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Nicotine (Nicotrol)

Trade Name : Nicotrol

Pharmacia and Upjohn Company LLC

INHALANT

Strength 4 mg/1

NICOTINE Cholinergic Nicotinic Agonist [EPC],Nicotine [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Nicotine (Nicotrol) which is also known as Nicotrol and Manufactured by Pharmacia and Upjohn Company LLC. It is available in strength of 4 mg/1 per ml. Read more

Nicotine (Nicotrol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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: CHNn
  • Molecular Weight: 162.23
  • Ionization Constants: pKa = 7.84, pKa = 3.04 at 15u00b0C
  • Octanol-Water Partition Coefficient: 15:1 at pH 7
  • 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.
  • No data
  • 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.
  • Use of NICOTROL Inhaler therapy is contraindicated in patients with known hypersensitivity or allergy to nicotine or to menthol.
  • 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.
  • No data
  • 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 symptoms of nicotine withdrawal in some patients and nicotine excess in others. The incidence of adverse events is confounded by: (1) the many minor complaints that smokers commonly have, (2) continued smoking by many patients and (3) the local irritation from both the active drug and the placebo.
  • NICOTROL Inhaler and the placebo were both associated with local irritant side effects. Local irritation in mouth and throat was reported by 40% of patients on active drug as compared to 18% of patients on placebo. Irritant effects were higher in the two pivotal trials with higher doses being 66% on active drug and 42% on placebo. Coughing (32% active versus 12% placebo) and rhinitis (23% active versus 16% placebo) were also higher on active drug. The majority of patients rated these symptoms as mild. The frequency of cough, and mouth and throat irritation declined with continued use of NICOTROL Inhaler. Other adverse events that occurred in over 3% of patients on active drug in placebo controlled pivotal trials considered possibly related to the local irritant effects of the NICOTROL Inhaler are taste comments, pain in jaw and neck, tooth disorders and sinusitis.
  • 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 absorption, smaller fluctuations in blood levels and lower blood levels of nicotine. NICOTROL Inhaler, like many other nicotine-based smoking cessation therapies, does not produce arterial concentrations similar to cigarettes. However, nicotine withdrawal symptoms were noted in clinical trials at the time of NICOTROL Inhaler tapering and after NICOTROL Inhaler discontinuation.
  • Dependence might occur from transference of tobacco-related nicotine dependence to the NICOTROL Inhaler. The use of the inhaler beyond 6 months has not been evaluated in clinical trials and is not recommended. To minimize the risk of dependence, patients should be encouraged to withdraw gradually from NICOTROL Inhaler therapy after 3 months of usage (See ). If necessary, dose reduction can be achieved by gradual reduction of the dose over a 6 to 12 week period.
  • No data
  • Patients must desire to stop smoking and should be instructed to as they begin using NICOTROL Inhaler. It is important that patients understand the instructions, and have their questions answered. They should clearly understand the directions for using the NICOTROL Inhaler and safely disposing of the used cartridges.
  • The initial dosage of NICOTROL Inhaler is individualized. Patients may selftitrate to the level of nicotine they require. Most successful patients in the clinical trials used between 6 and 16 cartridges a day. Best effect was achieved by frequent continuous puffing (20 minutes). The recommended duration of treatment is 3 months, after which patients may be weaned from the NICOTROL Inhaler by gradual reduction of the daily dose over the following 6 to 12 weeks. The safety and efficacy of the continued use of NICOTROL Inhaler for periods longer than 6 months have not been studied and such use is not recommended.
  • Dosing recommendations are summarized in the table below.
  • No data
  • Rx only
  • LAB-0804-2.0Revised August 2019
  • Nicotrol Inhaler
  • An Aid to Help YouStop Smoking
  • Patient Information
  • Read and follow carefully.
  • If you have questions or want more information, ask your doctor or pharmacist.
  • IMPORTANT INFORMATION - Read carefully
  • NICOTROL Inhaler Contents
  • WARNINGS: Read before using NICOTROL Inhaler
  • BEFORE YOU USE - Read information on both sides. FOLLOW ALL DIRECTIONS Exactly!
  • QUESTIONS? Call 1-888-642-6876
  • LAB-0345-4.0Revised August 2019
  • Ncotrol Inhaler
  • Rx only
  • 10 mg/cartridge
  • FOR ORAL INHALATION USE ONLY
  • DOSAGE:
  • Distributed by n- Pharmacia & Upjohn Co
  • DO NOT USE IF SEAL ON TRAY IS BROKENStore at room temperature, not to exceed77u00b0F (25u00b0C). Protect from light.
  • 6 Cartridges
  • u00a9 2007 Pharmacia & Upjohn Company LLCMADE IN SWEDEN870154
  • NDC 0009-5400-01
  • Ncotroln n- Inhaler
  • 10 mg/cartridgetttttt(4 mg delivered)
  • Rx only
  • FOR ORAL INHALATION USE ONLYKEEP OUT OF THE REACH OF CHILDREN
  • 168 Cartridges5 Mouthpieces, 1 Plastic Case

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