Nicotine Pol 2mg Mint Gum 110s

Manufacturer PADAGIS Active Ingredient Nicotine Gum(nik oh TEEN) Pronunciation NIK-oh-teen
It is used to treat nicotine withdrawal.It is used to curb the craving to smoke.
đŸˇī¸
Drug Class
Smoking Cessation Aid
đŸ§Ŧ
Pharmacologic Class
Nicotinic Acetylcholine Receptor Agonist
🤰
Pregnancy Category
Category D
✅
FDA Approved
Aug 1984
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Nicotine gum is a medicine that helps you stop smoking by giving your body a small, controlled amount of nicotine. This helps reduce the strong cravings and uncomfortable feelings you get when you quit smoking, making it easier to break the habit.
📋

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 when you have your first cigarette of the day. If you smoke your first cigarette within 30 minutes of waking up, you will need one dose, while if you smoke your first cigarette more than 30 minutes after waking up, you will need the other dose. If you are 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 Instructions

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 at the same time.

Storing and Disposing of Your Medication

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

What to Do If You Miss a Dose

If you miss a dose, use it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
* Do not use two doses at the same time or take extra doses.
💡

Lifestyle & Tips

  • Combine nicotine gum with a quit plan and behavioral support (e.g., counseling, support groups) for the best chance of success.
  • Avoid eating or drinking anything (except water) for 15 minutes before and during chewing the gum, as acidic beverages can reduce nicotine absorption.
  • Chew the gum slowly until you feel a tingling sensation or a peppery taste. Then, 'park' the gum between your cheek and gum. When the tingle fades, chew a few more times until the tingle returns, then park it again. Repeat this process for about 30 minutes.
  • Do not chew the gum continuously or too quickly, as this can release too much nicotine too fast, leading to side effects like hiccups, heartburn, or nausea.
  • Gradually reduce the number of pieces of gum you use each day over the 12-week treatment period, as directed by the package instructions or your healthcare provider.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: For individuals smoking less than 25 cigarettes per day: Weeks 1-6: 1 piece every 1-2 hours. Weeks 7-9: 1 piece every 2-4 hours. Weeks 10-12: 1 piece every 4-8 hours. Max 24 pieces/day.
Dose Range: 1 - 24 mg

Condition-Specific Dosing:

smoking_less_than_25_cigarettes_per_day: 2mg gum recommended. Start with 1 piece every 1-2 hours for the first 6 weeks.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not recommended for individuals under 18 years of age without medical supervision.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor for increased side effects.
Moderate: Use with caution; monitor for increased side effects.
Severe: Use with caution; monitor for increased side effects. Reduced clearance may occur.
Dialysis: Considerations: Nicotine is dialyzable, but clinical significance for gum use is low. Use with caution and monitor for adverse effects.

Hepatic Impairment:

Mild: Use with caution; monitor for increased side effects.
Moderate: Use with caution; monitor for increased side effects. Reduced clearance may occur.
Severe: Use with caution; monitor for increased side effects. Significant reduction in clearance is expected; consider lower doses or extended intervals.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Nicotine acts as an agonist at nicotinic acetylcholine receptors (nAChRs) in the central and peripheral nervous systems, particularly the ι4β2 subtype in the brain's mesolimbic dopamine system. This binding stimulates dopamine release, mimicking the effects of nicotine from tobacco and reducing the severity of nicotine withdrawal symptoms and cravings associated with smoking cessation.
📊

Pharmacokinetics

Absorption:

Bioavailability: 50-70% (of released nicotine from gum)
Tmax: 15-30 minutes
FoodEffect: Acidic beverages (e.g., coffee, soda, juice) can significantly reduce buccal absorption of nicotine if consumed immediately before or during chewing. Avoid eating or drinking anything except water for 15 minutes before and during gum use.

Distribution:

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

Elimination:

HalfLife: 1-2 hours (nicotine); 15-20 hours (cotinine)
Clearance: Approximately 1.2 L/min (nicotine)
ExcretionRoute: Renal (pH-dependent, increased with acidic urine)
Unchanged: 10-30%
âąī¸

Pharmacodynamics

OnsetOfAction: Rapid (within minutes of proper chewing)
PeakEffect: 15-30 minutes
DurationOfAction: Acute craving relief lasts as long as nicotine levels are elevated, typically 30-60 minutes per piece.

Safety & Warnings

âš ī¸

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
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. 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:

Trouble sleeping
Bad dreams
Feeling nervous and excitable
Headache
Joint pain
Back pain
Irritation at the site of application
Mouth tingling
* Gum changes

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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Signs of nicotine overdose: severe nausea, vomiting, dizziness, cold sweat, weakness, confusion, blurred vision, hearing difficulties, rapid or irregular heartbeat, seizures.
  • Signs of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
📋

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. 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
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 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.
âš ī¸

Precautions & Cautions

It is essential to inform all of 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 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 alter the effectiveness of other medications you are taking, so consult with your doctor to discuss any potential interactions.

If you have not been able to quit smoking after using this medication for the recommended duration, 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.

This medication can be hazardous or even fatal if ingested by children or pets, so it is vital to keep it out of their reach. If a child uses this medication or if it is swallowed by a child or pet, 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.
🆘

Overdose Information

Overdose Symptoms:

  • Severe nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Headache
  • Cold sweat
  • Weakness
  • Confusion
  • Blurred vision
  • Hearing difficulties
  • Rapid or irregular heartbeat
  • Low blood pressure
  • Difficulty breathing
  • Seizures

What to Do:

If you suspect an overdose, stop using the gum immediately. Call your doctor or poison control center (1-800-222-1222) right away. Seek emergency medical attention if symptoms are severe.

