Nicotine 2mg Mint Lozenge 81s
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 nicotine without the harmful chemicals found in cigarettes. This helps reduce cravings and withdrawal symptoms, making it easier to stop smoking.
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 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 be prescribed one dose; if you smoke your first cigarette more than 30 minutes after waking up, you will be prescribed a different 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; do not chew, break, or crush it.
3. Do not swallow the lozenge whole.
4. Periodically move the lozenge to the other side of your mouth as it dissolves, which may take about 20 to 30 minutes.
5. Try to minimize swallowing while sucking on the lozenge.
6. Avoid eating or drinking within 15 minutes before using the lozenge or while it is dissolving.
7. 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
1. Store the medication at room temperature, protected from light.
2. When disposing of unused medication, wrap any remaining portion in paper before throwing it away.
Missing 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 make up for a missed dose.
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. This product is available in two 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 be prescribed one dose; if you smoke your first cigarette more than 30 minutes after waking up, you will be prescribed a different 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; do not chew, break, or crush it.
3. Do not swallow the lozenge whole.
4. Periodically move the lozenge to the other side of your mouth as it dissolves, which may take about 20 to 30 minutes.
5. Try to minimize swallowing while sucking on the lozenge.
6. Avoid eating or drinking within 15 minutes before using the lozenge or while it is dissolving.
7. 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
1. Store the medication at room temperature, protected from light.
2. When disposing of unused medication, wrap any remaining portion in paper before throwing it away.
Missing 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 make up for a missed dose.
Lifestyle & Tips
- Set a quit date and stick to it.
- Use the lozenge as directed, do not chew or swallow it whole.
- 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.
- Do not eat or drink anything (especially acidic beverages like coffee, soda, or juice) 15 minutes before or during lozenge use, as this can reduce nicotine absorption.
- Combine NRT with behavioral support programs, counseling, or support groups for the best chance of success.
- Identify and avoid triggers that make you want to smoke.
- Engage in healthy coping mechanisms for stress or cravings (e.g., exercise, hobbies, deep breathing).
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: 1 lozenge (2mg) every 1 to 2 hours for the first 6 weeks, then 1 lozenge every 2 to 4 hours for weeks 7-9, then 1 lozenge every 4 to 8 hours for weeks 10-12. Do not use more than 5 lozenges in 6 hours or 20 lozenges per day.
Dose Range:
1 - 20 mg
Condition-Specific Dosing:
initial_phase:
1 lozenge every 1-2 hours (weeks 1-6)
taper_phase_1:
1 lozenge every 2-4 hours (weeks 7-9)
taper_phase_2:
1 lozenge every 4-8 hours (weeks 10-12)
max_daily_dose:
20 lozenges/day
max_6hr_dose:
5 lozenges/6 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Not recommended for individuals under 18 years of age)
Adolescent:
Not established (Not recommended for individuals under 18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution.
Dialysis:
Considerations: Nicotine is partially cleared by hemodialysis. Use with caution and monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution.
Pharmacology
Mechanism of Action
Nicotine is an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems. It binds to these receptors, mimicking the effects of acetylcholine, leading to the release of neurotransmitters such as dopamine, norepinephrine, and serotonin. In the context of smoking cessation, nicotine replacement therapy (NRT) provides a controlled dose of nicotine to reduce withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) associated with quitting smoking, without the harmful toxins found in tobacco smoke.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (approximately 50-70% of the nicotine released from the lozenge is absorbed buccally, with some swallowed nicotine undergoing first-pass metabolism)
Tmax:
Approximately 30-60 minutes (for lozenge)
FoodEffect:
Acidic beverages (e.g., coffee, soda, juice) can decrease buccal absorption of nicotine; avoid consumption 15 minutes before or during lozenge use.
