Nicotine TD 14mg/24h Patch 28's

Manufacturer RUGBY LABORATORIES Active Ingredient Nicotine Patch(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
Dec 1991
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nicotine patches help you quit smoking by giving your body a steady, controlled amount of nicotine through your skin. This reduces the cravings and withdrawal symptoms you get when you stop smoking, making it easier to quit.
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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. 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 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 do not use any patches that are damaged.

Storing and Disposing of Your Medication

Store your medication at room temperature, keeping it in a safe place that is 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 best disposal method or inquire about potential 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 one.
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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, upper arm, back).
  • Rotate the application site daily to prevent skin irritation.
  • Do not cut the patch or wear more than one patch at a time.
  • Remove the old patch before applying a new one.
  • Wash hands after applying the patch.
  • Avoid smoking or using other nicotine products (e.g., e-cigarettes, chewing tobacco) 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, as they still contain nicotine.
  • Combine patch use with behavioral support programs for best results.

Dosing & Administration

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Adult Dosing

Standard Dose: 14 mg/24h patch, applied once daily for 2-4 weeks, as part of a step-down regimen.
Dose Range: 7 - 21 mg

Condition-Specific Dosing:

heavySmokers: Typically start with 21 mg/24h for 6 weeks, then 14 mg/24h for 2-4 weeks, then 7 mg/24h for 2-4 weeks.
lightSmokers: Typically start with 14 mg/24h for 6 weeks, then 7 mg/24h for 2-4 weeks.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (generally not recommended for individuals under 18 years)
Adolescent: Not established (use only under medical supervision if smoking cessation is critical and other methods fail, generally 18+)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but monitor for increased side effects.
Moderate: Use with caution; monitor for increased side effects due to potential for reduced clearance.
Severe: Use with caution; monitor for increased side effects due to potential for significantly reduced clearance.
Dialysis: Not available (nicotine is extensively metabolized, dialysis unlikely to be effective for acute toxicity)

Hepatic Impairment:

Mild: No specific adjustment recommended, but monitor for increased side effects.
Moderate: Use with caution; monitor for increased side effects due to potential for reduced clearance.
Severe: Use with caution; monitor for increased side effects due to potential for significantly reduced clearance.
Confidence: Medium

Pharmacology

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Mechanism of Action

Nicotine acts as an agonist at nicotinic acetylcholine receptors (nAChRs) in the central and peripheral nervous systems. In smoking cessation, it replaces the nicotine from cigarettes, reducing withdrawal symptoms and cravings. It binds to ι4β2 nAChRs in the brain's ventral tegmental area, leading to dopamine release in the nucleus accumbens, which mediates the rewarding effects of nicotine.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 75-80% (transdermal)
Tmax: 6-10 hours (for steady-state plasma concentrations with 24-hour patch)
FoodEffect: Not applicable (transdermal)

Distribution:

Vd: 2.6 L/kg
ProteinBinding: Less than 5%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 2-3 hours (nicotine); 15-19 hours (cotinine)
Clearance: Approximately 1.2 L/min
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: 10-20% (nicotine)
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Pharmacodynamics

OnsetOfAction: Gradual (plasma concentrations rise over 2-4 hours after patch application)
PeakEffect: 6-10 hours (for steady-state plasma concentrations)
DurationOfAction: 24 hours (for 24-hour patch)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Mood changes
Confusion
Chest pain or pressure
Fast or abnormal heartbeat
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 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, 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:

  • Severe skin rash or swelling at the patch site
  • Dizziness, lightheadedness, or fainting
  • Nausea, vomiting, or stomach pain that is severe or persistent
  • Headache that is severe or unusual
  • Rapid or irregular heartbeat (palpitations)
  • Difficulty breathing
  • Cold sweats
  • Confusion or weakness
  • Seizures (rare)
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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
Your use of tobacco products, such as smoking, chewing tobacco, or using nicotine-containing products, while taking this medication
Your age, particularly 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 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 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. 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, notify your doctor.

When attempting to quit smoking, even with the assistance of this medication, you may experience symptoms of nicotine withdrawal, such as irritability, anxiety, or difficulty concentrating. Inform your doctor if you encounter any adverse effects. Until you understand how this medication affects you, avoid operating vehicles or engaging in activities that require alertness.

After quitting smoking, the effectiveness of other medications you are taking may be altered. Consult your doctor to discuss potential interactions. 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 crucial to remove it before undergoing an MRI. If you experience vivid dreams or sleep disturbances, consider removing the patch at bedtime. This medication can be harmful if chewed or swallowed. If the patch is ingested, immediately contact a doctor or poison control center.

Keep this medication out of reach of children and pets, as it can be harmful or even fatal if ingested. If a child uses this medication or ingests it, or if a pet ingests it, promptly contact a doctor or poison control center.

If you are 65 years or older, exercise caution when using this medication, 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 are pregnant while taking this medication, notify your doctor immediately. If you are breastfeeding, consult your doctor to discuss potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Severe nausea and vomiting
  • Diarrhea
  • Abdominal pain
  • Dizziness
  • Headache
  • Cold sweats
  • Pallor
  • Salivation
  • Weakness
  • Tremors
  • Confusion
  • Hearing and vision disturbances
  • Rapid or irregular heartbeat
  • Hypotension (low blood pressure)
  • Respiratory depression
  • Seizures
  • Coma

What to Do:

Immediately remove the patch(es) and seek emergency medical attention. Call 911 or a poison control center (1-800-222-1222). Activated charcoal may be administered if ingestion is suspected. Supportive care for respiratory and cardiovascular function may be necessary.

