Nicotine (oral)

Nicotine (oral)
	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 (oral) is a Dependency Agent that is FDA approved for the treatment of Reducing the 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

Directions to use

if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.

before using this product, read the enclosed User’s Guide for complete directions and other important information

begin using the lozenge on your quit day

if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge

if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:

This image is provided by the National Library of Medicine.

nicotine lozenge is a medicine and must be used a certain way to get the best results

place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge.

you may feel a warm or tingling sensation

occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes)

do not eat or drink 15 minutes before using or while the lozenge is in your mouth

to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks

do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects

do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.

it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nicotine (oral) in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Nicotine (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Nicotine (oral) 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.

Ask a doctor before use if you have

a sodium-restricted diet

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.

stomach ulcer or diabetes

Ask a doctor or pharmacist before use if you are

using a non-nicotine stop smoking drug

taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

mouth problems occur

persistent indigestion or severe sore throat occurs

irregular heartbeat or palpitations occur

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

Keep out of reach of children and pets.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Nicotine (oral) in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Nicotine (oral) in the drug label.

Drug Interactions

There is limited information regarding Nicotine (oral) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Nicotine (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Nicotine (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Nicotine (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Nicotine (oral) with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Oral

Monitoring

There is limited information regarding Monitoring of Nicotine (oral) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Nicotine (oral) in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Nicotine (oral) in the drug label.

Pharmacology

There is limited information regarding Nicotine (oral) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Nicotine (oral) Mechanism of Action in the drug label.

Structure

There is limited information regarding Nicotine (oral) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Nicotine (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Nicotine (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Nicotine (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Nicotine (oral) in the drug label.

How Supplied

There is limited information regarding Nicotine (oral) How Supplied in the drug label.

Storage

There is limited information regarding Nicotine (oral) 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 (oral) in the drug label.

Precautions with Alcohol

Alcohol-Nicotine (oral) 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 (oral) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Nicotine (oral) 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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