Nicotine TD 14mg/24h Patch 7s

Manufacturer DR.REDDY'S 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 transdermal patches are a type of nicotine replacement therapy (NRT) that helps you quit smoking by delivering a steady, controlled amount of nicotine through your skin. This helps reduce the cravings and withdrawal symptoms you feel when you stop smoking, making it easier to quit.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, 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. Rotate the site with each new patch to avoid skin irritation. Choose a hair-free area to apply 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 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 your doctor instructs you to do so, 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 This Medication

Store this 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 by your pharmacist. You can also check with your pharmacist 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 patches to make up for a missed dose.
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Lifestyle & Tips

  • Set a quit date and start using the patch on that day.
  • Apply a new patch once every 24 hours to a clean, dry, hairless area of skin on your upper body (e.g., chest, back, upper arm).
  • Rotate application sites daily to minimize skin irritation.
  • Do NOT smoke or use any other nicotine-containing products (e.g., gum, lozenges, e-cigarettes) while wearing the patch, as this can lead to nicotine overdose.
  • Follow the recommended step-down dosing schedule (e.g., 21mg, then 14mg, then 7mg) to gradually reduce your nicotine intake.
  • 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 (counseling, support groups) for the best chance of quitting successfully.
  • Avoid prolonged exposure to water (e.g., swimming, long showers) as it may affect patch adhesion.

Dosing & Administration

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Adult Dosing

Standard Dose: For individuals smoking <10 cigarettes/day: Step 2 (14 mg/24h) for 6 weeks, then Step 3 (7 mg/24h) for 2 weeks. For individuals smoking >10 cigarettes/day, the 14mg/24h patch is typically the second step after 21mg/24h.
Dose Range: 7 - 21 mg

Condition-Specific Dosing:

smoking_cessation_initial: Typically, for heavy smokers (>10 cigarettes/day), start with 21 mg/24h for 6 weeks, then 14 mg/24h for 2 weeks, then 7 mg/24h for 2 weeks. For light smokers (<10 cigarettes/day), start with 14 mg/24h for 6 weeks, then 7 mg/24h for 2 weeks.
smoking_cessation_maintenance: The 14 mg/24h patch is a step-down dose used in the later stages of a 8-10 week cessation program.
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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, as efficacy and safety are not well-established in this population for smoking cessation)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but monitor for increased side effects.
Moderate: Use with caution; consider lower doses or extended intervals if severe renal impairment is present, as nicotine metabolites are renally excreted.
Severe: Use with caution; consider lower doses or extended intervals. Monitor for increased side effects.
Dialysis: Not specifically studied; use with caution and monitor for increased side effects due to potential accumulation of nicotine and its metabolites.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: Use with caution; nicotine is extensively metabolized by the liver. Consider lower doses or extended intervals.
Severe: Use with caution; consider lower doses or extended intervals. Monitor for increased side effects due to reduced nicotine clearance.

Pharmacology

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Mechanism of Action

Nicotine acts as an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems. In smoking cessation, it replaces the nicotine from tobacco, reducing withdrawal symptoms and cravings associated with nicotine dependence. The transdermal patch delivers a continuous, controlled dose of nicotine to maintain steady plasma levels.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 68-92% (transdermal)
Tmax: 6-10 hours (for steady-state plasma concentrations after patch application)
FoodEffect: Not applicable (transdermal)

Distribution:

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

Elimination:

HalfLife: 2-4 hours (nicotine); 15-20 hours (cotinine)
Clearance: Approximately 1.2 L/min
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: 10-20% (nicotine)
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Pharmacodynamics

OnsetOfAction: Slow (hours for steady-state levels after initial application)
PeakEffect: Prolonged (maintained over 24 hours with continuous wear)
DurationOfAction: 24 hours (while patch is applied)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention 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 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
+ 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 that bother you or do not go away, contact your doctor:

Sleep disturbances
Bad dreams
Nervousness or excitability
Headache
Joint pain
Back pain
Irritation at the site of application

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe skin rash, swelling, or blistering at the patch site
  • Dizziness, lightheadedness, or fainting
  • Nausea, vomiting, or diarrhea (especially if severe or persistent)
  • Headache (severe or unusual)
  • Rapid or irregular heartbeat (palpitations)
  • Difficulty breathing
  • Chest pain
  • Confusion or unusual behavior
  • Seizures
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any 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 crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To increase your chances of quitting smoking, consider seeking counseling to help you overcome nicotine addiction.

