NICOTROL® NS (nicotine) CLINICAL TRIALS

(nicotine)

Prescribing Information

CLINICAL TRIALS

The efficacy of NICOTROL NS therapy as an aid to smoking cessation was demonstrated in three single-center, placebo-controlled, double-blind trials with a total of 730 patients. One of the trials used NICOTROL NS with individual counseling while the other two used group support. Patients with severe or symptomatic cardiovascular disease, hypertension, asthma, diabetes or severe allergy were not included in the studies. The amount of NICOTROL NS used was left to the discretion of each patient, with a minimum dose of 8 mg/day and a maximum dose of 40 mg/day.

In all three studies, the recommended duration of treatment was 3 months; however in two of these trials, 241 patients were permitted to continue to use the product for up to 1 year, if they wished. Among the 64 patients abstinent from cigarettes at the end of a year, 23 (36%) were still using the spray, and probable dependence on the spray was seen in several patients (See DRUG ABUSE AND DEPENDENCE).

Quitting was defined as total abstinence from smoking for at least 4 weeks. The "quit rates" are the percentage of all persons initially enrolled who continuously abstained after week 2 or 4.

In all three studies, NICOTROL NS was more effective than placebo at 6 weeks, 3 months, 6 months, and 1 year. The two studies where NICOTROL NS could be used for more than 6 months did not have a better outcome at 1 year than the study in which NICOTROL NS was discontinued at 6 months.

Table 3: Quit Rates by Treatment (N=730 smokers in 3 Studies)
Group	Size (n)	At 6 Weeks	At 3 Months	At 6 Months	At 1 Year
NICOTROL NS	369	49–58%	41–45%	31–35%	23–27%
Placebo	361	21–32%	17–20%	12–15%	10–15%

Patients treated with NICOTROL NS had more relief of the urge to smoke and withdrawal symptoms compared with placebo-treated patients.

NICOTROL NS allows the patient to vary the dose of nicotine on a short-term basis. As with other variable dose smoking cessation products, NICOTROL NS may be useful in the management of highly dependent smokers.

Medication Guide

NICOTROL®NS(NICOTINE NASAL SPRAY)

Nicotrol®NS (nicotine nasal spray)

An Aid To Help You Stop Smoking

PATIENT INFORMATION

Read and follow carefully. If you have questions or want more information, ask your doctor or pharmacist.

IMPORTANT INFORMATION—Read carefully

1.

NICOTROL® NS Nasal Spray is designed to help you quit smoking by reducing your urge to smoke. What causes the urge to smoke? It is the nicotine in cigarettes. NICOTROL® NS contains nicotine. Your doctor may increase or decrease dosage during the first few weeks. As your body adjusts to not smoking, your doctor will either tell you to stop using NICOTROL® NS or gradually reduce your dose.

•: People who use NICOTROL® NS with a comprehensive behavioral smoking cessation program are more successful in quitting smoking. This program can include support groups, counseling or specific behavior change techniques.

2.

Side Effects—During the first week or so most people experience the following side effects: hot, peppery feeling in back of throat or nose, sneezing, coughing, watery eyes, or runny nose. Wait 5 minutes before driving. Be sure to use regularly for the first week to help adjust to the side effects.

3.

Because nicotine is addictive, it is possible to become dependent on the Nasal Spray. It is important to use the Nasal Spray only for as long as needed to overcome your smoking habit (as directed by your doctor). Your chance of becoming dependent on the Nasal Spray increases if you use it longer than 6 months.

WARNINGS—Read before using NICOTROL® NS

1. Commit yourself—NO SMOKING! For NICOTROL® NS to help, you must be firmly committed to quitting! Stop smoking as soon as you start using NICOTROL® NS. Do not smoke or use any other tobacco product at any time while under treatment with NICOTROL® NS—nicotine overdose can occur. If symptoms of overdose occur, call a doctor or Poison Control Center. Nicotine overdose symptoms include:
• bad headaches • dizziness • upset stomach	• drooling • vomiting • diarrhea	• cold sweat • weak and irregular pulse • blurred vision	• hearing difficulties • mental confusion • weakness and fainting
2. Keep out of reach of children and pets. NICOTROL® NS can cause serious illness in children and pets—even in very small amounts. If a child uses or handles NICOTROL® NS, call a doctor or Poison Control Center. When the bottle is empty, replace cap and throw away out of reach of children and pets. Even empty bottles contain enough nicotine to seriously harm children and pets. 3. Tell your doctor if you have:
• chronic nasal problems such as nasal allergies, inflammation, sinusitis or nasal polyps (growths) • heart problems (recent heart attack, irregular heartbeat, severe or worsening heart pain) • high blood pressure		• drug allergies • stomach ulcers or heartburn • wheezing or asthma • overactive thyroid • diabetes requiring insulin • kidney or liver disease
Tell your doctor about any medicines you are taking—the dosages may need to be changed. Check with your doctor before taking any new medicine while using NICOTROL® NS.
4. If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

FOLLOW DIRECTIONS

BEFORE YOU USE — Read information on both sides

BEFORE YOU USE—Read information on both sides

FOLLOW DOSAGE:	WHAT TO EXPECT (First Week):
• Use as directed by doctor. • But do not use more than 5 times an hour or 40 times in 24 hours. • Stop smoking completely during NICOTROL® NS treatment program.	• Hot, peppery feeling in back of throat or nose, sneezing, coughing, watery eyes, or runny nose. • To Help Adjust to Spray—use regularly for first week. • Side effects will lessen for most people in a few days—don't stop using the Nasal Spray. If side effects do not lessen after a week, call your doctor.

REMOVE CAP:	PRIME PUMP (before first use):
• Press in circles on sides of bottle. • Pull off cap as shown.	• Get a tissue or paper towel. • Hold bottle as shown. • Press up on bottom with thumb. • Pump into tissue until you see a fine spray (6 to 8 times). • Throw tissue away.
FOLLOW DIRECTIONS EXACTLY — Questions? (call 1-888-642-6876)

• Blow nose if it is not clear. • Tilt head back slightly. • Hold bottle as shown.	• Insert tip of bottle into nostril—as far as is comfortable. • Breathe through mouth. • Spray once in each nostril. Do not sniff or inhale while spraying. • If nose runs, gently sniff to keep the Nasal Spray in nose. Wait 2 or 3 minutes before blowing nose.
	AVOID contact with skin, eyes, and mouth. If bottle breaks, wear rubber gloves, wipe up with paper towel and wash surfaces thoroughly. Do not let nicotine come in contact with your skin, mouth, or eyes. If it does, rinse with plain water immediately. Nicotine overdose can occur when nicotine is absorbed through the skin. If symptoms of overdose occur (see other side for symptoms), call a doctor or Poison Control Center.
• Place cap back on bottle after use. • Store at room temperature, 59°F to 86°F (15°C to 30°C), out of reach of children. • If you don't use the Nasal Spray for 24 hours, prime pump in tissue 1 or 2 times. • Most vials of NICOTROL® NS contain 100 doses (200 sprays), but excessive priming will reduce the amount of medicine available for use. Avoid excessive priming.

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