Nicotine TD 7mg/24h Patch 7s

Manufacturer DR.REDDY'S LABORATORIES, INC. 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 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 strong 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. Do not cut or divide the patches, and do not use any that are damaged.

Storing and Disposing of the Medication

Store the patches at room temperature, keeping them in a safe place out of the reach of children and pets. Dispose of unused or expired patches properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of the medication, as there may be drug take-back programs available 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

  • Do not smoke, chew tobacco, or use other nicotine products (e.g., gum, lozenges, inhalers) while wearing 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 upper outer arm. Press firmly for 10 seconds.
  • Rotate the application site daily to prevent skin irritation. Do not use the same site for at least 7 days.
  • Remove the patch before going to bed if you experience sleep disturbances (e.g., vivid dreams, insomnia), and apply a new patch in the morning.
  • Wash your hands thoroughly after handling the patch.
  • Fold the used patch in half with the sticky sides together before discarding to prevent accidental exposure to children or pets.
  • Keep all patches, new and used, out of reach of children and pets.
  • Combine patch use with a comprehensive smoking cessation program (counseling, support groups) for best results.

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 â‰Ĩ10 cigarettes/day: Step 1 (21 mg/24h) for 6 weeks, then Step 2 (14 mg/24h) for 2 weeks, then Step 3 (7 mg/24h) for 2 weeks. The 7mg/24h patch is typically the final step in a step-down regimen.
Dose Range: 7 - 21 mg

Condition-Specific Dosing:

smoking_cessation: Apply one patch to a clean, dry, hairless area of skin on the upper body or upper outer arm once daily for 24 hours. Rotate application sites daily. Do not use the same site for at least 7 days.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (generally not recommended for individuals under 18 years of age)
Adolescent: Not established (use only under medical supervision if considered)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended, use with caution
Severe: Use with caution; monitor for increased side effects due to potential accumulation. Dose reduction may be considered.
Dialysis: Considerations: Nicotine is not significantly removed by dialysis. Use with caution.

Hepatic Impairment:

Mild: No specific adjustment recommended
Moderate: Use with caution; monitor for increased side effects. Dose reduction may be considered.
Severe: Use with caution; monitor for increased side effects due to impaired metabolism. Dose reduction may be considered.
Confidence: Medium

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 continuous, controlled release of nicotine, which helps to reduce the craving and withdrawal symptoms associated with smoking cessation by replacing the nicotine previously obtained from tobacco.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 68-92% (transdermal)
Tmax: 6-10 hours (for steady-state plasma concentrations with continuous patch application)
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)
Unchanged: 10-20%
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours (initial absorption from patch)
PeakEffect: 6-10 hours (for steady-state plasma concentrations)
DurationOfAction: 24 hours (as long as 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
+ Dizziness
+ Fainting
+ 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, contact your doctor for advice:

Sleep disturbances
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, 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:

  • Severe dizziness or faintness
  • Nausea and vomiting that is severe or persistent
  • Rapid or irregular heartbeat (palpitations)
  • Severe headache
  • Cold sweat
  • Confusion or difficulty speaking
  • Seizures
  • Severe skin rash or swelling at the application site
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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 and its symptoms.
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 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 the addiction.

Do not exceed the recommended dosage, as this may lead to unsafe side effects. If you are currently taking another medication to help you stop smoking, be sure to inform your doctor. You may experience symptoms of nicotine withdrawal when attempting to quit smoking, even with the assistance of this medication. Nicotine withdrawal can manifest in various ways, 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. When you stop smoking, the effectiveness of other medications you are taking may be altered, so consult with your doctor to discuss any potential interactions.

If you have been using this medication for the recommended duration and have not been able to quit smoking, 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.

This medication can be harmful if chewed or swallowed. If the medication is ingested, immediately contact a doctor or a poison control center. Additionally, 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 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 also 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 breast-feeding, consult with your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Severe nausea and vomiting
  • Diarrhea
  • Dizziness, faintness, or weakness
  • Headache
  • Cold sweat
  • Pale skin
  • Abdominal pain
  • Salivation
  • Visual and hearing disturbances
  • Confusion
  • Tremors
  • Rapid or irregular heartbeat
  • Low blood pressure (hypotension)
  • Difficulty breathing
  • Seizures
  • Coma

What to Do:

Immediately remove the patch and wash the skin with water (no soap, as soap can increase absorption). Contact a poison control center (Call 1-800-222-1222) or seek emergency medical attention immediately. If symptoms are severe, go to the nearest emergency room.

