Nicotine SF 2mg Cinn Gum 100's

Manufacturer RUGBY 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.
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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
Jan 1984
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nicotine gum is a medicine that helps you quit smoking by giving your body a small amount of nicotine, which reduces the strong cravings and uncomfortable feelings you get when you stop smoking. It helps you gradually reduce your dependence on 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 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 use one dose; if you smoke your first cigarette more than 30 minutes after waking up, 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 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. 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.

Missing 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.
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Lifestyle & Tips

  • Set a quit date and stick to it.
  • Identify and avoid triggers that make you want to smoke.
  • Seek behavioral support, counseling, or a quitline (e.g., 1-800-QUIT-NOW) to increase your chances of success.
  • Engage in healthy activities and stress-reduction techniques.
  • Inform family and friends about your quit attempt for support.

Dosing & Administration

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Adult Dosing

Standard Dose: For those smoking 25 or more cigarettes per day: 4mg gum. For those smoking less than 25 cigarettes per day: 2mg gum. Chew one piece every 1 to 2 hours for the first 6 weeks, then one piece every 2 to 4 hours for weeks 7-9, then one piece every 4 to 8 hours for weeks 10-12. Do not exceed 24 pieces per day.
Dose Range: 1 - 24 mg

Condition-Specific Dosing:

initialPhase: 1 piece every 1-2 hours
taperPhase1: 1 piece every 2-4 hours (weeks 7-9)
taperPhase2: 1 piece every 4-8 hours (weeks 10-12)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not recommended for individuals under 18 years of age without medical supervision.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: Use with caution; reduced clearance may occur. Monitor for increased side effects.
Severe: Use with caution; reduced clearance may occur. Monitor for increased side effects.
Dialysis: Considerations: Nicotine is dialyzable, but clinical significance for gum is limited due to slow absorption. Use with caution and monitor.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: Use with caution; reduced clearance may occur. Monitor for increased side effects.
Severe: Use with caution; reduced clearance may occur. Monitor for increased side effects.
Confidence: Medium

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 (e.g., irritability, anxiety, difficulty concentrating, cravings) and the urge to smoke.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (buccal absorption), approximately 50-70% of the released nicotine is absorbed.
Tmax: 15-30 minutes (from chewing gum)
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 chewing.

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 in acidic urine)
Unchanged: 10-20% (nicotine, higher in acidic urine)
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of chewing)
PeakEffect: 15-30 minutes
DurationOfAction: Short (due to rapid metabolism, but effects on cravings can last longer)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 immediately or seek emergency medical attention:

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
Mouth tingling
* Gum changes

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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, headache, cold sweat, confusion, weakness, seizures.
  • Chest pain, irregular heartbeat, or severe palpitations (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. Describe the allergic reaction and its symptoms.
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 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 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 prescribed may lead to unsafe side effects. If you are using another medication to aid in smoking cessation, notify your doctor to avoid potential interactions.

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, exercise caution when engaging in activities that require alertness, such as driving. Additionally, quitting smoking may impact the efficacy or safety of other medications you are taking, so consult your doctor to discuss any necessary adjustments.

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, particularly if you have dental work, may cause problems. If you are on a low-sodium or sodium-free diet, consult your doctor, as some products 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. Pregnant women or those who become pregnant while taking this medication should notify their doctor promptly, as it may harm the unborn baby. Breastfeeding women should also consult their doctor to discuss potential risks to their baby.
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Overdose Information

Overdose Symptoms:

  • Severe nausea and vomiting
  • Diarrhea
  • Dizziness
  • Headache
  • Cold sweat
  • Confusion
  • Weakness
  • Fainting
  • Seizures
  • Trouble breathing
  • Irregular heartbeat

What to Do:

If you suspect an overdose, stop using the gum immediately and call a poison control center (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

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Moderate Interactions

  • Adenosine (Nicotine can increase heart rate and blood pressure, potentially reducing adenosine's effectiveness in treating supraventricular tachycardia.)
  • Beta-blockers (Smoking cessation can lead to increased levels of some beta-blockers due to reduced enzyme induction; nicotine itself can cause transient increases in BP/HR.)
  • Insulin (Smoking cessation can improve insulin sensitivity, potentially requiring a reduction in insulin dose.)
  • Theophylline (Smoking cessation can lead to increased theophylline levels due to reduced enzyme induction, requiring dose adjustment.)
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Minor Interactions

  • Caffeine (Smoking cessation can lead to increased caffeine levels due to reduced enzyme induction, potentially requiring a reduction in caffeine intake.)
  • Flecainide (Smoking cessation can lead to increased flecainide levels.)
  • Propoxyphene (Smoking cessation can lead to increased propoxyphene levels.)