Distribution:
Vd:
Approximately 2-3 L/kg
ProteinBinding:
Less than 5% (to plasma proteins)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2 hours (nicotine); 18-20 hours (cotinine)
Clearance:
Approximately 1.2 L/min (nicotine)
ExcretionRoute:
Renal (primarily, pH-dependent)
Unchanged:
Approximately 10-30% (nicotine, highly dependent on urine pH)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of dissolution)
PeakEffect:
Approximately 30-60 minutes
DurationOfAction:
Relief of withdrawal symptoms can last for several hours, but nicotine levels decline, necessitating frequent dosing.
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
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
Burning, numbness, or tingling sensations that are not normal
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
Drooling
Shakiness
Sore throat
Mouth, teeth, or jaw problems
Cold sweats
Blurred vision
Changes in hearing
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Trouble sleeping
Bad dreams
Feeling nervous and excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Warmth or tingling in the mouth
* Hiccups
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Mood changes
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
Burning, numbness, or tingling sensations that are not normal
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
Drooling
Shakiness
Sore throat
Mouth, teeth, or jaw problems
Cold sweats
Blurred vision
Changes in hearing
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Trouble sleeping
Bad dreams
Feeling nervous and excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Warmth or tingling in the mouth
* Hiccups
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of nicotine overdose: severe nausea, vomiting, dizziness, weakness, rapid heartbeat, cold sweats, confusion, seizures.
- Persistent or severe mouth/throat irritation, hiccups, or heartburn.
- 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
If you currently use tobacco products, such as smoking or chewing tobacco, or use other nicotine-containing products while taking this medication.
If you 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 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
If you currently use tobacco products, such as smoking or chewing tobacco, or use other nicotine-containing products while taking this medication.
If you 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 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 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 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 widely, so it's crucial to discuss any adverse effects with your doctor.
Until you understand how this medication affects you, avoid operating vehicles or engaging in activities that require alertness. Additionally, be aware that quitting smoking can alter the effectiveness of other medications you are taking, so consult with your doctor to adjust your treatment plan as necessary.
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 before using this medication, 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.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Pregnant women or those who become pregnant while taking this medication should contact their doctor immediately, as it may pose a risk to the unborn baby. Breastfeeding mothers should also discuss the potential risks to their baby with their doctor.
To minimize the risk of adverse effects, do not exceed the recommended dosage. Taking more than prescribed may lead to unsafe side effects. If you are using another medication to aid in smoking cessation, be sure to 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 widely, so it's crucial to discuss any adverse effects with your doctor.
Until you understand how this medication affects you, avoid operating vehicles or engaging in activities that require alertness. Additionally, be aware that quitting smoking can alter the effectiveness of other medications you are taking, so consult with your doctor to adjust your treatment plan as necessary.
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 before using this medication, 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.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Pregnant women or those who become pregnant while taking this medication should contact their doctor immediately, as it may pose a risk to the unborn baby. Breastfeeding mothers should also discuss the potential risks to their baby with their doctor.
Overdose Information
Overdose Symptoms:
- Severe nausea and vomiting
- Diarrhea
- Dizziness
- Weakness
- Cold sweats
- Pale skin
- Rapid or irregular heartbeat (tachycardia or arrhythmias)
- Low blood pressure (hypotension)
- Confusion
- Seizures
- Difficulty breathing
What to Do:
If you suspect an overdose, seek immediate medical attention. Call 911 or your local emergency number. You can also contact a poison control center at 1-800-222-1222. Remove any remaining lozenges from the mouth. Supportive care will be provided as needed.
Drug Interactions
Contraindicated Interactions
- Not available
Major Interactions
- Not available
Moderate Interactions
- Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Beta-blockers (smoking cessation may increase levels of some beta-blockers due to reduced CYP1A2 activity)
- Insulin (smoking cessation may increase insulin absorption and sensitivity, requiring dose adjustment)
- Theophylline (smoking cessation may increase theophylline levels due to reduced CYP1A2 activity)
- Caffeine (smoking cessation may increase caffeine levels due to reduced CYP1A2 activity)
- Fluvoxamine (smoking cessation may increase fluvoxamine levels due to reduced CYP1A2 activity)
- Olanzapine (smoking cessation may increase olanzapine levels due to reduced CYP1A2 activity)
- Clozapine (smoking cessation may increase clozapine levels due to reduced CYP1A2 activity)
Minor Interactions
- Adrenergic agonists (e.g., phenylephrine, isoproterenol - nicotine may potentiate cardiovascular effects)
- Adrenergic antagonists (e.g., prazosin, labetalol - nicotine may reduce hypotensive effects)
Monitoring
Baseline Monitoring
Smoking history and current smoking status
Rationale: To determine appropriate 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 conditions.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to dosing regimen
Frequency: Regularly during therapy
Target: As prescribed/directed
Action Threshold: Non-adherence may lead to withdrawal symptoms or continued smoking; provide counseling.
