Nicotine 2mg Mini Mint Loz 72s

Manufacturer RISING PHARMACEUTICALS 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 Cholinergic Receptor Agonist
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Pregnancy Category
D
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FDA Approved
Jul 2002
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nicotine lozenges are small, mint-flavored tablets that dissolve slowly in your mouth. They deliver nicotine to your body to help reduce cravings and withdrawal symptoms when you stop smoking. This helps you gradually reduce your dependence on nicotine and quit smoking.
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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 accompanying information carefully. This product is available in two different doses, which are determined by when you typically smoke your first cigarette of the day. If you smoke your first cigarette within 30 minutes of waking up, you will 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 while 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 your 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 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.
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Lifestyle & Tips

  • Set a quit date and stop smoking completely on that day.
  • Use the lozenge as directed; do not chew or swallow it.
  • Allow the lozenge to dissolve slowly in your mouth (about 20-30 minutes).
  • Move the lozenge from side to side in your mouth occasionally.
  • Do not eat or drink anything (especially acidic beverages like coffee, soda, or juice) for 15 minutes before or during lozenge use, as this can reduce absorption.
  • Combine NRT with behavioral support programs (e.g., counseling, quit lines) for the best chance of success.
  • Keep out of reach of children and pets, as nicotine can be toxic if ingested.

Dosing & Administration

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Adult Dosing

Standard Dose: For those who smoke their first cigarette more than 30 minutes after waking: Weeks 1-6: 1 lozenge every 1 to 2 hours. Weeks 7-9: 1 lozenge every 2 to 4 hours. Weeks 10-12: 1 lozenge every 4 to 8 hours.

Condition-Specific Dosing:

maximumDailyDose: Do not use more than 5 lozenges in 6 hours or 20 lozenges per day. Do not use for more than 12 weeks without consulting a doctor.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Contraindicated)
Adolescent: Not established (Contraindicated for those under 18 years of age)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment provided; use with caution.
Moderate: No specific adjustment provided; use with caution, monitor for increased side effects.
Severe: No specific adjustment provided; use with caution, monitor for increased side effects due to potential accumulation of nicotine and its metabolites.
Dialysis: Considerations: Nicotine is dialyzable, but clinical guidance for NRT in dialysis patients is limited. Use with caution and close monitoring.

Hepatic Impairment:

Mild: No specific adjustment provided; use with caution.
Moderate: No specific adjustment provided; use with caution, monitor for increased side effects due to reduced metabolism.
Severe: No specific adjustment provided; use with caution, monitor for increased side effects due to significantly reduced metabolism.
Confidence: Medium

Pharmacology

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Mechanism of Action

Nicotine acts as an agonist at nicotinic acetylcholine receptors (nAChRs) in the central and peripheral nervous systems. In the brain, this binding stimulates the release of various neurotransmitters, including dopamine, in the mesolimbic reward pathway, mimicking the effects of nicotine from tobacco. This action helps to alleviate nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating) and reduce cravings associated with smoking cessation.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50-80% (from lozenge via buccal absorption)
Tmax: 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 or during lozenge use.

Distribution:

Vd: 2-3 L/kg
ProteinBinding: <5%
CnssPenetration: Yes

Elimination:

HalfLife: 2-4 hours (nicotine); 15-20 hours (cotinine)
Clearance: Approximately 1.2 L/min (nicotine)
ExcretionRoute: Renal (unchanged nicotine and metabolites)
Unchanged: 10-20% (pH-dependent; increased in acidic urine)
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Pharmacodynamics

OnsetOfAction: Within minutes (as lozenge dissolves)
PeakEffect: 30-60 minutes (corresponding to Tmax)
DurationOfAction: Relief of withdrawal symptoms lasts as long as nicotine levels are maintained, typically requiring repeated dosing every 1-2 hours initially.
Confidence: Medium

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help 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 attention 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. 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 application
Warmth or tingling in the mouth
* Hiccups

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Signs of nicotine overdose: severe nausea, vomiting, dizziness, cold sweat, confusion, weakness, seizures, difficulty breathing.
  • Persistent irregular heartbeat or chest pain.
  • Severe mouth or throat irritation.
  • 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 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
If you currently use tobacco products, such as smoking or chewing tobacco, or use other nicotine-containing products while taking this medication.
If you are under 18 years of age. This medication is not recommended for children under 18 years old without first consulting a doctor.

This list is not exhaustive, and it is 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. Do not initiate, stop, or adjust the dosage 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 the prescribed amount can 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, 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 your full attention. Additionally, be aware that quitting smoking can 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. 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.

Older adults (65 years and older) should exercise caution when using this medication, as they may be more susceptible to side effects. Furthermore, this medication may pose a risk to the unborn baby if taken during pregnancy. If you become pregnant or are planning to become pregnant, notify your doctor promptly.

