Nicotine 21mg/24h Patch 14s
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?
This patch helps you quit smoking by providing a steady, controlled amount of nicotine to your body through your skin. This reduces the strong cravings and withdrawal symptoms 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 the right dose for you, consult with your pharmacist or doctor.
Applying the Patch
Apply the patch to clean, dry, and healthy skin on your chest, back, belly, or upper arm. Rotate the site with each new patch to avoid skin irritation. Choose a hair-free area for the patch. After handling 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 in the morning, 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 your doctor advises otherwise, do not apply more than one patch at a time. Avoid cutting or dividing the patches, and do not use any that are damaged.
Storing and Disposing of Your Medication
Store your medication at room temperature, keeping it out of 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 with 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 the right dose for you, consult with your pharmacist or doctor.
Applying the Patch
Apply the patch to clean, dry, and healthy skin on your chest, back, belly, or upper arm. Rotate the site with each new patch to avoid skin irritation. Choose a hair-free area for the patch. After handling 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 in the morning, 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 your doctor advises otherwise, do not apply more than one patch at a time. Avoid cutting or dividing the patches, and do not use any that are damaged.
Storing and Disposing of Your Medication
Store your medication at room temperature, keeping it out of 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 with 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 any other nicotine products (e.g., gum, lozenges, e-cigarettes) while wearing the patch, as this can lead to nicotine overdose.
- Apply the patch to a clean, dry, hairless area of skin on your upper body or outer arm. Avoid irritated, cut, or scarred skin.
- Rotate application sites daily to prevent skin irritation. Do not apply to the same spot for at least a week.
- Wash your hands thoroughly after applying or removing the patch.
- Remove the old patch before applying a new one.
- Dispose of used patches by folding them in half with the sticky sides together and placing them in a child-proof container or trash can.
- Combine patch use with a behavioral support program for the best chance of quitting successfully.
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:
21 mg/24 hours for 4-6 weeks, then step down to lower doses.
Dose Range:
21 - 21 mg
Condition-Specific Dosing:
heavySmokers:
Initial dose for individuals smoking >10 cigarettes/day.
lightSmokers:
Not recommended as initial dose; start with lower strengths (e.g., 14 mg or 7 mg).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (generally not recommended for individuals under 18 years of age without medical supervision)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, use with caution.
Moderate:
Use with caution; monitor for increased side effects due to reduced clearance.
Severe:
Use with caution; monitor for increased side effects due to reduced clearance. Consider starting with lower doses.
Dialysis:
Not available (nicotine is not significantly removed by dialysis)
Hepatic Impairment:
Mild:
No specific adjustment, use with caution.
Moderate:
Use with caution; monitor for increased side effects due to reduced clearance.
Severe:
Use with caution; monitor for increased side effects due to reduced clearance. Consider starting with lower doses.
Confidence:
Medium
Pharmacology
Mechanism of Action
Nicotine, a nicotinic acetylcholine receptor agonist, binds stereoselectively to nicotinic receptors in the central nervous system (CNS) and autonomic ganglia. This binding provides a controlled release of nicotine to the systemic circulation, replacing the nicotine from tobacco products and thereby reducing the severity of nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, restlessness, cravings) experienced during smoking cessation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 70-80% (transdermal)
Tmax:
3-12 hours (for transdermal patch, steady-state plasma concentrations are achieved within 2-3 days of continuous application)
FoodEffect:
Not applicable (transdermal administration)
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
<5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2 hours (nicotine), 19 hours (cotinine)
Clearance:
Approximately 1.2 L/min (nicotine)
ExcretionRoute:
Renal (pH-dependent), also via bile
Unchanged:
Approximately 10-30% (nicotine, dependent on urine pH)
Pharmacodynamics
OnsetOfAction:
Slow (hours for significant plasma levels with patch)
PeakEffect:
Steady-state plasma concentrations achieved within 2-3 days of continuous patch application.
