Nicotrol NS

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the nose only.
• Keep out of your eyes.
• You will need to prime the pump before first use. You may also need to prime the pump if it has not been used for some time. Be sure you know when you need to prime the pump and how to do it. Talk with your doctor or pharmacist if you have questions.
• Blow your nose before use.
• Tilt your head back.
• Spray up the nose only. Do not spray onto the wall joining the two nostrils.
• Do not sniff, swallow, or breathe in through your nose while you are using your dose of Nicotrol NS (nicotine nasal spray).
• Breathe out from your mouth.
• Put the cap back on after you are done using your dose.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Use of Nicotrol NS therapy is contraindicated in patients with known hypersensitivity or allergy to nicotine or to any component of the product.

It is important that patients understand the instructions for use of Nicotrol NS, and have their questions answered. They should clearly understand the directions for using Nicotrol NS and safely disposing of the used container. They should be instructed to stop smoking completely when they begin using the product.

Patients should be instructed not to sniff, swallow or inhale through the nose as the spray is being administered. They should also be advised to administer the spray with the head tilted back slightly.

The dose of Nicotrol NS, should be individualized on the basis of each patient's nicotine dependence and the occurrence of symptoms of nicotine excess (See Individualization of Dosage).

Each actuation of Nicotrol NS delivers a metered 50 microliter spray containing 0.5 mg of nicotine. One dose is 1 mg of nicotine (2 sprays, one in each nostril).

Patients should be started with 1 or 2 doses per hour, which may be increased up to a maximum recommended dose of 40 mg (80 sprays, somewhat less than 1/2 bottle) per day. For best results, patients should be encouraged to use at least the recommended minimum of 8 doses per day, as less is unlikely to be effective. In clinical trials, the patients who successfully quit smoking used the product heavily when nicotine withdrawal was at its peak, sometimes up to the recommended maximum of 40 doses per day ( in heavier smokers). Dosing recommendations are summarized in Table 4.

No tapering strategy has been shown to be optimal in clinical studies. Many patients simply stopped using the spray at their last clinic visit.

Recommended strategies for discontinuation of use include suggesting that patients: use only 1/2 a dose (1 spray) at a time, use the spray less frequently, keep a tally of daily usage, try to meet a steadily reducing usage target, skip a dose by not medicating every hour, or set a planned "quit date" for stopping use of the spray.

Individualization of Dosage

The success or failure of smoking cessation is influenced by the quality, intensity and frequency of supportive care. Patients are more likely to quit smoking if they are seen frequently and participate in formal smoking cessation programs.

The goal of Nicotrol NS therapy is complete abstinence. If a patient is unable to stop smoking by the fourth week of therapy, treatment should probably be discontinued.

Patients who fail to quit on any attempt may benefit from interventions to improve their chances for success on subsequent attempts. Patients who were unsuccessful should be counseled and should then probably be given a "therapy holiday" before the next attempt. A new quit attempt should be encouraged when conditions are more favorable.

Based on the clinical trials, a reasonable approach to assisting patients in their attempt to quit smoking is to begin initial treatment, using the recommended dosage (See DOSAGE AND ADMINISTRATION). Regular use of the spray during the first week of treatment may help patients adapt to the irritant effects of the spray. Dosage can then be adjusted in those subjects with signs or symptoms of nicotine withdrawal or excess. Patients who are successfully abstinent on Nicotrol NS should be treated at the selected dosage for up to 8 weeks, following which use of the spray should be discontinued over the next 4 to 6 weeks. Some patients may not require gradual reduction of dosage and may abruptly stop treatment successfully. Treatment with Nicotrol NS for longer periods has not been shown to improve outcome, and the safety of use for periods longer than 6 months has not been established.

The symptoms of nicotine withdrawal overlap those of nicotine excess (See Pharmacodynamics and ADVERSE REACTIONS sections). Since patients using Nicotrol NS may also smoke intermittently, it is sometimes difficult to determine if patients are experiencing nicotine withdrawal or nicotine excess. Controlled clinical trials of nicotine products suggest that palpitations, nausea and sweating are more often symptoms of nicotine excess, whereas anxiety, nervousness and irritability are more often symptoms of nicotine withdrawal.

