Nicotine 2mg SF Fruit Gum 100s

Manufacturer RUGBY LABORATORIES 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
Jan 1984
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Nicotine gum is a medicine that helps you quit smoking by giving you a small, controlled amount of nicotine to reduce cravings and withdrawal symptoms. It's not a regular chewing gum; you chew it slowly until you feel a tingle, then 'park' it between your cheek and gum to let the nicotine absorb, repeating this process for about 30 minutes.
📋

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 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 again slowly.
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. However, do not use two pieces of gum 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 resume your regular schedule.
* Do not use two doses at the same time or take extra doses.
💡

Lifestyle & Tips

  • Do not eat or drink anything (except water) for 15 minutes before and during chewing the gum, as acidic beverages can reduce nicotine absorption.
  • Chew the gum slowly until a tingling sensation or peppery taste is felt, then 'park' it between your cheek and gum. When the tingling fades, chew again and repeat the process. This is called 'chew and park'.
  • Do not chew the gum too fast or swallow it, as this can lead to stomach upset, hiccups, or too much nicotine too quickly.
  • Follow the recommended dosing schedule and gradually reduce the number of pieces used over 12 weeks.
  • Set a quit date and use the gum consistently starting on that day.
  • Combine gum use with behavioral support and counseling for best results.
  • Store out of reach of children and pets, as nicotine can be toxic if ingested.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: One 2mg piece of gum every 1 to 2 hours for the first 6 weeks, then taper.
Dose Range: 9 - 24 mg

Condition-Specific Dosing:

initial_use: Use at least 9 pieces per day for the first 6 weeks to improve chances of quitting.
tapering_phase: Weeks 7-9: 1 piece every 2-4 hours. Weeks 10-12: 1 piece every 4-8 hours. Discontinue after 12 weeks.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Not recommended for individuals under 18 years of age)
Adolescent: Not established (Not recommended for individuals under 18 years of age)
âš•ī¸

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 reduced clearance.
Dialysis: Use with caution; nicotine and its metabolites are dialyzable, but clinical significance is unclear. Monitor for adverse effects.

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 reduced clearance.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Nicotine acts as an agonist at nicotinic acetylcholine receptors (nAChRs) in the central and peripheral nervous systems. In the brain, it binds to nAChRs, particularly the ι4β2 subtype, leading to the release of neurotransmitters like dopamine, norepinephrine, and serotonin. This action helps to alleviate nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) experienced during smoking cessation, by providing a controlled, therapeutic dose of nicotine without the harmful toxins found in tobacco smoke.
📊

Pharmacokinetics

Absorption:

Bioavailability: 50-70% (variable, depends on chewing technique and pH)
Tmax: 15-30 minutes (from gum)
FoodEffect: Acidic beverages (e.g., coffee, soda, fruit juice) can decrease buccal absorption of nicotine. Avoid eating or drinking anything except water for 15 minutes before and during chewing the gum.

Distribution:

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

Elimination:

HalfLife: 1-2 hours (nicotine); 18-20 hours (cotinine)
Clearance: Approximately 70 L/hour (nicotine)
ExcretionRoute: Renal (pH-dependent)
Unchanged: 10-20% (nicotine, highly dependent on urine pH)
âąī¸

Pharmacodynamics

OnsetOfAction: Rapid (within minutes of proper chewing)
PeakEffect: 15-30 minutes
DurationOfAction: Short (due to rapid metabolism and distribution, but effects on cravings can be sustained by regular dosing)

Safety & Warnings

âš ī¸

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
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 unusual 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 application
Mouth tingling
* Gum changes

This list is not exhaustive, and you may experience other side effects not mentioned here. 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:

  • Severe nausea or vomiting
  • Dizziness or lightheadedness
  • Weakness
  • Cold sweat
  • Palpitations or irregular heartbeat
  • Chest pain
  • Difficulty breathing
  • Seizures
📋

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. 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 tobacco use, including smoking, chewing tobacco, or using nicotine products, as these may interact with 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 existing health conditions and other drugs. Never start, stop, or change the dosage of any medication without first consulting your doctor.
âš ī¸

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, 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 may impact the effectiveness of other medications you are taking, so consult with your doctor.

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, such as nicotine gum, may cause problems with dental work, such as loose teeth or dental implants.

If you are on 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. 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.

For pregnant or breastfeeding women, it is essential to exercise caution when taking this medication. If you become pregnant or are currently pregnant while taking this medication, notify your doctor immediately. Additionally, if you are breastfeeding, discuss the potential risks to your baby with your doctor.
🆘

Overdose Information

Overdose Symptoms:

  • Severe nausea and vomiting
  • Abdominal pain
  • Diarrhea
  • Excessive salivation
  • Sweating
  • Headache
  • Dizziness
  • Confusion
  • Weakness
  • Fainting
  • Rapid or irregular heartbeat
  • Low blood pressure
  • Seizures
  • Respiratory depression (slow, shallow breathing)

What to Do:

If you suspect an overdose, seek immediate medical attention or call a Poison Control Center at 1-800-222-1222. Remove any remaining gum from the mouth. Provide supportive care as needed.