DurationOfAction:
24 hours (for 24-hour patch)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
+ Dizziness
+ Fainting
+ 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
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
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
+ Dizziness
+ Fainting
+ 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
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
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation (blistering, swelling, rash that spreads)
- Chest pain, irregular heartbeat, or palpitations
- Severe dizziness, lightheadedness, or fainting
- Difficulty breathing
- Vision changes
- Unusual weakness or fatigue
- Signs of nicotine overdose (see below)
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
If you currently use tobacco products, such as smoking or chewing tobacco, or use other nicotine-containing products while taking this medication.
If you are under 18 years of age. This medication is not recommended for children under 18 without first 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.
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
If you currently use tobacco products, such as smoking or chewing tobacco, or use other nicotine-containing products while taking this medication.
If you are under 18 years of age. This medication is not recommended for children under 18 without first 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.
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 help you quit smoking, inform 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 understand how this medication affects you, avoid driving and engaging in activities that require alertness. Additionally, be aware that quitting smoking may alter the effectiveness of other medications you are taking. Consult your doctor to discuss potential changes.
If you have not been able to quit smoking after using this medication for the recommended duration, inform your doctor. The patch contains metal, so it is essential to remove it before undergoing an MRI.
Some users may experience strange dreams or sleep disturbances. If this occurs, consider removing the patch at bedtime. It is vital to handle the patch with care, as chewing or swallowing it can cause harm. If the patch is accidentally ingested, immediately contact a doctor or poison control center.
This medication can be hazardous or even fatal if ingested by children or pets. If a child uses the patch or ingests it, or if a pet ingests the patch, promptly contact a doctor or poison control center.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant women should exercise extreme caution, as this medication may harm the unborn baby. If you become pregnant while taking this medication, notify your doctor immediately.
Breastfeeding women should consult their doctor to discuss potential risks to their baby. Your doctor will help you weigh the benefits and risks of using this medication while breastfeeding.
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 help you quit smoking, inform 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 understand how this medication affects you, avoid driving and engaging in activities that require alertness. Additionally, be aware that quitting smoking may alter the effectiveness of other medications you are taking. Consult your doctor to discuss potential changes.
If you have not been able to quit smoking after using this medication for the recommended duration, inform your doctor. The patch contains metal, so it is essential to remove it before undergoing an MRI.
Some users may experience strange dreams or sleep disturbances. If this occurs, consider removing the patch at bedtime. It is vital to handle the patch with care, as chewing or swallowing it can cause harm. If the patch is accidentally ingested, immediately contact a doctor or poison control center.
This medication can be hazardous or even fatal if ingested by children or pets. If a child uses the patch or ingests it, or if a pet ingests the patch, promptly contact a doctor or poison control center.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant women should exercise extreme caution, as this medication may harm the unborn baby. If you become pregnant while taking this medication, notify your doctor immediately.
Breastfeeding women should consult their doctor to discuss potential risks to their baby. Your doctor will help you weigh the benefits and risks of using this medication while breastfeeding.
Overdose Information
Overdose Symptoms:
- Severe nausea and vomiting
- Diarrhea
- Abdominal pain
- Dizziness, lightheadedness
- Headache
- Cold sweat
- Palpitations, rapid or irregular heartbeat
- Confusion, weakness
- Seizures (rare)
- Difficulty breathing
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). Keep out of reach of children and pets.
Drug Interactions
Moderate Interactions
- Adenosine (nicotine may increase risk of adverse cardiovascular effects)
- Beta-blockers (nicotine may decrease hypotensive effects)
- Insulin (nicotine may increase blood glucose levels, requiring increased insulin dose)
- Caffeine (nicotine may increase caffeine metabolism, requiring increased caffeine dose)
- Theophylline (nicotine may increase theophylline metabolism, requiring increased theophylline dose)
- Adrenergic agonists/antagonists (nicotine may alter their effects)
Monitoring
Baseline Monitoring
Smoking status and history
Rationale: To determine appropriate starting dose and duration of therapy.
Timing: Prior to initiation of therapy.