As with all medicines, especially ones in liquid form, care should be taken in handling Nicotrol NS during periods of opening and closing the container (See WARNINGS and Safety Note Concerning Children). If it is dropped it may break. If this occurs, the spill should be cleaned up immediately with an absorbent cloth/paper towel. Care should be taken to avoid contact of the solution with the skin. Broken glass should be picked up carefully, using a broom. The area of the spill should be washed several times. Absorbent material may be disposed of as any other household waste. Should even a small amount of Nicotrol NS come in contact with the skin, lips, mouth, eyes or ears, the affected area(s) should be immediately rinsed with water only.

Disposal

Used bottles of Nicotrol NS should be disposed of with their child-resistant caps in place. Used bottles should be disposed of in such a way as to prevent access by children or pets. See patient information for further information on handling and disposal.

How Supplied

Nicotrol NS (nicotine nasal spray) 10 mg/mL, is supplied as four 10 mL bottles (NDC 0009-5401-01). Each unit consists of a glass container, mounted with a metered spray pump.
A patient information leaflet is enclosed with the package.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Rx only

LAB-0677-1.0
June 2013

NDC 0009-5401-01

Nicotrol®NS
(nicotine
nasal spray)

10 mg/mL

FOR NASAL USE ONLY
KEEP OUT OF REACH OF CHILDREN

10 mL

NDC 0009-5401-01

Nicotrol®NS
(nicotine
nasal spray)

10 mg/mL

Pharmacist: Place prescription label here.
This package contains prescribing information which includes patient instructions.

Applies to nicotine: gum, lozenge/troche

Other dosage forms:

• inhalation aerosol liquid, inhalation aerosol powder, inhalation device
• nasal spray
• transdermal patch extended release

Along with its needed effects, nicotine (the active ingredient contained in Nicotrol NS) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nicotine:

• Blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears

• Fast or irregular heartbeat
• hives, itching, rash, redness, or swelling of the skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking nicotine:

• Dizziness
• fast heartbeat
• nausea or vomiting
• weakness

Some side effects of nicotine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Mouth sores, blisters, or irritation
• nausea or vomiting
• sore throat

• Acid or sour stomach
• belching
• diarrhea
• dizziness
• heartburn
• hiccups
• mouth, tooth, jaw, or neck pain
• problems with teeth
• unusual tiredness or weakness

Applies to nicotine: compounding powder, inhalation device, nasal spray, oral transmucosal gum, oral transmucosal lozenge, transdermal film extended release

General

Oral Formulations: The most commonly reported side effects were cough and irritation of the throat and mouth.
Nasal Spray: The most commonly reported side effects included nasal irritation, watering eyes, and cough.
Transdermal Patch: The most commonly reported side effects included local skin reactions (e.g., burning, edema, erythema, irritation, urticaria).[Ref]

Respiratory

Very common (10% or more): Throat irritation (up to 40%), cough (up to 32%)
Common (1% to 10%): Hiccups, nasal congestion, pharyngitis, pharyngolaryngeal pain
Uncommon (0.1% to 1%): Bronchospasm, dysphonia, dyspnea, sneezing, throat tightness, oropharyngeal pain, rhinorrhea

INHALATOR/INHALER:
Very common (10% oR more): Cough (up to 32%), rhinitis (up to 23%)
Common (1% to 10%): Sinusitis, bronchitis, hiccup

MOUTH SPRAY:
Frequency not reported: Cough, nasopharyngitis, hiccups

NASAL SPRAY:
Common (1% to 10%): Cough, throat irritation, dyspnea, epistaxis
Frequency not reported: Hiccup, sneezing, transient epistaxis, pharyngitis, hoarseness, bronchitis, bronchospasm, increased sputum oropharyngeal discomfort and pain

NICOTINE BITARTRATE LOZENGE:
Common (1% to 10%): Hiccups

TRANSDERMAL PATCH:
Common (1% to 10%): Cough
Uncommon (0.1% to 1%): Dyspnea, upper respiratory tract infections[Ref]

Nervous system

Very common (10% or more): Headache (up to 26%)
Common (1% to 10%): Burning sensation, dizziness, dysgeusia, paresthesia
Frequency not reported: Poor concentration
Postmarketing reports: Tremor, seizures

INHALATOR/INHALER:
Very common (10% or more): Headache (up to 26%)
Common (1% to 10%): Paresthesia, dizziness

MOUTH SPRAY:
Frequency not reported: Dizziness

NASAL SPRAY:
Very common (10% or more): Headache (up to 18%)
Common (1% to 10%): Dizziness, paresthesia or mouth/head/limb paresthesia
Frequency not reported: Aphasia, numbness, amnesia, migraines, impaired/poor concentration, somnolence, tremor, incoordination, transient changes in taste

