NICOTROL Inhaler (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Pharmacia & Upjohn Company LLC

Λέξεις κλειδιά

0009-5400

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1. Description

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 ...

2. Clinical Pharmacology

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, ...

3. Indications and Usage

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 ...

4. Contraindications

Use of NICOTROL Inhaler therapy is contraindicated in patients with known hypersensitivity or allergy to nicotine or to menthol.

5. Warnings

Nicotine from any source can be toxic and addictive. Smoking causes lung disease, cancer and heart disease, and may adversely affect pregnant women or the fetus. For any smoker, with or without concomitant ...

6. Precautions

Bronchospastic Disease NICOTROL Inhaler has not been specifically studied in asthma or chronic pulmonary disease. Nicotine is an airway irritant and might cause bronchospasm. NICOTROL Inhaler should be ...

6.1. General

The patient should be urged to stop smoking completely when initiating NICOTROL Inhaler therapy (See DOSAGE AND ADMINISTRATION). Patients should be informed that if they continue to smoke while using the ...

6.2. Information for Patients

A patient information sheet is included in the package of NICOTROL Inhaler cartridges dispensed to the patient. Patients should be encouraged to read the information sheet carefully and to ask their physician ...

6.4. Drug Interactions

Physiological changes resulting from smoking cessation, with or without nicotine replacement, may alter the pharmacokinetics of certain concomitant medications, such as tricyclic antidepressants and theophylline. ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Nicotine itself does not appear to be a carcinogen in laboratory animals. However, nicotine and its metabolites increased the incidences of tumors in the cheek pouches of hamsters and forestomach of F344 ...

6.7. Pregnancy

The harmful effects of cigarette smoking on maternal and fetal health are clearly established. These include low birth weight, an increased risk of spontaneous abortion, and increased perinatal mortality. ...

6.8. Labor and Delivery

NICOTROL Inhaler is not recommended for use during labor and delivery. The effect of nicotine on a mother or the fetus during labor is unknown.

6.9. Nursing Mothers

Caution should be exercised when the NICOTROL Inhaler is administered to nursing mothers. The safety of NICOTROL Inhaler therapy in nursing infants has not been examined. Nicotine passes freely into breast ...

6.10. Pediatric Use

Safety and effectiveness in pediatric and adolescent patients below the age of 18 years have not been established for any nicotine replacement product. However, no specific medical risk is known or expected ...

6.11. Geriatric Use

Clinical studies of NICOTROL Inhaler did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Other reports on clinical experience ...

7. Adverse Reactions

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 ...

8. Drug Abuse and Dependence

NICOTROL Inhaler is likely to have a low abuse potential based on differences between the product and cigarettes in three characteristics commonly considered important in contributing to abuse: slower ...

9. Overdosage

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, ...

10. Dosage and Administration

Patients must desire to stop smoking and should be instructed to <em>stop smoking completely</em> as they begin using NICOTROL Inhaler. It is important that patients understand the instructions, and have ...

11. How Supplied

NICOTROL INHALER (nicotine inhalation system) is supplied as 168 cartridges each containing 10 mg (4 mg is delivered) nicotine (NDC 0009-5400-01). Each unit consists of 5 mouthpieces, 28 storage trays ...

12. Storage and Handling

Store at room temperature not to exceed 77°F (25°C). Protect cartridges from light. Disposal See patient information sheet for instructions on handling and disposal. After using the NICOTROL Inhaler, carefully ...