Nicotine 14mg/24h Patch 14s

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
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 are a type of medicine that helps 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 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 applying or removing 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 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.
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Lifestyle & Tips

  • Set a quit date and start using the patch on that day.
  • Apply one new patch each morning to a clean, dry, hairless area of skin (e.g., upper arm, chest, back).
  • Press firmly for 10 seconds to ensure good contact.
  • Rotate application sites daily to prevent skin irritation.
  • Remove the old patch before applying a new one.
  • Do NOT smoke or use any other nicotine products (e.g., e-cigarettes, chewing tobacco) while using the patch, as this can lead to nicotine overdose.
  • Combine patch use with behavioral support programs for the best chance of quitting.
  • Avoid cutting the patch, as this can affect its delivery system.
  • Dispose of used patches safely by folding the sticky sides together and placing them in a child-proof container, as they still contain nicotine.

Dosing & Administration

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Adult Dosing

Standard Dose: 14 mg/24 hours for 2-4 weeks, typically as Step 2 in a step-down program after 21 mg/24 hours.
Dose Range: 14 - 14 mg

Condition-Specific Dosing:

heavySmokers: Typically start with 21 mg/24 hours for 6 weeks, then 14 mg/24 hours for 2-4 weeks, then 7 mg/24 hours for 2-4 weeks.
lightSmokers: Typically start with 14 mg/24 hours for 6 weeks, then 7 mg/24 hours for 2-4 weeks.
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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 without medical supervision)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution; monitor for increased side effects.
Dialysis: Considerations: Nicotine is not significantly removed by dialysis. Use with caution and monitor for adverse effects.

Hepatic Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution; monitor for increased side effects.
Severe: No specific adjustment recommended, use with caution; monitor for increased side effects.

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 cigarettes, reducing withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) and the urge to smoke.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 60-80% (transdermal)
Tmax: 6-10 hours (for steady-state plasma concentrations after patch application)
FoodEffect: Not applicable for transdermal patch

Distribution:

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

Elimination:

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

OnsetOfAction: Gradual, within hours of patch application (for steady-state levels)
PeakEffect: Steady-state plasma concentrations achieved within 2-3 days of continuous patch use.
DurationOfAction: 24 hours (while patch is applied)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

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
Feeling confused
Chest pain or pressure
Fast heartbeat 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 where the medication was administered

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 diarrhea that is severe or persistent
  • Rapid or irregular heartbeat (palpitations)
  • Chest pain
  • Difficulty breathing
  • Cold sweats
  • Confusion or 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.

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. You may experience symptoms of nicotine withdrawal, such as irritability, anxiety, or depression, when attempting to quit smoking, even with the assistance of this medication. Report any adverse effects to your doctor.

Until you understand how this medication affects you, avoid operating a vehicle or engaging in activities that require alertness. When you stop smoking, the effectiveness of other medications you are taking may be altered; therefore, consult your doctor. 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.

Chewing or swallowing this medication can be harmful; if this occurs, immediately contact a doctor or a poison control center. This medication can be hazardous or even fatal if ingested by children or pets, so keep it out of their reach. If a child uses this medication or if it is swallowed by a child or pet, promptly contact a doctor or a poison control center.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. This medication may harm an unborn baby if taken during pregnancy. If you become pregnant while using 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
  • Dizziness
  • Weakness
  • Rapid heartbeat
  • Low blood pressure
  • Difficulty breathing
  • Seizures
  • Confusion
  • Fainting

What to Do:

Remove the patch immediately. If symptoms are severe, call 911 or your local emergency number. For less severe symptoms, call a poison control center (1-800-222-1222) or seek immediate medical attention.

Drug Interactions

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Moderate Interactions

  • Adrenergic agonists (e.g., phenylephrine, isoproterenol): Nicotine may potentiate cardiovascular effects.
  • Adenosine: Nicotine may increase heart rate and blood pressure, potentially reducing adenosine's effectiveness.
  • Insulin: Smoking cessation (and thus nicotine replacement) may increase insulin absorption or decrease insulin requirements due to improved glucose metabolism. Monitor blood glucose.
  • Theophylline: Smoking cessation may lead to increased theophylline levels due to reduced CYP1A2 induction. Monitor theophylline levels.
  • Caffeine: Smoking cessation may lead to increased caffeine levels due to reduced CYP1A2 induction. Monitor for caffeine toxicity.
  • Flecainide: Smoking cessation may lead to increased flecainide levels due to reduced CYP2D6 induction. Monitor for toxicity.
  • Propoxyphene: Smoking cessation may lead to increased propoxyphene levels due to reduced CYP2D6 induction. Monitor for toxicity.

