NICORETTE (nicotine polacrilex)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Temporomandibular joint disorder

There are 8 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

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

There are 8 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Disease of liver
Esophagitis
Hyperthyroidism
Peptic ulcer
Pharyngitis
Pheochromocytoma
Prinzmetal angina
Type 1 diabetes mellitus

There are 15 severe adverse reactions.

More Frequent	Less Frequent
Mouth irritation	Hypertension

Rare/Very Rare
Allergic dermatitis Angioedema Atrial fibrillation Cardiac arrhythmia Erythema Hypersensitivity drug reaction Hypertension Pruritus of skin Seizure disorder Skin rash Tachycardia Urticaria Wheezing

There are 52 less severe adverse reactions.

More Frequent	Less Frequent
Dysgeusia Eructation Headache disorder Hiccups Increased appetite Jaw pain Nausea Sialorrhea Sore throat Tachycardia	Abdominal pain with cramps Aphthous stomatitis Constipation Dizziness Flatulence Flushing Hoarseness Vomiting

Rare/Very Rare

Abdominal pain with cramps Acute cognitive impairment Anorexia Arthralgia Constipation Cough Depression Diarrhea Dizziness Drowsy Dysgeusia Dysmenorrhea Edema Euphoria Flatulence Gastric acid hypersecretory conditions General weakness Headache disorder Heartburn Hiccups Hyperhidrosis Hypoesthesia Insomnia Irritability Myalgia Nausea Nervousness Nightmares Paresthesia Sneezing Syncope Tinnitus Vomiting Xerostomia

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: 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.