Nicotine Mini Mint 2mg Loz 81s

Manufacturer RUGBY LABORATORIES Active Ingredient Nicotine Lozenges(nik oh TEEN) Pronunciation NIK-oh-teen
It is used to treat nicotine withdrawal.It is used to curb the craving to smoke.
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Drug Class
Smoking cessation aid
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Pharmacologic Class
Nicotinic acetylcholine receptor agonist
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Pregnancy Category
Category D
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FDA Approved
May 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nicotine lozenges are a type of nicotine replacement therapy (NRT) that helps you quit smoking by giving your body a small, controlled amount of nicotine. This helps reduce the strong cravings and withdrawal symptoms you get when you stop smoking, making it easier to quit. You dissolve the lozenge slowly in your mouth, allowing the nicotine to be absorbed through your mouth lining.
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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 when you have your first cigarette of the day. If you smoke your first cigarette within 30 minutes of waking up, you will use one dose; if you smoke your first cigarette more than 30 minutes after waking up, you will use the other dose. If you are unsure about which dose to use, consult your pharmacist or doctor.

Using the Oral Lozenge

1. Use the lozenge immediately after opening.
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

Store the medication at room temperature, protected from light. When disposing of unused portions, wrap them in paper before throwing them away.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses.
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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.
  • Avoid eating or drinking anything (especially acidic beverages like coffee, soda, or juice) for 15 minutes before and during lozenge use, as this can reduce nicotine absorption.
  • Do not chew or swallow the lozenge; let it dissolve slowly in your mouth (about 20-30 minutes).

Dosing & Administration

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Adult Dosing

Standard Dose: For individuals who smoke their first cigarette more than 30 minutes after waking: 2 mg lozenge. Use 1 lozenge every 1-2 hours for the first 6 weeks, then 1 lozenge every 2-4 hours for weeks 7-9, then 1 lozenge every 4-8 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:

smoking_cessation_initial: 1 lozenge every 1-2 hours for weeks 1-6
smoking_cessation_taper_1: 1 lozenge every 2-4 hours for weeks 7-9
smoking_cessation_taper_2: 1 lozenge every 4-8 hours for weeks 10-12
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (contraindicated for use in persons under 18 years of age)
Adolescent: Not established (contraindicated for use in persons under 18 years of age)
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution due to potential for increased nicotine levels.
Dialysis: Use with caution; nicotine and its metabolites are not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution due to potential for increased nicotine levels.

Pharmacology

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Mechanism of Action

Nicotine acts as an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems. In smoking cessation, it replaces the nicotine from tobacco, reducing withdrawal symptoms and cravings associated with nicotine dependence.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50-60% (buccal absorption from lozenge)
Tmax: Approximately 30-60 minutes
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: Approximately 2.6 L/kg
ProteinBinding: Less than 5%
CnssPenetration: Yes

Elimination:

HalfLife: Nicotine: Approximately 2 hours; Cotinine: Approximately 15-20 hours
Clearance: Approximately 1.2 L/min
ExcretionRoute: Renal (primarily as metabolites, 10-20% unchanged nicotine depending on urine pH)
Unchanged: 10-20%
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Pharmacodynamics

OnsetOfAction: Within minutes (as nicotine is absorbed buccally)
PeakEffect: Approximately 30-60 minutes
DurationOfAction: Effects related to nicotine levels persist for several hours, but the lozenge is designed for frequent dosing to maintain levels.

Safety & Warnings

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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
+ Dizziness
+ Fainting
+ 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
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 that bother you or do not go away, contact your doctor:

Sleep disturbances
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Warmth or tingling in the mouth
* Hiccups

This is not an exhaustive list of possible side effects. 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.
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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, irregular heartbeat, or shortness of breath (seek immediate medical attention).
  • Severe allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing).
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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 and its symptoms.
Certain health conditions, including:
+ Chest pain or pressure
+ An abnormal heartbeat
+ A recent heart attack
Your tobacco use, including smoking, chewing tobacco, or using nicotine products, as these may interact with this medication.
Your age, particularly if you are under 18 years old, as this medication is not recommended for children under 18 without 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 drugs and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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 vehicles 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. Individuals with phenylketonuria (PKU) should consult with their doctor before using this product, as some formulations may 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, consult with 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 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 consult with their doctor to discuss any potential risks to their baby.
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Overdose Information

Overdose Symptoms:

  • Severe nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Weakness
  • Cold sweats
  • Confusion
  • Fainting
  • Seizures
  • Rapid or irregular heartbeat
  • Low blood pressure

What to Do:

If you suspect an overdose, stop using the lozenge immediately and call a poison control center (1-800-222-1222) or seek emergency medical attention. Remove any remaining lozenge from the mouth. Treatment is supportive.

