NIK-o-teen

Therapeutic Classification:

• Adjunct therapy (with behavior modification) in the management of nicotine withdrawal in patients desiring to give up cigarette smoking.

• Provides a source of nicotine during controlled withdrawal from cigarette smoking.

• Lessened sequelae of nicotine withdrawal (irritability, insomnia, somnolence, headache, and increased appetite).

Absorption: Gum, lozenge: Slowly absorbed from buccal mucosa during chewing/sucking. Nasal spray: 53% absorbed from nasal mucosa. Transdermal: 70% of nicotine released from the system is absorbed through the skin.

Distribution: Enter breast milk.

Metabolism/Excretion: Mostly metabolized by the liver. Small amounts are metabolized by kidneys and lungs; 10–20% excreted unchanged by kidneys.

Half-life: 1–2 hr.

(plasma concentrations)

Contraindicated in:

• Hypersensitivity
• Recent history of MI (nasal spray)
• Arrhythmias (nasal spray)
• Severe or worsening angina (nasal spray)
• Severe cardiovascular disease
• OB: Pregnancy.

Use Cautiously in:

• Cardiovascular disease (including hypertension)
• Recent history of MI (gum, lozenge, patch)
• Arrhythmias (gum, lozenge, patch)
• Severe or worsening angina (gum, lozenge, patch)
• Diabetes mellitus
• Pheochromocytoma
• Peripheral vascular diseases
• Hyperthyroidism
• Continued smoking
• Peptic ulcer disease
• Seizures
• Hepatic disease
• Bronchospastic lung disease (nasal spray)
• Allergic reaction to adhesive tape (patch)
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children
• Geri: Begin at lower dosages in older adults.

CV: tachycardia, chest pain, hypertension.

Derm: transdermal: burning at patch site, erythema, pruritus, cutaneous hypersensitivity, rash, sweating.

EENT: sinusitis.
gum: pharyngitis.
nasal spray: nasopharyngeal irritation, sneezing, watering eyes, change in smell, earache, epistaxis, eye irritation, hoarseness.

Endo: dysmenorrhea.

GI: abdominal pain, abnormal taste, constipation, diarrhea, dry mouth, dyspepsia, hiccups, nausea, vomiting.
gum: belching, ↑appetite, ↑salivation, oral injury, sore mouth.

MS: arthralgia, back pain, myalgia.
gum: jaw muscle ache.

Neuro: paresthesia, headache, insomnia, abnormal dreams, dizziness, drowsiness, impaired concentration, nervousness, seizures, weakness.

Resp: Nasal spray: cough, dyspnea.

Drug-Drug:

• Effects of acetaminophen, caffeine, imipramine, insulin, oxazepam, propranolol, or other beta blockers, adrenergic antagonists (prazosin, labetalol), and theophylline may be ↑ upon smoking cessation; dose ↓ at cessation may be necessary.
• Effects of adrenergic agonists (e.g., isoproterenol, phenylephrine) may be ↓ upon smoking cessation; dose ↑ at cessation may be necessary.
• Concurrent treatment with bupropion may cause treatment-emergent hypertension.

• Gum (Adults): If first cigarette is desired >30 min after awakening, start with 2 mg gum; if first cigarette is desired <30 min after awakening, start with 4 mg gum. Patients should chew one piece of gum every 1–2 hr for 6 wk, then one piece of gum every 2–4 hr for 3 wk, then one piece of gum every 4–8 hr for 3 wk, then discontinue. Should not exceed 24 pieces of gum/day.
• Lozenge (Adults): If first cigarette is desired >30 min after awakening, start with 2 mg lozenge; if first cigarette is desired <30 min after awakening, start with 4 mg lozenge. Patients should use one lozenge every 1–2 hr for 6 wk, then one lozenge every 2–4 hr for 3 wk, then one lozenge every 4–8 hr for 3 wk, then discontinue. Should not exceed 20 lozenges/day or more than 5 lozenges in 6 hr.
• Intranasal (Adults): One spray in each nostril 1–2 times/hr (up to 5 times/hr); may be ↑ up to maximum of 40 times/day (should not exceed 3 mo of therapy).
• Transdermal (Adults): Patients smoking >10 cigarettes/day: Begin with Step 1 (21 mg/day) for 6 wk, followed by Step 2 (14 mg/day) for 2 wk, and then Step 3 (7 mg/day) for 2 wk, then stop (total of 10 wk) (new patch should be applied every 24 hr); Patients smoking 10 cigarettes/day: Begin with Step 2 (14 mg/day) for 6 wk, followed by Step 3 (7 mg/day) for 2 wk, then stop (total of 8 wk) (new patch should be applied every 24 hr).

(Generic available)

• Chewing gum (cinnamon, mint, spearmint, white ice, and fruit chill flavors): 2 mg^OTC; 4 mg^OTC;
• Lozenges (original, mint, cherry, and cappuccino flavors): 2 mg^OTC; 4 mg^OTC;
• Nasal spray: 0.5 mg/spray in 10-mL bottles (200 sprays);
• Transdermal patch: 7 mg/day^OTC; 14 mg/day^OTC; 21 mg/day^OTC;

• Prior to therapy, assess smoking history (number of cigarettes smoked daily, smoking patterns, nicotine content of preferred brand, degree to which patient inhales smoke).
  • Assess patient for symptoms of smoking withdrawal (irritability, drowsiness, fatigue, headache, nicotine craving) periodically during nicotine replacement therapy (NRT).
  • Evaluate progress in smoking cessation periodically during therapy.

