pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Cholinergic Nicotinic Agonists.

Cholinergic Nicotinic

Indications

Sourced from openFDA
  • Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Dosage & administration

Sourced from openFDA

Directions if you are under 18 years of age, ask a doctor before use before using this product, read the enclosed User's Guide for complete directions and other important information begin using the gum on your quit day if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours nicotine gum is a medicine and must be used a certain way to get the best results chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. repeat this process until most of the tingle is gone (about 30 minutes) do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. do not use more than 24 pieces a day it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Warnings & precautions

Sourced from openFDA

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 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, teeth or jaw problems occur 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. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Approval history

Sourced from openFDA
  • Jan 13, 1984NDANDA018612Haleon Us Holdings
  • Nov 7, 1991NDANDA020165Chattem Sanofi
  • Nov 27, 1991NDANDA020076Dr Reddys Labs Sa
  • Jun 8, 1992NDANDA020066Haleon Us Holdings
  • Mar 22, 1996NDANDA020385Pfizer Inc
  • Oct 20, 1997ANDAANDA074612Difgen Pharms
  • Oct 31, 2002NDANDA021330Haleon Us Holdings
  • May 18, 2009NDANDA022360Haleon Us Holdings

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
60,245 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective7,53613%
  2. 2Nicotine Dependence6,16110%
  3. 3Nausea4,6497.7%
  4. 4Intentional Drug Misuse3,7826.3%
  5. 5Application Site Erythema3,5535.9%
  6. 6Application Site Pruritus3,5005.8%
  7. 7Dizziness2,6034.3%
  8. 8Product Quality Issue2,4964.1%
  9. 9Malaise2,3874.0%
  10. 10Product Adhesion Issue2,1783.6%
  11. 11Headache2,1593.6%
  12. 12Vomiting1,7572.9%
  13. 13Wrong Technique In Product Usage Process1,7322.9%
  14. 14Overdose1,6812.8%
  15. 15Treatment Noncompliance1,5902.6%

Literature

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Recent PubMed references pinned to Nicotine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 2,418 ClinicalTrials.gov registrations naming Nicotine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Nicotine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CHRNA3CPIC D (provisional)ClinPGx 3
  • COMTCPIC C/D (provisional)ClinPGx 3

Frequently asked questions

How does Nicotine work?
Mechanism-of-action class: Cholinergic Nicotinic Agonists.
What is Nicotine used for?
According to FDA labeling, Nicotine carries indications including: Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Nicotine?
Nicotine is classified as Drugs used in nicotine dependence, Cholinergic Nicotinic Agonist, Cholinergic Nicotinic Agonists, Increased Central Nervous System Acetylcholine Activity, Increased Medullary Respiratory Drive, Increased Muscular System Acetylcholine Activity, Increased Peripheral Nervous System Acetylcholine Activity.
What are the brand names for Nicotine?
Nicotine is marketed under brand names including Habitrol, Nicduic, Nicoderm C-Q, Nicorelief, Nicorette, Nicotrol, Thrive.
Note. Data for nicotine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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