Nicotine gum
NICORETTE
Pronunciation: NIK-oe-teen
What it isNicotinic acetylcholine-receptor agonist used as replacement therapy for smoking cessation.
Why this oneCombining a patch for baseline coverage with a short-acting form for cravings works better than either alone.
What limits itIt does not address behavioral cues alone. Local irritation and vivid dreams can limit the patch.
FDA-approved for
- smoking cessation (1984)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Smoking cessation — reduces withdrawal symptoms incl. nicotine craving (OTC) | 2 mg gum: first cigarette >30 min after waking; adults (<18 y: ask a doctor) | Weeks 1–6: 1 piece q1–2h (use ≥9 pieces/day) | Weeks 7–9: 1 piece q2–4h → Weeks 10–12: 1 piece q4–8h; stop at 12 wks | 24 pieces/day (a 2nd piece within the hour allowed for strong/frequent cravings) |
| Smoking cessation — reduces withdrawal symptoms incl. nicotine craving (OTC) | 4 mg gum: first cigarette within 30 min of waking; adults (<18 y: ask a doctor) | Weeks 1–6: 1 piece q1–2h (use ≥9 pieces/day) | Weeks 7–9: 1 piece q2–4h → Weeks 10–12: 1 piece q4–8h; stop at 12 wks | 24 pieces/day (a 2nd piece within the hour allowed for strong/frequent cravings) |
Titration Fixed 12-week step-down by interval: q1–2h (wk 1–6) → q2–4h (wk 7–9) → q4–8h (wk 10–12); no dose titration beyond 2 mg vs 4 mg selection
Renal Undefined
Hepatic Undefined
Strength selection by time-to-first-cigarette: ≤30 min after waking → 4 mg; >30 min → 2 mg
Instructions
- Begin on quit day; read enclosed User's Guide first
- Chew slowly until it tingles, then park between cheek and gum; when tingle fades, chew again; repeat until most tingle is gone (~30 min)
- No food or drink 15 min before or while chewing
- Use at least 9 pieces/day for the first 6 weeks to improve odds of quitting
- Do not chew one piece after another continuously (hiccups, heartburn, nausea)
- Do not exceed 24 pieces/day
- Complete the full 12 weeks; talk to a health care provider if longer use is needed
- Wrap used pieces in paper and discard in trash (enough nicotine to harm children/pets)
Available strengths
- gum 2, 4 mg
Cautions
- Ask a doctor before use if: sodium-restricted diet; heart disease, recent heart attack, or irregular heartbeat (nicotine raises heart rate); high blood pressure not controlled with medication (nicotine raises BP); stomach ulcer or diabetes; history of seizures
- Ask a doctor or pharmacist before use if using a non-nicotine stop-smoking drug, or taking a prescription medicine for depression or asthma (dose may need adjustment)
- Stop use and ask a doctor if: mouth, teeth or jaw problems; irregular heartbeat or palpitations; nicotine-overdose symptoms (nausea, vomiting, dizziness, diarrhea, weakness, rapid heartbeat); oral blistering (Cinnamon Surge); allergic reaction (difficulty breathing, rash)
- Keep out of reach of children and pets; overdose → medical help or Poison Control
- Under 18 years: ask a doctor before use
Adverse reactions
- Mouth, teeth or jaw problems
- Irregular heartbeat or palpitations
- Hiccups, heartburn, nausea (with continuous piece-after-piece use)
- Nicotine-overdose symptoms: nausea, vomiting, dizziness, diarrhea, weakness, rapid heartbeat
- Oral blistering (Cinnamon Surge flavor)
- Allergic reaction (difficulty breathing, rash)
Pregnancy Use only on advice of a health care provider; believed safer than smoking but risks to the child not fully known — try to quit without NRT first
Lactation Use only on advice of a health care provider (same OTC pregnancy/breast-feeding statement)
Cost
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 2 mg | gum | per unit | $0.23/ea | offered |
| 4 mg | gum | per unit | $0.29/ea | offered |
Other forms: Nicotine patch (NICODERM CQ) · Nicotine lozenge (NICORETTE) · Nicotine inhaler (NICOTROL INHALER)
Generic entry1997
NO BOXED WARNINGS
Principal riskLocal irritation; vivid dreams with the overnight patch
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
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