• Monitor for nausea, vomiting, diarrhea, increased salivation, abdominal pain, headache, dizziness, auditory and visual disturbances, weakness, dyspnea, hypotension, and irregular pulse.

• Gum: Protect gum from light; exposure to light causes gum to turn brown.
• Lozenge: Lozenge should be allowed to dissolve slowly in the mouth; it should not be chewed or swallowed.
• Transdermal: Patch can be worn for 16 or 24 hr; the patch can be removed before the patient goes to bed (especially if patient has vivid dreams or sleep disturbances) or can remain on while the patient sleeps (especially if patient craves cigarettes upon awakening).
• Nasal Spray: Regular use of the spray during the first wk of therapy may help patient adjust to irritant effects of the spray.

• Encourage patient to participate in a smoking cessation program while using this product.
  • Review the patient instruction sheet enclosed in the package.
  • Instruct patient in proper method of disposal of unit. Emphasize need to keep out of the reach of children or pets.
  • Nicotine in any form can be harmful to a pregnant woman and/or the fetus. Assist patient in determining risk/benefit of NRT and harm to the fetus versus the likelihood of stopping smoking without NRT. Maternal smoking and nicotine increase risk of sudden infant death syndrome.
  • Emphasize the importance of regular visits to health care professional to monitor progress of smoking cessation.
• Gum: Explain purpose of nicotine gum to patient. Patient should chew 1 piece of gum whenever a craving for nicotine occurs or according to a fixed schedule (every 1–2 hr while awake) as directed. Chew gum slowly until a tingling sensation is felt (about 15 chews). Then, patient should stop chewing and store the gum between the cheek and gums until the tingling sensation disappears (about 1 min). Process of stopping, then resuming chewing should be repeated for approximately 30 min until most of the tingle has disappeared. Rapid, vigorous chewing may result in side effects similar to those of smoking too many cigarettes (headache, dizziness, nausea, increased salivation, heartburn, and hiccups). For best chances of quitting, chew at least 9 pieces of gum/day during 1st 6 wk.
  • Inform patient that the gum has a slight tobacco/pepper-like taste. Many patients initially find it unpleasant and slightly irritating to the mouth. This usually resolves after several days of therapy.
  • Advise patient to carry gum at all times during therapy.
  • Advise patient to avoid eating or drinking for 15 min before and during chewing of nicotine gum; these interfere with buccal absorption of nicotine.
  • The gum usually can be chewed by denture wearers. Contact dentist if the gum adheres to bridgework.
  • Inform patient that if they still feel need to use gum after completion of treatment period, advise them to contact a health care professional.
  • Instruct patient not to swallow gum.
  • Dispose of the gum by wrapping in wrapper to prevent ingestion by children and animals. Call the poison control center, emergency department, or health care professional immediately if a child ingests the gum.
  • Emphasize the need to discontinue the gum and to inform health care professional if pregnancy occurs.
• Transdermal: Instruct patient in application and use of patch. Apply patch at the same time each day. Keep patch in sealed pouch until ready to apply. Apply to clean, dry skin of upper arm or torso free of oil, hair, scars, cuts, burns, or irritation. Press patch firmly in place with palm for 10 sec, making sure there is good contact, especially around the edges. Keep patch in place during showering, bathing, or swimming; replace patches that have fallen off. Wash hands with soap and water after handling patches. Do not trim or cut patch. No more than 1 patch should be worn at a time. Alternate application sites. Dispose of used patches by folding adhesive sides together and replacing in protective pouch or aluminum foil; keep out of reach of children.
  • Advise patient that redness, itching, and burning at application site usually subside within 1 hr. Instruct patient to notify health care professional and not apply new patch if signs of allergic reaction (urticaria, generalized rash, hives) or persistent local skin reactions (severe erythema, pruritus, edema) occur.
  • May cause drowsiness or dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Advise patient referred for MRI test to discuss patch with referring health care professional and MRI facility to determine if removal of patch is necessary prior to test and for directions for replacing patch.
• Nasal Spray: Instruct patient in proper use of spray. Tilt head back slightly. Do not sniff, swallow, or inhale through nose as spray is being administered. Patients who have successfully stopped smoking should continue to use the same dose for up to 8 wk, after which the spray should be discontinued over the next 4–6 wk.
  • Discontinue nasal spray by using ½ dose (1 spray at a time), using the spray less frequently, skipping a dose by not using every hr, or setting a planned stop date for use of the spray.
  • Treatment should be discontinued in patients who are unable to stop smoking by the 4th wk of therapy (patient is unlikely to quit on that attempt).
  • Patients who fail to stop smoking should be given a therapy holiday before another attempt.
  • Instruct patient to replace childproof cap after using and before disposal.
• Lozenge: Instruct patient to place lozenge in mouth and allow it to slowly dissolve (20–30 min). Minimize swallowing; advise patient not to chew or swallow lozenge. May cause a warm tingling sensation in mouth. Advise patient to occasionally move lozenge from side to side of mouth until completely dissolved. Instruct patient not to eat or drink 15 min before or while lozenge is in mouth. For best chances of quitting, use at least 9 lozenges/day during 1st 6 wk. Do not use more than 1 lozenge at a time or use continuously one after the another. Lozenge should not be used after 12 wk without consulting health care professional.

• Lessened sequelae of nicotine withdrawal (irritability, insomnia, somnolence, headache, and increased appetite) during smoking cessation.

nicotine chewing gum: Nicorette

nicotine lozenge: Nicorette

nicotine nasal spray: Nicotrol NS

Nicotine Transdermal Patch: Habitrol, Nicoderm CQ