Nicotine patch

Nicotine patch
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: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indication

• 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 patch in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nicotine patch in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Nicotine patch FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nicotine patch in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nicotine patch in pediatric patients.

Contraindications

There is limited information regarding Nicotine patch 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.

Ask a doctor or pharmacist before use if you are

• 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 Nicotine patch Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Nicotine patch Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Nicotine patch Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Nicotine patch in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nicotine patch in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nicotine patch during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Nicotine patch in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Nicotine patch in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Nicotine patch in geriatric settings.

Gender

There is no FDA guidance on the use of Nicotine patch with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nicotine patch with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Nicotine patch in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Nicotine patch in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nicotine patch in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nicotine patch in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Nicotine patch Administration in the drug label.

Monitoring

There is limited information regarding Nicotine patch Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Nicotine patch and IV administrations.

Overdosage

There is limited information regarding Nicotine patch overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Nicotine patch Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Nicotine patch Mechanism of Action in the drug label.

Structure

There is limited information regarding Nicotine patch Structure in the drug label.

Pharmacodynamics

There is limited information regarding Nicotine patch Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Nicotine patch Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Nicotine patch Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Nicotine patch Clinical Studies in the drug label.

How Supplied

There is limited information regarding Nicotine patch How Supplied in the drug label.

Storage

●Store at 20-25°C (68-77°F)

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

If you are under 18 years of age, ask a doctor before use

• Before using this product, read the enclosed self-help guide for complete directions and other information
• Stop smoking completely when you begin using the patch
• If you smoke more than 10 cigarettes per day, use the following schedule below:

This image is provided by the National Library of Medicine.

• If you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stop
• Apply one new patch every 24 hours on skin that is dry, clean and hairless
• Remove backing from patch and immediately press onto skin. Hold for 10 seconds.
• Wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of * The used patches by folding sticky ends together and putting in pouch.
• The used patch should be removed and a new one applied to a different skin site at the same time each day
• If you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning
• Do not wear more than one patch at a time
• Do not cut patch in half or into smaller pieces
• Do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours
• To avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures
• Stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.

Precautions with Alcohol

Alcohol-Nicotine patch 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 patch Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Nicotine patch 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.