Monitoring

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Baseline Monitoring

Smoking status (number of cigarettes per day, duration of smoking)

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 have cardiovascular effects; caution is advised in patients with pre-existing conditions.

Timing: Prior to initiation of therapy

Skin integrity at application site

Rationale: To ensure proper adhesion and minimize irritation.

Timing: Prior to first application

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Routine Monitoring

Adherence to therapy

Frequency: At each follow-up visit

Target: Consistent daily use as prescribed

Action Threshold: Non-adherence may require counseling or dose adjustment.

Withdrawal symptoms (e.g., cravings, irritability, anxiety, difficulty concentrating)

Frequency: Daily, then weekly

Target: Reduction or absence of symptoms

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

Side effects (e.g., skin irritation, nausea, dizziness, sleep disturbances)

Frequency: Daily, then weekly

Target: Minimal or manageable side effects

Action Threshold: Severe or intolerable side effects may require dose reduction, change in application site, or discontinuation.

Smoking status (abstinence)

Frequency: Weekly, then monthly

Target: Complete cessation of smoking

Action Threshold: Continued smoking while on NRT requires re-evaluation of therapy and counseling.

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Symptom Monitoring

  • Skin irritation (redness, itching, burning) at application site
  • Nausea
  • Vomiting
  • Dizziness
  • Headache
  • Sleep disturbances (insomnia, vivid dreams)
  • Palpitations
  • Increased heart rate
  • Chest pain

Special Patient Groups

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Pregnancy

Category D. Nicotine crosses the placenta and can harm the fetus. However, the risks of continued smoking during pregnancy are significantly higher than the risks of nicotine replacement therapy. Use only if the potential benefit justifies the potential risk to the fetus, and under strict medical supervision. Behavioral counseling is preferred first-line.

Trimester-Specific Risks:

First Trimester: Increased risk of miscarriage, congenital malformations (though less clear for NRT vs. smoking).
Second Trimester: Increased risk of preterm birth, low birth weight.
Third Trimester: Increased risk of preterm birth, low birth weight, stillbirth, and potential long-term neurodevelopmental effects.
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Lactation

Nicotine is excreted into breast milk. While NRT delivers less nicotine than smoking, it is still present. If NRT is necessary, consider using shorter-acting forms (e.g., gum, lozenge) immediately after breastfeeding to minimize infant exposure. Consult with a healthcare provider.

Infant Risk: L3 (Moderate risk). Potential for infant exposure to nicotine, leading to irritability, sleep disturbances, and potential long-term effects. Risk is lower than continued maternal smoking.
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Pediatric Use

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

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Geriatric Use

No specific dose adjustments are typically required. However, older adults may be more sensitive to the cardiovascular effects of nicotine. Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • The 14mg/24h patch is typically used as Step 2 in a step-down program for heavy smokers (after 21mg) or as a starting dose for light smokers (less than 10 cigarettes/day).
  • Encourage patients to set a quit date and start the patch on that day, not before.
  • Emphasize the importance of not smoking or using other nicotine products while on the patch to avoid nicotine overdose.
  • Advise patients to rotate patch application sites daily to minimize skin irritation.
  • Counsel patients that the patch provides a steady level of nicotine, which helps with background cravings, but they may still experience breakthrough cravings, for which short-acting NRTs (gum, lozenge, inhaler, nasal spray) can be used as needed.
  • Remind patients that NRT is most effective when combined with behavioral support and counseling.
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Alternative Therapies

  • Other Nicotine Replacement Therapies (NRTs): Nicotine gum, nicotine lozenge, nicotine inhaler, nicotine nasal spray, nicotine oral spray.
  • Non-nicotine pharmacotherapies: Bupropion (Zyban, Wellbutrin), Varenicline (Chantix).
  • Behavioral therapies: Counseling, support groups, cognitive behavioral therapy (CBT), motivational interviewing.
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Cost & Coverage

Average Cost: $30 - $60 per 14 patches (2-week supply)
Generic Available: Yes
Insurance Coverage: Often covered by most prescription drug plans (Tier 1 or 2), especially with a prescription for smoking cessation programs. May be covered by Medicaid/Medicare.
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.