Nicotrol Recall

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Questions & Answers

Side Effects & Adverse Reactions

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 disease or pregnancy, the risk of nicotine replacement in a smoking cessation program should be weighed against the hazard of continued smoking, and the likelihood of achieving cessation of smoking without nicotine replacement.

Pregnancy, Warning

Tobacco smoke, which has been shown to be harmful to the fetus, contains nicotine, hydrogen cyanide, and carbon monoxide. The NICOTROL Inhaler does not deliver hydrogen cyanide and carbon monoxide. However, nicotine has been shown in animal studies to cause fetal harm. It is therefore presumed that NICOTROL Inhaler can cause fetal harm when administered to a pregnant woman. The effect of nicotine delivery by NICOTROL Inhaler has not been examined in pregnancy (See PRECAUTIONS). Therefore, pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches. If NICOTROL Inhaler is used during pregnancy, or if the patient becomes pregnant while using it, the patient should be apprised of the potential hazard to the fetus.

Safety Note Concerning Children

This product contains nicotine and should be kept out of the reach of children and pets. The amounts of nicotine that are tolerated by adult smokers can produce symptoms of poisoning and could prove fatal if the nicotine from the NICOTROL Inhaler is inhaled, ingested, or buccally absorbed by children or pets. A cartridge contains about 60% of its initial drug content when it is discarded, which is about 6 mg. Patients should be cautioned to keep both the used and unused cartridges of NICOTROL Inhaler out of the reach of children and pets.

All components of the NICOTROL Inhaler system should also be kept out of the reach of children and pets to avoid accidental swallowing and choking.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


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.


There is currently no drug history available for this drug.

Other Information

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: C10H14N2

Molecular Weight: 162.23

Ionization Constants: pKa1 = 7.84, pKa2 = 3.04 at 15°C

Octanol-Water Partition Coefficient: 15:1 at pH 7

Chemical Structure

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.

Nicotrol Manufacturers

  • U.s. Pharmaceuticals
    Nicotrol (Professional Sample) (Nicotine) Inhalant [U.s. Pharmaceuticals]
  • Physicians Total Care, Inc.
    Nicotrol (Nicotine) Inhalant [Physicians Total Care, Inc.]
  • Us Pharmaceuticals
    Nicotrol (Professional Sample) (Nicotine) Inhalant [Us Pharmaceuticals]
  • Pharmacia And Upjohn Company
    Nicotrol (Nicotine) Inhalant [Pharmacia And Upjohn Company]
  • Pharmacia And Upjohn Company
    Nicotrol (Nicotine) Spray, Metered [Pharmacia And Upjohn Company]

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