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nicotine intranasal (Rx)

Brand and Other Names:Nicotrol NS
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intranasal spray

  • 0.5mg/actuation

Smoking Cessation

Nicotine replacement therapy to reduce withdrawal symptoms during smoking cessation

1 spray/nostril (ie, 2 sprays to provide 1 mg/dose); typically 10-12 sprays/day in each nostril PRN

Initiate with 1-2 doses/hr; for greatest success, instruct patient to use at least 8 doses/day initially

Depending on individual addiction; may increase up to maximum dose of 40 mg (80 sprays/day)

Administration

Tilt head back when administering

Do not sniff, swallow, or inhale through the nose as the spray is being administered

Safety and efficacy not established

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Interactions

Interaction Checker

and nicotine intranasal

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     activity indicator 
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    Contraindicated

      Serious

        Significant - Monitor Closely

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             activity indicator 

            Contraindicated (0)

              Serious (0)

                Monitor Closely (11)

                • adenosine

                  nicotine intranasal increases effects of adenosine by unknown mechanism. Use Caution/Monitor. Adenosine associated tachycardia and chest pain.

                • cimetidine

                  cimetidine increases levels of nicotine intranasal by decreasing metabolism. Use Caution/Monitor.

                  cimetidine increases levels of nicotine intranasal by decreasing renal clearance. Use Caution/Monitor.

                • esketamine intranasal

                  esketamine intranasal, nicotine intranasal. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

                • green tea

                  green tea, nicotine intranasal. Other (see comment). Use Caution/Monitor. Comment: Green tea may include caffeine. Caffeine is a CNS-stimulant and additive effects may be seen when coadministered with other CNS stimulants. Caffeine should be avoided or used cautiously.

                • naphazoline

                  naphazoline decreases levels of nicotine intranasal by Other (see comment). Use Caution/Monitor. Comment: Nasal vasoconstrictors prolong the time to peak concentrations by ~40% and decreases peak concentration by ~20%.

                • oxymetholone

                  oxymetholone decreases levels of nicotine intranasal by Other (see comment). Use Caution/Monitor. Comment: Nasal vasoconstrictors prolong the time to peak concentrations by ~40% and decreases peak concentration by ~20%.

                • phenylephrine nasal

                  phenylephrine nasal decreases levels of nicotine intranasal by Other (see comment). Use Caution/Monitor. Comment: Nasal vasoconstrictors prolong the time to peak concentrations by ~40% and decreases peak concentration by ~20%.

                • propylhexedrine

                  propylhexedrine decreases levels of nicotine intranasal by Other (see comment). Use Caution/Monitor. Comment: Nasal vasoconstrictors prolong the time to peak concentrations by ~40% and decreases peak concentration by ~20%.

                • solriamfetol

                  nicotine intranasal and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

                • varenicline

                  varenicline increases toxicity of nicotine intranasal by Other (see comment). Use Caution/Monitor. Comment: Varenicline is a partial agonist at the nicotinic Ach receptor; concomitant use with nicotine replacement therapy may increase adverse effects.

                • xylometazoline

                  xylometazoline decreases levels of nicotine intranasal by Other (see comment). Use Caution/Monitor. Comment: Nasal vasoconstrictors prolong the time to peak concentrations by ~40% and decreases peak concentration by ~20%.

                Minor (5)

                • bupropion

                  bupropion, nicotine intranasal. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypertension.

                • dihydroergotamine

                  dihydroergotamine, nicotine intranasal. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive vasospasm.

                • dihydroergotamine intranasal

                  dihydroergotamine intranasal, nicotine intranasal. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive vasospasm.

                • niacin

                  nicotine intranasal increases effects of niacin by pharmacodynamic synergism. Minor/Significance Unknown.

                • rose hips

                  nicotine intranasal decreases levels of rose hips by increasing elimination. Minor/Significance Unknown.

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                Adverse Effects

                >10%

                Local irritation (94%)

                1-10%

                Anxiety

                Irritability

                Restlessness

                Cravings

                Dizziness

                Impaired concentration

                Weight increase

                Emotional lability

                Somnolence and fatigue

                Increased sweating

                Insomnia

                Confusion

                Depression

                Apathy

                Tremor

                Increased appetite

                Incoordination

                Increased dreaming

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                Warnings

                Contraindications

                Hypersensitivity

                Cautions

                Irritating to nasal mucosa

                Not studied in reactive airway disease; may cause bronchospasm

                Caution with hypertension, cardiovascular, or peripheral vascular disease

                Caution with hyperthyroidism, pheochromocytoma, or insulin-dependent diabetes, since nicotine causes the release of catecholamines by the adrenal medulla

                Delays healing of peptic ulcer disease

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                Pregnancy & Lactation

                Pregnancy Category: D

                Lactation: Distributed in breast milk; milk to plasma ratio is 2.9

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Agonist at nicotinic receptors

                Absorption

                Bioavailability: 53%

                Peak plasma time: 4-15 minutes

                Peak plasma concentration: 2-12 ng/mL

                Absorption half-life: 3 minutes

                Distribution

                Protein bound: <5%

                Vd: 2-3 L/kg

                Metabolism

                Metabolized primarily in the liver; some metabolism also takes place in kidney and lungs

                More than 20 metabolites of nicotine identified, all are less active than the parent compound

                The primary urinary metabolite is cotinine (15% of the dose)

                Elimination

                Half-life: 1-2 hr (nicotine); 15-20 hr (cotinine)

                Plasma clearance: 1.2 L/min

                Excretion: Urine (10-30% unchanged)

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Create Your List of Plans

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                View explanations for tiers and restrictions
                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.