Nicotine 21mg/24h Patch 28s
It is used to treat nicotine withdrawal.It is used to curb the craving to smoke.
Drug Class
Smoking Cessation Aid
Pharmacologic Class
Nicotinic Acetylcholine Receptor Agonist
Pregnancy Category
Category D
FDA Approved
Dec 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nicotine patches help you quit smoking by providing a steady, controlled dose of nicotine through your skin. This reduces the withdrawal symptoms and cravings you feel when you stop 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. The patch is available in three different doses, which are determined by the number of cigarettes you smoke per day. If you're unsure about which dose to use, consult your pharmacist or doctor.
Applying the Patch
Apply the patch to clean, dry, healthy skin on your chest, back, belly, or upper arm. Choose a different site for each new patch to avoid skin irritation. Select a site without hair to ensure proper adhesion. After applying the patch, wash your hands thoroughly.
Wearing the Patch
Each patch can be worn for 16 to 24 hours. If you experience cravings for cigarettes when you wake up, you can wear the patch for the full 24 hours. However, do not leave the patch on your skin for more than 24 hours. Unless directed by your doctor, do not apply more than one patch at a time. Do not cut or divide the patches, and do not use any that are damaged.
Storing and Disposing of Your Medication
Store your medication at room temperature, keeping it in a safe place out of the reach of children and pets. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, apply a new patch as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not apply two patches at the same time or use extra doses to make up for a missed one.
To use this medication effectively, follow your doctor's instructions and read all the information provided. The patch is available in three different doses, which are determined by the number of cigarettes you smoke per day. If you're unsure about which dose to use, consult your pharmacist or doctor.
Applying the Patch
Apply the patch to clean, dry, healthy skin on your chest, back, belly, or upper arm. Choose a different site for each new patch to avoid skin irritation. Select a site without hair to ensure proper adhesion. After applying the patch, wash your hands thoroughly.
Wearing the Patch
Each patch can be worn for 16 to 24 hours. If you experience cravings for cigarettes when you wake up, you can wear the patch for the full 24 hours. However, do not leave the patch on your skin for more than 24 hours. Unless directed by your doctor, do not apply more than one patch at a time. Do not cut or divide the patches, and do not use any that are damaged.
Storing and Disposing of Your Medication
Store your medication at room temperature, keeping it in a safe place out of the reach of children and pets. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, apply a new patch as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not apply two patches at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Do not smoke or use other nicotine products (e.g., e-cigarettes, chewing tobacco) while using the patch, as this can lead to nicotine overdose.
- Combine patch use with behavioral support programs, counseling, or quitlines for best results.
- Identify and avoid triggers for smoking.
- Engage in stress-reducing activities and healthy lifestyle choices.
Available Forms & Alternatives
Available Strengths:
- Nicotine Gum 2mg Mint Refill 50's
- Nicotine Gum 4mg Starter Kit 110's
- Nicotine Polacr 4mg Mint Gum 40's
- Nicotine Polacr 4mg Mintgum 100s
- Nicotine Polacr 2mg Gum 40's
- Nicotine Pol 2mg Mint Gum 100s
- Nicotine Polacr 4mg Cinn Gum 100's
- Nicotine Polacr 4mg Orig Gum 50's
- Nicotine Polacr 2mg Gum Orig 50s
- Nicotine Pol 2mg Original Gum
- Nicotine Polacr 4mg Mint Loz 72's
- Nicotine Polacrilex 4mg Gum 100's
- Nicotine Pol 4mg Orig Gum
- Nicotine TD 7mg/24h Patch 14s
- Nicotine Polacrilex 4mg Chewing Gum
- Nicotine Polacrilex 2mg Chewing Gum
- Nicotine 14mg/24h Patch 14s
- Nicotine 21mg/24h Patch 28s
- Nicotine 21mg/24h Patch 14s
- Nicotine TD 21mg/24h Patch 7s
- Nicotine TD 14mg/24h Patch 7s
- Nicotine SF 2mg Cinn Gum 100's
- Nicotine Lozenge 4mg Mint
- Nicotine 2mg Original Gum 20s
- Nicotine 2mg Mint Lozenge 81s
- Nicotine 4mg Mint Gum 110s
- Nicotine 4mg Mint Gum 20s
- Nicotine TD 7mg/24h Patch 7s
- Nicotine 2mg SF Fruit Gum 100s
- Nicotine TD 21mg/24h Patch 14s
