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Nicotrol NS

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Nicotrol NS

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Nicotrol® NS
(nicotine) Nasal Spray 10 mg/mL

DRUG DESCRIPTION

Nicotrol® NS (nicotine nasal spray) is an aqueous solution of nicotine intended for administration as a metered spray to the nasal mucosa.

Nicotine is a tertiary amine composed of 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 NICOTROL NS (nicotine nasal spray) . 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

Nicotrol® (nicotine) Structural Formula Illustration

Each 10 mL spray bottle contains 100 mg nicotine (10 mg/mL) in an inactive vehicle containing disodium phosphate, sodium dihydrogen phosphate, citric acid, methylparaben, propylparaben, edetate disodium, sodium chloride, polysorbate 80, aroma and water. The solution is isotonic with a pH of 7. It contains no chlorofluorocarbons.

After priming the delivery system for NICOTROL NS (nicotine nasal spray) , each actuation of the unit delivers a metered dose spray containing approximately 0.5 mg of nicotine. The size of the droplets produced by the unit is in excess of 8 microns. One NICOTROL NS unit delivers approximately 200 applications.

What are the possible side effects of nicotine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using nicotine and call your doctor at once if you have any of these serious side effects:

  • seizures; or
  • chest pain or uneven heartbeats.

Less serious side effects may include:

  • dizziness;
  • belching or hiccups;
  • stomach upset or nausea;
  • mouth or throat soreness;
  • dry or watering...

Read All Potential Side Effects and See Pictures of Nicotrol NS »

Last reviewed on RxList: 3/10/2009
This monograph has been modified to include the generic and brand name in many instances.

Additional Nicotrol NS Information

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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