Nicotine Pol 2mg Mint Loz 72s
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
Jul 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine lozenges are a type of nicotine replacement therapy (NRT) that helps you quit smoking by providing a controlled amount of nicotine to reduce cravings and withdrawal symptoms. You place the lozenge in your mouth and allow it to dissolve slowly, absorbing nicotine through the lining of your mouth.
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 smoke your first cigarette within 30 minutes of waking up, you will use one dose; if you smoke your first cigarette more than 30 minutes after waking up, you will use 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 it.
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 while it dissolves, which may take about 20 to 30 minutes.
4. Try to swallow as little as possible 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 your medication at room temperature, protected from light. When disposing of any unused portion, wrap it in paper before throwing it 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 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 smoke your first cigarette within 30 minutes of waking up, you will use one dose; if you smoke your first cigarette more than 30 minutes after waking up, you will use 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 it.
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 while it dissolves, which may take about 20 to 30 minutes.
4. Try to swallow as little as possible 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 your medication at room temperature, protected from light. When disposing of any unused portion, wrap it in paper before throwing it 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.
Lifestyle & Tips
- Set a quit date and start using the lozenges on that day.
- Use the lozenge as directed, do not chew or swallow it whole, as this can reduce effectiveness and increase side effects.
- Place the lozenge in your mouth and allow it to dissolve slowly (about 20-30 minutes). Move it from one side of your mouth to the other occasionally.
- Avoid eating or drinking anything (especially acidic beverages like coffee, soda, or juice) for 15 minutes before and during lozenge use, as this can interfere with nicotine absorption.
- Combine lozenge use with a comprehensive smoking cessation program, including behavioral counseling and support groups, for best results.
- Identify and avoid triggers that make you want to smoke.
- Gradually reduce the number of lozenges used over the 12-week period as directed to wean off nicotine.
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 more than 30 minutes after waking: Weeks 1-6: 1 lozenge every 1 to 2 hours. Weeks 7-9: 1 lozenge every 2 to 4 hours. Weeks 10-12: 1 lozenge every 4 to 8 hours. Do not use more than 5 lozenges in 6 hours or more than 20 lozenges per day. Complete the 12-week program.
Condition-Specific Dosing:
initial_smoking_time:
>30 minutes after waking
Pediatric Dosing
Neonatal:
Not established (contraindicated for smoking cessation)
Infant:
Not established (contraindicated for smoking cessation)
Child:
Not established (contraindicated for smoking cessation)
Adolescent:
Not established (contraindicated for smoking cessation, generally not recommended for individuals under 18 years without medical supervision)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
Use with caution, monitor for increased side effects. Consider dose reduction if severe side effects occur.
Severe:
Use with caution, monitor for increased side effects. Consider dose reduction or extended dosing intervals due to potential for reduced clearance.
Dialysis:
Not specifically studied; use with caution and monitor for adverse effects. Nicotine is not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
Use with caution, monitor for increased side effects. Consider dose reduction due to reduced nicotine metabolism.
Severe:
Use with caution, monitor for increased side effects. Significant dose reduction or extended dosing intervals may be necessary due to severely impaired metabolism.
Confidence:
Medium
Pharmacology
Mechanism of Action
Nicotine acts as an agonist at nicotinic acetylcholine receptors (nAChRs) in the central and peripheral nervous systems. By binding to these receptors, particularly the ι4β2 subtype in the brain, it mimics the effects of nicotine from tobacco, thereby reducing nicotine withdrawal symptoms (e.g., cravings, irritability, anxiety, difficulty concentrating) and the urge to smoke.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-60% (oral mucosal absorption, variable)
Tmax:
30-60 minutes (for lozenges)
FoodEffect:
Acidic beverages (e.g., coffee, soda, juice) can decrease the absorption of nicotine from the oral mucosa. Avoid eating or drinking for 15 minutes before and during lozenge use.
Distribution:
Vd:
2-3 L/kg
ProteinBinding:
Less than 5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Nicotine: Approximately 2 hours; Cotinine: Approximately 18-20 hours
Clearance:
Approximately 1.2 L/min (nicotine)
ExcretionRoute:
Renal (primarily as metabolites, with 10-20% excreted unchanged depending on urine pH)
Unchanged:
10-20% (renal, pH-dependent)
Pharmacodynamics
OnsetOfAction:
Within minutes (oral mucosal absorption)
PeakEffect:
30-60 minutes
DurationOfAction:
Relief of cravings can last for several hours, but the pharmacokinetic half-life is short.
