Dosing & Uses
Dosage Forms & Strengths
transdermal patch
- 5mg/day
- 7mg/day
- 10mg/day
- 14mg/day
- 15mg/day
- 21mg/day
Smoking Cessation
>10 cigarettes/day
- 21/14/7-mg regimen: 21-mg patch once daily for 6 weeks, then 14-mg patch once daily for 2 weeks, then 7-mg patch once daily for 2 weeks
- 15/10/5-mg regimen: 15-mg patch once daily for 6 weeks, then 10-mg patch once daily for 2 weeks, then 5-mg patch once daily for 2 weeks
≤10 cigarettes/day
- 14/7-mg regimen: 14-mg patch once daily for 6 weeks, then 7-mg patch once daily for 2 weeks
- 10/5-mg regimen: 10-mg patch once daily for 6 weeks, then 5-mg patch once daily for 2 weeks
Administration
Apply to clean, dry, nonhairy area of skin (typically upper arm or shoulder)
Apply new patch upon awakening and wear patch for 24 hours, unless vivid dreams or insomnia occur (then remove patch before bedtime)
Do not cut patch
There are no significant safety concerns associated with using more than 1 over-the-counter (OTC) nicotine replacement therapy (NRT) simultaneously or at same time as another nicotine-containing product (including cigarettes)
Patients who use OTC NRT while trying to quit smoking but slip up and smoke should not stop using NRT but should keep trying to quit
NRT users should still pick "quit day" and begin using OTC NRT product on that day even if they are not immediately able to stop smoking
It is important for patients to complete the full program, but some may need to use NRT for longer periods to keep from smoking
<18 years: Safety and efficacy not established
Adverse Effects
Frequency Not Defined
Acne
Anorexia
Arthralgia
Back pain
Bronchitis
Cough
Diarrhea
Dizziness
Dysmenorrhea
Dyspepsia
Headache
Hiccups
Increased blood pressure
Increased salivation
Indigestion
Insomnia
Irritability
Irritation at application site
Jaw or neck pain
Migraine
Nausea
Rhinitis
Sinusitis
Tachycardia
Taste disturbance
Tooth abrasions
Vomiting
Xerostomia
Warnings
Contraindications
Hypersensitivity to nicotine or menthol
Patients who smoke after myocardial infarction (MI)
Life-threatening arrhythmias
Significant worsening of angina pectoris
Active temperomandibular joint disease (gum)
Nonsmokers
Cautions
Coronary artery disease (eg, history of MI or angina pectoris)
Serious cardiac arrhythmias
Use caution in patients with oropharyngeal inflammation, peptic ulcer disease, or history of esophagitis
Hypertension
Use with caution in patients with insulin-dependent diabetes, pheochromocytoma, or hyperthyroidism
Vasospastic disease (eg, Prinzmetal angina, Raynaud phenomena)
Extensively metabolized in liver; hepatic impairment may decrease clearance
Peptic ulcer formation and delayed wound healing associated with nicotine replacement therapies
Poisoning or fatality may occur in children if agent is inhaled, ingested, or buccally absorbed
Before using consider the following
- Heart disease, recent heart attack, or irregular heartbeat; nicotine can increase heart rate
- High blood pressure not controlled with medication; nicotine can increase blood pressure
- An allergy to adhesive tape or have skin problems because you are more likely to get rashes
- Diabetes
- History of seizures
Stop use if the following occur
- Skin redness caused by the patch does not go away after four days, or if skin swells, or get a rash
- Irregular heartbeat or palpitations
- Experience symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness, and rapid heartbeat
- Symptoms of an allergic reaction (such as difficulty breathing or rash)
Pregnancy & Lactation
Pregnancy category: D; tobacco smoke is known to cause low birth weight, spontaneous abortion, increased perinatal mortality, decreased placental perfusion; however, nicotine replacement is believed to be safer during pregnancy than smoking
Lactation: Nicotine and metabolite (cotinine) pass into breast milk after maternal smoking; risk of exposing infant to 2nd-hand smoke may be more detrimental than that posed by NRT; nicotine may increase infant heart rate
Pregnant or breastfeeding patients should seek advice of healthcare professional before using OTC drugs
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Systemically absorbed; binds to nicotine receptors; reduces withdrawal symptoms (including nicotine craving) associated with smoking cessation
Absorption
Absorption: 68%
Duration: 24 hr
Peak plasma time: 8-9 hr
Peak plasma concentration: 5-17 ng/mL (average)
Elimination
Half-life: 3-4 hr
Excretion: Urine
