Nicotine

Trade Names:
Commit
- Lozenges 2 mg
- Lozenges 4 mg

Trade Names:
Habitrol
- Transdermal system 17.5 mg
- Transdermal system 35 mg
- Transdermal system 52.5 mg

Trade Names:
Nicoderm
- Transdermal system 36 mg
- Transdermal system 78 mg
- Transdermal system 114 mg

Trade Names:
Nicorette
- Chewing gum 2 mg/square

Trade Names:
Nicorette DS
- Chewing gum 4 mg/square

Trade Names:
Nicotrol
- Transdermal system 8.3 mg
- Transdermal system 16.6 mg
- Transdermal system 24.9 mg

Trade Names:
Nicotrol NS
- Spray pump 0.5 mg nicotine/actuation

Trade Names:
Nicotrol Inhaler
- Inhaler 4 mg delivered (10 mg/cartridge)

Trade Names:
ProStep
- Transdermal system 15 mg
- Transdermal system 30 mg

Pharmacology

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Reduces nicotine withdrawal symptoms by providing nicotine levels lower than those associated with smoking.

Indications and Usage

Aid to smoking cessation. Part of comprehensive behavioral smoking-cessation program.

Contraindications

Nonsmokers; during immediate post-MI period; life-threatening arrhythmias; severe or worsening angina pectoris; active temporomandibular joint disease (nicotine polacrilex gum).

Dosage and Administration

Advise patient to stop smoking completely when beginning to use smoking cessation therapy.

PO If patient smokes less than 25 cigarettes/day, chew 2 mg gum (max, 24 pieces/day) for up to 12 wk. If patient smokes at least 25 cigarettes/day, chew 4 mg gum (max, 24 pieces/day) for up to 12 wk.

PO If patient smokes first cigarette more than 30 min after waking up, start with the 2 mg lozenge. If patient smokes first cigarette within 30 min after waking up, start with the 4 mg lozenge. Week 1 to 6, slowly dissolve 1 lozenge in the mouth every 1 to 2 h; week 7 to 9, slowly dissolve 1 lozenge in the mouth every 2 to 4 h; week 10 to 12, slowly dissolve 1 lozenge in the mouth every 4 to 8 h.

Inhaler 6 to 16 cartridges/day for up to 6 mo.

Topical If patient smokes at least 10 cigarettes/day, start with 21 mg/day for first 4 wk, then decrease dose to 14 mg/day for next 2 wk, then decrease dose to 7 mg/day for last 2 wk. If patient smokes less than 10 cigarettes/day, start with 14 mg/day for 6 wk then decrease dose to 7 mg/day for last 2 wk.

Topical If patient smokes at least 10 cigarettes/day, start with 21 mg/day for first 6 wk then decrease dose to 14 mg/day for next 2 wk, then decrease dose to 7 mg/day for last 2 wk. If patient smokes less than 10 cigarettes/day, start with 14 mg/day for 6 wk then decrease dose to 7 mg/day for last 2 wk.

Topical Use 15 mg/16 h for 6 wk.

Spray (Each actuation delivers 50 mcL spray containing 0.5 mg nicotine.) 8 to 40 doses/day for 3 to 6 mo.

General Advice

• Inhalation system
• Have patient continuously puff on mouthpiece (approximately 20 minutes).
• Discard used container in safe place.
• Store mouthpiece in plastic case between uses.
• Clean mouthpiece regularly with soap and water.

• Lozenge
• Place lozenge in mouth and allow to slowly dissolve (20 to 30 minutes) while occasionally moving the lozenge from one side of the mouth to the other.
• Do not chew or swallow lozenge.
• Do not eat or drink 15 minutes before using or while lozenge is in mouth.

• Nicotine chewing gum
• Instruct patient to chew gum 1 piece at a time.
• Tell patient to chew intermittently for about 30 min.
• Do not allow patient to eat or drink for 15 min before chewing and during chewing.

• Transdermal system
• Apply patch promptly on removal from pouch.
• Apply patch once daily to clean, dry skin site on upper body or upper outer arm.
• After patch has been on for 24 h, remove and apply new patch to alternate skin site. Do not reuse skin sites for at least 1 wk (exception is Nicotrol , which is applied on awakening and removed at bedtime).
• After handling active patch, wash hands with water alone. Do not touch eyes.
• After removing used patch from skin, fold over, place in protective pouch, and immediately dispose of it so that it is inaccessible to children and pets.

