Nicotine Transdermal System

FDA Drug Profile — Nicotine Transdermal System, foster and thrive STEP 1, foster and thrive STEP 3, foster and thrive STEP 2

Drug Details

Generic Name
Nicotine Transdermal System
Brand Names
Nicotine Transdermal System, foster and thrive STEP 1, foster and thrive STEP 3, foster and thrive STEP 2
Application Number
ANDA074612
Sponsor
Walgreens
NDC Codes
33
Dosage Forms
PATCH, EXTENDED RELEASE, PATCH
Routes
TRANSDERMAL
Active Ingredients
NICOTINE

Indications and Usage

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

Warnings

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 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. 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 a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. When using this product if you have vivid dreams or other sleep disturbances, remove the patch at bedtime 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 you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of children and pets Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.