Nicotine TD 21mg/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
Jan 1970
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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, low dose 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

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. Each time you apply a new patch, choose a different site to avoid skin irritation. Select a hair-free area to ensure the patch adheres properly. After applying the patch, wash your hands thoroughly.

Wearing the Patch

You can wear each patch for 16 to 24 hours. If you experience strong cravings for cigarettes in the morning, 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. Do not cut or divide the patches, and discard any damaged patches.

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 your pharmacist. You may also have access to 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

  • Do not smoke or use any other nicotine-containing products (e.g., e-cigarettes, chewing tobacco, snuff) while using 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. Rotate application sites daily to prevent skin irritation.
  • Wash your hands after applying or removing the patch.
  • Remove the patch before going to bed if you experience vivid dreams or sleep disturbances, and apply a new one in the morning (some patches are designed for 16-hour wear).
  • Dispose of used patches safely by folding the sticky sides together and placing them in a child-proof container, as they still contain nicotine that can be harmful to children or pets.
  • Combine patch use with behavioral support programs (counseling, quitlines) for the best chance of quitting successfully.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply one 21 mg/24h patch once daily for 6 weeks, then step down to 14 mg/24h for 2 weeks, then 7 mg/24h for 2 weeks. Total treatment duration is typically 10 weeks.
Dose Range: 7 - 21 mg

Condition-Specific Dosing:

heavySmokers: Start with 21 mg/24h patch if smoking >10 cigarettes/day.
lightSmokers: Start with 14 mg/24h patch if smoking <=10 cigarettes/day.
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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 without medical supervision)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: Use with caution; consider lower starting dose or slower titration due to potential for reduced clearance.
Severe: Use with caution; consider lower starting dose or slower titration due to potential for reduced clearance. Monitor for adverse effects.
Dialysis: Not well studied; use with caution and monitor for adverse effects. Nicotine is not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Use with caution; consider lower starting dose or slower titration due to reduced metabolism.
Severe: Use with caution; consider lower starting dose or slower titration due to significantly reduced metabolism. Monitor for adverse effects.

Pharmacology

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Mechanism of Action

Nicotine is an agonist at nicotinic acetylcholine receptors in the central and peripheral nervous systems. When administered transdermally, it provides a steady, controlled release of nicotine, which replaces the nicotine from cigarettes, thereby reducing the severity of nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) experienced during smoking cessation.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 68-92% (transdermal)
Tmax: 2-12 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: Approximately 2 hours (nicotine), 18-20 hours (cotinine)
Clearance: Approximately 1.2 L/min
ExcretionRoute: Renal (primarily as metabolites, ~10-20% as unchanged nicotine depending on urine pH)
Unchanged: 10-20% (renal)
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours (for detectable plasma levels after patch application)
PeakEffect: 6-10 hours (for steady-state plasma levels)
DurationOfAction: 24 hours (while patch is applied)

Safety & Warnings

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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 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 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

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.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of nicotine overdose: severe nausea, vomiting, dizziness, headache, cold sweat, confusion, weakness, fainting, seizures, rapid or irregular heartbeat.
  • Severe skin reactions: blistering, swelling, or rash that spreads beyond the patch site.
  • Chest pain, shortness of breath, or severe palpitations.
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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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Chest pain or pressure
+ An irregular heartbeat
+ A recent heart attack
Your nicotine use, including smoking, chewing tobacco, or using other nicotine products, while taking this medication.
Your age, particularly if you are under 18 years old. 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 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 prescribed may lead to unsafe side effects. If you are using another medication to aid in smoking cessation, 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 widely, so it's crucial to report any adverse effects to your doctor.

Until you understand how this medication affects you, avoid operating vehicles or engaging in activities that require alertness. Additionally, be aware that quitting smoking may alter the effectiveness of other medications you are taking, so consult with your doctor to adjust your treatment plan as needed.

If you have not successfully quit smoking after using this medication for the recommended duration, inform your doctor. The patch contains metal, so it's essential to remove it before undergoing an MRI.

Some users may experience vivid dreams or sleep disturbances. If this occurs, consider removing the patch at bedtime. It is critical 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 years 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 mothers should consult their doctor to discuss potential risks to their baby and determine the best course of action.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Headache
  • Cold sweat
  • Confusion
  • Weakness
  • Fainting
  • Blurred vision
  • Hearing disturbances
  • Palpitations
  • Rapid or irregular heartbeat
  • Seizures
  • Respiratory depression

What to Do:

If you suspect an overdose, remove the patch immediately and call a poison control center (1-800-222-1222) or seek emergency medical attention. If symptoms are severe, go to the nearest emergency room.

Drug Interactions

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Moderate Interactions

  • Adrenergic agonists (e.g., phenylephrine, isoproterenol): Nicotine may potentiate the cardiovascular effects of these agents.
  • Beta-blockers (e.g., propranolol): Smoking cessation (with or without NRT) can lead to increased plasma levels of beta-blockers due to reduced induction of hepatic enzymes by smoking. Dose adjustment may be needed.
  • Insulin: Smoking cessation (with or without NRT) can lead to increased subcutaneous insulin absorption and/or reduced insulin requirements. Monitor blood glucose and adjust insulin dose.
  • Theophylline: Smoking cessation (with or without NRT) can lead to increased plasma levels of theophylline due to reduced induction of hepatic enzymes by smoking. Monitor theophylline levels and adjust dose.
  • Opioid analgesics (e.g., propoxyphene): Smoking cessation may increase plasma levels of propoxyphene.
  • Caffeine: Smoking cessation may increase plasma levels of caffeine.

