Nicotine 4mg Mini 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
D
FDA Approved
Jul 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine lozenges are a type of medicine that helps you quit smoking by giving your body a small, controlled amount of nicotine. This helps reduce the strong cravings and uncomfortable withdrawal symptoms you might feel when you stop smoking, making it easier to quit.
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'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, 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 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. Use only one lozenge at a time, and do not use another lozenge immediately after the first one.
Storing and Disposing of Your Medication
Store the 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's 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 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 different 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, 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 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. Use only one lozenge at a time, and do not use another lozenge immediately after the first one.
Storing and Disposing of Your Medication
Store the 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's 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 use extra doses.
Lifestyle & Tips
- Do not chew, swallow, or crush the lozenge. Allow it to dissolve slowly in your mouth.
- Move the lozenge from one side of your mouth to the other occasionally.
- Avoid eating or drinking (especially acidic beverages like coffee, soda, or juice) for 15 minutes before and during lozenge use, as this can reduce nicotine absorption.
- Combine lozenge use with a comprehensive smoking cessation program that includes behavioral support and counseling for the best chance of quitting successfully.
- Gradually reduce the number of lozenges used over the 12-week treatment period as directed.
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.
Dose Range:
1 - 20 mg
Condition-Specific Dosing:
heavySmokers:
4 mg lozenge recommended if first cigarette is smoked within 30 minutes of waking.
lightSmokers:
2 mg lozenge recommended if first cigarette is smoked more than 30 minutes after waking (not applicable for this 4mg product).
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 dose adjustment provided; use with caution.
Moderate:
No specific dose adjustment provided; use with caution.
Severe:
No specific dose adjustment provided; use with caution due to potential for reduced clearance.
Dialysis:
Considerations: Nicotine is dialyzable, but clinical guidance for NRT in dialysis patients is limited. Use with caution and monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment provided; use with caution.
Moderate:
No specific dose adjustment provided; use with caution.
Severe:
No specific dose adjustment provided; use with caution due to potential for reduced clearance.
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's mesolimbic dopamine system, nicotine stimulates the release of neurotransmitters, including dopamine, norepinephrine, acetylcholine, serotonin, GABA, and glutamate. This action helps to alleviate nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating) and reduce cravings associated with smoking cessation, by providing a controlled, therapeutic dose of nicotine.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-80% of the nicotine from a lozenge is absorbed buccally.
Tmax:
30-60 minutes (for plasma nicotine concentration)
FoodEffect:
Acidic beverages (e.g., coffee, soda, juice) can decrease buccal absorption of nicotine; avoid eating or drinking for 15 minutes before and during lozenge use.
Distribution:
Vd:
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:
Renal (pH-dependent; acidic urine increases renal clearance)
Unchanged:
Approximately 10-30% (nicotine, depending on urine pH)
Pharmacodynamics
OnsetOfAction:
Within minutes (as nicotine is absorbed buccally)
PeakEffect:
Approximately 30-60 minutes (corresponding to Tmax)
DurationOfAction:
Effects related to a single dose may last for 1-2 hours, but the goal is sustained nicotine levels to reduce cravings throughout the day.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when 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
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. Although 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
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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
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. Although 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
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:
- Severe nausea or vomiting
- Severe dizziness or lightheadedness
- Weakness or fatigue
- Cold sweat
- Confusion
- Blurred vision
- Hearing problems
- Seizures
- Rapid or irregular heartbeat
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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ 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 the medication.
Your age, particularly if you are under 18 years old. This medication is not recommended for children under 18 without consulting a doctor.
This list is not exhaustive, and it is essential to discuss all your medications (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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ 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 the medication.
Your age, particularly if you are under 18 years old. This medication is not recommended for children under 18 without consulting a doctor.
This list is not exhaustive, and it is essential to discuss all your medications (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 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 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 alter 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. In the event of accidental ingestion, immediately contact a doctor or a poison control center.
Older adults (65 years and older) should exercise caution when using this medication, as they may be more susceptible to side effects. If you are pregnant or become pregnant while taking this medication, contact your doctor promptly, as it may pose a risk to the unborn baby. Breastfeeding mothers should also consult their doctor to discuss potential risks to their 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 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 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 alter 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. In the event of accidental ingestion, immediately contact a doctor or a poison control center.
Older adults (65 years and older) should exercise caution when using this medication, as they may be more susceptible to side effects. If you are pregnant or become pregnant while taking this medication, contact your doctor promptly, as it may pose a risk to the unborn baby. Breastfeeding mothers should also consult their doctor to discuss potential risks to their baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Weakness
- Cold sweat
- Pallor
- Headache
- Hearing and vision disturbances
- Confusion
- Fainting
- Rapid or irregular heartbeat
- Seizures (in severe cases)
What to Do:
If you suspect an overdose, stop using the lozenge immediately and seek emergency medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the U.S.).
Drug Interactions
Moderate Interactions
- Adrenergic agonists (e.g., phenylephrine, isoproterenol): Nicotine can potentiate cardiovascular effects.
