Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1743
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Nicotrol (Inhalant)
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Patients must desire to stop smoking and should be instructed to stop smoking completely as they begin using NICOTROL Inhaler. It is important that patients understand the instructions, and have their questions answered. They should clearly understand the directions for using the NICOTROL Inhaler and safely disposing of the used cartridges. The initial dosage of NICOTROL Inhaler is individualized. Patients may selftitrate to the level of nicotine they require. Most successful patients in the clinical trials used between 6 and 16 cartridges a day. Best effect was achieved by frequent continuous puffing (20 minutes). The recommended durationof treatment is 3 months, after which patients may be weaned from the NICOTROL Inhaler by gradual reduction of the daily dose over the following 6 to 12 weeks. The safety and efficacy of the continued use of NICOTROL Inhaler for periods longer than 6 months have not been studied and such use is not recommended. Dosing recommendations are summarized in the table below.
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NICOTROL Inhaler (nicotine inhalation system) consists of a mouthpiece and a plastic cartridge delivering 4 mg of nicotine from a porous plug containing 10 mg nicotine. The cartridge is inserted into the mouthpiece prior to use. Nicotine is a tertiary amine composed of a pyridine and a pyrrolidine ring. It is a colorless to pale yellow, freely water-soluble, strongly alkaline, oily, volatile,hygroscopic liquid obtained from the tobacco plant. Nicotine has a characteristic pungent odor and turns brown on exposure to air or light. Of its two stereoisomers, S(-)nicotine is the more active. It is the prevalent form in tobacco, and is the form in the NICOTROL Inhaler. The free alkaloid is absorbed rapidly through skin, mucous membranes, and the respiratory tract. Chemical Name: S-3-(1-methyl-2-pyrrolidinyl) pyridine Molecular Formula: CHN Molecular Weight: 162.23 Ionization Constants: pKa= 7.84, pKa= 3.04 at 15��C Octanol-Water Partition Coefficient: 15:1 at pH 7 Nicotine is the active ingredient; inactive components of the product are menthol and a porous plug which are pharmacologically inactive. Nicotine is released when air is inhaled through the Inhaler.
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Pharmacologic Action: Nicotine, the chief alkaloid in tobacco products, binds stereo-selectively to nicotinic-cholinergic receptors at the autonomic ganglia, in the adrenal medulla, at neuromuscular junctions, and in the brain. Two types of central nervous system effects are believed to be the basis of nicotine's positively reinforcing properties. A stimulating effect is exerted mainly in the cortex via the locus ceruleus and a reward effect is exerted in the limbic system. At low doses the stimulant effects predominate while at high doses the reward effects predominate. Intermittent intravenous administration of nicotine activates neurohormonal pathways, releasing acetylcholine, norepinephrine, dopamine, serotonin, vasopressin, beta-endorphin, growth hormone, and ACTH.<br/>Pharmacodynamics: The cardiovascular effects of nicotine include peripheral vasoconstriction, tachycardia, and elevated blood pressure. Acute and chronic tolerance to nicotine develops from smoking tobacco or ingesting nicotine preparations. Acute tolerance (a reduction in response for a given dose) develops rapidly (less than 1 hour), but not at the same ratefor different physiologic effects (skin temperature, heart rate, subjective effects). Withdrawal symptoms such as cigarette craving can be reduced in most individuals by plasma nicotine levels lower than those from smoking. Withdrawal from nicotine in addicted individuals can be characterized by craving, nervousness, restlessness, irritability, mood lability, anxiety, drowsiness, sleep disturbances, impaired concentration, increased appetite, minor somatic complaints (headache, myalgia, constipation, fatigue), and weight gain. Nicotine toxicity is characterized by nausea, abdominal pain, vomiting, diarrhea, diaphoresis, flushing, dizziness, disturbed hearing and vision, confusion, weakness, palpitations, altered respiration and hypotension. Both smoking and nicotine can increase circulating cortisol and catecholamines, and tolerance does not develop to the catecholaminereleasing effects of nicotine. Changes in the response to a concomitantly administered adrenergic agonist or antagonist should be watched for when nicotine intake is altered during NICOTROL Inhaler therapy and/or smoking cessation .
