nicotine lozenge

Nicotine is a chemical compound that naturally occurs in tobacco plants. Nicotine is a potent stimulant and a highly addictive substance that is the primary chemical present in all tobacco products. Nicotine stimulates the central nervous system producing rewarding effects, but it is also a toxic chemical that increases heart rate and blood pressure and is associated with hardening of arteries, heart disease, cancers and many other chronic diseases.

Nicotine lozenges are used as nicotine replacement therapy (NRT) to help give up smoking tobacco. Abrupt discontinuation of tobacco products causes nicotine craving and withdrawal symptoms. Nicotine lozenges help relieve the craving and withdrawal symptoms while gradually weaning off nicotine. NRT helps reduce the urge to smoke cigarettes because the body still gets nicotine from another safer method.

• Do not use nicotine lozenges in smokers with the following conditions:
  • Hypersensitivity to any of the components in nicotine lozenge
  • Life-threatening irregular heart rhythms (arrhythmia)
  • Severe or worsening chest pain from coronary artery disease (angina pectoris)
  • Recovery period after a heart attack (myocardial infarction)
  • Soya allergy, some products contain soya
• Use nicotine with caution in smokers with the following conditions:
  • High blood pressure (hypertension)
  • Serious cardiac arrhythmias
  • History of coronary artery disease, angina pectoris, and myocardial infarction
  • History of gastrointestinal conditions including esophagus inflammation (esophagitis), inflammation of oral tissue and throat (oropharyngeal) and peptic ulcer disease
  • Insulin dependent diabetes
  • History of seizures
  • Impairment of liver or kidney function
  • Pheochromocytoma, a type of adrenal cancer
  • Thyroid gland overactivity (hyperthyroidism)
  • Vascular diseases such as Raynaud’s phenomenon and Prinzmetal angina
• Nicotine lozenges may contain phenylalanine and may not be suitable for people who have phenylketonuria, a condition with the inability to break down phenylalanine.

Common side effects of nicotine lozenge include:

• Palpitations
• Irregular heart rhythm (cardiac arrhythmia)
• Rapid heart rate (tachycardia)
• Dizziness
• Increase in blood pressure
• Oral irritation
• Increased salivation
• Sore throat
• Hiccups
• Heartburn
• Indigestion (dyspepsia)
• Nausea
• Vomiting
• Loss of appetite (anorexia)
• Sleep disturbance
• Abnormal dreams
• Insomnia
• Irritability
• Headache
• Cough

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Lozenge

• 2 mg
• 4 mg

Adult:

Smoking Cessation

• Weeks 1-6: 1 lozenge every 1-2 hours
• Weeks 7-9: 1 lozenge every 2-4 hours
• Weeks 10-12: 1 lozenge every 4-8 hours
• Do not exceed more than 5 lozenges/6 hours
• Do not exceed more than 20 lozenges/day
• First cigarette smoked more than 30 minutes after awakening: Initiate with 2 mg
• First cigarette smoked within 30 minutes of awakening: Initiate with 4 mg

Pediatric:

• Safety and efficacy not established

• Nicotine lozenge overdose can cause symptoms that include nausea, vomiting, diarrhea, abdominal pain, sweating, flushing, dizziness, weakness, disturbed hearing and vision, confusion, palpitations, altered respiration, and low blood pressure.
• Nicotine overdose is treated with symptomatic and supportive care.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Nicotine lozenge has no known severe or serious interactions with other drugs.
• Moderate interactions of nicotine lozenge include:
  • adenosine
  • methysergide
  • varenicline
• Nicotine lozenge has no known mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Do not smoke tobacco if you are pregnant, smoking can cause low birth weight, spontaneous abortion, and increase the risk of mortality of the newborn.
• Nicotine replacement with lozenges is safer than smoking tobacco during pregnancy, however, avoiding nicotine altogether is the safest for maternal and fetal health. Try to stop smoking without any nicotine replacement if you are pregnant.
• Nicotine is present in breast milk and can harm the breastfed infant. Second-hand smoke exposure can greatly harm the infant. Stopping smoking without replacement nicotine is the safest for the breastfed infant’s health, however, nicotine lozenges are less harmful than smoking while breastfeeding.
• If you are pregnant or breastfeeding, check with your healthcare provider before using OTC nicotine lozenge to give up smoking.

• Follow label instructions exactly when taking OTC nicotine lozenge.
• Let the lozenge slowly dissolve in the mouth, do not bite, chew or swallow.
• Complete the full treatment. If you need to use the nicotine lozenge for a longer period to quit smoking, talk to your healthcare provider.
• Stop using nicotine lozenge and consult with your healthcare provider if you have persistent bothersome side effects.
• Store safely out of reach of children and pets.
• In case of accidental consumption by children or nicotine lozenge overdose, seek medical help or contact Poison Control.