as some formulations contain phenylalanine. Similarly, if you are on a low-sodium or sodium-free diet, discuss this with your doctor, as some products contain sodium. If you have a soy allergy, consult your doctor, as some products may contain soy.
This medication can be harmful 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. Additionally, this medication may pose risks to an unborn baby if taken during pregnancy. If you become pregnant or are already pregnant while taking this medication, contact your doctor immediately.
Breastfeeding mothers should consult their doctor to discuss potential risks to their baby associated with this medication.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Weakness
- Rapid heartbeat
- Cold sweat
- Confusion
- Seizures
- Fainting
- Trouble breathing
What to Do:
If you suspect an overdose, stop using the lozenges immediately. Call your doctor or Poison Control (1-800-222-1222) right away, or seek emergency medical attention.
Drug Interactions
Moderate Interactions
- Caffeine (smoking cessation can increase levels)
- Theophylline (smoking cessation can increase levels)
- Fluvoxamine (smoking cessation can increase levels)
- Olanzapine (smoking cessation can increase levels)
- Clozapine (smoking cessation can increase levels)
- Insulin (smoking cessation can increase absorption/effect, may require dose reduction)
- Beta-blockers (e.g., Propranolol - smoking cessation can increase hypotensive effect)
Monitoring
Baseline Monitoring
Smoking history (cigarettes/day, time to first cigarette)
Rationale: To determine appropriate lozenge strength (2mg vs 4mg) and assess dependence level.
Timing: Prior to initiation of therapy.
Cardiovascular status
Rationale: Nicotine can affect heart rate and blood pressure; caution in patients with pre-existing cardiovascular conditions.
Timing: Prior to initiation of therapy.
Current medications
Rationale: To identify potential drug interactions, especially those affected by smoking cessation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Adherence to lozenge regimen
Frequency: Regularly during therapy (e.g., weekly check-ins)
Target: As per dosing instructions (e.g., not exceeding max daily dose)
Action Threshold: Non-adherence or overuse; provide counseling.
Side effects (e.g., nausea, dizziness, hiccups, mouth/throat irritation)
Frequency: Regularly during therapy
Target: Absence or mild, tolerable symptoms
Action Threshold: Persistent or severe side effects; adjust dose or consider alternative NRT.
Smoking cessation progress
Frequency: Regularly during therapy
Target: Complete abstinence from smoking
Action Threshold: Continued smoking; provide additional counseling or consider alternative strategies.
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Hiccups
- Mouth or throat irritation
- Heartburn
- Palpitations
- Insomnia
- Excessive salivation
Special Patient Groups
Pregnancy
Category D. While nicotine itself poses risks to the fetus, the risks of continued smoking during pregnancy (e.g., low birth weight, premature birth, stillbirth) are significantly higher. Nicotine lozenges should only be used during pregnancy if the benefits of quitting smoking outweigh the potential risks to the fetus, and under the guidance of a healthcare professional.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development; however, continued smoking is more harmful.
Second Trimester:
Potential for adverse effects on fetal development; however, continued smoking is more harmful.
Third Trimester:
Potential for adverse effects on fetal development and labor; however, continued smoking is more harmful.
Lactation
L3 (Moderately Safe). Nicotine is excreted into breast milk and can be harmful to the infant. However, the levels of nicotine from NRT are lower than from smoking. If NRT is used, advise the mother to use the lowest effective dose and to time lozenge use immediately after breastfeeding to minimize infant exposure.
Infant Risk:
Risk of infant exposure to nicotine, which can cause irritability, sleep disturbances, and potential long-term developmental effects. Risk is lower than from active smoking.
Pediatric Use
Contraindicated for individuals under 18 years of age. Safety and efficacy have not been established in this population.
Geriatric Use
Use with caution. No specific dose adjustment is typically required, but older adults may be more sensitive to the cardiovascular effects of nicotine. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Proper technique is crucial for efficacy: Do not chew, crush, or swallow the lozenge. Allow it to dissolve slowly in your mouth (typically 20-30 minutes), moving it from one side of your mouth to the other occasionally. A tingling sensation is normal.
- Patients should be encouraged to stop smoking completely when starting nicotine lozenges. Continued smoking while using NRT can lead to nicotine overdose.
- The 4mg strength is generally recommended for individuals who smoke their first cigarette within 30 minutes of waking, indicating higher nicotine dependence.
- Nicotine lozenges are intended for short-term use (up to 12 weeks) to aid in smoking cessation, not for long-term nicotine maintenance.
- Combining nicotine lozenges with behavioral counseling or support programs significantly increases the chances of successful quitting.
Alternative Therapies
- Bupropion (Zyban, Wellbutrin)
- Varenicline (Chantix)
Cost & Coverage
Average Cost:
$20 - $60 per 80-100 lozenges
Generic Available:
Yes
Insurance Coverage:
Often available over-the-counter (OTC). May be covered by some insurance plans, FSA, or HSA accounts.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.