Nicotrol NS

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 »


Nicotrol NS Patient Information Including Side Effects

Brand Names: Commit, Commit Cappuccino, Commit Cherry, Habitrol, Leader Nicotine Polacrilex, Nicoderm C-Q, Nicoderm C-Q Clear, Nicorelief, Nicorette, Nicorette Cinnamon Surge, Nicorette Fruit Chill, Nicorette Mint, Nicotrol Inhaler, Nicotrol NS

Generic Name: nicotine (oral/patches/nasal) (Pronunciation: NIK oh teen)

  • What is nicotine (Nicotrol NS)?
  • What are the possible side effects of nicotine?
  • What is the most important information I should know about nicotine?
  • What should I discuss with my healthcare provider before using nicotine?
  • How should I take nicotine?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking nicotine?
  • What other drugs will affect nicotine?
  • Where can I get more information?

What is nicotine (Nicotrol NS)?

Nicotine is the primary ingredient in tobacco products.

Nicotine in medical products is used to aid in smoking cessation. Using a controlled amount of nicotine helps reduce nicotine withdrawal symptoms when you quit smoking.

Nicotine may also be used for other purposes not listed in this medication guide.

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 mouth;
  • watering eyes;
  • headache;
  • runny or stuffy nose (when using the nasal spray);
  • white patches or sores inside your mouth or on your lips (when using the inhaler);
  • constipation;
  • sneezing and coughing;
  • changes in taste; or
  • redness, itching, or burning where the patch is worn.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nicotine?

Do not use this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

You may not be able to use certain forms of this medicine if you have medical conditions that could interfere with use. Nasal or sinus problems (allergies, nasal polyps, sinusitis) could affect safe use of the nasal spray form of nicotine. Mouth or dental problems may affect safe use of nicotine gum or lozenges. A skin condition may affect safe use of nicotine transdermal patches. Talk with your doctor about the best form of nicotine for you to use.

Do not smoke while you are using nicotine. Stop smoking as soon as your treatment begins. Smoking while using this medication can be dangerous.

The nicotine transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

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