nicotine bitartrate dihydrate: clinical use

Prescribing considerations

• Confirm smoking status, nicotine dependence and suitability of the selected lozenge.
• Encourage behavioural support alongside pharmacotherapy.
• Seek close medical supervision after non-pharmacological measures fail in recent myocardial infarction, unstable or worsening angina, severe arrhythmia, uncontrolled hypertension or recent stroke.
• Use caution with stable cardiovascular disease, diabetes, epilepsy, hyperthyroidism, phaeochromocytoma, or severe renal or hepatic impairment.
• Oral nicotine may aggravate active oesophagitis, oral or pharyngeal inflammation, gastritis or peptic ulcer disease.
• Review medicines affected by changes in smoking status, particularly narrow-therapeutic-index medicines.

Contraindications and cautions

• Hypersensitivity to nicotine or an excipient
• Use by a non-smoker
• The selected lozenge is unsuitable in hereditary fructose intolerance because it contains maltitol; aspartame is a source of phenylalanine and requires particular caution in phenylketonuria

Monitoring

• Smoking status, withdrawal symptoms and continued tobacco exposure
• Blood glucose more closely when NRT is initiated in people with diabetes
• Cardiovascular symptoms or clinically significant increases in heart rate or blood pressure
• Seizures in people with epilepsy or taking antiseizure treatment
• Toxicity or loss of efficacy from medicines affected by smoking cessation or resumption

Clinical pharmacology

Nicotine is a central and peripheral nicotinic receptor agonist. Buccal absorption partly replaces tobacco-derived nicotine, reducing withdrawal and craving; swallowed nicotine undergoes substantial first-pass metabolism. Nicotine is principally metabolised in the liver, with cotinine as its main metabolite.

Formulation and product differences

• The selected product is a white, round, mint-flavoured compressed lozenge.
• It contains aspartame and maltitol; maltitol may have a mild laxative effect.
• Acidic beverages can reduce buccal nicotine absorption.
• The selected product is intended for low-to-moderate nicotine dependence and is not interchangeable with higher-strength products without considering dependence and tolerability.

Lozenge

Route: Oromucosal

Strengths: 1 mg, 2 mg