"As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency's tobacco authority to cover addi"...
(nicotine) Nasal Spray 10 mg/mL
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
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 nasal or inhalation (Nicotrol Inhaler, Nicotrol NS)?
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 this medication and call your doctor at once if you have a serious side effect such as:
- fast or pounding heartbeats, fluttering in your chest;
- extreme weakness or dizziness;
- severe nausea and vomiting;
- bronchospasm (wheezing, tightness in your chest, trouble breathing);
- severe stinging, burning, or other irritation in your nose,...
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
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