Drug Interactions

🟡

Moderate Interactions

  • Caffeine (smoking cessation may increase caffeine levels due to reduced CYP1A2 induction)
  • Theophylline (smoking cessation may increase theophylline levels due to reduced CYP1A2 induction)
  • Imipramine (smoking cessation may increase imipramine levels due to reduced CYP1A2 induction)
  • Olanzapine (smoking cessation may increase olanzapine levels due to reduced CYP1A2 induction)
  • Clozapine (smoking cessation may increase clozapine levels due to reduced CYP1A2 induction)
  • Fluvoxamine (smoking cessation may increase fluvoxamine levels due to reduced CYP1A2 induction)
  • Insulin (smoking cessation may increase subcutaneous insulin absorption, requiring dose adjustment)
  • Adrenergic agonists (e.g., phenylephrine, isoproterenol - smoking cessation may reduce pressor response)
  • Adrenergic antagonists (e.g., labetalol, prazosin - smoking cessation may increase hypotensive effect)

Monitoring

đŸ”Ŧ

Baseline Monitoring

Smoking history (number of cigarettes/day, duration)

Rationale: To determine appropriate nicotine gum strength (2mg vs 4mg) and initial dosing regimen.

Timing: Prior to initiation of therapy.

Cardiovascular status (history of MI, angina, arrhythmias)

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

Timing: Prior to initiation of therapy.

Dental health/Jaw pain history

Rationale: Gum chewing can exacerbate jaw pain or dental issues.

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Adherence to chewing technique and dosing schedule

Frequency: At each follow-up visit (weekly initially, then bi-weekly/monthly)

Target: Consistent use as directed, gradual reduction over 12 weeks.

Action Threshold: Poor adherence or incorrect technique may lead to treatment failure or side effects; provide re-education.

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

Frequency: Daily self-monitoring, reviewed at each follow-up visit.

Target: Reduction in severity and frequency of symptoms.

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

Side effects (e.g., nausea, dyspepsia, jaw pain, mouth/throat irritation, dizziness)

Frequency: Daily self-monitoring, reviewed at each follow-up visit.

Target: Minimal or tolerable side effects.

Action Threshold: Intolerable side effects may require dose reduction, change in chewing technique, or discontinuation.

đŸ‘ī¸

Symptom Monitoring

  • Nausea
  • Vomiting
  • Dizziness
  • Headache
  • Palpitations
  • Jaw pain
  • Mouth/throat irritation
  • Heartburn
  • Indigestion
  • Hiccups

Special Patient Groups

🤰

Pregnancy

Category D. Smoking during pregnancy poses significant risks to the fetus. Non-pharmacological interventions (e.g., behavioral counseling) are the first-line approach for smoking cessation in pregnant women. If these methods are unsuccessful, and the pregnant woman is unable to quit smoking, NRT may be considered under medical supervision, as the risks of continued smoking generally outweigh the risks of NRT. Intermittent NRT (like gum) may be preferred over continuous NRT (like patches) to allow for nicotine-free periods.

Trimester-Specific Risks:

First Trimester: Potential for adverse developmental effects, though less than continued smoking.
Second Trimester: Potential for adverse developmental effects, though less than continued smoking.
Third Trimester: Potential for adverse developmental effects, including fetal breathing pattern changes and reduced fetal movements, though less than continued smoking. Risk of premature birth and low birth weight.
🤱

Lactation

L3 (Moderately Safe). Nicotine is excreted into breast milk. While NRT delivers less nicotine than smoking, it is still present. Advise breastfeeding mothers to use the lowest effective dose and to use the gum immediately after breastfeeding to minimize infant exposure, allowing time for nicotine levels to decrease before the next feeding. Non-pharmacological methods are preferred.

Infant Risk: Low to moderate. Potential for infant exposure to nicotine and its metabolites, which could lead to irritability, sleep disturbances, or gastrointestinal upset. Risk is lower than with continued smoking.
đŸ‘ļ

Pediatric Use

Not recommended for individuals under 18 years of age without medical supervision. Safety and efficacy have not been established in pediatric populations for smoking cessation.

👴

Geriatric Use

Use with caution in elderly patients, especially those with cardiovascular disease, due to potential for increased sensitivity to nicotine's effects. No specific dose adjustment is typically required, but monitor for adverse effects.

Clinical Information

💎

Clinical Pearls

  • Proper chewing technique is critical for effective nicotine delivery and to minimize side effects. Emphasize 'chew and park' method.
  • Advise patients to avoid acidic beverages (coffee, soda, juice) 15 minutes before and during gum use, as they can significantly impair nicotine absorption.
  • Nicotine gum is a temporary aid; the goal is to gradually reduce and discontinue its use over the 12-week treatment period.
  • Encourage patients to combine nicotine gum with behavioral counseling or support programs for the highest success rates in quitting smoking.
  • Patients should be aware of the signs of nicotine overdose and seek immediate medical attention if they occur.
🔄

Alternative Therapies

  • Bupropion (Zyban, Wellbutrin)
  • Varenicline (Chantix)
💰

Cost & Coverage

Average Cost: Varies widely ($20-$60) per 100-110 pieces
Generic Available: Yes
Insurance Coverage: Often covered by prescription drug plans (Tier 1 or 2), or available OTC. Some state quitlines or public health programs may offer free or discounted products.
📚

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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.