- Nicotine Pol 4mg Mint Lozenges
- Nicotine TD 14mg/24h Patch 28's
- Nicotine Pol 2mg Mint Loz 72s
- Nicotine Polacr 4mg Mint Loz 72s
- Nicotine Pol 2mg Mint Gum 110s
- Nicotine 2mg Mini Mint Loz 72s
- Nicotine 4mg Mini Mint Loz 72s
- Nicotine Pol 4mg Mint Gum
- Nicotine Mini Mint 2mg Loz 81s
Dosing & Administration
Adult Dosing
Standard Dose:
Apply one 21 mg/24h patch once daily to a clean, dry, hairless area of skin on the upper body or upper outer arm. Rotate application sites daily. Use for 6 weeks, then step down to 14 mg/24h for 2 weeks, then 7 mg/24h for 2 weeks. Total treatment duration typically 10 weeks.
Dose Range:
7 - 21 mg
Condition-Specific Dosing:
heavySmokers:
Start with 21 mg/24h patch if smoking more than 10 cigarettes/day.
lightSmokers:
Consider starting with 14 mg/24h patch if smoking 10 or fewer cigarettes/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not recommended for individuals under 18 years of age without medical supervision.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
Use with caution; monitor for increased side effects. Consider lower starting dose.
Severe:
Use with caution; monitor for increased side effects. Consider lower starting dose.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Use with caution; monitor for increased side effects. Consider lower starting dose.
Severe:
Use with caution; monitor for increased side effects. Consider lower starting dose.
Confidence:
Medium
Pharmacology
Mechanism of Action
Nicotine is an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems. In smoking cessation, it replaces the nicotine from cigarettes, reducing withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) and the urge to smoke.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 75-80% (transdermal)
Tmax:
6-10 hours (for patch, steady-state levels achieved within 2-3 days)
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
Less than 5%
CnssPenetration:
Yes
Elimination:
HalfLife:
2-3 hours (nicotine); 15-19 hours (cotinine)
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
10-20% (renal excretion of unchanged nicotine, pH dependent)
Pharmacodynamics
OnsetOfAction:
Slow (hours for patch to reach therapeutic levels)
PeakEffect:
Steady-state levels achieved within 2-3 days of continuous patch use.
DurationOfAction:
24 hours (for 24-hour patch)
Confidence:
Medium
Safety & Warnings
Side Effects
Serious 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 or seek immediate 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
Abnormal sensations, such as burning, numbness, or tingling
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
Drooling
Shakiness
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, contact your doctor for advice:
Trouble sleeping
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
* Irritation at the site of application
Reporting Side Effects
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.
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 immediate 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
Abnormal sensations, such as burning, numbness, or tingling
Dizziness, tiredness, or weakness
Diarrhea, upset stomach, or vomiting
Drooling
Shakiness
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, contact your doctor for advice:
Trouble sleeping
Bad dreams
Feeling nervous or excitable
Headache
Joint pain
Back pain
* Irritation at the site of application
Reporting Side Effects
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 skin irritation, blistering, or swelling at the patch site.
- Symptoms of nicotine overdose: severe nausea, vomiting, dizziness, headache, cold sweat, confusion, blurred vision, hearing difficulties, weakness, fainting, rapid or irregular heartbeat, seizures.
- Chest pain or shortness of breath.
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. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ 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.
Your age, particularly if you are under 18 years old. 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. Never start, stop, or change the dosage of any medication without consulting your doctor first.
It is crucial to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ 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.
Your age, particularly if you are under 18 years old. 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. Never start, stop, or change the dosage of any medication without consulting your doctor first.