Drug Interactions

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Major Interactions

  • Adrenergic agonists (e.g., phenylephrine, isoproterenol): Nicotine may potentiate the cardiovascular effects.
  • Adrenergic antagonists (e.g., prazosin, labetalol): Nicotine may reduce the hypotensive effects.
  • Insulin: Nicotine may decrease subcutaneous insulin absorption and increase insulin resistance, potentially requiring increased insulin dosage.
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Moderate Interactions

  • Caffeine: Nicotine cessation may lead to increased caffeine levels due to reduced metabolism.
  • Theophylline: Nicotine cessation may lead to increased theophylline levels due to reduced metabolism.
  • Flecainide: Nicotine cessation may lead to increased flecainide levels due to reduced metabolism.
  • Opioid analgesics (e.g., propoxyphene): Nicotine may decrease their analgesic effect.
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Minor Interactions

  • Acetaminophen: Nicotine may decrease absorption.
  • Oxazepam: Nicotine may decrease absorption.

Monitoring

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Baseline Monitoring

Smoking status and history

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 exacerbate these conditions; contraindications or precautions apply.

Timing: Prior to initiation of therapy

Skin integrity at application sites

Rationale: To ensure proper absorption and prevent irritation.

Timing: Prior to first application

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Routine Monitoring

Smoking status

Frequency: Regularly throughout therapy

Target: Complete cessation

Action Threshold: Continued smoking while on patch requires re-evaluation and counseling due to risk of nicotine overdose.

Adherence to patch application

Frequency: At each follow-up visit

Target: Consistent daily use

Action Threshold: Poor adherence may indicate need for additional support or alternative strategies.

Local skin reactions (e.g., 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 brand/formulation.

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

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

Target: Absence of symptoms

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

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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
  • Diarrhea or constipation

Special Patient Groups

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Pregnancy

Category D. Nicotine crosses the placenta and can cause fetal harm. However, the risks of continued smoking during pregnancy (e.g., low birth weight, premature birth, stillbirth) are significant. The decision to use nicotine replacement therapy (NRT) during pregnancy should be made after careful consideration of the risks of NRT versus the risks of continued smoking, and under the guidance of a healthcare provider. Intermittent NRT (e.g., gum, lozenge) may be preferred over patches to allow for nicotine-free periods.

Trimester-Specific Risks:

First Trimester: Potential for adverse effects on fetal development, including cardiovascular and respiratory systems.
Second Trimester: Continued risk of fetal growth restriction, premature birth, and other adverse outcomes.
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 to the infant is lower with NRT than with smoking. The benefits of smoking cessation for the mother and infant should be weighed against the potential risks of nicotine exposure through breast milk. If NRT is used, intermittent forms (gum, lozenge) may be preferred to allow for periods of lower nicotine levels in milk, especially after the longest interval between feedings. The 24-hour patch provides continuous exposure. Monitor infant for signs of nicotine exposure (e.g., irritability, poor feeding, sleep disturbances).

Infant Risk: L3 (Moderate Concern) - Nicotine is present in breast milk. Potential for infant irritability, sleep disturbances, and cardiovascular effects. Risk is lower than with active smoking.
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Pediatric Use

Not recommended for use in individuals under 18 years of age. Safety and efficacy have not been established in this population. Smoking cessation in adolescents should be managed under strict medical supervision.

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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 underlying cardiovascular conditions. Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • The 7mg/24h patch is typically the last step in a step-down regimen for smoking cessation. Ensure patients understand the full regimen.
  • Emphasize the importance of not smoking or using other nicotine products while on the patch to avoid nicotine overdose.
  • Advise patients to rotate application sites daily to minimize skin irritation. Hydrocortisone cream can be used for mild irritation.
  • For patients experiencing sleep disturbances (insomnia, vivid dreams), advise them to remove the patch at bedtime and apply a new one in the morning (16-hour use).
  • Nicotine patches are most effective when used as part of a comprehensive smoking cessation program that includes behavioral support and counseling.
  • Counsel patients that withdrawal symptoms (e.g., irritability, difficulty concentrating) may still occur, but the patch helps to mitigate their severity.
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Alternative Therapies

  • Other Nicotine Replacement Therapies (NRTs): Nicotine gum, nicotine lozenge, nicotine inhaler, nicotine nasal spray.
  • Bupropion (Zyban, Wellbutrin SR)
  • Varenicline (Chantix)
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Cost & Coverage

Average Cost: $30 - $60 per 7 patches (7mg/24h)
Generic Available: Yes
Insurance Coverage: Often covered by most prescription drug plans, sometimes as a preventive benefit. Coverage may vary by plan and state.
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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.