Storage/Stability

Store cartridge at 77°F or below. Protect from light.

Store at controlled room temperature (68° to 77°F). Protect from light.

Store at controlled room temperature (68° to 77°F). Protect from light.

Store at controlled room temperature (68° to 77°F). Do not store out of pouch.

Drug Interactions

Smoking tends to increase metabolism and may lower blood levels of these drugs or others. Smoking cessation, with or without nicotine medication, may reverse these effects.

Effective absorption of nicotine gum depends on mildly alkaline saliva. Coffee, cola, and other drinks or food may reduce salivary pH and should probably be avoided 15 min before and during chewing of gum.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Edema; flushing; hypertension; palpitations; tachyarrhythmias; tachycardia; MI; CHF; cardiac arrest; cerebrovascular accident.

CNS

Insomnia; dizziness; lightheadedness; irritability; headache; impaired concentration; confusion; convulsions; depression; paresthesia; abnormal dreams.

Dermatologic

Erythema; rash; itching; urticaria.

EENT

Buccal cavity irritation; mouth or throat soreness or dryness. With gum chewing: traumatic injury to oral mucosa or teeth; jaw ache; changes in taste perception.

GI

GI distress; belching; indigestion; nausea; vomiting; excess salivation; hiccoughs; anorexia; constipation; diarrhea.

Hepatic

Alterations of LFTs.

Respiratory

Increased cough; pharyngitis; sinusitis; difficulty breathing; hoarseness; sneezing.

Miscellaneous

Pain; myalgia; arthralgia; dysmenorrhea.

Precautions

Pregnancy

Category C (nicotine polacrilex gum); Category D (inhaler, spray, transdermal nicotine).

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established.

Elderly

May be more susceptible to adverse reactions.

Hepatic Function

Hepatic function impairment may reduce nicotine Cl.

Abuse/Dependence

Transference of nicotine dependence from smoking to deterrent product exists. If patient continues to smoke while on nicotine therapy, severe effects caused by higher nicotine levels may be experienced.

CV effects

Patients with coronary heart disease, serious cardiac arrhythmias, systemic hypertension, or vasospastic disease need to be carefully evaluated and monitored closely because of cardiac effects.

Debilitated patients

May be more susceptible to adverse reactions.

Dental problems

Might be exacerbated by chewing nicotine gum.

Endocrine effects

Use with caution in patients with hyperthyroidism, pheochromocytoma, or insulin-dependent diabetes because of action of nicotine on adrenal medulla.

GI effects

May delay healing in patients with peptic ulcer disease.

Overdosage

Symptoms

Nausea, salivation, abdominal pain, vomiting, diarrhea, cold sweat, headache, dizziness, disturbed hearing and vision, mental confusion, marked weakness, faintness, prostration, hypotension, difficult breathing, rapid, weak, irregular pulse, respiratory collapse.

Patient Information

• Review package insert information with patient.
• Inform patient of serious effects if continuing to smoke while chewing gum or using patch. Instruct patient to stop smoking. Encourage patient to participate in comprehensive smoking cessation program.
• Warn patient of possible dependence of medication.
• Tell patient that gum or patch is not for long-term use and that dose will be gradually tapered off over course of a few weeks to a month.
• Inform patient it will take a few days to adjust to taste of gum.
• Instruct patient to avoid drinking or eating 15 min before and during chewing of gum.
• Advise patient to chew gum slowly 1 piece at a time when urge to start smoking is felt.
• Instruct patient regarding proper use of gum (intermittent technique of slow-paced chewing and “parking”).
• Advise patient not to exceed 30 pieces of gum/day (2 mg size) or 20 pieces/day (4 mg size) and to decrease this number gradually over first month.
• Tell patient to inspect mouth daily (if chewing gum) for signs of irritation.
• Instruct patient in proper use and disposal of patch. Tell patient to always remove old patch before applying new one, and to wash hands after applying patch.
• Advise patient regarding proper storage of patch (eg, heat sensitive, rapid evaporation once opened).
• Instruct patient to report the following symptoms to health care provider: GI distress (ie, constipation, diarrhea, nausea), headache, depression, dizziness, hiccoughs, sore throat or pain, or mouth discomfort.

• Nasal spray
• Encourage patient to participate in a smoking cessation program.
• If the patient has not stopped smoking by the fourth week of therapy, discontinue treatment.

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