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.
Do not exceed the recommended dosage, as this may lead to unsafe side effects. If you are using another medication to help you stop smoking, be sure to tell your doctor. You may experience symptoms of nicotine withdrawal, such as irritability, anxiety, or difficulty concentrating, when attempting to quit smoking, even with the assistance of this medication. Notify your doctor if you encounter any adverse effects.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in activities that require your full attention. When you stop smoking, the effectiveness of other medications you are taking may be altered. 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. The patch may contain metal, so it is crucial to remove it before undergoing an MRI. If you experience vivid dreams or difficulty sleeping, consider removing the patch at bedtime.
This medication can be harmful if chewed or swallowed. If the patch is accidentally ingested, immediately contact a doctor or poison control center. Additionally, 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, promptly 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. This medication may pose a risk to the unborn baby if taken during pregnancy. If you become pregnant or suspect you are pregnant while using this medication, notify your doctor immediately.
If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Do not exceed the recommended dosage, as this may lead to unsafe side effects. If you are using another medication to help you stop smoking, be sure to tell your doctor. You may experience symptoms of nicotine withdrawal, such as irritability, anxiety, or difficulty concentrating, when attempting to quit smoking, even with the assistance of this medication. Notify your doctor if you encounter any adverse effects.
Until you are familiar with how this medication affects you, avoid operating a vehicle or engaging in activities that require your full attention. When you stop smoking, the effectiveness of other medications you are taking may be altered. 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. The patch may contain metal, so it is crucial to remove it before undergoing an MRI. If you experience vivid dreams or difficulty sleeping, consider removing the patch at bedtime.
This medication can be harmful if chewed or swallowed. If the patch is accidentally ingested, immediately contact a doctor or poison control center. Additionally, 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, promptly 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. This medication may pose a risk to the unborn baby if taken during pregnancy. If you become pregnant or suspect you are pregnant while using this medication, notify your doctor immediately.
If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea, vomiting, diarrhea, abdominal pain
- Dizziness, headache, confusion
- Weakness, fatigue
- Cold sweat, pallor
- Salivation
- Blurred vision, hearing disturbances
- Tremors, muscle twitching
- Rapid or irregular heartbeat (tachycardia, arrhythmias)
- Hypotension (low blood pressure)
- Seizures
- Respiratory depression, coma (severe cases)
What to Do:
Remove the patch immediately. If symptoms are severe or persistent, seek emergency medical attention or call a Poison Control Center (1-800-222-1222). Activated charcoal may be administered if ingestion is suspected. Supportive care for respiratory and cardiovascular function.
Drug Interactions
Major Interactions
- Bupropion (increased risk of seizures when combined with NRT, though rare)
- Varenicline (increased risk of adverse effects when combined with NRT, not recommended)
Moderate Interactions
- Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Beta-blockers (smoking cessation can increase beta-blocker levels due to reduced CYP1A2 induction by smoking; monitor blood pressure and heart rate)
- Insulin (smoking cessation can increase insulin absorption and effectiveness; monitor blood glucose and adjust insulin dose)
- Theophylline (smoking cessation can increase theophylline levels due to reduced CYP1A2 induction by smoking; monitor theophylline levels)
- Caffeine (smoking cessation can increase caffeine levels due to reduced CYP1A2 induction by smoking; monitor for increased caffeine effects)
- Flecainide (smoking cessation can increase flecainide levels due to reduced CYP1A2 induction by smoking; monitor for increased effects)
Minor Interactions
- Opioid analgesics (nicotine may reduce analgesic effect)
Monitoring
Baseline Monitoring
Smoking history and current smoking status
Rationale: To determine appropriate starting dose and assess readiness for cessation.
Timing: Prior to initiation of therapy.
Cardiovascular status (e.g., recent MI, unstable angina, severe arrhythmias)
Rationale: Nicotine can exacerbate cardiovascular conditions; NRT is generally contraindicated or requires caution in these patients.
Timing: Prior to initiation of therapy.