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 immediately or seek medical attention:
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 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:
Trouble sleeping
Bad dreams
Feeling nervous and 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 about side effects, contact your doctor for medical advice. 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 immediately or seek medical attention:
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 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:
Trouble sleeping
Bad dreams
Feeling nervous and 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 about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of nicotine overdose: severe nausea, vomiting, dizziness, weakness, rapid heartbeat, cold sweats, confusion, fainting, seizures.
- Persistent or severe hiccups, heartburn, or indigestion.
- Chest pain or irregular heartbeat.
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 tobacco use, including smoking, chewing tobacco, or using nicotine products, as these may interact with this medication.
Your age, particularly if you are under 18 years old. This medication is not recommended for children under 18 years of age without first 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 dosage of any medication without consulting your doctor first.
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 tobacco use, including smoking, chewing tobacco, or using nicotine products, as these may interact with this medication.
Your age, particularly if you are under 18 years old. This medication is not recommended for children under 18 years of age without first 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 dosage of any medication without consulting your doctor first.
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 the prescribed amount can lead to unsafe side effects. If you are using another medication to help you quit 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. These symptoms can vary, so it is crucial to discuss any adverse effects with your doctor.
Until you understand how this medication affects you, avoid driving and engaging in other activities that require your full attention. Additionally, be aware that quitting smoking can impact the effectiveness of other medications you are taking, so consult with your doctor to discuss any potential interactions.
If you have been unable to quit smoking after using this medication for the recommended duration, inform your doctor.
Certain individuals require special consideration when taking this medication. If you have phenylketonuria (PKU), consult with your doctor, as some products contain phenylalanine. Similarly, if you are on a low-sodium or sodium-free diet, discuss this with your doctor, as some products contain sodium. Individuals with a soy allergy should also consult with their doctor, as some products contain soy.
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 poison control center.
Older adults (65 years and older) should exercise caution when taking this medication, as they may be more susceptible to side effects. Furthermore, this medication may harm an unborn baby if taken during pregnancy. If you become pregnant or are pregnant while taking this medication, contact your doctor promptly.
Breastfeeding mothers should discuss the potential risks to their baby with their doctor, as they will need to weigh the benefits and risks of continuing treatment.
To minimize the risk of adverse effects, do not exceed the recommended dosage. Taking more than the prescribed amount can lead to unsafe side effects. If you are using another medication to help you quit 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. These symptoms can vary, so it is crucial to discuss any adverse effects with your doctor.
Until you understand how this medication affects you, avoid driving and engaging in other activities that require your full attention. Additionally, be aware that quitting smoking can impact the effectiveness of other medications you are taking, so consult with your doctor to discuss any potential interactions.
If you have been unable to quit smoking after using this medication for the recommended duration, inform your doctor.
Certain individuals require special consideration when taking this medication. If you have phenylketonuria (PKU), consult with your doctor, as some products contain phenylalanine. Similarly, if you are on a low-sodium or sodium-free diet, discuss this with your doctor, as some products contain sodium. Individuals with a soy allergy should also consult with their doctor, as some products contain soy.
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 poison control center.
Older adults (65 years and older) should exercise caution when taking this medication, as they may be more susceptible to side effects. Furthermore, this medication may harm an unborn baby if taken during pregnancy. If you become pregnant or are pregnant while taking this medication, contact your doctor promptly.
Breastfeeding mothers should discuss the potential risks to their baby with their doctor, as they will need to weigh the benefits and risks of continuing treatment.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Weakness
- Cold sweats
- Confusion
- Fainting
- Seizures
- Rapid or irregular heartbeat
- Difficulty breathing
What to Do:
If you suspect an overdose, immediately stop using the lozenge and seek emergency medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US).
Drug Interactions
Moderate Interactions
- Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Beta-blockers (e.g., propranolol, labetalol - smoking cessation can increase their levels due to reduced metabolism)
- Caffeine (smoking cessation can increase caffeine levels due to reduced metabolism)
- Clozapine (smoking cessation can increase clozapine levels due to reduced metabolism)
- Insulin (smoking cessation can increase subcutaneous insulin absorption, potentially requiring dose reduction)
- Theophylline (smoking cessation can increase theophylline levels due to reduced metabolism)
- Tricyclic antidepressants (e.g., imipramine, clomipramine, fluvoxamine - smoking cessation can increase their levels due to reduced metabolism)
Minor Interactions
- Adrenergic agonists (e.g., phenylephrine, isoproterenol - smoking cessation may reduce their pressor response)
- Adrenergic antagonists (e.g., prazosin - smoking cessation may enhance their hypotensive effects)
Monitoring
Baseline Monitoring
Smoking history and current smoking status
Rationale: To determine appropriate nicotine lozenge strength (2mg vs 4mg) and to establish a baseline for cessation progress.
