Nicotine Polacr 4mg 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 giving you a small, controlled amount of nicotine. This helps reduce the cravings and withdrawal symptoms you feel when you stop smoking, making it easier to quit. The lozenge dissolves slowly in your mouth, releasing nicotine that is absorbed through your mouth lining.
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 when you typically smoke your first cigarette of the day. If you smoke your first cigarette within 30 minutes of waking up, you will need one dose, and if you smoke your first cigarette more than 30 minutes after waking up, you will need 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, but do not chew, break, or crush it. Also, 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 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 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 resume your regular dosing 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 when you typically smoke your first cigarette of the day. If you smoke your first cigarette within 30 minutes of waking up, you will need one dose, and if you smoke your first cigarette more than 30 minutes after waking up, you will need 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, but do not chew, break, or crush it. Also, 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 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 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 resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Set a quit date and stick to it.
- Identify and avoid smoking triggers (e.g., certain places, people, activities).
- Develop coping strategies for cravings (e.g., deep breathing, distraction, physical activity).
- Seek behavioral support or counseling to increase your chances of success.
- Do not chew or swallow the lozenge; allow it to dissolve slowly in your mouth.
- Do not eat or drink anything (especially acidic beverages) for 15 minutes before or during lozenge use.
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 those who smoke their first cigarette within 30 minutes of waking: 4 mg lozenge. Weeks 1-6: 1 lozenge every 1-2 hours. Weeks 7-9: 1 lozenge every 2-4 hours. Weeks 10-12: 1 lozenge every 4-8 hours. Do not use more than 5 lozenges in 6 hours or 20 lozenges per day. Complete 12-week program.
Dose Range:
1 - 20 mg
Condition-Specific Dosing:
smoking_cessation:
Gradual reduction over 12 weeks. Lozenge should be allowed to dissolve slowly in the mouth (approx. 20-30 minutes), not chewed or swallowed. Periodically move lozenge from one side of the mouth to the other.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not recommended for individuals under 18 years of age without medical supervision.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment necessary.
Moderate:
No specific adjustment necessary.
Severe:
Use with caution; nicotine is extensively excreted by the kidneys. Monitor for increased side effects.
Dialysis:
Use with caution; monitor for increased side effects. Consult physician.
Hepatic Impairment:
Mild:
No specific adjustment necessary.
Moderate:
No specific adjustment necessary.
Severe:
Use with caution; nicotine is extensively metabolized by the liver. Monitor for increased side effects.
Confidence:
Medium
Pharmacology
Mechanism of Action
Nicotine, an agonist at nicotinic acetylcholine receptors, binds to these receptors in the central nervous system and other sites. This binding leads to the release of neurotransmitters, including dopamine, which contributes to the rewarding effects of smoking. In the context of smoking cessation, nicotine replacement therapy (NRT) provides a controlled dose of nicotine to alleviate withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) associated with abrupt cessation of tobacco use, without the harmful chemicals found in tobacco smoke.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-60% of the nicotine released from the lozenge is absorbed buccally. Systemic bioavailability is lower due to some swallowed nicotine undergoing first-pass metabolism.
Tmax:
30-60 minutes (buccal absorption)
FoodEffect:
Acidic beverages (e.g., coffee, juice, soft drinks) can decrease buccal absorption of nicotine. Avoid eating or drinking 15 minutes before or during lozenge use.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
Less than 5% (to plasma proteins)
CnssPenetration:
Yes, readily crosses the blood-brain barrier.
Elimination:
HalfLife:
Approximately 2 hours (nicotine); 15-20 hours (cotinine)
Clearance:
Approximately 1.2 L/min (nicotine)
ExcretionRoute:
Renal (primarily, pH-dependent), also biliary.
Unchanged:
Approximately 10-30% (nicotine, dependent on urine pH)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of buccal absorption)
PeakEffect:
Approximately 30-60 minutes
DurationOfAction:
Effects related to withdrawal symptom relief can last for several hours, but nicotine levels decline within a few hours.
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 immediate 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
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, contact your doctor for advice:
Sleep disturbances
Bad dreams
Nervousness or excitability
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, 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 immediate 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
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, contact your doctor for advice:
Sleep disturbances
Bad dreams
Nervousness or excitability
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, 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 nicotine overdose: severe nausea, vomiting, dizziness, weakness, rapid heartbeat, cold sweats, confusion, fainting, seizures.
- Chest pain or irregular heartbeat.
- Severe allergic reaction (rash, itching/swelling, 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
If you currently use tobacco products, such as smoking or chewing tobacco, or use other nicotine-containing products while taking this medication.
If you are under 18 years of age. This medication is not recommended for children under 18 years old 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 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
If you currently use tobacco products, such as smoking or chewing tobacco, or use other nicotine-containing products while taking this medication.
If you are under 18 years of age. This medication is not recommended for children under 18 years old 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 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 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 widely, so it is crucial to report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, be aware that quitting smoking may 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:
- If you have phenylketonuria (PKU), consult with your doctor before using this product, as some formulations contain phenylalanine.
- 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, talk to your 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 accidentally ingested by a child or pet, immediately contact a doctor or a poison control center.
