Nicotine Lozenge 4mg Mint
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) designed to help you quit smoking. They work by giving you a small, controlled amount of nicotine, which helps reduce the cravings and withdrawal symptoms you feel when you stop smoking. This allows you to focus on breaking the habit of smoking.
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 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 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's in your mouth.
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.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or use extra doses.
To use this medication effectively, follow your doctor's instructions and read all the information provided. This product is available in two 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 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's in your mouth.
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.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or use extra doses.
Lifestyle & Tips
- Set a 'quit date' and stop smoking completely on that day.
- Use the lozenge as directed, do not chew or swallow it. Let it dissolve slowly in your mouth.
- Avoid eating or drinking (especially acidic beverages like coffee, juice, or soda) for 15 minutes before and during lozenge use, as this can reduce nicotine absorption.
- Combine lozenge use with a behavioral support program or counseling for the best chance of quitting successfully.
- Identify and avoid triggers that make you want to smoke.
- Engage in healthy activities to manage stress and cravings (e.g., exercise, hobbies).
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: 1 lozenge (4mg) every 1-2 hours for weeks 1-6, then 1 lozenge every 2-4 hours for weeks 7-9, then 1 lozenge every 4-8 hours for weeks 10-12. Max 5 lozenges in 6 hours, max 20 lozenges per day.
Condition-Specific Dosing:
initial_phase:
Weeks 1-6: 1 lozenge every 1-2 hours
taper_phase_1:
Weeks 7-9: 1 lozenge every 2-4 hours
taper_phase_2:
Weeks 10-12: 1 lozenge every 4-8 hours
max_daily_dose:
20 lozenges/day
max_6hr_dose:
5 lozenges/6 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (generally not recommended for individuals under 18 years of age without medical supervision)
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. Monitor for increased adverse effects.
Dialysis:
Considerations: Nicotine is dialyzable, but clinical significance for NRT is low. Use with caution.
Hepatic Impairment:
Mild:
No specific adjustment, use with caution.
Moderate:
No specific adjustment, use with caution. Monitor for increased adverse effects.
Severe:
No specific adjustment, use with caution. Monitor for increased adverse effects.
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, it provides a controlled dose of nicotine, which helps to alleviate nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) experienced during smoking cessation.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, approximately 50-80% of the nicotine released from the lozenge is absorbed buccally.
Tmax:
Approximately 30-60 minutes after lozenge dissolution.
FoodEffect:
Acidic beverages (e.g., coffee, juice, soft drinks) can decrease buccal absorption of nicotine. Avoid eating or drinking 15 minutes before and during lozenge use.
Distribution:
Vd:
Approximately 2-3 L/kg
ProteinBinding:
<5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Nicotine: Approximately 2 hours; Cotinine: Approximately 18-20 hours.
Clearance:
Approximately 1.2 L/min (nicotine)
ExcretionRoute:
Primarily renal (urine).
Unchanged:
Approximately 10-20% (highly dependent on urine pH; more acidic urine increases renal excretion).
Pharmacodynamics
OnsetOfAction:
Within minutes of dissolution.
PeakEffect:
Approximately 30-60 minutes.
DurationOfAction:
Effects related to withdrawal symptom relief can last for the duration of the lozenge's absorption and beyond, but the acute effects of nicotine are relatively short-lived due to its short half-life.
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
Feeling dizzy, tired, or weak
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 administration
Warmth or tingling in the mouth
Hiccups
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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
Feeling dizzy, tired, or weak
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 administration
Warmth or tingling in the mouth
Hiccups
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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, cold sweat, confusion, rapid or irregular heartbeat, seizures.
- Signs of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is 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. Describe the allergic reactions you have experienced.
Certain health conditions, including:
+ Chest pain or pressure
+ An abnormal heartbeat
+ A recent heart attack
Your use of tobacco products, such as smoking, chewing tobacco, or using nicotine-containing products, while taking this medication.
Your age, particularly if you are under 18 years old. This medication is not recommended for children under 18 years old without consulting a doctor.
This list is not exhaustive, and it is essential 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 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. Describe the allergic reactions you have experienced.
Certain health conditions, including:
+ Chest pain or pressure
+ An abnormal heartbeat
+ A recent heart attack
Your use of tobacco products, such as smoking, chewing tobacco, or using nicotine-containing products, while taking this medication.
Your age, particularly if you are under 18 years old. This medication is not recommended for children under 18 years old without consulting a doctor.
This list is not exhaustive, and it is essential 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 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 report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid driving and engaging in other activities that require 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. Individuals with phenylketonuria (PKU) should consult with their doctor before using this medication, 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 may contain sodium. If you have a soy allergy, inform your doctor, as some products may 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.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant women or those who become pregnant while taking this medication should contact their doctor right away, as it may harm the unborn baby. Breastfeeding women should also consult with their doctor to discuss any potential risks to their baby.
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 report any adverse effects to your doctor.