- Adrenergic antagonists (e.g., labetalol, prazosin): Nicotine can reduce their hypotensive effects.
- Insulin: Smoking cessation (and thus nicotine replacement) can increase insulin sensitivity, potentially requiring insulin dose reduction.
- Caffeine, Theophylline, Imipramine, Pentazocine: Nicotine can increase the metabolism of these drugs (via enzyme induction). Smoking cessation may lead to increased plasma levels of these drugs, potentially requiring dose adjustments.
Monitoring
Baseline Monitoring
Smoking history (number of cigarettes per day, time to first cigarette)
Rationale: To determine appropriate lozenge strength (2mg vs. 4mg) and guide cessation plan.
Timing: Prior to initiation of therapy
Cardiovascular status (e.g., history of heart attack, stroke, arrhythmias)
Rationale: Nicotine can affect the cardiovascular system; caution is advised in patients with pre-existing conditions.
Timing: Prior to initiation of therapy
Current medications
Rationale: To identify potential drug interactions, especially with drugs metabolized by CYP2A6 or those affected by adrenergic activity.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to dosing schedule
Frequency: Regularly throughout therapy
Target: As prescribed (e.g., 1 lozenge every 1-2 hours initially)
Action Threshold: Frequent missed doses or overuse; counsel on proper use and adherence.
Side effects (e.g., nausea, dizziness, headache, palpitations, mouth/throat irritation)
Frequency: Daily, especially during initial weeks
Target: Absence or mild, tolerable symptoms
Action Threshold: Severe or persistent side effects; consider dose reduction or alternative NRT.
Smoking cessation progress (e.g., reduction in smoking, complete abstinence)
Frequency: Weekly or bi-weekly
Target: Progress towards complete abstinence
Action Threshold: Continued smoking or relapse; reinforce behavioral support, reassess therapy.
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Palpitations
- Insomnia
- Mouth or throat irritation
- Heartburn
- Hiccups
- Excessive salivation
Special Patient Groups
Pregnancy
Pregnancy Category D. While nicotine itself is harmful to the fetus, smoking is more harmful. Nicotine replacement therapy (NRT) should be considered only after non-pharmacological methods have failed and under strict medical supervision. The lowest effective dose should be used for the shortest possible duration. Intermittent NRT forms (like lozenges) may be preferred over continuous forms (like patches) to allow for nicotine-free periods.
Trimester-Specific Risks:
First Trimester:
Nicotine exposure in the first trimester is associated with increased risks of congenital malformations, although the direct causal link is complex due to confounding factors of smoking.
Second Trimester:
Nicotine can cause fetal growth restriction, premature birth, and adverse neurodevelopmental outcomes.
Third Trimester:
Continued nicotine exposure can lead to reduced fetal breathing movements, altered fetal heart rate, and long-term neurobehavioral deficits in the child.
Lactation
Nicotine is excreted into breast milk. While NRT is preferred over continued smoking during lactation, it's important to minimize infant exposure. Advise mothers to use the lozenge immediately after breastfeeding and to choose the lowest effective dose. Shorter-acting NRT forms like lozenges allow for more control over nicotine exposure and can be timed to minimize levels in breast milk during feeding.
Infant Risk:
Infants exposed to nicotine via breast milk may experience irritability, restlessness, poor feeding, and sleep disturbances. Long-term effects are not fully established but are a concern.
Pediatric Use
Generally contraindicated for individuals under 18 years of age. Nicotine can be harmful to developing brains and bodies. Accidental ingestion by children can lead to severe nicotine poisoning.
Geriatric Use
No specific dose adjustments are typically required for elderly patients. However, caution is advised due to potential for increased sensitivity to nicotine's cardiovascular effects and potential for polypharmacy and comorbidities. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Proper lozenge technique is crucial: 'Park and chew' - place the lozenge in your mouth and allow it to dissolve slowly. Do not chew or swallow it whole. Move it from side to side in your mouth occasionally.
- Avoid acidic beverages (e.g., coffee, soda, juice) for 15 minutes before and during lozenge use, as they can significantly reduce nicotine absorption.
- The 4mg strength is typically recommended for individuals who smoke their first cigarette within 30 minutes of waking, indicating higher nicotine dependence.
- Combining nicotine lozenges with behavioral counseling or support programs significantly increases the chances of successful smoking cessation.
- Gradual reduction of lozenge use over the 12-week period is key to successful cessation and preventing dependence on the NRT itself.
- If you experience hiccups or heartburn, try dissolving the lozenge more slowly or moving it around less frequently.
Alternative Therapies
- Bupropion (Zyban, Wellbutrin)
- Varenicline (Chantix)
Cost & Coverage
Average Cost:
$30 - $50 per 72 lozenges
Generic Available:
Yes
Insurance Coverage:
Often available over-the-counter (OTC). Some insurance plans, including certain Medicaid programs, may cover NRT products with or without a prescription.
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.