Formulary
Nicotine: Indications, Dosing, Side Effects and Interactions
Nicotine clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 9 min read
Nicotine: Indications, Dosing, Side Effects and Interactions
Nicotine clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Nicotine replacement therapy in individuals who smoke fewer than 20 cigarettes each day**
- **Adult** (By Mouth Using Chewing Gum): 1 tablet every 1 hour, increased to 2 tablets every 1 hour if required, if attempting smoking cessation, treatment should continue for up to 3 months before reducing the dose; maximum 40 tablets per day.
**Nicotine replacement therapy in individuals who smoke more than 20 cigarettes each day or who require more than 15 pieces of 2-mg strength gum each day**
- **Adult** (By Mouth Using Chewing Gum): 4 mg as required, chew 1 piece of gum when the urge to smoke occurs or to prevent cravings, individuals should not exceed 15 pieces of 4-mg strength gum daily, if attempting smoking cessation, treatment should continue for 3 months before reducing the dose.
**Nicotine replacement therapy**
- **Adult** (By Inhalation Using Inhalator): As required, the cartridges can be used when the urge to smoke occurs or to prevent cravings, individuals should not exceed 12 cartridges of the 10-mg strength daily, or 6 cartridges of the 15-mg strength daily.
- **Adult** (By Mouth Using Lozenges): 1 lozenge every 1-2 hours as required, one lozenge should be used when the urge to smoke occurs, individuals who smoke less than 20 cigarettes each day should usually use the lower-strength lozenges; individuals who smoke more than 20 cigarettes each day and those who fail to stop smoking with the low-strength lozenges should use the higher-strength lozenges; If attempting smoking cessation, treatment should continue for 6-12 weeks before attempting a reduction in dose; maximum 15 lozenges per day.
- **Adult** (By Mouth Using Oromucosal Spray): 1 spray as required, individuals can spray into each nostril when the urge to smoke occurs, up to twice every hour for 16 hours daily, if attempting smoking cessation, treatment should continue for 8 weeks before reducing the dose; maximum 64 sprays per day.
- **Adult** (By Transdermal Application Using Patches): Individuals who smoke more than 10 cigarettes daily should apply a high-strength patch daily for 6-8 weeks, followed by the medium-strength patch for 2 weeks, and then the low-strength patch for the final 2 weeks; individuals who smoke fewer than 10 cigarettes daily can usually start with the medium-strength patch for 6-8 weeks, followed by the low-strength patch for 2-4 weeks; a slower titration schedule can be used in individuals who are not ready to quit but want to reduce cigarette consumption before a quit attempt; if abstinence is not achieved, or if withdrawal symptoms are experienced, the strength of the patch used should be maintained or increased until the patient is stabilised; individuals using the high-strength patch who experience excessive side-effects, that do not resolve within a few days, should change to a medium-strength patch for the remainder of the initial period and then use the low-strength patch for 2-4 weeks.
**Nicotine replacement therapy in individuals who smoke fewer than 20 cigarettes each day for nicotine**
- **Child 12-17 years** (By mouth using chewing gum): 2 mg as required, chew 1 piece of gum when the urge to smoke occurs or to prevent cravings, if attempting smoking cessation, treatment should continue for 3 months before reducing the dose.
- **Child 12-17 years** (By sublingual administration using sublingual tablets): 1 tablet every 1 hour, increased to 2 tablets every 1 hour if required, if attempting smoking cessation, treatment should continue for up to 3 months before reducing the dose; maximum 40 tablets per day.
**Nicotine replacement therapy in individuals who smoke more than 20 cigarettes each day or who require more than 15 pieces of 2-mg strength gum each day for nicotine**
- **Child 12-17 years** (By mouth using chewing gum): 4 mg as required, chew 1 piece of gum when the urge to smoke occurs or to prevent cravings, individuals should not exceed 15 pieces of 4-mg strength gum daily, if attempting smoking cessation, treatment should continue for 3 months before reducing the dose.
**Nicotine replacement therapy in individuals who smoke more than 20 cigarettes each day for nicotine**
- **Child 12-17 years** (By sublingual administration using sublingual tablets): 2 tablets every 1 hour, if attempting smoking cessation, treatment should continue for up to 3 months before reducing the dose; maximum 40 tablets per day.
**Nicotine replacement therapy for nicotine**
- **Child 12-17 years** (By inhalation using inhalator): As required, the cartridges can be used when the urge to smoke occurs or to prevent cravings, individuals should not exceed 12 cartridges of the 10-mg strength daily, or 6 cartridges of the 15-mg strength daily.
- **Child 12-17 years** (By mouth using lozenges): 1 lozenge every 1-2 hours as required, one lozenge should be used when the urge to smoke occurs, individuals who smoke less than 20 cigarettes each day should usually use the lower-strength lozenges; individuals who smoke more than 20 cigarettes each day and those who fail to stop smoking with the low-strength lozenges should use the higher-strength lozenges; If attempting smoking cessation, treatment should continue for 6-12 weeks before attempting a reduction in dose; maximum 15 lozenges per day.
- **Child 12-17 years** (By mouth using oromucosal spray): 1-2 sprays as required, individuals can spray in the mouth when the urge to smoke occurs or to prevent cravings, individuals should not exceed 2 sprays per episode (up to 4 sprays every hour); maximum 64 sprays per day.
- **Child 12-17 years** (By intranasal administration using nasal spray): 1 spray as required, individuals can spray into each nostril when the urge to smoke occurs, up to twice every hour for 16 hours daily, if attempting smoking cessation, treatment should continue for 8 weeks before reducing the dose; maximum 64 sprays per day.