Until you are familiar with how this medication affects you, avoid driving and engaging in other activities that require 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. Individuals with phenylketonuria (PKU) should consult with their doctor before using this medication, 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 may contain sodium. If you have a soy allergy, inform your doctor, as some products may 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.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant women or those who become pregnant while taking this medication should contact their doctor right away, as it may harm the unborn baby. Breastfeeding women should also consult with their doctor to discuss any potential risks to their baby.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Weakness
- Cold sweat
- Confusion
- Fainting
- Rapid or irregular heartbeat (tachycardia or arrhythmias)
- Low blood pressure (hypotension)
- Difficulty breathing
- Seizures
What to Do:
If you suspect an overdose, immediately stop using the lozenge and call your local poison control center (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Moderate Interactions
- Adenosine (increased risk of cardiovascular effects)
- Beta-blockers (e.g., propranolol, labetalol - smoking cessation may increase levels)
- Caffeine (smoking cessation may increase caffeine levels)
- Insulin (smoking cessation may increase subcutaneous insulin absorption)
- Opioid analgesics (e.g., propoxyphene - smoking cessation may increase levels)
- Theophylline (smoking cessation may increase theophylline levels)
- Tricyclic antidepressants (e.g., imipramine, desipramine - smoking cessation may increase levels)
- Clozapine, Olanzapine, Fluvoxamine (smoking cessation may increase levels)
Monitoring
Baseline Monitoring
Smoking history and current smoking status
Rationale: To determine appropriate lozenge strength (2mg vs 4mg) and to establish a baseline for cessation progress.
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 conditions.
Timing: Prior to initiation of therapy.
Motivation and readiness to quit smoking
Rationale: NRT is most effective when combined with behavioral support and a strong desire to quit.
Timing: Prior to initiation of therapy.
Routine Monitoring
Adherence to dosing regimen
Frequency: Regularly during therapy (e.g., weekly or bi-weekly check-ins).
Target: Consistent use as directed, tapering as recommended.
Action Threshold: Inconsistent use or overuse; provide counseling and support.
Nicotine withdrawal symptoms (e.g., cravings, irritability, anxiety, difficulty concentrating)
Frequency: Regularly during therapy.
Target: Reduction or absence of severe withdrawal symptoms.
Action Threshold: Persistent or severe withdrawal symptoms; consider dose adjustment or additional support.
Adverse effects (e.g., nausea, dizziness, heartburn, mouth/throat irritation, hiccups)
Frequency: Regularly during therapy.
Target: Absence or mild, tolerable adverse effects.
Action Threshold: Persistent or severe adverse effects; consider dose adjustment, alternative NRT, or discontinuation.
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Hiccups
- Heartburn
- Mouth or throat irritation
- Palpitations
- Increased salivation
- Cold sweat
- Confusion
- Weakness
Special Patient Groups
Pregnancy
Category D. Nicotine crosses the placenta and can cause fetal harm. However, the risks of continued smoking during pregnancy are significantly higher than the risks of nicotine replacement therapy. NRT should be considered only after non-pharmacological methods have failed and under strict medical supervision, with the goal of complete smoking cessation.
Trimester-Specific Risks:
First Trimester:
Nicotine exposure in the first trimester is associated with increased risk of congenital malformations, although the direct causal link is complex due to confounding factors of smoking.
Second Trimester:
Continued nicotine exposure can lead to adverse pregnancy outcomes including preterm birth, low birth weight, and stillbirth.
Third Trimester:
Continued nicotine exposure can lead to adverse pregnancy outcomes including preterm birth, low birth weight, and stillbirth. Nicotine can also affect fetal brain and lung development.
Lactation
Nicotine is excreted into breast milk. While NRT delivers less nicotine than smoking, it is still present. NRT is generally preferred over continued smoking for breastfeeding mothers. To minimize infant exposure, mothers can use the lozenge immediately after breastfeeding and avoid use just before feeding. Consider using the lowest effective dose.
Infant Risk:
Infant exposure to nicotine via breast milk can lead to irritability, restlessness, poor feeding, and changes in sleep patterns. Long-term effects are not fully established but are a concern.
Pediatric Use
Not recommended for use in individuals under 18 years of age without medical supervision. Safety and efficacy have not been established in pediatric populations for smoking cessation.
Geriatric Use
No specific dose adjustment is generally required for elderly patients. However, use with caution in elderly patients with underlying cardiovascular disease or other comorbidities, and monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Do not chew, crush, or swallow the lozenge. Allow it to dissolve slowly in your mouth, moving it from one side to the other occasionally.
- The lozenge should cause a warm or tingling sensation. If it causes a strong peppery taste or burning, you may be dissolving it too quickly.
- For best results, use the lozenge on a fixed schedule (e.g., every 1-2 hours) rather than waiting for cravings to become severe.
- It is crucial to stop smoking completely when starting nicotine lozenges. Using both simultaneously can lead to nicotine overdose.
- The duration of therapy is typically 12 weeks. Do not use for longer than 12 weeks without consulting a healthcare professional.
- Combine NRT with behavioral counseling or support programs for significantly higher success rates in quitting smoking.
Alternative Therapies
- Bupropion (Zyban, Wellbutrin)
- Varenicline (Chantix)
Cost & Coverage
Average Cost:
$40 - $60 per 80-100 lozenges
Generic Available:
Yes
Insurance Coverage:
Often covered by most prescription drug plans, especially under smoking cessation benefits. May be Tier 1 or Tier 2.
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.