To minimize the risk of adverse effects, do not exceed the recommended dosage. Taking more than the prescribed amount can lead to unsafe side effects. If you are using another medication to help you quit smoking, be sure to inform your doctor.

When attempting to quit smoking, even with the assistance of medications like this one, you may experience symptoms of nicotine withdrawal. These symptoms can vary, so it is crucial to report any adverse effects to your doctor.

Until you are familiar with how this medication affects you, avoid driving and engaging in other activities that require your full attention. Additionally, be aware that quitting smoking can alter the effectiveness of other medications you are taking. Therefore, consult your doctor to discuss any 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 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 if it is swallowed by a child or pet, 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. Additionally, this medication may pose a risk to the unborn baby if taken during pregnancy. If you become pregnant or 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.
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Overdose Information

Overdose Symptoms:

  • Severe nausea and vomiting
  • Diarrhea
  • Abdominal pain
  • Dizziness, lightheadedness, fainting
  • Headache
  • Cold sweat
  • Palpitations, rapid or irregular heartbeat
  • Weakness, fatigue
  • Confusion
  • Blurred vision, hearing disturbances
  • Tremors
  • Seizures
  • Hypotension (low blood pressure)
  • Respiratory depression (slow, shallow breathing)
  • Coma

What to Do:

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

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Contraindicated Interactions

  • Not applicable (no absolute contraindications based on drug-drug interactions)
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Major Interactions

  • Not applicable
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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; monitor blood pressure and heart rate)
  • Insulin (smoking cessation can increase insulin absorption and sensitivity; monitor blood glucose and adjust insulin dose)
  • Theophylline (smoking cessation can increase theophylline levels due to reduced CYP1A2 induction; monitor theophylline levels)
  • Caffeine (smoking cessation can increase caffeine levels due to reduced CYP1A2 induction; monitor for increased caffeine side effects)
  • Adrenergic agonists (e.g., phenylephrine, isoproterenol) (nicotine may potentiate cardiovascular effects)
  • Adrenergic antagonists (e.g., prazosin, labetalol) (nicotine may reduce their hypotensive effects)
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Minor Interactions

  • Not applicable

Monitoring

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Baseline Monitoring

Smoking status (cigarettes per day, duration)

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

Timing: Prior to initiation of therapy

Cardiovascular history (MI, unstable angina, severe arrhythmias, stroke)

Rationale: Nicotine can have cardiovascular effects; use with caution in patients with pre-existing cardiovascular disease.

Timing: Prior to initiation of therapy

Skin integrity at application site

Rationale: To identify potential irritation or contraindications for patch use.

Timing: Prior to initial application

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Routine Monitoring

Adherence to therapy and complete cessation of smoking

Frequency: At each follow-up visit (e.g., weekly for first few weeks)

Target: 100% adherence to patch use, 0 cigarettes smoked

Action Threshold: Continued smoking while on NRT increases risk of nicotine toxicity; non-adherence reduces efficacy. Re-evaluate treatment plan.

Local skin reactions (redness, itching, swelling)

Frequency: Daily by patient, at each follow-up visit by clinician

Target: Minimal to no reaction

Action Threshold: Severe or persistent reactions may require discontinuation or change in NRT type.

Symptoms of nicotine withdrawal (cravings, irritability, anxiety, difficulty concentrating)

Frequency: Daily by patient, at each follow-up visit

Target: Reduced or absent

Action Threshold: Persistent severe withdrawal symptoms may indicate need for dose adjustment or adjunctive therapy.