If you are breastfeeding, consult with your doctor to discuss the potential risks to your baby and determine the best course of action.
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Overdose Information

Overdose Symptoms:

  • Severe nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Headache
  • Cold sweat
  • Confusion
  • Weakness
  • Fainting
  • Salivation
  • Abdominal pain
  • Hearing and vision disturbances
  • Rapid or irregular heartbeat
  • Low blood pressure
  • Seizures
  • Respiratory depression

What to Do:

If you suspect an overdose, immediately call a poison control center (1-800-222-1222 in the US) or emergency medical services (911). Seek immediate medical attention. Remove any remaining lozenges from the mouth. Provide supportive care as needed.

Drug Interactions

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Moderate Interactions

  • Caffeine
  • Theophylline
  • Imipramine
  • Pentazocine
  • Furosemide
  • Adrenergic agonists (e.g., phenylephrine, isoproterenol)
  • Adrenergic antagonists (e.g., labetalol, prazosin)
  • Insulin

Monitoring

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Baseline Monitoring

Smoking history and current smoking status

Rationale: To determine appropriate lozenge strength (2mg vs 4mg) and guide treatment plan.

Timing: Prior to initiation of therapy

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

Rationale: Nicotine can have cardiovascular effects; caution is advised in patients with pre-existing conditions.

Timing: Prior to initiation of therapy

History of peptic ulcer disease or esophagitis

Rationale: Nicotine lozenges can cause GI irritation.

Timing: Prior to initiation of therapy

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Routine Monitoring

Adherence to NRT regimen

Frequency: Regularly during treatment

Target: As prescribed

Action Threshold: Poor adherence may indicate need for counseling or dose adjustment.

Assessment of withdrawal symptoms and cravings

Frequency: Regularly during treatment

Target: Reduction in severity

Action Threshold: Persistent severe symptoms may indicate need for dose adjustment or alternative therapy.

Monitoring for adverse effects

Frequency: Regularly during treatment

Target: Absence or mild, tolerable effects

Action Threshold: Severe or persistent adverse effects (e.g., nausea, dizziness, palpitations, mouth irritation) may require dose reduction or discontinuation.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Dizziness
  • Headache
  • Insomnia
  • Hiccups
  • Heartburn
  • Indigestion
  • Mouth or throat irritation
  • Palpitations

Special Patient Groups

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Pregnancy

Category D. Nicotine crosses the placenta and can cause fetal harm. However, the risks of continued smoking during pregnancy (e.g., low birth weight, premature birth, stillbirth) are significantly higher than the risks associated with NRT. NRT should be considered only if behavioral therapy alone is unsuccessful and under medical supervision. Intermittent NRT forms like lozenges may be preferred over continuous forms (e.g., patch) to allow for nicotine-free periods.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data are mixed. Risk of miscarriage.
Second Trimester: Increased risk of premature birth, low birth weight, and adverse neurodevelopmental outcomes.
Third Trimester: Increased risk of premature birth, low birth weight, stillbirth, and respiratory complications in the newborn.
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Lactation

L3 (Moderate risk). Nicotine and its metabolites (e.g., cotinine) are excreted into breast milk. While NRT delivers less nicotine than smoking, it is still present. If NRT is used, advise breastfeeding mothers to use intermittent forms (lozenge, gum) and to breastfeed just before using the lozenge to minimize infant exposure. Monitor the infant for signs of nicotine exposure (e.g., irritability, poor feeding, sleep disturbances).

Infant Risk: Potential for irritability, sleep disturbances, increased heart rate, and reduced weight gain in the infant. The benefits of breastfeeding should be weighed against the potential risks of nicotine exposure.
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Pediatric Use

Contraindicated for individuals under 18 years of age. Nicotine can be highly toxic to children, and accidental ingestion can lead to severe poisoning or death. Keep all nicotine products out of reach of children.

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Geriatric Use

Use with caution in elderly patients, especially those with cardiovascular disease. Monitor closely for adverse effects, as older adults may be more sensitive to the effects of nicotine.

Clinical Information

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Clinical Pearls

  • Emphasize that nicotine lozenges are a temporary aid to help quit smoking, not a substitute for cigarettes.
  • Stress the importance of not chewing or swallowing the lozenge, as this can lead to rapid nicotine release, causing hiccups, heartburn, or nausea.
  • Advise patients to avoid acidic beverages (e.g., coffee, soda, juice) for 15 minutes before and during lozenge use, as they can impair nicotine absorption.
  • Encourage patients to combine NRT with behavioral support (e.g., counseling, quit lines) for optimal success rates.
  • Inform patients that the lozenge should be used at the first sign of a craving, rather than waiting until the craving becomes intense.
  • Explain the step-down dosing schedule to ensure gradual reduction of nicotine dependence.
  • Remind patients that if they feel lightheaded, nauseated, or have hiccups, they may be using the lozenge too quickly or using too many.
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Alternative Therapies

  • Bupropion (Zyban, Wellbutrin)
  • Varenicline (Chantix)
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Cost & Coverage

Average Cost: $30 - $60 per 72 lozenges
Generic Available: Yes
Insurance Coverage: Often available over-the-counter (OTC). Some insurance plans or state programs may cover NRT as part of smoking cessation benefits.
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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.