OVERDOSAGE

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Prescribing Information

NICOTROL^® NS (nicotine nasal spray)
Overdosage


	Return to the NICOTROL NS Product Center

The oral LD₅₀ for nicotine is >5 mg/kg in dogs and >24 mg/kg in rodents. Death is due to respiratory paralysis. The oral minimum acute lethal dose for nicotine in adult humans is reported to be 40 to 60 mg (<1 mg/kg). A full bottle of NICOTROL NS contains 100 mg of nicotine.

NICOTROL NS would be expected to be irritating if sprayed in the eyes, mouth or ears. Eye exposure should be treated with copious irrigation with water for 20 minutes. Large oral nicotine ingestions cause vomiting, and the consequences of an overdose will vary; should this occur, patients should contact their physician immediately. For additional emergency information, call your regional poison center.

Signs and Symptoms of Nicotine Toxicity
Signs and symptoms of an overdose of NICOTROL NS would be expected to be the same as those of acute nicotine poisoning including: pallor, cold sweat, nausea, salivation, vomiting, abdominal pain, diarrhea, headache, dizziness, disturbed hearing and vision, tremor, mental confusion, and weakness. Prostration, hypotension, and respiratory failure may ensue with large overdoses. Lethal doses produce convulsions quickly and death follows as a result of peripheral or central respiratory paralysis or, less frequently, cardiac failure.

Overdose from Ingestion
If emesis has not occurred, it should be induced in conscious patients with a suitable emetic followed by an appropriate dose of activated charcoal. In unconscious patients with a secure airway, instill activated charcoal via a nasogastric tube. A saline cathartic or sorbitol may be added to the first dose of activated charcoal.

Management of Nicotine Poisoning
Other supportive measures include diazepam or barbiturates for seizures, atropine for excessive bronchial secretions or diarrhea, respiratory support for respiratory failure, and vigorous fluid support for hypotension and cardiovascular collapse.

PRINTER-FRIENDLY

NICOTROL Safety Information

NICOTROL® NS (nicotine nasal spray) 10 mg/mL

NICOTROL NS (nicotine nasal spray) is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. NICOTROL NS therapy should be used as a part of a comprehensive behavioral smoking cessation program.

Important Safety Information

Use of NICOTROL NS is contraindicated in patients with known hypersensitivity or allergy to nicotine, menthol or to any component of the product.

The safety and efficacy of the continued use of NICOTROL NS for periods longer than 6 months have not been adequately studied and such use is not recommended.

The patient must stop smoking completely before using NICOTROL NS.

Because nicotine is addictive, patient dependency upon NICOTROL NS is possible. It is important the patient use it only for as long as needed to overcome a smoking habit.

Prior to starting NICOTROL NS, the patient must inform the healthcare professional of all medications he or she is taking. Certain concomitant medications may require a dosage adjustment.

A special note about children and pets. NICOTROL NS can cause serious illness in children and pets—even in very small amounts. If a child or pet uses or ingests NICOTROL NS, immediately call a doctor or call your regional poison center.

Adverse reactions. The patient may experience mild to moderate nasal irritation when treating with NICOTROL NS. In clinical trials, other common side effects were: runny nose, throat irritation, watering eyes, sneezing, and coughing. Common complaints experienced by the smokers in the study (users of both active and placebo spray) include: chest tightness, dyspepsia, paraesthesia (tingling) in limbs, constipation, and stomatitis.

Pregnancy and nursing. The specific effects of NICOTROL NS treatment on fetal development and nursing infants are unknown. Therefore, pregnant and nursing smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches.

Asthma, bronchospasm and reactive airway disease. Use of NICOTROL NS is not recommended in patients with known chronic nasal disorders (eg, allergy, rhinitis, nasal polyps and sinusitis), asthma, bronchospasm, and severe reactive airway disease.

Cardiovascular or peripheral vascular diseases. NICOTROL NS should be used with caution in patients with cardiovascular and peripheral vascular diseases, specifically coronary heart disease, serious cardiac arrhythmias, or vasospastic diseases. In these situations, the potential risks of using NICOTROL NS should be discussed with the patient.

Please see full prescribing information.

NICOTROL^® NS (nicotine nasal spray)

Full Prescribing Information