Nicotine Polarilex

FDA Drug Information • Also known as: Nicotine

Brand Names: Nicotine
Drug Class: Cholinergic Nicotinic Agonist [EPC]
Route: ORAL
Dosage Form: LOZENGE
Product Type: HUMAN OTC DRUG

What Is Nicotine Polarilex Used For?

Use

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Dosage and Administration

Directions

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: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours

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.

Warnings and Precautions

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

history of seizures 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 and rapid heartbeat

you have symptoms of an allergic reaction (such as difficulty breathing or rash) 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. (1-800-222-1222)

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.