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Use of NICOTROL Inhaler therapy is contraindicated in patients with known hypersensitivity or allergy to nicotine or to menthol.
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NICOTROL INHALER (nicotine inhalation system) is supplied as 168 cartridges each containing 10 mg (4 mg is delivered) nicotine. Each unit consists of 5 mouthpieces, 28 storage trays each containing 6 cartridges and 1 plastic storage case. A patient information leaflet is enclosed with the package. Store at room temperature not to exceed 77��F (25��C).Protect cartridges from light.
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Signs and Symptoms of Nicotine Toxicity: Signs and symptoms of an overdose of the NICOTROL Inhaler 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.<br/>Overdose from Inhalation: The oral LDfor 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). The effects of using several cartridges in rapid succession are unknown . One cartridge of NICOTROL Inhaler contains 10 mg nicotine, of which, approximately 4 mg is delivered nicotine. It is unlikely that an excessive nicotine overdose will occur via inhalation. Should such an overdose occur, however, with signs of nicotine poisoning, the patient should be instructed to contact his/her physician immediately. For additional emergency information, call your regional poison center or call the National Capital Poison Center toll free(1-800-222-1222).<br/>Overdose from Ingestion: Persons ingesting NICOTROL Inhaler cartridges should be referred to a health care facility for management. 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. Repeated doses of activated charcoal should be administered as long as the cartridge remains in the gastrointestinal tract since it will continue to release nicotine for many hours. The NICOTROL Inhaler cartridges can be identified with a radiogram.<br/>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.
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nicotine
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Nicotrol (Inhalant)
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Assessment of adverse events in the 1,439 patients (730 on active drug) who participated in controlled clinical trials (including three dose finding studies) is complicated by the occurrence of signs and symptoms of nicotine withdrawal in some patients and nicotine excess in others. The incidence of adverse events is confounded by: (1) the many minor complaints that smokers commonly have, (2) continued smoking by many patients and (3) the local irritation from both the active drug and the placebo.<br/>Local Irritation: NICOTROL Inhaler and the placebo were both associated with local irritant side effects. Local irritation in mouth and throat was reported by 40% of patients on active drug as compared to 18% of patients on placebo. Irritant effects were higher in the two pivotal trials with higher doses being 66% on active drug and 42% on placebo. Coughing (32% active versus 12% placebo) and rhinitis (23% active versus 16% placebo) were also higher on active drug. The majority of patients rated these symptoms as mild. The frequency of cough, and mouth and throat irritation declined with continued use of NICOTROL Inhaler. Other adverse events that occurred in over 3% of patients on active drug in placebo controlled pivotal trials considered possibly related to the local irritant effects of the NICOTROL Inhaler are taste comments, pain in jaw and neck, tooth disorders and sinusitis.<br/>Withdrawal: Symptoms of withdrawal were common in both active and placebo groups. Common withdrawal symptoms seen in over 3% of patients on active drug included: dizziness, anxiety, sleep disorder, depression, withdrawal syndrome, drug dependence, fatigue and myalgia.<br/>Nicotine-Related Adverse Events: The most common nicotine-related adverse event was dyspepsia. This was present in 18% of patients in the active group compared to 9% of patients in the placebo group. Other nicotine related events present in greater than 3% of patients on active drug include nausea, diarrhea, and hiccup.<br/>Smoking Related Adverse Events: Smoking related adverse events present in greater than 3% of patients on active drug include chest discomfort, bronchitis, and hypertension.<br/>Other Adverse Events: Adverse events of unknown relationship to nicotine occurring in greater than 3% of patients on active drug include headache (26% of patients on active and 15% of patients on placebo), influenza-like symptoms, pain, back-pain, allergy, paresthesias, flatulence and fever.
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NICOTROL Inhaler is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. NICOTROL Inhaler therapy is recommended for use as part of a comprehensive behavioral smoking cessation program.
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Nicotrol
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