Nicotine (transdermal)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]
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Overview
Nicotine (transdermal) is a depending agent that is FDA approved for the treatment of Reducing withdrawal symptoms, including nicotine craving, associated with quitting smoking. Common adverse reactions include skin irritation, nasal irritation, nasal spray, oral irritation, dizziness, headache, insomnia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Nicotine (transdermal) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Nicotine (transdermal) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Nicotine (transdermal) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Nicotine (transdermal) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Nicotine (transdermal) in pediatric patients.
Contraindications
There is limited information regarding Nicotine (transdermal) Contraindications in the drug label.
Warnings
- If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.
- Do Not Use
- if you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use another nicotine patch or other nicotine containing products
- Ask a doctor before use if you have
- Heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
- high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
- an allergy to adhesive tape or have skin problems, because you are more likely to get rashes
- using a non-nicotine stop smoking drug
- taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted
- When using this product
- do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch.
- if you have vivid dreams or other sleep disturbances remove this patch at
- Stop use and ask a doctor if
- skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash
- irregular heartbeat or palpitations occur
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Nicotine (transdermal) in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Nicotine (transdermal) in the drug label.
Drug Interactions
There is limited information regarding Nicotine (transdermal) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): D
There is no FDA guidance on usage of Nicotine (transdermal) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nicotine (transdermal) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Nicotine (transdermal) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Nicotine (transdermal) with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Nicotine (transdermal) with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Nicotine (transdermal) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Nicotine (transdermal) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Nicotine (transdermal) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Nicotine (transdermal) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Nicotine (transdermal) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Nicotine (transdermal) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Nicotine (transdermal) in patients who are immunocompromised.
Administration and Monitoring
Administration
- Transdermal
Monitoring
There is limited information regarding Monitoring of Nicotine (transdermal) in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Nicotine (transdermal) in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Nicotine (transdermal) in the drug label.
Pharmacology
There is limited information regarding Nicotine (transdermal) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Nicotine (transdermal) Mechanism of Action in the drug label.
Structure
There is limited information regarding Nicotine (transdermal) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Nicotine (transdermal) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Nicotine (transdermal) in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Nicotine (transdermal) in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Nicotine (transdermal) in the drug label.
How Supplied
- store at 20-25°C (68-77°F)
Storage
There is limited information regarding Nicotine (transdermal) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Nicotine (transdermal) in the drug label.
Precautions with Alcohol
- Alcohol-Nicotine (transdermal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Nicotine (transdermal) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Nicotine (transdermal) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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