NICOTINE BITARTRATE LOZENGE:
Common (1% to 10%): Dizziness, headache

TRANSDERMAL PATCH:
Common (1% to 10%): Dizziness, headache, motor dysfunction
Uncommon (0.1% to 1%): Paresthesia, dysgeusia, somnolence
Rare (0.01% to 0.1%): Tremor[Ref]

Local

NASAL SPRAY:
Very common (10% or more): Rhinorrhea/nasal irritation or discomfort (up to 94%)
Frequency not reported: Nasal congestion, sinus irritation, transient changes in the sense of smell, runny nose, nasal paresthesia, numbness of nose, nasal ulcer/blister, burning of nose or eyes

TRANSDERMAL PATCH:
Very common (10% or more): Local skin/application site reactions (up to 20%)
Uncommon (0.1% to 1%): Localized myalgia, irritation, burning, edema, pain and discomfort[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, abdominal pain/upper abdominal pain, diarrhea, dry mouth, dyspepsia, flatulence, salivary hypersecretion, constipation, vomiting, oral discomfort, stomatitis, toothache
Uncommon (0.1% to 1%): Eructation, glossitis, oral paresthesia, gingivitis, oral mucosal blistering and exfoliation
Rare (0.01% to 0.1%): Dysphagia, oral hypoesthesia, retching
Frequency not reported: Dry throat, gastrointestinal discomfort, lip pain
Postmarketing reports: Ulcerative/aphthous stomatitis

GUM:
Frequency not reported: Indigestion and heartburn

INHALATOR/INHALER:
Very common (10% or more): Dyspepsia (up to 18%)
Common (1% to 10%): Tooth disorders, taste disturbances, nausea, diarrhea, flatulence, mouth and throat irritation
Frequency not reported: Aphthous stomatitis

MOUTH SPRAY:
Frequency not reported: Constipation, mouth ulceration, gingival bleeding, mouth or throat irritation

NASAL SPRAY:
Common (1% to 10%): Nausea, vomiting, dyspepsia, constipation, stomatitis, flatulence, tooth disorder, gum problems
Frequency not reported: Gastrointestinal discomfort, abdominal pain, nausea, dry mouth, diarrhea, aphthous ulcer

NICOTINE BITARTRATE LOZENGE:
Common (1% to 10%): Nausea, flatulence, gastritis, dry mouth, stomatitis, esophagitis


TRANSDERMAL PATCH:
Common (1% to 10%): Nausea, vomiting, abdominal pain, dyspepsia
Rare (0.01% to 0.1%): Gastrointestinal discomfort, constipation, diarrhea, flatulence, dry mouth
Frequency not reported: Aphthous stomatitis[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Abnormal dreams
Frequency not reported: Dysphoria, depression/depressed mood, irritability, aggression, frustration/anger, restlessness/impatience, anxiety, cravings/urges to smoke, nighttime awakenings/sleep disturbances
Postmarketing reports: Nervousness

INHALATOR/INHALER:
Common (1% to 10%): Withdrawal symptoms/syndrome, anxiety, sleep disorder, depression, drug dependence

MOUTH SPRAY:
Frequency not reported: Dysphoria, depression/depressed mood, irritability, frustration/anger, difficulty concentrating, restlessness/impatience, insomnia, anxiety

NASAL SPRAY:
Common (1% to 10%): Anxiety, irritability, restlessness, emotional lability, insomnia, withdrawal symptoms, cravings/urges to smoke
Frequency not reported: Confusion, aggression, dysphoria, depression, apathy, nighttime awakenings/sleep disturbances, increased dreaming, feelings of dependence

NICOTINE BITARTRATE LOZENGE:
Frequency not reported: Insomnia, nicotine (the active ingredient contained in Nicotrol NS) dependence, withdrawal symptoms

TRANSDERMAL PATCH:
Common (1% to 10%): Agitation, anxiety, nervousness, insomnia, abnormal dreams
Uncommon (0.1% to 1%): Attention disturbance, affect lability, irritability, depressed mood, confusion
Frequency not reported: Sleep disturbances[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions
Rare (0.01% to 0.1%): Allergic reactions and angioedema
Frequency not reported: Anaphylactic reactions

NASAL SPRAY:
Uncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Angioedema, anaphylactic reactions