Drug Interactions

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Moderate Interactions

  • Adenosine (nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness)
  • Beta-blockers (smoking cessation may increase beta-blocker levels due to reduced induction of metabolism)
  • Insulin (smoking cessation may increase insulin absorption or sensitivity, requiring dose adjustment)
  • Theophylline (smoking cessation may increase theophylline levels due to reduced induction of metabolism)
  • Caffeine (smoking cessation may increase caffeine levels due to reduced induction of metabolism)
  • Flecainide (smoking cessation may increase flecainide levels due to reduced induction of metabolism)
  • Warfarin (smoking cessation may alter warfarin metabolism, requiring INR monitoring)

Monitoring

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Baseline Monitoring

Smoking history and current smoking status

Rationale: To determine appropriate starting dose and duration of therapy.

Timing: Prior to initiation of therapy

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

Rationale: Nicotine can exacerbate cardiovascular conditions; caution is advised.

Timing: Prior to initiation of therapy

Skin integrity at application site

Rationale: To ensure proper adhesion and minimize irritation.

Timing: Prior to initiation of therapy

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Routine Monitoring

Adherence to patch application

Frequency: Daily

Target: Consistent use as directed

Action Threshold: Non-adherence may lead to withdrawal symptoms or treatment failure; provide counseling.

Local skin reactions (redness, itching, swelling)

Frequency: Daily

Target: Minimal to no reaction

Action Threshold: Severe or persistent reactions may require patch rotation, topical corticosteroids, or discontinuation.

Symptoms of nicotine overdose (nausea, vomiting, dizziness, headache, palpitations)

Frequency: Daily

Target: Absence of symptoms

Action Threshold: Presence of symptoms may indicate excessive nicotine exposure; reduce dose or discontinue.

Smoking status (abstinence)

Frequency: Weekly initially, then as needed

Target: Complete cessation

Action Threshold: Continued smoking while on patch increases risk of nicotine toxicity; counsel patient on cessation strategies or consider alternative therapies.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Dizziness
  • Headache
  • Insomnia
  • Vivid dreams
  • Palpitations
  • Increased heart rate
  • Skin irritation at application site
  • Muscle weakness
  • Tremors
  • Confusion
  • Seizures (rare, severe overdose)

Special Patient Groups

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Pregnancy

Category D. Nicotine crosses the placenta and is associated with adverse fetal outcomes (e.g., low birth weight, preterm birth, stillbirth, respiratory problems). While quitting smoking is paramount, the risks of nicotine replacement therapy (NRT) during pregnancy must be weighed against the risks of continued smoking. NRT should only be used if the pregnant woman is unable to quit smoking without it and under strict medical supervision. Intermittent NRT (e.g., gum, lozenge) may be preferred over continuous transdermal patches to allow for nicotine-free periods.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though less clear than direct smoking. Nicotine is a vasoconstrictor and can reduce uteroplacental blood flow.
Second Trimester: Increased risk of fetal growth restriction, preterm birth.
Third Trimester: Increased risk of fetal growth restriction, preterm birth, stillbirth, and potential for neonatal nicotine withdrawal.
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Lactation

Nicotine is excreted into breast milk. While NRT delivers less nicotine than smoking, it still exposes the infant. The benefits of NRT for smoking cessation in the mother must be weighed against the risks of infant exposure. If NRT is used, intermittent forms (gum, lozenge) immediately after breastfeeding may be preferred to minimize infant exposure. Patches should be removed before the longest sleep period to reduce overnight exposure. Monitor infant for signs of nicotine exposure (e.g., irritability, poor feeding, sleep disturbances).

Infant Risk: L3 (Moderate risk). Nicotine can cause irritability, restlessness, poor feeding, and sleep disturbances in the infant. Long-term effects are not fully known.
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Pediatric Use

Not recommended for individuals under 18 years of age. Safety and efficacy have not been established. If smoking cessation is critical for an adolescent, use should be under strict medical supervision and after failure of non-pharmacologic methods.

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Geriatric Use

No specific dose adjustment is generally required based on age alone. However, elderly patients may be more sensitive to the effects of nicotine and may have age-related reductions in renal or hepatic function, requiring careful monitoring for adverse effects. Start with lower doses and titrate slowly if necessary.

Clinical Information

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Clinical Pearls

  • Nicotine patches provide a steady, controlled release of nicotine, which can help reduce cravings and withdrawal symptoms throughout the day.
  • It is crucial to set a quit date and stop smoking completely on that day when starting the patch. Continued smoking while on the patch can lead to nicotine overdose.
  • Rotate the patch application site daily to minimize skin irritation. If irritation occurs, topical corticosteroids may be used.
  • The 14mg patch is typically used as a step-down dose after a higher dose (21mg) or as a starting dose for lighter smokers (less than 10 cigarettes/day).
  • Combining nicotine patch therapy with behavioral counseling or support programs significantly increases the chances of successful smoking cessation.
  • Patients should be advised on proper disposal of used patches, as they still contain significant amounts of nicotine and can be harmful to children or pets.
  • Insomnia and vivid dreams are common side effects, especially with 24-hour patches. Switching to a 16-hour patch (if available) or removing the 24-hour patch before bedtime may help.
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Alternative Therapies

  • Bupropion SR (Zyban, Wellbutrin SR)
  • Varenicline (Chantix)
  • Cytisine
  • Behavioral counseling
  • Hypnotherapy
  • Acupuncture
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Cost & Coverage

Average Cost: Varies widely, typically $30-$60 per 28 patches (14mg)
Generic Available: Yes
Insurance Coverage: Often covered by most prescription drug plans, typically Tier 1 or 2. Many state Medicaid programs and some private insurers cover smoking cessation products.
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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.