Drug Interactions

🟡

Moderate Interactions

  • Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
  • Caffeine (smoking cessation can increase caffeine levels due to reduced CYP1A2 induction)
  • Theophylline (smoking cessation can increase theophylline levels due to reduced CYP1A2 induction)
  • Imipramine (smoking cessation can increase imipramine levels due to reduced CYP1A2 induction)
  • Oxazepam (smoking cessation can increase oxazepam levels due to reduced CYP1A2 induction)
  • Pentazocine (smoking cessation can increase pentazocine levels due to reduced CYP1A2 induction)
  • Insulin (smoking cessation can increase subcutaneous insulin absorption and effectiveness, requiring dose adjustment)
  • Adrenergic agonists (e.g., phenylephrine, isoproterenol - nicotine may potentiate cardiovascular effects)
  • Adrenergic antagonists (e.g., labetalol, prazosin - nicotine may reduce their hypotensive effects)

Monitoring

đŸ”Ŧ

Baseline Monitoring

Smoking status and history

Rationale: To assess nicotine dependence level and tailor treatment plan.

Timing: Prior to initiation of therapy

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

Rationale: Nicotine can have cardiovascular effects; NRT is generally contraindicated or requires caution in these conditions.

Timing: Prior to initiation of therapy

Dental/oral health assessment

Rationale: To identify any pre-existing conditions that might be exacerbated by gum chewing (e.g., TMJ, dental work).

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Adherence to dosing regimen

Frequency: Weekly during initial phase, then as needed

Target: As prescribed (e.g., 9-24 pieces/day initially)

Action Threshold: Consistent under-dosing or over-dosing; adjust counseling or dose.

Side effects (e.g., nausea, dyspepsia, jaw pain, headache, dizziness)

Frequency: Weekly during initial phase, then as needed

Target: Minimal to none

Action Threshold: Persistent or severe side effects; adjust chewing technique, dose, or consider alternative NRT.

Smoking cessation progress (e.g., number of cigarettes smoked, cravings)

Frequency: Weekly during initial phase, then as needed

Target: Progressive reduction in smoking, decreased cravings

Action Threshold: Lack of progress, continued heavy smoking, or severe cravings; reassess dose, counseling, or consider combination NRT/other pharmacotherapy.

đŸ‘ī¸

Symptom Monitoring

  • Nausea
  • Vomiting
  • Dyspepsia (heartburn, indigestion)
  • Jaw muscle soreness/pain
  • Headache
  • Dizziness
  • Irritation of mouth/throat
  • Hiccups
  • Palpitations
  • Chest pain (seek immediate medical attention if severe)

Special Patient Groups

🤰

Pregnancy

Category D. Nicotine crosses the placenta and can cause fetal harm. While smoking is more harmful than NRT, NRT should only be used if the pregnant woman is unable to quit smoking without it and the benefits outweigh the risks. Non-pharmacological methods should be tried first.

Trimester-Specific Risks:

First Trimester: Potential for adverse effects on fetal development, including cardiovascular and respiratory systems.
Second Trimester: Continued exposure can affect fetal growth and development.
Third Trimester: Increased risk of preterm birth, low birth weight, and adverse neurodevelopmental outcomes.
🤱

Lactation

Nicotine is excreted into breast milk. The American Academy of Pediatrics considers nicotine to be contraindicated during breastfeeding due to potential adverse effects on the infant (e.g., irritability, poor feeding, increased heart rate). If NRT is used, consider using the gum immediately after breastfeeding to minimize infant exposure, or consider alternative NRT forms with shorter half-lives.

Infant Risk: L3 (Moderate risk). Potential for infant irritability, sleep disturbances, increased heart rate, and reduced milk supply. Risk is lower than continued smoking.
đŸ‘ļ

Pediatric Use

Not recommended for individuals under 18 years of age. Safety and efficacy have not been established in this population for smoking cessation. Nicotine can be toxic to children.

👴

Geriatric Use

No specific dose adjustment is generally required. Use with caution in elderly patients with pre-existing cardiovascular disease or other comorbidities. Monitor for adverse effects.

Clinical Information

💎

Clinical Pearls

  • Proper chewing technique is crucial for effective nicotine absorption and to minimize side effects. Instruct patients to 'chew and park' rather than continuous chewing.
  • Acidic beverages can significantly reduce nicotine absorption from the gum; advise patients to avoid them for 15 minutes before and during use.
  • Nicotine gum is often recommended for smokers who prefer to actively manage their cravings or who have irregular smoking patterns.
  • Encourage patients to use enough gum, especially in the initial weeks, to manage cravings effectively. Under-dosing is a common reason for NRT failure.
  • Tapering the dose over the recommended 12-week period is important to gradually reduce nicotine dependence.
  • Combine NRT with behavioral counseling and support for the highest success rates in smoking cessation.
🔄

Alternative Therapies

  • Bupropion (Zyban, Wellbutrin SR)
  • Varenicline (Chantix)
  • Behavioral counseling and support programs (e.g., quitlines, group therapy)
💰

Cost & Coverage

Average Cost: $30 - $70 per 100 pieces (2mg)
Generic Available: Yes
Insurance Coverage: Often covered by prescription drug plans (Rx or OTC benefit), sometimes available through public health programs. Tier 1 or 2.
📚

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.