Nts Step 1 (nicotine)

The manufacturers recommend that nicotine replacement therapy (NRT) be initiated on a planned quit date for cigarette smoking. However, there is some evidence supporting the efficacy of initiating NRT in people who continue to smoke and do not plan to quit immediately. It is important to complete the full treatment regimen to increase the likelihood of successful smoking cessation.

Nicotine gum and lozenges are available as nicotine polacrilex; dosage is expressed in terms of nicotine.

Administer nicotine replacement products buccally (using a lozenge or chewing gum), transdermally (using a patch), or intranasally (using a metered-dose spray pump).

Cigarette smoke and nicotine induce hepatic enzymes. Therefore, the effect of smoking cessation in patients receiving nicotine replacement therapy should be considered when the patient is receiving other drugs concomitantly.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity or allergy to nicotine or any component in the formulation.

• Magnetic resonance imaging

• 30 day risk period post-myocardial infarction
• Acute myocardial infarction
• Angina
• Buerger's disease
• Coronary artery disease
• Life-threatening cardiac arrhythmias
• Raynaud's phenomenon
• Severe uncontrolled hypertension
• Unstable angina pectoris

• Contact dermatitis
• Diabetes mellitus
• Disease of liver
• Esophagitis
• Gastrointestinal ulcer
• Hyperthyroidism
• Kidney disease with likely reduction in glomerular filtration rate (GFr)
• Lower seizure threshold
• Pheochromocytoma
• Prinzmetal angina
• Seizure disorder

Buccal therapy (gum): Indigestion; nausea; hiccups; traumatic injury to oral mucosa and/or teeth; irritation and/or tingling of the tongue, mouth, and throat; oral mucosal ulceration; jaw-muscle ache; eructation; gum sticking to teeth; unpleasant taste; dizziness; lightheadedness; headache.

Buccal therapy (lozenges): Nausea, dyspepsia, flatulence, headache, upper respiratory tract infections.

Transdermal therapy: Application site reactions (i.e., pruritus, burning, or erythema), dyspepsia, abdominal pain, dry mouth.

Intranasal therapy: Nasal irritation, runny nose, throat irritation, watery eyes, sneezing, cough.

Less Frequent

• Dyspnea

Rare or Very Rare

• Angioedema
• Atrial fibrillation
• Dermatitis due to topical drug
• Erythema
• Impaired wound healing
• Peptic ulcer
• Pruritus of skin
• Seizure disorder
• Skin burn caused by transdermal patch worn during MRI
• Urticaria

More Frequent

• Application site skin reactions
• Increased appetite
• Palpitations
• Tachycardia

Less Frequent

• Abdominal pain with cramps
• Constipation
• Dizziness
• Dream disorder
• Drowsy
• Hyperhidrosis
• Nervousness

Rare or Very Rare

• Anorexia
• Arthralgia
• Concentration difficulty
• Cough
• Depression
• Diarrhea
• Dysmenorrhea
• Headache disorder
• Insomnia
• Irritability
• Localized edema
• Myalgia
• Nightmares
• Paresthesia
• Skin rash
• Vertigo
• Xerostomia

No enhanced messaging available.

Safety and efficacy not evaluated in the pediatric population.

Individuals <18 years of age should consult a clinician prior to use of OTC nicotine replacement therapy products.

Use or ingestion of used or unused nicotine replacement systems by children may cause poisoning or be fatal; keep used and unused containers out of the reach of children.

Animal studies indicate that nicotine may cause fetal harm when administered to pregnant women. Tobacco smoke, which contains nicotine, hydrogen cyanide, and carbon monoxide, has been shown to be harmful to the fetus; adverse effects include fetal growth retardation, increased risk of spontaneous abortion, and increased perinatal mortality. Substantial evidence indicates that decreased birthweight in neonates born to women who smoke is in part caused by a direct vasoconstrictive effect of nicotine on uterine vasculature resulting in fetal hypoxia.

The teratogenic potential of cigarette smoking or nicotine in humans has not been clearly established. Cigarette smoking is known to increase fetal aortic blood flow and heart rate and decrease uterine blood flow and fetal breathing movements. In a limited study of pregnant (e.g., between 24-36 weeks of gestation) women who continued to smoke at least 10 cigarettes daily for 5 days or who discontinued smoking and began taking nicotine polacrilex gum for 5 days at a dosage of at least 6 pieces of 2-mg gum (up to 30 pieces) daily chewed at a rate not to exceed 2 pieces hourly, there were no differences between the groups in changes in maternal or fetal hemodynamic measurements (e.g., maternal heart rate and mean arterial pressure, fetal heart rate, uterine resistance index, umbilical resistance index). The maternal serum cotinine concentration after 5 days was decreased with nicotine polacrilex gum but did not change with continuance of smoking. Peak and trough maternal serum nicotine concentrations after 5 days were lower with nicotine polacrilex gum than with continuance of smoking.

Individuals who are pregnant should consult a healthcare provider prior to the use of OTC nicotine replacement therapy products. Although these products are believed to be safer than smoking, the fetal/neonatal risks are not fully known. The USPHS guideline states that behavioral counseling interventions are effective in improving smoking cessation during pregnancy, but additional research is needed on pharmacotherapy options.

Nicotine is distributed into human milk in a milk to plasma ratio averaging 2.9. Proper use of nicotine polacrilex preparations or transdermal or intranasal nicotine would be expected to produce lower nicotine concentrations in milk than would cigarette smoking because of lower maternal plasma nicotine concentrations with nicotine replacement therapy. Although some clearance of orally absorbed nicotine in infants will occur through first-pass metabolism in the liver, the efficiency of nicotine removal is probably lowest at birth. Nicotine replacement therapy should be used with caution in breastfeeding individuals. The safety of nicotine replacement therapy in infants who are breastfeeding has not been evaluated. Whether to use nicotine replacement therapy in a nursing woman should be based on comparison of the risks associated with exposure to tobacco smoke from continued smoking by the mother, and those associated with use of nicotine replacement therapy alone or in combination with continued smoking. Individuals who are breastfeeding should consult a healthcare provider prior to the use of any nicotine replacement therapy product.

Nicotine nasal spray: Select dosage with caution.

Nicotine nasal spray: Insufficient experience in patients >=65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease.

Pharmacokinetics of nicotine in geriatric patients have not been studied.