Nicotine Pol 2mg Mint Gum 100s

Manufacturer RUGBY Active Ingredient Nicotine Gum(nik oh TEEN) Pronunciation NIK-oh-teen POL-uh-kril-ex
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
D
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FDA Approved
Jan 1984
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nicotine gum is a type of medicine that helps you quit smoking by giving your body a small amount of nicotine, which reduces the cravings and withdrawal symptoms you get when you stop smoking. It's a piece of gum you chew slowly to release the nicotine.
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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 your first cigarette is within 30 minutes of waking up, you will use one dose; if it's after 30 minutes, you will use the other dose. If you're unsure about which dose to use, consult your pharmacist or doctor.

Using the Gum

1. Use the gum immediately after opening the package.
2. Do not swallow the gum. Instead, chew it slowly until you experience a tingling or peppery taste in your mouth.
3. Once you feel the tingling or peppery taste, place the gum between your cheek and gum.
4. After the taste or tingling sensation has disappeared, chew the gum slowly again.
5. Move the gum to a different location between your cheek and gum when the taste or tingling returns. Repeat this process for about 30 minutes or until the taste or tingling is gone.

Important Reminders

Avoid eating or drinking within 15 minutes before using the gum or while you are using it.
If needed, you can use a second piece of gum within an hour, but do not use two pieces back-to-back.

Storing and Disposing of Your Medication

Store the gum at room temperature, protected from light.
After using the gum, wrap it in paper before disposing of it.

What to Do If You Miss a Dose

If you miss a dose, use it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and return to your regular schedule.
* Do not use two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Chew the gum slowly until you feel a tingling sensation, then 'park' it between your cheek and gum. When the tingling fades, chew again. Repeat this for about 30 minutes.
  • Do not eat or drink anything (especially acidic beverages like coffee, soda, or juice) for 15 minutes before or during chewing the gum, as this can reduce nicotine absorption.
  • Do not chew the gum too fast or swallow it, as this can lead to side effects like hiccups, heartburn, or nausea.
  • Set a quit date and use the gum consistently as directed.
  • Combine gum use with behavioral support programs for best results.
  • Gradually reduce the number of pieces of gum used per day over the course of the 12-week program.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 mg gum: Chew one piece every 1-2 hours for the first 6 weeks, then every 2-4 hours for weeks 7-9, then every 4-8 hours for weeks 10-12. Do not exceed 24 pieces per day.

Condition-Specific Dosing:

initial_therapy: For individuals who smoke their first cigarette more than 30 minutes after waking, or who smoke less than 25 cigarettes per day.
max_daily_dose: Do not use more than 24 pieces per day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (generally not recommended for individuals under 18 years of age without medical supervision)
Adolescent: Not established (generally not recommended for individuals under 18 years of age without medical supervision)
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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 and its metabolites are renally excreted. Monitor for increased side effects. Consult physician.

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

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Mechanism of Action

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

Absorption:

Bioavailability: Approximately 50-60% (buccal absorption, highly variable depending on chewing technique and pH)
Tmax: Approximately 15-30 minutes (buccal absorption)
FoodEffect: Acidic beverages (e.g., coffee, soda, fruit juice) can decrease buccal absorption of nicotine. Avoid eating or drinking for 15 minutes before and during gum use.

Distribution:

Vd: Approximately 2.6 L/kg
ProteinBinding: Less than 5%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 1-2 hours (nicotine); 15-19 hours (cotinine)
Clearance: Approximately 1.2 L/min
ExcretionRoute: Renal (pH-dependent; acidic urine increases excretion)
Unchanged: Approximately 10-20% (highly variable, depends on urine pH)
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of chewing)
PeakEffect: Approximately 15-30 minutes after chewing
DurationOfAction: Effects persist as long as nicotine is absorbed and present, typically for the duration of chewing and shortly thereafter, but the therapeutic effect of craving reduction can last longer.

Safety & Warnings

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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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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
Abnormal sensations, such as burning, numbness, or tingling
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 or excitable
Headache
Joint pain
Back pain
Irritation at the site of administration
Mouth tingling
Gum changes

Reporting Side Effects

This list is not exhaustive, and you may experience other 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe jaw pain
  • Persistent indigestion or heartburn
  • Severe nausea or vomiting
  • Dizziness or lightheadedness
  • Chest pain or irregular heartbeat
  • Difficulty breathing
  • Signs of nicotine overdose (see below)
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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 symptoms you experienced.
Certain health conditions, including:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your use of tobacco products, such as smoking, chewing tobacco, or using nicotine-containing products, while taking this medication
If you have temporomandibular joint (TMJ) disease
* If you are under 18 years of age, as this medication is not recommended for children 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 medications 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 the prescribed amount can lead to unsafe side effects. If you are using another medication to aid in smoking cessation, be sure to notify 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 impact the effectiveness of other medications you are taking, so consult with your doctor to discuss any potential interactions.

If you have been using this medication for the recommended duration and have not been able to quit smoking, inform your doctor. It is also important to note that chewing gum can potentially cause problems with dental work, such as loose teeth or dental implants.

