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nicotine transdermal (OTC)Brand and Other Names:Nicoderm CQ, Nicotrol

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

transdermal patch

  • 5mg/day
  • 7mg/day
  • 10mg/day
  • 14mg/day
  • 15mg/day
  • 21mg/day
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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

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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

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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)
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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.

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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

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