Nicotine TD 21mg/24h Patch 14s
It is used to treat nicotine withdrawal.It is used to curb the craving to smoke.
Drug Class
Smoking Cessation Aids
Pharmacologic Class
Nicotinic Acetylcholine Receptor Agonist
Pregnancy Category
Category D
FDA Approved
Dec 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
The nicotine patch is a small, adhesive patch that you stick on your skin once a day. It delivers a steady amount of nicotine into your body to help reduce cravings and withdrawal symptoms when you're trying to quit smoking. It helps your body gradually adjust to less nicotine.
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 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 application site with each new patch to avoid skin irritation. Choose 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. Additionally, do not cut or divide the patches, and avoid using damaged patches.
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. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the proper disposal method. You may also want to explore 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 resume your regular schedule. Do not apply two patches at the same time or use extra doses to make up for a missed dose.
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 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 application site with each new patch to avoid skin irritation. Choose 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. Additionally, do not cut or divide the patches, and avoid using damaged patches.
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. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the proper disposal method. You may also want to explore 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 resume your regular schedule. Do not apply two patches at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Set a quit date and start using the patch on that day.
- Apply the patch to a clean, dry, hairless area of skin on your upper body (e.g., chest, back, upper arm).
- Rotate application sites daily to prevent skin irritation.
- Do not cut the patch or use more than one patch at a time.
- Remove the patch before having an MRI scan.
- Do not smoke or use other nicotine products (e.g., gum, lozenges) while wearing the patch, as this can lead to nicotine overdose.
- Dispose of used patches safely by folding the sticky sides together and placing them in a child-proof container or the original pouch.
- Combine patch use with behavioral support programs 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:
One 21 mg/24h patch applied once daily for 4-6 weeks, then step down to lower doses (14 mg/24h, then 7 mg/24h) for 2-4 weeks each.
Dose Range:
21 - 21 mg
Condition-Specific Dosing:
heavySmokers:
Initial step for individuals smoking more than 10 cigarettes per day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (generally not recommended for individuals under 18 years of age for smoking cessation without medical supervision)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution due to altered nicotine and metabolite excretion.
Dialysis:
Considerations: No specific guidelines, monitor for increased side effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution due to altered nicotine metabolism.
Severe:
No specific dose adjustment recommended, but use with caution due to altered nicotine metabolism.
Pharmacology
Mechanism of Action
Nicotine acts as an agonist at nicotinic acetylcholine receptors (nAChRs) in the central and peripheral nervous systems. By binding to these receptors, particularly the ι4β2 subtype in the brain, it stimulates the release of neurotransmitters, including dopamine, which mimics the rewarding effects of smoking. This action helps to alleviate nicotine withdrawal symptoms (e.g., cravings, irritability, anxiety, difficulty concentrating) experienced during smoking cessation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 70-80% (transdermal)
Tmax:
6-10 hours (to reach steady-state plasma concentrations)
FoodEffect:
Not applicable (transdermal)
Distribution:
Vd:
Approximately 2.6 L/kg
ProteinBinding:
<5%
CnssPenetration:
Yes
Elimination:
HalfLife:
Nicotine: 1-2 hours; Cotinine: 15-20 hours
Clearance:
Approximately 1.2 L/min
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Approximately 10-20% (nicotine)
Pharmacodynamics
OnsetOfAction:
Hours (to reach steady-state therapeutic levels and significant reduction in withdrawal symptoms)
PeakEffect:
Sustained over 24 hours while patch is applied
DurationOfAction:
24 hours (while patch is applied)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention 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 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
+ 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 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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 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
+ 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 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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 rash or blistering at the application site
- Chest pain or irregular heartbeat
- Severe dizziness or lightheadedness
- Signs of nicotine overdose (see overdose section)
- Difficulty breathing or wheezing
- Allergic reaction (e.g., swelling of face/tongue, severe rash)
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
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 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 dose 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, 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
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 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 dose 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 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, 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 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, 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.
The patch contains metal, so it is essential to remove it before undergoing an MRI. If you experience strange dreams or sleep disturbances, consider removing the patch at bedtime to alleviate these symptoms.
This medication can be harmful if chewed or swallowed. If the patch is ingested, immediately contact a doctor or poison control center. It is also critical to keep this medication out of reach of children and pets, as it can be harmful or even fatal if ingested. If a child or pet ingests this medication, 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 the potential risks to their baby and determine the best course of action.
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, 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 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, 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.
The patch contains metal, so it is essential to remove it before undergoing an MRI. If you experience strange dreams or sleep disturbances, consider removing the patch at bedtime to alleviate these symptoms.
This medication can be harmful if chewed or swallowed. If the patch is ingested, immediately contact a doctor or poison control center. It is also critical to keep this medication out of reach of children and pets, as it can be harmful or even fatal if ingested. If a child or pet ingests this medication, 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 the potential risks to their baby and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Cold sweat
- Pallor (pale skin)
- Abdominal pain
- Hearing or vision disturbances
- Confusion
- Weakness
- Fainting
- Seizures
- Rapid or irregular heartbeat
- Low blood pressure
What to Do:
If you suspect an overdose, immediately remove the patch and seek emergency medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US).