Monitoring

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Baseline Monitoring

Smoking history (cigarettes/day, duration)

Rationale: To determine appropriate starting dose and treatment duration.

Timing: Prior to initiation of therapy.

Cardiovascular disease history (MI, angina, arrhythmia, hypertension)

Rationale: Nicotine can exacerbate cardiovascular conditions. Use with caution in patients with recent MI, unstable angina, severe arrhythmias, or uncontrolled hypertension.

Timing: Prior to initiation of therapy.

Skin integrity at application sites

Rationale: To ensure suitable areas for patch application and prevent irritation.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Smoking status (abstinence)

Frequency: Weekly or as needed

Target: Complete abstinence from all tobacco products

Action Threshold: Continued smoking while on patch indicates need for re-evaluation of therapy or counseling.

Adverse effects (e.g., skin irritation, sleep disturbances, nausea, headache)

Frequency: Daily/Weekly

Target: Minimal to no adverse effects

Action Threshold: Persistent or severe adverse effects may require dose reduction, change in patch type, or discontinuation.

Patch adherence and proper application

Frequency: At each patient contact

Target: Consistent daily application to clean, dry, hairless skin, rotating sites.

Action Threshold: Improper use can lead to inadequate nicotine delivery or increased side effects.

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Symptom Monitoring

  • Symptoms of nicotine withdrawal (e.g., irritability, anxiety, difficulty concentrating, restlessness, increased appetite, cravings)
  • Symptoms of nicotine overdose (e.g., nausea, vomiting, dizziness, headache, palpitations, cold sweat, confusion, weakness, seizures)
  • Local skin reactions (e.g., redness, itching, burning, swelling at patch site)
  • Sleep disturbances (e.g., vivid dreams, insomnia)

Special Patient Groups

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Pregnancy

Nicotine is classified as Pregnancy Category D. While nicotine itself is harmful to the fetus (e.g., low birth weight, premature birth, respiratory problems), the risks of continued smoking during pregnancy are significantly higher. If a pregnant woman cannot quit smoking through non-pharmacological methods, NRT may be considered under 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 data are mixed. Risk of spontaneous abortion.
Second Trimester: Increased risk of premature birth, low birth weight, and fetal growth restriction.
Third Trimester: Increased risk of premature birth, low birth weight, and potential for neonatal nicotine withdrawal.
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Lactation

Nicotine is excreted into breast milk. The amount of nicotine transferred is lower with NRT compared to smoking. If a lactating mother cannot quit smoking without NRT, it is generally considered safer than continued smoking. Use the lowest effective dose, and consider intermittent NRT (e.g., gum, lozenge) immediately after breastfeeding to minimize infant exposure. Monitor the infant for signs of nicotine exposure (e.g., irritability, poor feeding, sleep disturbances).

Infant Risk: L3 (Moderately Safe) - Nicotine is present in breast milk, but the benefits of smoking cessation for the mother and infant generally outweigh the risks of NRT. Monitor infant for adverse effects.
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Pediatric Use

Nicotine patches are not indicated for smoking cessation in individuals under 18 years of age without specific medical supervision. Safety and efficacy have not been established in this population.

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Geriatric Use

No specific dose adjustment is generally required for elderly patients. However, use with caution in elderly patients with underlying cardiovascular disease or other comorbidities, and monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Advise patients to set a quit date and start using the patch on that day.
  • Emphasize the importance of not smoking or using other nicotine products while on the patch to avoid nicotine overdose.
  • Rotate patch application sites daily to minimize skin irritation. Do not apply to irritated, broken, or scarred skin.
  • The patch should be applied to a clean, dry, hairless area of the upper body or outer arm.
  • Some patients may experience vivid dreams or sleep disturbances; if so, advise them to remove the 24-hour patch before bedtime and apply a new one in the morning (consider a 16-hour patch if available).
  • Proper disposal of used patches is crucial, as they still contain enough nicotine to be harmful to children or pets.
  • Encourage patients to combine NRT with behavioral counseling or support programs for optimal success.
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Alternative Therapies

  • Other Nicotine Replacement Therapies (NRT): Nicotine gum, lozenge, inhaler, nasal spray.
  • Bupropion (Zyban, Wellbutrin SR): An antidepressant that also aids in smoking cessation.
  • Varenicline (Chantix): A partial nicotinic receptor agonist.
  • Behavioral counseling and support programs (e.g., quitlines, group therapy, individual counseling).
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Cost & Coverage

Average Cost: $30 - $60 per 7 patches (1-week supply)
Generic Available: Yes
Insurance Coverage: Often covered by prescription drug plans (Rx) or as an over-the-counter (OTC) benefit, especially for smoking cessation programs. Coverage varies by plan.
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.