Skin integrity at application sites
Rationale: To ensure proper adhesion and minimize irritation.
Timing: Prior to first application.
Routine Monitoring
Smoking cessation progress
Frequency: Weekly or as needed
Target: Complete abstinence from smoking
Action Threshold: Continued smoking while on NRT may lead to nicotine overdose; adjust therapy or provide additional support.
Adverse effects (e.g., skin irritation, nausea, dizziness, sleep disturbances, palpitations)
Frequency: Daily/Weekly
Target: Minimal to no adverse effects
Action Threshold: Severe or persistent side effects may require dose reduction, change in NRT form, or discontinuation.
Adherence to patch application instructions
Frequency: Weekly
Target: Consistent daily application and site rotation
Action Threshold: Poor adherence reduces effectiveness; reinforce proper use.
Symptom Monitoring
- Skin irritation (redness, itching, burning) at application site
- Nausea, vomiting, diarrhea
- Dizziness, lightheadedness
- Headache
- Sleep disturbances (insomnia, vivid dreams)
- Palpitations, rapid heartbeat
- Muscle aches, stiffness
Special Patient Groups
Pregnancy
Category D. Nicotine crosses the placenta and can harm the fetus. However, the risks of continued smoking during pregnancy generally outweigh the risks of NRT. NRT should be considered only if the pregnant woman is unable to quit smoking without it, and under medical supervision. Intermittent NRT (e.g., gum, lozenge) may be preferred over patches to allow for nicotine-free periods.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, including neural tube defects, cleft lip/palate, and limb reduction defects (though data are mixed and often confounded by smoking).
Second Trimester:
Increased risk of preterm birth, low birth weight, and placental abnormalities.
Third Trimester:
Increased risk of preterm birth, low birth weight, stillbirth, and potential for neonatal nicotine withdrawal syndrome.
Lactation
Nicotine is excreted into breast milk. While NRT exposes the infant to nicotine, it is generally considered safer than continued maternal smoking. If NRT is used, choose intermittent forms (gum, lozenge) immediately after breastfeeding to minimize infant exposure. Patches may be used, but consider removing them for a few hours before the longest sleep period to reduce nighttime exposure.
Infant Risk:
L3 (Moderate risk). Potential for infant irritability, sleep disturbances, and gastrointestinal upset. Long-term effects on neurodevelopment are not fully established but are less than from smoking.
Pediatric Use
Not recommended for individuals under 18 years of age for smoking cessation without medical supervision. Safety and efficacy not established in younger children.
Geriatric Use
No specific dose adjustment is generally required. However, older adults may be more sensitive to the cardiovascular effects of nicotine. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- The 21mg/24h patch is typically the starting dose for individuals smoking more than 10 cigarettes per day.
- Proper application is crucial: apply to a clean, dry, hairless area of skin, and rotate sites daily to minimize irritation.
- Patches can be worn for 16 hours (removing at bedtime) if sleep disturbances (e.g., vivid dreams, insomnia) are a significant issue, though 24-hour wear provides continuous nicotine levels.
- Combining the patch with a short-acting NRT (e.g., gum, lozenge, inhaler) for breakthrough cravings can significantly improve success rates.
- Emphasize that the patch is a tool to manage physical withdrawal; behavioral support is essential for addressing psychological dependence.
- Advise patients to dispose of used patches safely, as they still contain residual nicotine that can be harmful to children or pets.
Alternative Therapies
- Nicotine gum
- Nicotine lozenge
- Nicotine inhaler
- Nicotine nasal spray
- Bupropion SR (Zyban, Wellbutrin SR)
- Varenicline (Chantix)
- Cytisine (Tabex - not FDA approved in US)
Cost & Coverage
Average Cost:
$30 - $60 per 28 patches (generic)
Generic Available:
Yes
Insurance Coverage:
Often Tier 1 or Tier 2, frequently covered by insurance plans for smoking cessation.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, 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 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 details about the overdose, including the medication taken, the amount, and the time it occurred.