Side effects (e.g., nausea, hiccups, heartburn, mouth/throat irritation, dizziness)
Frequency: Regularly during therapy
Target: Absence or mild, tolerable symptoms
Action Threshold: Persistent or severe side effects may require dose adjustment, change in administration technique, or discontinuation.
Progress towards smoking cessation
Frequency: Weekly or bi-weekly during initial phase, then monthly
Target: Reduction in cigarette consumption leading to complete cessation
Action Threshold: Lack of progress may indicate need for behavioral support, higher dose, or alternative therapy.
Symptom Monitoring
- Nausea
- Hiccups
- Heartburn
- Indigestion
- Mouth or throat irritation
- Dizziness
- Headache
- Insomnia
- Palpitations
- Chest discomfort
Special Patient Groups
Pregnancy
Nicotine crosses the placenta and can harm the fetus. However, the risks of continued smoking during pregnancy are significantly higher than the risks associated with nicotine replacement therapy (NRT). If a pregnant woman cannot quit smoking without pharmacologic aid, NRT may be considered under medical supervision, with the lowest effective dose and shortest duration. Behavioral counseling should always be the first-line approach.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, including neural tube defects, cardiovascular malformations, and oral clefts. However, the risks of smoking are greater.
Second Trimester:
Increased risk of preterm birth, low birth weight, and placental complications.
Third Trimester:
Increased risk of preterm birth, low birth weight, stillbirth, and sudden infant death syndrome (SIDS) post-delivery.
Lactation
Nicotine is excreted into breast milk and can be harmful to the infant. However, the risks of infant exposure to nicotine from NRT are generally considered lower than the risks from 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).
Infant Risk:
Risk L3 (Moderately safe; nicotine is present in breast milk, but the benefits of NRT over smoking generally outweigh the risks. Monitor infant for adverse effects.)
Pediatric Use
Not recommended for individuals under 18 years of age. Safety and efficacy have not been established in this population for smoking cessation. Behavioral interventions are preferred for adolescent smokers.
Geriatric Use
No specific dose adjustments are generally required based on age alone. However, older adults may be more sensitive 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
- Instruct patients to 'park' the lozenge in their mouth and allow it to dissolve slowly, rather than chewing or swallowing it, to maximize buccal absorption and minimize side effects like hiccups or heartburn.
- Emphasize the importance of avoiding acidic beverages (coffee, soda, juice) 15 minutes before and during lozenge use, as they can significantly reduce nicotine absorption.
- Remind patients that NRT is most effective when combined with behavioral support, counseling, or a quit program.
- Advise patients to start with the 2mg lozenge if they smoke their first cigarette more than 30 minutes after waking, and the 4mg lozenge if they smoke within 30 minutes of waking.
- Explain that the goal is to gradually reduce the number of lozenges used over the 12-week period to wean off nicotine completely.
Alternative Therapies
- Other Nicotine Replacement Therapies (NRTs): Nicotine gum, nicotine patch, nicotine inhaler, nicotine nasal spray
- Prescription medications: Bupropion (Zyban, Wellbutrin SR), Varenicline (Chantix)
- Behavioral therapy and counseling (e.g., individual counseling, group therapy, telephone quitlines, online resources)
Cost & Coverage
Average Cost:
$20 - $40 per 81 lozenges
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance plans (Rx or OTC benefit) or FSA/HSA eligible. Varies by plan.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.