Monitoring

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Baseline Monitoring

Smoking history (number of cigarettes/day, previous quit attempts)

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

Timing: Prior to initiation of therapy

Cardiovascular status (history of heart attack, stroke, arrhythmias, angina)

Rationale: Nicotine can affect the cardiovascular system; caution is advised in patients with pre-existing conditions.

Timing: Prior to initiation of therapy

Dental health/Oral conditions

Rationale: Gum can stick to dentures, dental work, or irritate existing oral conditions.

Timing: Prior to initiation of therapy

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Routine Monitoring

Smoking status (abstinence, number of cigarettes smoked)

Frequency: Weekly initially, then as needed

Target: Complete abstinence from smoking

Action Threshold: Continued smoking or relapse indicates need for counseling, dose adjustment, or alternative therapy.

Adherence to gum chewing instructions

Frequency: Regularly during follow-up visits

Target: Correct 'chew and park' technique, appropriate frequency

Action Threshold: Incorrect use can lead to inadequate nicotine delivery or excessive side effects.

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

Frequency: Regularly during follow-up visits

Target: Minimal to no side effects

Action Threshold: Persistent or severe side effects may require dose adjustment, change in technique, or discontinuation.

Cravings and withdrawal symptoms

Frequency: Regularly during follow-up visits

Target: Reduced intensity and frequency of cravings/withdrawal

Action Threshold: Uncontrolled cravings/withdrawal may indicate need for higher dose, more frequent use, or adjunctive therapy.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Dizziness
  • Headache
  • Hiccups
  • Indigestion
  • Sore jaw/mouth
  • Throat irritation
  • Palpitations
  • Chest pain (seek immediate medical attention if severe)

Special Patient Groups

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Pregnancy

Category D. Nicotine can harm a developing fetus. However, the risks of continued smoking during pregnancy generally outweigh the risks of nicotine replacement therapy (NRT). NRT should be used only if the pregnant woman has been unable to quit smoking without it and under the guidance of a healthcare professional, using the lowest effective dose for the shortest duration.

Trimester-Specific Risks:

First Trimester: Potential for adverse effects on fetal development; however, continued smoking poses greater risks.
Second Trimester: Potential for adverse effects on fetal development; however, continued smoking poses greater risks.
Third Trimester: Potential for adverse effects on fetal development, including reduced fetal breathing movements and increased risk of preterm birth; however, continued smoking poses greater risks.
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Lactation

L3 (Moderately Safe). Nicotine and its metabolites are excreted into breast milk. While NRT exposes the infant to nicotine, it is generally considered safer than continued maternal smoking. Advise mothers to use the lowest effective dose, and consider timing doses immediately after breastfeeding to minimize infant exposure.

Infant Risk: Infants exposed to nicotine via breast milk may experience irritability, restlessness, or poor feeding. However, the risks are generally lower than those associated with direct exposure to cigarette smoke.
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Pediatric Use

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

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Geriatric Use

Use with caution in elderly patients, particularly those with pre-existing cardiovascular disease, diabetes, or other comorbidities. No specific dose adjustment is typically required, but monitor for side effects and cardiovascular effects.

Clinical Information

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Clinical Pearls

  • Instruct patients on the 'chew and park' method: chew slowly until a peppery taste or tingle is felt, then park the gum between the cheek and gum until the taste/tingle fades, then repeat. This ensures proper buccal absorption.
  • Emphasize that acidic beverages (e.g., coffee, soda, juice) should be avoided for 15 minutes before and during gum use, as they can reduce nicotine absorption.
  • Nicotine gum is not meant to be chewed like regular chewing gum; rapid chewing can lead to excessive nicotine release, causing side effects like hiccups, indigestion, and nausea.
  • Encourage patients to use the gum regularly, especially during anticipated craving times, rather than waiting until cravings become intense.
  • Combine NRT with behavioral counseling or support programs for the best chance of successful smoking cessation.
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Alternative Therapies

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

Average Cost: Varies widely, typically $20-$60 per 100 pieces
Generic Available: Yes
Insurance Coverage: Often covered by insurance plans, especially with a prescription, or available over-the-counter (OTC) with potential for FSA/HSA reimbursement. Coverage varies by plan.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.