If you are following a low-sodium or sodium-free diet, consult with your doctor before using this medication, as some products may contain sodium. It is also vital to keep this medication out of reach of children and pets, as it can be harmful or even fatal if ingested. If a child or pet accidentally ingests this medication, 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. Furthermore, if you are pregnant or become pregnant while taking this medication, notify your doctor promptly, as it may pose a risk to the unborn baby. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Weakness
  • Rapid heartbeat
  • Sweating
  • Salivation
  • Confusion
  • Seizures (severe cases)

What to Do:

If you suspect an overdose, stop using the gum immediately and seek emergency medical attention. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Moderate Interactions

  • Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
  • Beta-blockers (nicotine may reduce the hypotensive effects of beta-blockers)
  • Insulin (smoking cessation with NRT may increase insulin absorption or decrease insulin requirements due to improved glucose metabolism)
  • Adrenergic agonists (e.g., phenylephrine, isoproterenol) (nicotine may potentiate cardiovascular effects)
  • Adrenergic antagonists (e.g., prazosin, labetalol) (nicotine may reduce the therapeutic effects)

Monitoring

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Baseline Monitoring

Smoking history and current smoking status

Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and to establish a baseline for cessation progress.

Timing: Prior to initiation of therapy

Cardiovascular health assessment

Rationale: Nicotine can affect heart rate and blood pressure; caution in patients with pre-existing cardiovascular conditions.

Timing: Prior to initiation of therapy (especially for patients with known CVD)

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Routine Monitoring

Smoking cessation progress

Frequency: Weekly initially, then as needed

Target: Reduction in cigarette consumption, eventual abstinence

Action Threshold: Lack of progress or continued heavy smoking may indicate need for dose adjustment, combination therapy, or alternative strategies.

Nicotine withdrawal symptoms (e.g., cravings, irritability, anxiety)

Frequency: Daily/weekly

Target: Reduction or absence of symptoms

Action Threshold: Persistent or severe symptoms may indicate insufficient nicotine dose or need for behavioral support.

Adverse effects (e.g., jaw soreness, dyspepsia, nausea, hiccups)

Frequency: Daily/weekly

Target: Absence or mild, tolerable symptoms

Action Threshold: Persistent or severe side effects may require adjustment of chewing technique, dose reduction, or discontinuation.

Gum usage (pieces per day)

Frequency: Weekly

Target: Adherence to recommended tapering schedule

Action Threshold: Overuse or underuse may impact efficacy or lead to prolonged dependence.

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Symptom Monitoring

  • Jaw soreness
  • Hiccups
  • Nausea
  • Indigestion
  • Throat irritation
  • Lightheadedness
  • Headache
  • Palpitations
  • Sleep disturbances
  • Anxiety
  • Irritability
  • Cravings

Special Patient Groups

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Pregnancy

Category D. Nicotine can harm the fetus. Smoking cessation without NRT is preferred. If a pregnant woman cannot quit smoking without pharmacotherapy, NRT may be considered only if the benefits of quitting smoking outweigh the risks of nicotine exposure to the fetus, and under strict medical supervision. Gum may be preferred over patches due to intermittent nicotine delivery.

Trimester-Specific Risks:

First Trimester: Increased risk of miscarriage, congenital malformations (though less clear for NRT vs. smoking).
Second Trimester: Increased risk of preterm birth, low birth weight.
Third Trimester: Increased risk of preterm birth, low birth weight, stillbirth, respiratory problems, neurodevelopmental issues.
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Lactation

L3 (Moderate risk). Nicotine is excreted into breast milk and can harm the infant. Smoking cessation without NRT is preferred. If NRT is necessary, use the lowest effective dose and consider using the gum immediately after breastfeeding to minimize infant exposure. Monitor infant for signs of nicotine exposure (e.g., irritability, poor feeding, sleep disturbances).

Infant Risk: Irritability, restlessness, poor feeding, increased heart rate, sleep disturbances. Long-term effects on neurodevelopment are not fully established but are a concern.
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Pediatric Use

Not recommended for individuals under 18 years of age without medical supervision due to lack of established safety and efficacy data in this population. Nicotine can be harmful to developing brains.

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Geriatric Use

No specific dose adjustments are typically required. However, older adults may be more susceptible to cardiovascular side effects. Use with caution in patients with pre-existing cardiovascular disease. Monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Proper chewing technique is crucial for efficacy and to minimize side effects (e.g., hiccups, indigestion). 'Chew and park' method.
  • Avoid acidic beverages 15 minutes before and during use, as they can significantly reduce nicotine absorption.
  • Nicotine gum can be used in combination with other NRTs (e.g., nicotine patch) for more severe dependence, under medical supervision.
  • The 2mg strength is generally for those who smoke their first cigarette more than 30 minutes after waking, while 4mg is for those who smoke within 30 minutes of waking.
  • Patients should be encouraged to set a quit date and engage in behavioral support programs for optimal success.
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Alternative Therapies

  • Nicotine patch (transdermal)
  • Nicotine lozenge
  • Nicotine inhaler
  • Nicotine nasal spray
  • Bupropion (Zyban, Wellbutrin)
  • Varenicline (Chantix)
  • Behavioral counseling and support programs
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Cost & Coverage

Average Cost: Varies, typically $20-$50 per 100 pieces
Generic Available: Yes
Insurance Coverage: Often covered by insurance plans, especially with a prescription or as part of smoking cessation programs. May be available OTC without prescription.
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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 this 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 happened.