- **Child 12-17 years** (By transdermal application using patches): Individuals who smoke more than 10 cigarettes daily should apply a high-strength patch daily for 6-8 weeks, followed by the medium-strength patch for 2 weeks, and then the low-strength patch for the final 2 weeks; individuals who smoke fewer than 10 cigarettes daily can usually start with the medium-strength patch for 6-8 weeks, followed by the low-strength patch for 2-4 weeks; a slower titration schedule can be used in individuals who are not ready to quit but want to reduce cigarette consumption before a quit attempt; if abstinence is not achieved, or if withdrawal symptoms are experienced, the strength of the patch used should be maintained or increased until the patient is stabilised; individuals using the high-strength patch who experience excessive side-effects, that do not resolve within a few days, should change to a medium-strength patch for the remainder of the initial period and then use the low-strength patch for 2-4 weeks.
Cautions
General cautions: Diabetes mellitus-blood-glucose concentration should be monitored closely when initiating treatment; haemodynamically unstable patients hospitalised with cerebrovascular accident; haemodynamically unstable patients hospitalised with myocardial infarction; haemodynamically unstable patients hospitalised with severe arrhythmias; phaeochromocytoma; uncontrolled hyperthyroidism Specific cautions: When used by inhalation Bronchospastic disease; chronic throat disease; obstructive lung disease With intranasal use Bronchial asthma (may exacerbate) With oral use Gastritis (can be aggravated by swallowed nicotine); gum may also stick to and damage dentures; oesophagitis (can be aggravated by swallowed nicotine); peptic ulcers (can be aggravated by swallowed nicotine) With transdermal use Patches should not be placed on broken skin; patients with skin disorders Cautions, further information Most warnings for nicotine replacement therapy also apply to continued cigarette smoking, but the risk of continued smoking outweighs any risks of using nicotine preparations. Specific cautions for individual preparations are usually related to the local effect of nicotine.
Side effects
General side-effects: Common or very common Dizziness; headache; hyperhidrosis; nausea; palpitations; skin reactions; vomiting Uncommon Flushing Specific side-effects: Common or very common When used by inhalation Asthenia; cough; dry mouth; flatulence; gastrointestinal discomfort; hiccups; hypersensitivity; nasal complaints; oral disorders; taste altered; throat complaints With intranasal use Chest discomfort; cough; dyspnoea; epistaxis; nasal complaints; paraesthesia; throat irritation With oral use Anxiety; appetite abnormal; burping; diarrhoea; dyspepsia (may be caused by swallowed nicotine); gastrointestinal disorders; hiccups; increased risk of infection; mood altered; oral disorders; sleep disorders With sublingual use Asthenia; cough; dry mouth; flatulence; gastrointestinal discomfort; hiccups; hypersensitivity; oral disorders; rhinitis; taste altered; throat complaints Uncommon When used by inhalation Abnormal dreams; arrhythmias; bronchospasm; burping; chest discomfort; dysphonia; dyspnoea; hypertension; malaise With intranasal use Abnormal dreams; asthenia; hypertension; malaise With oral use Anger; asthma exacerbated; cough; dyspepsia aggravated; dysphagia; haemorrhage; laryngospasm; nasal complaints; nocturia; numbness; overdose; pain; palpitations exacerbated; peripheral oedema; tachycardia; taste altered; throat complaints; vascular disorders With sublingual use Abnormal dreams; arrhythmias; bronchospasm; burping; chest discomfort; dysphonia; dyspnoea; hypertension; malaise; nasal complaints With transdermal use Arrhythmias; asthenia; chest discomfort; dyspnoea; hypertension; malaise; myalgia; paraesthesia Rare or very rare When used by inhalation Dysphagia With intranasal use Arrhythmias With oral use Coagulation disorder; platelet disorder With sublingual use Dysphagia With transdermal use Abdominal discomfort; angioedema; pain in extremity Frequency not known When used by inhalation Angioedema; excessive tearing; vision blurred With intranasal use Abdominal discomfort; angioedema; excessive tearing; oropharyngeal complaints With sublingual use Excessive tearing; muscle tightness; vision blurred Side-effects, further information Some systemic effects occur on initiation of therapy, particularly if the patient is using high-strength preparations; however, the patient may confuse side-effects of the nicotine-replacement preparation with nicotine withdrawal symptoms. Common symptoms of nicotine withdrawal include malaise, headache, dizziness, sleep disturbance, coughing, influenza-like symptoms, depression, irritability, increased appetite, weight gain, restlessness, anxiety, drowsiness, aphthous ulcers, decreased heart rate, and impaired concentration.
Interactions
**Other interactions (2):**
- No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established.
- However nicotine may possibly enhance the haemodynamic effects of adenosine i.e.
Pregnancy
The use of nicotine replacement therapy is preferable to the continuation of smoking. Nicotine replacement therapy should be considered alongside behavioural support, at the earliest opportunity in pregnancy and continued after pregnancy if needed. If patches are used, they should be removed before bed. A See also Pregnancy in Smoking cessation .
Breast feeding
Nicotine is present in milk; however, the amount to which the infant is exposed is small and less hazardous than second-hand smoke. Intermittent therapy is preferred.
Hepatic impairment
Manufacturer advises caution in moderate to severe impairment (risk of decreased clearance).
Renal impairment
Use with caution in severe renal impairment. M
Medicinal forms
Tablet,Patch,Spray
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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