Timing: Prior to initiation of therapy
Medical history (especially cardiovascular disease, uncontrolled hypertension, recent MI, stroke, peptic ulcer disease, diabetes, hyperthyroidism, pheochromocytoma, renal/hepatic impairment)
Rationale: To identify contraindications or conditions requiring caution and closer monitoring.
Timing: Prior to initiation of therapy
Concomitant medications
Rationale: To identify potential drug interactions, especially those whose metabolism is affected by smoking cessation.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to lozenge regimen
Frequency: Regularly during therapy (e.g., weekly or bi-weekly)
Target: As per dosing instructions
Action Threshold: Non-adherence may lead to treatment failure or inadequate symptom control; provide counseling.
Smoking status (abstinence)
Frequency: Regularly during therapy
Target: Complete cessation
Action Threshold: Continued smoking while using NRT increases nicotine exposure and risk of adverse effects; reinforce cessation strategies.
Nicotine withdrawal symptoms (e.g., cravings, irritability, anxiety, difficulty concentrating)
Frequency: Regularly during therapy
Target: Minimized or absent
Action Threshold: Persistent severe symptoms may indicate need for dose adjustment, combination NRT, or behavioral support.
Adverse effects (e.g., nausea, hiccups, heartburn, headache, dizziness, palpitations)
Frequency: Regularly during therapy
Target: Tolerable or absent
Action Threshold: Persistent or severe side effects may require dose adjustment, change in administration technique, or discontinuation.
Symptom Monitoring
- Nausea
- Hiccups
- Heartburn
- Indigestion
- Headache
- Dizziness
- Sore throat
- Cough
- Palpitations
- Insomnia
- Anxiety
- Irritability
Special Patient Groups
Pregnancy
Nicotine crosses the placenta and can harm the fetus. While smoking is more harmful than NRT, NRT should only be used during pregnancy if the benefits of quitting smoking outweigh the potential risks of nicotine, and under medical supervision. Behavioral counseling should be tried first. If NRT is used, intermittent dosing forms (like lozenges) may be preferred over continuous forms (like patches) to allow for nicotine-free periods.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, including neural tube defects and cardiovascular abnormalities.
Second Trimester:
Increased risk of preterm birth, low birth weight, and respiratory problems.
Third Trimester:
Increased risk of preterm birth, low birth weight, stillbirth, and potential long-term neurodevelopmental effects.
Lactation
Nicotine is excreted into breast milk. While NRT delivers less nicotine than smoking, it is still present. If NRT is used, it is recommended to use intermittent forms (lozenge, gum) and to use them immediately after breastfeeding to minimize infant exposure. Monitor the infant for signs of nicotine exposure (e.g., irritability, poor feeding, sleep disturbances). Breastfeeding is still preferred over formula feeding, even with NRT use, as the risks of formula feeding outweigh the risks of NRT in milk.
Infant Risk:
Low to moderate risk. Nicotine and its metabolites can be detected in breast milk and may cause irritability, poor feeding, or sleep disturbances in the infant. However, the risks of continued maternal smoking are significantly higher.
Pediatric Use
Nicotine lozenges are not indicated for use in individuals under 18 years of age for smoking cessation. Safety and efficacy have not been established in this population. Nicotine can be toxic to children, and lozenges should be kept out of reach of children.
Geriatric Use
No specific dose adjustment is generally required for elderly patients. However, elderly patients may be more susceptible to the cardiovascular effects of nicotine. Use with caution and monitor for adverse effects, especially in those with pre-existing cardiovascular conditions.
Clinical Information
Clinical Pearls
- Ensure patients understand the correct way to use the lozenge (dissolve slowly, do not chew or swallow) to maximize absorption and minimize side effects like hiccups or heartburn.
- Emphasize the importance of avoiding acidic beverages 15 minutes before and during lozenge use.
- Counsel patients that NRT is most effective when combined with behavioral support and counseling.
- Remind patients that the goal is to gradually reduce nicotine dependence over the 12-week program, not to use the lozenges indefinitely.
- For patients who smoke their first cigarette within 30 minutes of waking, the 4mg lozenge is generally recommended, not the 2mg.
- Advise patients to keep all nicotine products out of reach of children and pets due to the risk of nicotine poisoning.
Alternative Therapies
- Bupropion (Zyban, Wellbutrin SR)
- Varenicline (Chantix)
- Behavioral counseling alone
- Hypnotherapy
- Acupuncture
Cost & Coverage
Average Cost:
$20 - $50 per 72 lozenges (approximate)
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans (Rx benefit) even though OTC, or through FSA/HSA. Some state Medicaid programs and private insurers cover NRTs.
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 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 medication taken, the amount, and the time it happened.