Nosmok (Nicotine) lozenges, sprays, gums, and transdermal patches are used in smoking cessation programs to help individuals quit smoking. These nicotine formulations provide nicotine to minimize the withdrawal syndromes after smoking cessation. Other drugs used to aid smoking cessation include:

• Bupropion (Wellbutrin) and
• Varenicline (chantix).

Nicotine Uses:

• Smoking cessation:

  • It is used to reduce the withdrawal effects of nicotine after smoking cessation.

Nosmok (Nicotine) dosage in adults:

Smoking cessation: (patients should completely stop smoking upon starting therapy):

Gum:

• When the urge for smoking occurs chew 1 gum, if it still persists chew the 2nd piece after one hour (it is recommended to chew the 2nd gum 1 hour after the first).
• Normally 2mg strength is used except for patients who smoke their first cigarette within a half-hour of waking( 4 mg strength).
• Use according to the following 3-month dosing schedule:
• • Weeks 1 to 6:
    • Chew 1 piece of gum every 60 to 120 minutes (maximum: 24 pieces/day) to increase chances of quitting, chew at least 9 pieces/day during the first 6 weeks.
  • Weeks 7 to 9:
    • Chew 1 piece of gum every 2 to 4 hours (maximum: 24 pieces/day)
  • Weeks 10 to 12:
    • Chew 1 piece of gum every 4 to 8 hours (maximum: 24 pieces/day)
• Inhalation: Oral:
  • Initial treatment: 6 to 16 cartridges/day (at least 6 cartridges/day for the first 3 to 6 weeks) for up to 3 months. maximum: 16 cartridges/day.
  • Note: Frequent continuous puffing for 20 minutes give the best effect. Use beyond 6 months is not recommended. If the patient cannot quit smoking after one month of therapy, consider discontinuation.

• Discontinuation of therapy:

  • Reduce the dose over 6-12 weeks after the initial therapy. However, some patients may stop the drug after initial therapy.
  • Lozenge: One Lozenge when an urge occurs (more than 1 is not advised).

• Use according to the following 3-month dosing schedule:

  • Weeks 1 to 6:
    • 1 lozenge every 60-120 minutes (maximum: 5 lozenges every 6 hours; 20 lozenges/day) to increase chances of quitting, use at least 9 lozenges/day during the first 6 weeks
  • Weeks 7 to 9:
    • 1 lozenge every 2 to 4 hours (maximum: 5 lozenges every 6 hours; 20 lozenges/day)
  • Weeks 10 to 12:
    • 1 lozenge every 4 to 8 hours (maximum: 5 lozenges every 6 hours; 20 lozenges/day)
• Nasal: Spray:
  • Initial: 1 to 2 doses/hour (2 sprays one in each nostril] contains 1 mg of nicotine.
  • Dose adjustment is based on patient response.
  • The dose should not exceed more than 5 doses per hour [maximum: 40 mg/day] or 3 months of treatment.
  • Note:
    • The recommended minimum of 8 doses per day is the best effective dose.
    • Therapy for more than 6 months is not recommended.
    • If the patient cannot quit smoking after one month of therapy, consider discontinuation.

• Discontinuation of therapy:

  • Reduce the dose over 4-6 weeks. However, some patients may stop the treatment abruptly.

• Transdermal patch: Topical:

• Note:
  • Adjustment is required during starting therapy such as giving a higher dose if having withdrawal symptoms or a lower dose in case of adverse effects.
  • Patients smoking >10 cigarettes/day:
    • Begin with step 1 (21 mg/day) for 6 weeks, followed by step 2 (14 mg/day) for 14 days, finish with step 3 (7 mg/day) for 14 days.
  • Patients smoking ≤10 cigarettes/day:
    • Begin with step 2 (14 mg/day) for 6 weeks, followed by step 3 (7 mg/day) for 14 days.

Use in Children:

Not indicated.

Nosmok (Nicotine) Pregnancy Category: D

• Nicotine can cross the placenta.
• Nicotine toxicity can be caused by multiple factors, including dose, route and time.
• Smoking may cause an increase in the risk of orofacial and ectopic births, stillbirths, preterm deliveries, stillbirths, IUGR, sudden Infant Death Syndrome, placenta abruption, placenta pravia, and other adverse effects on the brain and lungs of mothers.