Special precautions apply to certain populations:
- If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
- If you are pregnant or become pregnant while taking this medication, contact your doctor right away, as it may pose a risk to the unborn baby.
- If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
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 widely, so it is crucial to report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. Additionally, be aware that quitting smoking may 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:
- If you have phenylketonuria (PKU), consult with your doctor before using this product, as some formulations contain phenylalanine.
- 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, talk to your 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 accidentally ingested by a child or pet, immediately contact a doctor or a poison control center.
Special precautions apply to certain populations:
- If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
- If you are pregnant or become pregnant while taking this medication, contact your doctor right away, as it may pose a risk to the unborn baby.
- If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Weakness
- Headache
- Cold sweats
- Pallor
- Hearing disturbances
- Salivation
- Abdominal pain
- Confusion
- Fainting
- Hypotension
- Irregular pulse
- Rapid heartbeat
- Respiratory depression
- Seizures
What to Do:
If you suspect an overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Remove the lozenge from the mouth if still present. Treatment is supportive, focusing on respiratory and cardiovascular support.
Drug Interactions
Moderate Interactions
- Cimetidine (may increase nicotine levels by inhibiting metabolism)
- Adenosine (nicotine may potentiate effects of adenosine, leading to increased risk of adverse cardiovascular effects)
- Acidic beverages (may reduce buccal absorption of nicotine)
Monitoring
Baseline Monitoring
Smoking history and current smoking status
Rationale: To determine appropriate lozenge strength (2mg vs 4mg) and guide treatment plan.
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 conditions.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to dosing schedule
Frequency: Regularly during treatment
Target: As per recommended tapering schedule
Action Threshold: Non-adherence may lead to treatment failure or prolonged use; provide counseling.
Withdrawal symptoms (e.g., cravings, irritability, anxiety)
Frequency: Regularly during treatment
Target: Reduction in severity
Action Threshold: Persistent severe symptoms may indicate need for dose adjustment, combination therapy, or behavioral support.
Side effects (e.g., nausea, hiccups, heartburn, dizziness, palpitations)
Frequency: Regularly during treatment
Target: Minimal to none
Action Threshold: Persistent or severe side effects may require dose reduction, change in administration technique, or discontinuation.
Symptom Monitoring
- Nausea
- Hiccups
- Heartburn
- Indigestion
- Dizziness
- Headache
- Palpitations
- Sore throat
- Mouth irritation
Special Patient Groups
Pregnancy
Nicotine crosses the placenta and can cause fetal harm. However, the risks of continued smoking during pregnancy are significant and include low birth weight, premature birth, and stillbirth. If a pregnant woman cannot quit smoking without pharmacologic aid, NRT may be considered under medical supervision, as it delivers nicotine without the other harmful chemicals in tobacco smoke. The lowest effective dose for the shortest duration should be used.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects; use only if benefits outweigh risks and under strict medical guidance.
Second Trimester:
Continued risk of fetal growth restriction and other adverse outcomes; NRT may be considered if smoking cessation is not achieved otherwise.
Third Trimester:
Increased risk of fetal distress, premature labor, and other complications; NRT use should be carefully weighed against the risks of continued smoking.
Lactation
Nicotine is excreted into breast milk and can affect the infant. However, the risks of infant exposure to nicotine from NRT are generally considered less than the risks of continued maternal smoking. If NRT is used, consider using short-acting forms (like lozenges) immediately after breastfeeding to minimize infant exposure. Monitor the infant for signs of nicotine exposure (e.g., irritability, poor feeding, sleep disturbances). Consult with a healthcare provider.
Infant Risk:
Moderate risk (L3). Nicotine and its metabolites are present in breast milk. Potential for infant irritability, sleep disturbances, and cardiovascular effects. Risk is lower than from maternal smoking.
Pediatric Use
Not recommended for individuals under 18 years of age for smoking cessation without medical supervision. Safety and efficacy have not been established in this population. Accidental ingestion by children can be dangerous and potentially fatal.
Geriatric Use
No specific dose adjustments are typically required for elderly patients. However, older adults may be more susceptible to the cardiovascular effects of nicotine. Use with caution in patients with pre-existing cardiovascular disease. Monitor for adverse effects.
Clinical Information
Clinical Pearls
- Proper lozenge technique is crucial: allow it to dissolve slowly, do not chew or swallow. This ensures buccal absorption and minimizes gastrointestinal side effects.
- The 4mg strength is typically for individuals who smoke their first cigarette within 30 minutes of waking, indicating higher nicotine dependence.
- Combining NRT with behavioral counseling or support programs significantly increases the chances of successful quitting.
- Patients should be encouraged to complete the full 12-week treatment program, even if they feel they no longer need the lozenge, to prevent relapse.
- Avoid eating or drinking anything (especially acidic beverages like coffee, juice, or soda) for 15 minutes before and during lozenge use, as this can reduce nicotine absorption.
- Nicotine lozenges can be used in combination with a nicotine patch for more severe nicotine dependence, providing both a steady baseline and acute craving relief.
Alternative Therapies
- Bupropion (Zyban, Wellbutrin SR)
- Varenicline (Chantix)
- Behavioral counseling and support programs (e.g., Quitline, group therapy)
Cost & Coverage
Average Cost:
$30 - $60 per 72 lozenges (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 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 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.