Drug Interactions

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Moderate Interactions

  • Adenosine (nicotine may increase heart rate and blood pressure, potentially requiring higher adenosine doses)
  • Beta-blockers (smoking cessation may increase levels of some beta-blockers, requiring dose adjustment)
  • Caffeine (smoking cessation may increase caffeine levels, requiring dose reduction)
  • Insulin (smoking cessation may increase insulin absorption or decrease insulin requirements, requiring dose adjustment)
  • Theophylline (smoking cessation may increase theophylline levels, requiring dose reduction)
  • Adrenergic agonists (e.g., phenylephrine, isoproterenol - nicotine may potentiate cardiovascular effects)

Monitoring

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Baseline Monitoring

Smoking history and current smoking status

Rationale: To determine appropriate nicotine lozenge strength and dosing regimen.

Timing: Prior to initiation of therapy

Readiness to quit smoking

Rationale: To assess patient motivation and likelihood of success with NRT.

Timing: Prior to initiation of therapy

Cardiovascular disease history (e.g., recent MI, unstable angina, severe arrhythmias)

Rationale: Nicotine can exacerbate these conditions; NRT should be used with caution or under medical supervision.

Timing: Prior to initiation of therapy

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Routine Monitoring

Adherence to dosing regimen

Frequency: Weekly during initial phase, then as needed

Target: Consistent use as directed

Action Threshold: Frequent missed doses or overuse; counsel on proper use.

Withdrawal symptoms (e.g., cravings, irritability, anxiety)

Frequency: Weekly during initial phase, then as needed

Target: Reduction in severity

Action Threshold: Persistent severe symptoms; consider dose adjustment or combination therapy.

Side effects (e.g., nausea, hiccups, heartburn, dizziness)

Frequency: Weekly during initial phase, then as needed

Target: Minimal or manageable

Action Threshold: Intolerable side effects; counsel on proper lozenge technique or consider alternative NRT.

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Symptom Monitoring

  • Nausea
  • Hiccups
  • Heartburn
  • Dizziness
  • Headache
  • Sore throat
  • Cough
  • Insomnia
  • Irritability
  • Anxiety
  • Difficulty concentrating
  • Increased appetite/weight gain

Special Patient Groups

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Pregnancy

Nicotine is classified as Pregnancy Category D. Smoking during pregnancy is harmful. While NRT is generally preferred over continued smoking, behavioral therapy is the first-line treatment. If NRT is used, it should be under medical supervision, and intermittent dosing forms (like lozenges) may be preferred over continuous forms (like patches) to allow for nicotine-free periods. The lowest effective dose for the shortest duration should be used.

Trimester-Specific Risks:

First Trimester: Nicotine is associated with increased risk of congenital malformations, preterm birth, and low birth weight.
Second Trimester: Continued exposure to nicotine can impair fetal growth and development, affecting lung and brain development.
Third Trimester: Increased risk of preterm birth, low birth weight, stillbirth, and potential for neonatal nicotine withdrawal.
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Lactation

Nicotine passes into breast milk. While NRT exposes the infant to less nicotine than smoking, it is still present. If NRT is used, it is recommended to use intermittent forms (like lozenges) immediately after breastfeeding to minimize infant exposure, or to consider pumping and discarding milk for a few hours after use. Behavioral counseling is preferred.

Infant Risk: L3 (Moderate risk). Potential for infant exposure to nicotine, leading to irritability, sleep disturbances, and potential long-term developmental effects. However, the risks of continued maternal smoking to the infant are significantly higher than NRT.
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Pediatric Use

Nicotine lozenges are not indicated for use in individuals under 18 years of age. Nicotine is highly toxic to children, and even small amounts can cause severe poisoning or death. Keep out of reach of children and pets.

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Geriatric Use

No specific dose adjustments are generally required for elderly patients. However, elderly patients may be more sensitive to the cardiovascular effects of nicotine. Use with caution in patients with pre-existing cardiovascular conditions.

Clinical Information

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Clinical Pearls

  • Proper lozenge technique is crucial: do not chew or swallow. Place it in your mouth and allow it to dissolve slowly, moving it from side to side occasionally. This takes about 20-30 minutes.
  • Avoid acidic beverages (coffee, soda, juice) for 15 minutes before and during lozenge use, as they can reduce nicotine absorption.
  • The 2mg lozenge is typically for those who smoke their first cigarette more than 30 minutes after waking. If you smoke within 30 minutes of waking, the 4mg lozenge is usually recommended.
  • Combine NRT with behavioral support (counseling, support groups) for the best chance of quitting successfully.
  • If you experience hiccups or heartburn, try dissolving the lozenge more slowly or moving it less frequently.
  • Do not use more than the recommended daily limit to avoid nicotine overdose.
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Alternative Therapies

  • Other Nicotine Replacement Therapies (NRTs): Nicotine patch, nicotine gum, nicotine inhaler, nicotine nasal spray.
  • Bupropion (Zyban, Wellbutrin SR/XL) - prescription antidepressant that reduces nicotine cravings and withdrawal symptoms.
  • Varenicline (Chantix) - prescription medication that reduces the pleasure of smoking and withdrawal symptoms.
  • Behavioral counseling and support programs (e.g., quitlines, group therapy, individual counseling).
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Cost & Coverage

Average Cost: $20 - $40 per 81 lozenges (2mg)
Generic Available: Yes
Insurance Coverage: Often covered by most prescription drug plans and some state Medicaid programs, especially for smoking cessation programs. May be covered as an OTC benefit.
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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.