Drug Interactions
Moderate Interactions
- Adenosine (Nicotine can increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
- Beta-blockers (Smoking cessation can increase levels of some beta-blockers due to reduced metabolism)
- Insulin (Smoking cessation can increase insulin sensitivity, potentially requiring dose adjustment)
- Theophylline (Smoking cessation can increase theophylline levels due to reduced CYP1A2 induction)
- Caffeine (Smoking cessation can increase caffeine levels due to reduced CYP1A2 induction)
- Imipramine (Smoking cessation can increase imipramine levels due to reduced CYP1A2 induction)
- Olanzapine (Smoking cessation can increase olanzapine levels due to reduced CYP1A2 induction)
- Clozapine (Smoking cessation can increase clozapine levels due to reduced CYP1A2 induction)
Monitoring
Baseline Monitoring
Smoking history
Rationale: To determine appropriate starting dose and duration of therapy.
Timing: Prior to initiation of therapy
Cardiovascular status
Rationale: To assess risk, especially in patients with pre-existing cardiovascular disease.
Timing: Prior to initiation of therapy
Motivation to quit
Rationale: To ensure patient readiness and likelihood of success.
Timing: Prior to initiation of therapy
Routine Monitoring
Adherence to patch use
Frequency: Daily/Weekly
Target: Consistent application as directed
Action Threshold: Non-adherence may lead to treatment failure or withdrawal symptoms
Smoking status
Frequency: Weekly/Bi-weekly
Target: Complete abstinence from smoking
Action Threshold: Continued smoking while on patch increases risk of nicotine overdose; relapse requires re-evaluation of strategy
Side effects (e.g., skin irritation, sleep disturbances, nausea)
Frequency: Daily/Weekly
Target: Minimal to tolerable
Action Threshold: Severe or persistent side effects may require dose adjustment, change in patch type, or discontinuation
Withdrawal symptoms
Frequency: Daily/Weekly
Target: Reduced or manageable
Action Threshold: Persistent severe withdrawal symptoms may indicate need for dose adjustment or adjunctive therapy
Symptom Monitoring
- Nausea
- Vomiting
- Dizziness
- Headache
- Palpitations
- Skin irritation (redness, itching, swelling at application site)
- Sleep disturbances (insomnia, vivid dreams)
- Irritability
- Anxiety
- Difficulty concentrating
- Nicotine cravings
Special Patient Groups
Pregnancy
Category D. Nicotine can harm the fetus. However, the risks of continued smoking during pregnancy (e.g., low birth weight, premature birth, stillbirth) are significant. Nicotine replacement therapy (NRT) may be considered if behavioral therapy alone is unsuccessful and the potential benefit of quitting smoking outweighs the potential risk of NRT to the fetus. Use under strict medical supervision, at the lowest effective dose, and for the shortest duration possible.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development.
Second Trimester:
Potential for adverse effects on fetal growth and development.
Third Trimester:
Potential for adverse effects on fetal growth and development, and neonatal withdrawal symptoms.
Lactation
Nicotine is excreted in breast milk and can be harmful to the nursing infant. Use with caution. If NRT is necessary, consider using shorter-acting forms (e.g., gum, lozenge) immediately after breastfeeding to minimize infant exposure, or apply the patch after the longest feeding interval and remove it before the next feed. Consult with a healthcare provider.
Infant Risk:
Risk level: Moderate (L3). Potential for infant exposure to nicotine, leading to irritability, sleep disturbances, and potential long-term developmental effects. The risks of continued maternal smoking are significantly higher than NRT.
Pediatric Use
Nicotine patches are not indicated for smoking cessation in individuals under 18 years of age. Safety and efficacy have not been established in this population.
Geriatric Use
No specific dose adjustment is generally required for elderly patients. However, monitor for increased sensitivity to adverse effects, particularly cardiovascular effects, and adjust therapy as needed. Use with caution in patients with pre-existing cardiovascular conditions.
Clinical Information
Clinical Pearls
- For best results, combine nicotine patch therapy with a comprehensive behavioral support program.
- Apply the patch to a clean, dry, hairless area of skin. Avoid oily, broken, or irritated skin.
- Rotate application sites daily to minimize skin irritation. Do not apply to the same site for at least a week.
- If vivid dreams or sleep disturbances occur, consider removing the 24-hour patch before bedtime (after 16 hours of wear) and applying a new one in the morning. However, this may reduce the effectiveness of overnight craving control.
- Ensure proper disposal of used patches, as they still contain residual nicotine that can be harmful to children and pets.
- Patients should be strongly advised against smoking or using any other nicotine-containing products while on the patch due to the risk of nicotine overdose.
Alternative Therapies
- Bupropion (Zyban, Wellbutrin)
- Varenicline (Chantix)
Cost & Coverage
Average Cost:
Varies widely by brand/generic and pharmacy per 14 patches
Generic Available:
Yes
Insurance Coverage:
Often covered by most prescription drug plans, typically Tier 1 or 2 for generics. Some plans may require prior authorization or step therapy.
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 overdose, including the medication taken, the amount, and the time it occurred.