Nicotine use during breastfeeding:

• The serum of breastfed infants can detect nicotine from cigarette smoke.
• The newborn has the lowest nicotine clearance.
• It is preferable to use gum/lozenges.
• Manufacturer suggests that breastfeeding mothers exercise caution when using nicotine replacement products.

Dose in Kidney Disease:

• There are no dosage adjustments provided in the manufacturer's labeling.
• Only severe renal impairment should affect nicotine clearance or its metabolites from circulation.

Dose in Liver disease:

There are no dosage adjustments provided in the manufacturer's label.

Nasal spray/inhaler:

Common Side Effects of Nosmok (Nicotine):

• Central nervous system:

  • Headache

• Gastrointestinal:

  • Inhaler:
    • Mouth irritation
    • Dyspepsia

• Respiratory:

  • Inhaler:
    • Throat irritation
    • Cough
    • Rhinitis

Rare Side Effects of Nosmok (Nicotine):

• Central Nervous System:

  • Withdrawal Syndrome

• Dermatologic:

  • Acne Vulgaris
  • Burning Sensation Of The Nose (Nasal Spray)

• Gastrointestinal:

  • Flatulence
  • Gingival Disease
  • Diarrhea
  • Dysgeusia
  • Hiccups
  • Nausea
  • Tooth Enamel Damage (Abrasions)

• Genitourinary:

  • Dysmenorrhea

• Neuromuscular & Skeletal:

  • Back Pain
  • Arthralgia
  • Jaw Pain
  • Neck Pain

• Respiratory:

  • Sinusitis

Uncommon side effects of Nosmok (Nicotine) Frequency not defined:

• Central Nervous System:

  • Depression
  • Dizziness
  • Headache
  • Insomnia
  • Lack Of Concentration
  • Nervousness
  • Pain
  • Paresthesia

• Dermatologic:

  • Diaphoresis

• Gastrointestinal:

  • Aphthous Stomatitis
  • Constipation
  • Diarrhea
  • Dysgeusia
  • Dyspepsia
  • Flatulence
  • Gingival Hemorrhage
  • Glossitis
  • Hiccups
  • Nausea
  • Sialorrhea
  • Stomatitis
  • Tooth Enamel Damage (Abrasions)
  • Xerostomia

• Dermatologic:

  • Skin Rash

• Hypersensitivity:

  • Hypersensitivity Reaction

• Local:

  • Application Site Reaction
  • Localized Edema
  • Localized Erythema

• Neuromuscular & Skeletal:

  • Arthralgia
  • Jaw Pain
  • Myalgia

• Respiratory:

  • Cough
  • Sinusitis

Contraindications to Nosmok (Nicotine):

Hypersensitivity to nicotine and any other component of the formulation If you have an allergy to soya, Nicorette lozenge shouldn't be used.

Warnings and precautions

• Cardiovascular disease

  • Nicotine can increase pulse rate and BP.
  • Patients with angina, hypertension, and recent myocardial injury should be cautious.
  • It should be stopped in case of arrhythmias/palpitation, worsening angina, post-myocardial infarction.

• Diabetes:

  • Patients with insulin-dependent diabetes should be cautious.

• Gastrointestinal Disease:

  • Patients with active peptic ulcer diseases should be cautious as it may delay healing.

• Hepatic impairment

  • Patients with severe liver dysfunction should be cautious.

• Hyperthyroidism:

  • Patients with hyperthyroidism should be cautious.

• Pheochromocytoma:

  • Patients with pheochromocytoma should be cautious.

• Renal impairment

  • Patients with severe renal impairment should be cautious.

Nicotine: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

Parameters including signs indicating nicotine toxicity such as severe headache, dizziness, confusion, hearing/vision disturbance, abdominal pain, irregular pulse, salivation, nausea, vomiting, diarrhea, cold sweat, weakness should be looked for.

How to administer Nosmok (Nicotine)?

Gum:

• Chew slowly until it tingles, placement of the gum between cheek and gum until tingling stops; repeat the process until most of the tingle is gone for an approximate half-hour.
• Do not eat or drink 15 minutes before using or while the gum is in the mouth.

Lozenge:

• No chewing or swallowing, allow to dissolve slowly in half-hour minimize swallowing and occasionally move the lozenge from one side of the mouth to the other until completely dissolved.
• Do not eat or drink 15 minutes before using or while the lozenge is in the mouth.

