Nicotine TD 7mg/24h Patch 14s

Nicotine is a ganglionic cholinergic receptor agonist. It binds stereoselectively to nicotinic-cholinergic receptors in the central and peripheral nervous systems, mimicking the effects of nicotine obtained from tobacco. This binding leads to the release of neurotransmitters (e.g., dopamine, norepinephrine, acetylcholine, serotonin, GABA, glutamate) which are associated with the reinforcing effects of smoking. By providing a controlled, sustained release of nicotine, the transdermal patch helps to reduce nicotine withdrawal symptoms (e.g., irritability, anxiety, difficulty concentrating, cravings) experienced during smoking cessation, thereby aiding in the cessation process.

Serious 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 or 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, contact your doctor for advice:

Trouble sleeping
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.

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. Be sure to 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 tobacco use, including smoking, chewing tobacco, or using nicotine products, as these may interact with this medication.
Your age, particularly if you are under 18 years old. This medication is not recommended for children under 18 without first 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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

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 ensure safe and effective treatment.

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 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. 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 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 ingests it, or if a pet ingests the patch, 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. 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.

• Bupropion (increased risk of seizures when used concurrently for smoking cessation, though often managed with careful monitoring)
• Varenicline (concurrent use with NRT not recommended due to increased adverse effects)

• Adrenergic agonists (e.g., phenylephrine, isoproterenol): Nicotine can increase cardiovascular effects.
• Adrenergic antagonists (e.g., prazosin, labetalol): Nicotine can reduce their hypotensive effects.
• Insulin: Nicotine can cause an increase in blood glucose, potentially requiring increased insulin dosage.
• Theophylline: Nicotine can increase the metabolism of theophylline, potentially requiring increased dosage.
• Caffeine: Nicotine can increase the metabolism of caffeine, potentially requiring increased dosage.
• Imipramine: Nicotine can increase the metabolism of imipramine.
• Furosemide: Nicotine can decrease the diuretic response to furosemide.
• Propoxyphene: Nicotine can increase the metabolism of propoxyphene.

• Acetaminophen (potential for altered metabolism)
• Oxazepam (potential for altered metabolism)

• Nausea
• Vomiting
• Dizziness
• Headache
• Palpitations
• Increased heart rate
• Increased blood pressure
• Skin irritation (redness, itching, burning, swelling at application site)
• Sleep disturbances (insomnia, vivid dreams)
• Gastrointestinal upset (diarrhea, dyspepsia)
• Muscle aches
• Nervousness
• Tremor

Category D. Nicotine crosses the placenta and can cause fetal harm, including reduced birth weight, premature birth, and adverse effects on fetal brain and lung development. However, the risks of continued smoking during pregnancy are significantly higher than the risks associated with NRT. NRT should be considered only 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 patches to allow for nicotine-free periods, but patches may be considered for women who struggle with intermittent dosing.

Nicotine and its metabolites (e.g., cotinine) are excreted into breast milk. Nicotine can cause adverse effects in the infant (e.g., irritability, sleep disturbances, increased heart rate). However, the risks of infant exposure to nicotine from breast milk are generally considered less than the risks of infant exposure to nicotine and other toxins from maternal smoking. If NRT is used, the lowest effective dose should be chosen, and the patch should be removed before the longest sleep period of the infant (e.g., at night) to minimize exposure. Intermittent NRT may be preferred immediately after breastfeeding.

Not recommended for routine use in individuals under 18 years of age without medical supervision. Safety and efficacy have not been established in pediatric populations for smoking cessation. If used in adolescents, it should be part of a comprehensive cessation program and under the guidance of a healthcare professional.

No specific dose adjustments are generally required for elderly patients, but caution is advised due to potential for age-related decreases in renal or hepatic function, which could affect nicotine clearance. Start with lower doses and monitor closely for adverse effects.

• Emphasize that the patch is a tool to help manage withdrawal symptoms, but behavioral support and counseling are crucial for successful smoking cessation.
• Advise patients to apply the patch to a different site each day to minimize skin irritation. Do not apply to irritated, cut, or broken skin.
• Remind patients that the patch should be worn for 24 hours, but if vivid dreams or sleep disturbances occur, they can remove the patch before bedtime and apply a new one in the morning (though this may reduce efficacy).
• Stress the importance of not smoking or using other nicotine products while on the patch to avoid nicotine overdose.
• Educate patients on proper disposal of used patches, as they still contain significant amounts of nicotine and can be harmful to children or pets.
• For heavy smokers (>10 cigarettes/day), starting with the 21mg patch is essential for adequate nicotine replacement.
• Combination NRT (e.g., patch plus gum or lozenge for breakthrough cravings) can be more effective than monotherapy for some individuals, but should be discussed with a healthcare provider.

• Nicotine gum
• Nicotine lozenge
• Nicotine inhaler
• Nicotine nasal spray
• Bupropion SR (Zyban, Wellbutrin SR)
• Varenicline (Chantix)
• Behavioral counseling and support programs (e.g., quitlines, group therapy, individual counseling)

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 this 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 overdose, including the medication taken, the amount, and the time it occurred.