Drugplain

Nicotine transdermal system step 1 21 mg/24h

Nicotine · PATCH, EXTENDED RELEASE · Golden State Medical Supply, Inc.

No Recall History
Plain English

Nicotine transdermal system step 1 is a patch, extended release containing nicotine at 21 mg/24h, taken transdermal. Manufactured by Golden State Medical Supply, Inc..

Key Facts

Brand Name
Nicotine transdermal system step 1
Generic Name
Nicotine
NDC Code (Product)
60429-445
Manufacturer
Golden State Medical Supply, Inc.
Strength
21 mg/24h
Dosage Form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Marketing Status
Application #
NDA020076
Drug Class
Cholinergic Nicotinic Agonist [EPC]
Marketing Start
11/12/1999

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,730 reports
nausea1,078 reports
product adhesion issue905 reports
overdose771 reports
headache759 reports
nicotine dependence752 reports
foetal exposure during pregnancy745 reports
treatment noncompliance679 reports
dyspnoea628 reports
pain626 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions • 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 • begin using the patch on your quit day • if you smoke more than 10 cigarettes per day, use the following schedule below: STEP 1 STEP 2 STEP 3 Use one 21 mg patch/day Use one 14 mg patch/day Use one 7 mg patch/day Weeks 1-4 Weeks 5-6 Weeks 7-8 • if you smoke 10 or less cigarettes per day , start with Step 2 for 6 weeks, then Step 3 for 2 weeks • 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

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. 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 blood stream for several hours after you take off the patch. • if you have vivid dreams or other sleep disturbances remove this patch at bedtime Stop use and ask a doctor if • skin redness caused by

Frequently Asked Questions

What is Nicotine transdermal system step 1 used for?

Nicotine transdermal system step 1 contains Nicotine. It is a patch, extended release taken transdermal. Consult your doctor for specific uses.

Is Nicotine transdermal system step 1 a controlled substance?

Nicotine transdermal system step 1 is not classified as a controlled substance by the DEA.

What is the generic name for Nicotine transdermal system step 1?

The generic name for Nicotine transdermal system step 1 is Nicotine. There are 12 other brand versions of Nicotine.

What is the NDC code for Nicotine transdermal system step 1 21 mg/24h?

The NDC (National Drug Code) for Nicotine transdermal system step 1 21 mg/24h is 60429-445, listed by Golden State Medical Supply, Inc..