Nasal spray:

• Prime pump before first use (pump 6 to 8 times until fine spray appears) or if it has not been used for 24 hours (pump 1 to 2 times), avoid excessive priming.
• Blowing of the nose before use should be done.
• Tilt the head back slightly and insert the tip of the bottle into the nostril.
• Breathe through the mouth and spray once in each nostril.
• Sniffing/swallowing/or inhalation should be avoided through the nose during therapy.
• After administration, wait for 2 to 3 minutes before blowing the nose.
• Avoid contact with skin, eyes, and mouth.

Oral Inhalation:

• Insert the cartridge into the inhaler and push hard until it pops into place.
• Replace the mouthpiece and twist the top and bottom so that markings do not line up.
• Inhale deeply into the back of the throat or puff in short breaths.
• Nicotine in the cartridge is used up after about 20 minutes of active puffing.
• Clean mouthpiece regularly with soap and water.

Transdermal patch:

• It should be applied on non-hairy skin.
• Each patch should be applied at different locations.
• After removing the backing apply it instantly by pressing onto the skin for 10 seconds.
• It can be worn for 16 or 24 hours.
• In case of vivid dreams/sleep disturbances, remove the patch at bedtime, and apply a new patch in the morning.
• If a cigarette craving occurs apply the patch for 24 hours.
• Cutting the patch can cause rapid evaporation making it useless.
• Only 1 patch at a time should be worn.
• The patch should not be left on for more than 24 hours.
• Wash your hands before and after handling the patch.
• Properly dispose off the patch by joining the adhesive ends together.

Mechanism of action of Nosmok (Nicotine):

• Nicotine is a naturally occurring alkaloid that acts by selectively binding to nicotinic-cholinergic receptors at the autonomic ganglia in the adrenal medulla at neuromuscular junctions and in the brain.
• It is believed that nicotine's positive-reinforcing properties are due to two types of central nervous systems effects.
• A stimulating effect is felt primarily in the cortex via locus ceruleus, and a rewarding effect in limbic.
• Lower doses have more stimulant effects than high doses, while higher doses produce greater reward effects.

The beginning of action:

• Intranasal: This is a more accurate representation of the time course for plasma nicotine levels after cigarette smoking than any other dosage form.

Absorption:

• Buccal mucosa, transdermal: Slow;
• Intranasal: ~53%;
• Inhaler: <5% reaches the lower respiratory tract

Protein binding:

• 5% to 20%.

Metabolism:

• occurs in liver, kidney, and lung; >20 metabolites (primary metabolites are cotinine and trans-3-hydroxycotinine)

Half-life elimination:

• Transdermal: 4 hours
• Intranasal: 60 to 120 minutes
• Oral inhalation: 60 to 120 minutes

Time to peak, serum:

• Transdermal: 2 to 8 hours.
• Intranasal: 4 to 15 minutes
• Oral inhalation: ≤15 minutes
• Gum: 30 minutes (Svensson 1987)

Excretion:

• occurs in urine (~10% as unchanged)

International Brand Names of Nicotine:

• GoodSense Nicotine
• Nicoderm CQ
• Nicorelief
• Nicorette Mini
• Nicorette Starter Kit
• Nicorette
• Nicotine Mini
• Nicotine Step 1
• Nicotine Step 2
• Nicotine Step 3
• Nicotrol
• Nicotrol NS
• Thrive
• EKMO
• Habitrol Gum
• Nicabate
• Nicabate Clear
• Nicabate CQ
• Nicabate Lozenges
• Nicabate Soft Gum
• Nicolan TTS
• Nicoman
• Nicomild
• Nicopass sans sucre menthe fraicheur
• Nicopass sans sucre reghsse menthe
• Nicopatch
• Nicorest
• Nicorette
• Nicorette Coolmint
• Nicorette Fruit
• Nicorette Inhaler
• Nicorette Menthe
• Nicorette Menthe Fraiche
• Nicorette Orange
• Nicorette Orange sans sucre
• Nicostop
• Nicotab
• Nicotinell
• Nicotinell Chewing Gum
• Nicotinell Fruit sans sucre
• Nicotinell Menthe sans sucre
• Nicotinell Mint Lozenge
• Nicotinell TTS
• Nicotrans
• Nicotrol Gum
• Nikofrenon
• Niquitin
• NiQuitin
• Niquitin Clear
• Niquitin CQ
• Niquitin Mint
• Niquitin sans sucre
• Nobacco
• Nosmok
• Pelzont
• QuitX

Nicotine Brand Names in Pakistan:

No Brands Available in Pakistan.