Cardiovascular history (e.g., recent MI, unstable angina, severe arrhythmias)
Rationale: Nicotine can exacerbate cardiovascular conditions.
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
Adherence to patch application
Frequency: Daily
Target: Consistent application as directed
Action Threshold: Non-adherence may lead to withdrawal symptoms or treatment failure; provide counseling.
Withdrawal symptoms (e.g., cravings, irritability, anxiety)
Frequency: Daily/Weekly
Target: Reduction in severity
Action Threshold: Persistent severe symptoms may indicate need for dose adjustment or adjunctive therapy.
Side effects (e.g., skin irritation, sleep disturbances, nausea)
Frequency: Daily/Weekly
Target: Minimal or tolerable
Action Threshold: Severe or persistent side effects may require dose reduction, change in patch strength, or discontinuation.
Smoking cessation progress
Frequency: Weekly/Bi-weekly
Target: Abstinence from smoking
Action Threshold: Continued smoking while on patch increases risk of nicotine toxicity; counsel patient to stop smoking completely.
Symptom Monitoring
- Skin irritation (redness, itching, burning) at application site
- Sleep disturbances (insomnia, vivid dreams)
- Nausea, vomiting, diarrhea, or constipation
- Headache
- Dizziness
- Muscle aches
- Nervousness, anxiety, irritability
- Palpitations or rapid heartbeat (rare, but serious)
Special Patient Groups
Pregnancy
Category D. Nicotine can cause fetal harm. Quitting smoking without NRT is the preferred method for pregnant women. However, if a pregnant woman is unable to quit smoking without pharmacologic intervention, the benefits of NRT (which delivers lower, more consistent nicotine levels than smoking) may outweigh the risks of continued smoking. Use under strict medical supervision, with the lowest effective dose and shortest duration.
Trimester-Specific Risks:
First Trimester:
Increased risk of miscarriage, congenital malformations (though direct causation by NRT is less clear than smoking).
Second Trimester:
Increased risk of premature birth, low birth weight, placental abnormalities.
Third Trimester:
Increased risk of premature birth, low birth weight, stillbirth, respiratory problems in the newborn, neurodevelopmental issues.
Lactation
Nicotine passes into breast milk and can harm the nursing infant. Smoking cessation is strongly advised. If NRT is used, the patch is generally preferred over intermittent forms (gum, lozenge) due to more stable nicotine levels. Advise mothers to apply the patch after the last feeding of the day and remove it before the first feeding of the next day to minimize infant exposure.
Infant Risk:
Irritability, restlessness, poor feeding, increased heart rate, vomiting, diarrhea. Long-term effects on neurodevelopment are a concern.
Pediatric Use
Not recommended for use in individuals under 18 years of age. Safety and efficacy have not been established in this population. Nicotine can be toxic to children.
Geriatric Use
Use with caution in elderly patients, as they may be more sensitive to the effects of nicotine. Consider starting with a lower dose and monitor closely for adverse effects, especially cardiovascular effects.
Clinical Information
Clinical Pearls
- The 21mg/24h patch is typically the starting dose for heavy smokers (more than 10 cigarettes/day). Lighter smokers should start with lower doses (14mg or 7mg).
- Encourage patients to set a quit date and start using the patch on that date.
- Behavioral support and counseling significantly improve success rates when combined with nicotine patches.
- Patients should be advised to remove the patch before an MRI scan due to the metallic backing on some patches, which can cause burns.
- Do not cut the patch, as this can alter the controlled release of nicotine.
- If vivid dreams or sleep disturbances occur, consider switching to a 16-hour patch or removing the 24-hour patch before bedtime.
Alternative Therapies
- Other Nicotine Replacement Therapies (NRTs): Nicotine gum, lozenge, inhaler, nasal spray
- Bupropion (Zyban, Wellbutrin)
- Varenicline (Chantix)
Cost & Coverage
Average Cost:
$30 - $60 per 14 patches (generic)
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance plans, especially for smoking cessation programs. May be Tier 1 or 2. Many are available OTC.
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 happened.