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

Frequency: Daily by patient, at each follow-up visit

Target: Absent

Action Threshold: Presence of symptoms requires immediate removal of patch and medical evaluation.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Dizziness
  • Headache
  • Palpitations
  • Sleep disturbances (insomnia, vivid dreams)
  • Skin irritation (redness, itching, burning at application site)
  • Muscle aches
  • Tremor
  • Sweating
  • Confusion
  • Weakness
  • Seizures (rare, severe overdose)

Special Patient Groups

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Pregnancy

Category D. Nicotine crosses the placenta and can cause fetal harm, including reduced fetal breathing movements, increased fetal heart rate, and potential for adverse long-term neurodevelopmental effects. However, the risks of continued smoking during pregnancy are significantly higher than the risks of NRT. If a pregnant woman cannot quit smoking through non-pharmacological methods, NRT may be considered under strict medical supervision, with the lowest effective dose and shortest duration. Intermittent NRT (e.g., gum, lozenge) may be preferred over patches to allow for nicotine-free periods.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though less studied than smoking. Risk of spontaneous abortion.
Second Trimester: Increased risk of preterm birth, low birth weight, and potential for adverse neurodevelopmental outcomes.
Third Trimester: Increased risk of preterm birth, low birth weight, and potential for adverse neurodevelopmental outcomes. Fetal nicotine exposure can affect lung development and increase risk of SIDS.
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Lactation

Nicotine is excreted into breast milk and can be harmful to the infant. However, the risks of infant exposure to nicotine from NRT are significantly lower than the risks from maternal smoking. If NRT is used during lactation, the lowest effective dose should be used, and the patch should be removed before breastfeeding (e.g., remove 24-hour patch at night if breastfeeding in the morning) to minimize infant exposure. Intermittent NRT (gum, lozenge) may be preferred to allow for nicotine-free periods.

Infant Risk: L3 (Moderate risk). Potential for infant irritability, sleep disturbances, and cardiovascular effects. Benefits of breastfeeding generally outweigh risks if NRT is used cautiously and smoking is avoided.
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Pediatric Use

Not recommended for individuals under 18 years of age for smoking cessation without medical supervision. Efficacy and safety are not well-established in this population. Non-pharmacological interventions are preferred.

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Geriatric Use

Use with caution. Elderly patients may be more sensitive to the effects of nicotine, particularly cardiovascular effects. Consider starting with a lower dose (e.g., 14 mg/24h or 7 mg/24h) and titrating slowly based on tolerance and efficacy. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Emphasize complete cessation of smoking when starting NRT to avoid nicotine overdose.
  • Advise patients to rotate patch application sites daily to minimize skin irritation. Hydrocortisone cream can be used for mild irritation.
  • The 24-hour patch can cause sleep disturbances (insomnia, vivid dreams) in some patients. If this occurs, advise removing the patch at bedtime (after 16 hours of wear) and applying a new one in the morning, though this may reduce overall nicotine delivery.
  • NRT is most effective when combined with behavioral counseling and support programs.
  • Patients should be advised that the patch is not a 'magic bullet' but a tool to help manage withdrawal symptoms while they work on breaking the behavioral aspects of smoking.
  • Disposal of used patches is critical; they still contain enough nicotine to be harmful to children or pets. Fold sticky sides together and dispose of safely.
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Alternative Therapies

  • Other Nicotine Replacement Therapies (NRTs): Nicotine gum, nicotine lozenge, nicotine inhaler, nicotine nasal spray.
  • Pharmacological non-nicotine therapies: Bupropion SR (Zyban, Wellbutrin SR), Varenicline (Chantix).
  • Non-pharmacological therapies: Behavioral counseling, cognitive behavioral therapy (CBT), support groups, quitlines, acupuncture, hypnotherapy (efficacy varies).
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Cost & Coverage

Average Cost: $30 - $60 per 7 patches (1 week supply)
Generic Available: Yes
Insurance Coverage: Often covered by most prescription drug plans, typically Tier 1 or Tier 2. Many state Medicaid programs and some private insurers cover NRTs as part of smoking cessation benefits.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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.