Nicotine nasal spray

FDA label

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Titration Self-titrate by nicotine dependence and symptoms of nicotine excess vs withdrawal; if not abstinent by week 4, probably discontinue

Renal Consider dose reduction and monitor for nicotine-excess adverse events (nausea, dizziness); clearance decreased ~30% (moderate) and ~50% (severe) renal impairment

Hepatic Consider dose reduction and monitor for nicotine-excess adverse events; total clearance reduced ~40–50% at Child-Pugh 7; unaffected at Child-Pugh 5; no data beyond Child-Pugh 7

Continued use >6 months not recommended (not adequately studied)

Instructions

• Stop smoking completely when starting; use as part of a behavioral cessation program
• Tilt head back slightly; do not sniff, swallow, or inhale through the nose while spraying; avoid spraying eyes
• Regular use in week 1 helps adaptation to irritant effects (nasal irritation in 94% during first 2 days)
• Discontinuation strategies: use 1/2 dose (1 spray) at a time, use less often, keep a daily tally, set a reducing target, skip hourly doses, or set a planned stop date; some may stop abruptly
• Keep used and unused bottles away from children and pets (full bottle = 100 mg nicotine); dispose safely

Available strengths

• nasal spray 0.5 mg/spray (10 mg/mL; 1 dose = 2 sprays)

Contraindications

• Known hypersensitivity or allergy to nicotine or any component of the product

Cautions

• Nicotine from any source is toxic and addictive; weigh NRT risk vs hazard of continued smoking
• Continued smoking during use → peak nicotine levels higher than smoking alone; discontinue if clinically significant cardiovascular effects
• Severe reactive airway disease: use not recommended (bronchospasm exacerbation reported in pre-existing asthma)
• Nasal mucosa irritation; extended use beyond 6 months not recommended
• Cardiovascular/peripheral vascular disease (CHD, serious arrhythmias, vasospastic disease): evaluate carefully; generally avoid in immediate post-MI period, serious arrhythmias, severe or worsening angina
• Renal or hepatic impairment: decreased clearance — consider dose reduction and monitor
• Hyperthyroidism, pheochromocytoma, insulin-dependent diabetes: caution (catecholamine release)
• Esophagitis, active gastric or peptic ulcer: caution (delays ulcer healing)
• Accelerated hypertension: caution (risk factor for malignant hypertension)
• Common cold/rhinitis reduces absorption and delays peak; nasal vasoconstrictors (xylometazoline) further delay peak
• Smoking cessation may require dose decrease of acetaminophen, caffeine, imipramine, oxazepam, pentazocine, propranolol/beta-blockers, theophylline, insulin, prazosin/labetalol; dose increase of adrenergic agonists (isoproterenol, phenylephrine)
• Keep used and unused containers away from children and pets (poisoning can be fatal)
• Elderly: start at low end of dosage range

Adverse reactions

• Nasal irritation 94% (first 2 days; mostly moderate–severe), 81% at 3 weeks (mostly mild–moderate)
• Runny nose, throat irritation, watering eyes, sneezing, coughing (active and placebo)
• More common on active than placebo: nasal congestion, sinus irritation, transient epistaxis, eye irritation, taste/smell changes, pharyngitis, nasal/mouth paresthesia or numbness, burning nose/eyes, earache, facial flushing, hoarseness, nasal ulcer or blister
• Headache 18% (placebo 15%); back pain 6% (4%); dyspnea 5% (6%); nausea 5% (5%); arthralgia 5% (1%); menstrual disorder 4% (4%); palpitation 4% (4%); flatulence 4% (3%); tooth disorder 4% (1%); gum problems 4% (1%); myalgia 3% (4%); abdominal pain 3% (3%); confusion 3% (3%); acne 3% (1%); dysmenorrhea 3% (0%); pruritus 2% (3%)
• Feelings of dependence on the spray and calming drug-like effects more frequent on active spray
• <1%: peripheral edema, dry mouth, hiccup, diarrhea, purpura, aphasia, amnesia, migraine, bronchitis, bronchospasm, rash, abnormal vision
• Post-marketing: dysphagia, chest pain, anaphylactic reaction, seizure

Pregnancy Presumed to cause fetal harm (animal data); not studied in pregnant women; attempt behavioral cessation first; use only if likelihood of cessation justifies risk; spontaneous abortion reported with NRT; not recommended during labor and delivery

Lactation Caution; nicotine passes freely into breast milk (milk:plasma ratio 2.9); milk nicotine expected lower than with smoking; weigh infant exposure vs continued maternal smoking