NICOTINE BITARTRATE LOZENGE:
Rare (0.01% to 0.1%): Hypersensitivity, anaphylactic reactions

TRANSDERMAL PATCH:
Uncommon (0.1% to 1%): Hypersensitivity reaction
Rare (0.01% to 0.1%): Anaphylactic reaction, angioedema[Ref]

Other

Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Asthenia, malaise
Postmarketing reports: Influenza-type illness

GUM:
Frequency not reported: Denture damage

INHALATOR/INHALER:
Common (1% to 10%): Influenza-like symptoms, fatigue, pain, fever

NASAL SPRAY:
Uncommon (0.1% to 1%): Fatigue, malaise
Frequency not reported: Asthenia, pain, earache, calming sensation, abnormal taste or use of dosage form

TRANSDERMAL PATCH:
Uncommon (0.1% to 1%): Asthenia/asthenic conditions, malaise, fatigue[Ref]

Ocular

Frequency not reported: Blurred vision, increased lacrimation

NASAL SPRAY:
Common (1% to 10%): Increased lacrimation/watering eyes
Frequency not reported: Eye irritation, abnormal vision

TRANSDERMAL PATCH:
Uncommon (0.1% to 1%): Blurred vision[Ref]

Genitourinary

NASAL SPRAY:
Common (1% to 10%): Dysmenorrhea
Frequency not reported: Menstrual disorder[Ref]

Immunologic

INHALATOR/INHALER:
Common (1% to 10%): Allergy

NASAL SPRAY:
Frequency not reported: Allergy[Ref]

Dermatologic

Uncommon (0.1% to 1%): Flushing, hyperhidrosis, pruritus, rash, urticaria, dry skin
Frequency not reported: Erythema

NASAL SPRAY:
Common (1% to 10%): Hyperhidrosis/increased sweating, pruritus, rash, acne
Uncommon (0.1% to 1%): Flushing/facial flushing
Frequency not reported: Erythema, urticaria

NICOTINE BITARTRATE LOZENGE:
Rare (0.01% to 0.1%): Angioneurotic edema

TRANSDERMAL PATCH:
Common (1% to 10%): Pruritus, rash, urticaria with/without vesicles
Uncommon (0.1% to 1%): Flushing/hot flush, hyperhidrosis
Rare (0.01% to 0.1%): Erythema, skin discoloration, cutaneous vasculitis
Frequency not reported: Angioneurotic edema[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Palpitations, tachycardia, hypertension, chest discomfort and pain
Very rare (less than 0.01%): Reversible atrial fibrillation
Frequency not reported: Bradycardia/decreased heart rate, atrial fibrillation

INHALATOR/INHALER:
Common (1% to 10%): Chest discomfort, hypertension

NICOTINE BITARTRATE LOZENGE:
Uncommon (0.1% to 1%): Palpitations
Rare (0.01% to 0.1%): Atrial arrhythmia

MOUTH SPRAY:
Frequency not reported: Presyncopal symptoms

NASAL SPRAY:
Common (1% to 10%): Palpitations, chest discomfort/tightness and pain
Uncommon (0.1% to 1%): Hypertension
Very rare (less than 0.01%): Reversible atrial fibrillation
Frequency not reported: Tachycardia, peripheral edema, decreased heart rate/bradycardia

TRANSDERMAL PATCH:
Uncommon (0.1% to 1%): Palpitations, tachycardia, hypertension, chest discomfort and pain
Very rare (less than 0.01%): Reversible atrial fibrillation[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Jaw pain, musculoskeletal pain
Frequency not reported: Muscle tightness

INHALATOR/INHALER:
Common (1% to 10%): Myalgia, back pain, jaw and neck pain

NASAL SPRAY:
Common (1% to 10%): Back pain, arthralgia
Frequency not reported: Myalgia

TRANSDERMAL PATCH:
Common (1% to 10%): Myalgia, arthritis
Uncommon (0.1% to 1%): Arthralgia, muscle cramp, back pain
Rare (0.01% to 0.1%): Pain in extremity[Ref]

Metabolic

Frequency not reported: Increased appetite, weight gain

MOUTH SPRAY:
Frequency not reported: Increased appetite, weight gain

NASAL SPRAY:
Frequency not reported: Weight gain, increased appetite[Ref]

Hematologic

NASAL SPRAY:
Frequency not reported: Purpura[Ref]

Some side effects of Nicotrol NS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.