Nicotine (transdermal)

Nicotine (transdermal)
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

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

you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness and rapid heartbeat

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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