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Nasal Preparations
azelastine (Astelin ® )
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Mechanism of Action Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H1 -receptor antagonist activity in isolated tissues, animal models, and humans. ASTEPRO Nasal Spray is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in in vitro studies. The major metabolite, desmethylazelastine, also possesses H1 -receptor antagonist activity. INDICATIONS AND USAGE Allergic Rhinitis ASTEPRO Nasal Spray 0.1% and 0.15% is indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 12 years of age and older. Dosage Children >/= 12 years and Adults: Seasonal allergic rhinitis or vasomotor rhinitis: Intranasal: 2 sprays (137 mcg/spray) each nostril twice daily Supplied: Solution, intranasal spray, as hydrochloride (Astelin®): 1 mg/mL [137 mcg/spray] (17 mL, 30 mL) |
beclomethasone (Vancenase ® ,
Beconase ®)
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Mechanism of Action Following topical administration, beclomethasone dipropionate produces anti-inflammatory and vasoconstrictor effects. The mechanisms responsible for the anti-inflammatory action of beclomethasone dipropionate are unknown. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation. The direct relationship of these findings to the effects of beclomethasone dipropionate on allergic rhinitis symptoms is not known. Biopsies of nasal mucosa obtained during clinical studies showed no histopathologic changes when beclomethasone dipropionate was administered intranasally. Beclomethasone dipropionate is a pro-drug with weak glucocorticoid receptor binding affinity. It is hydrolyzed via esterase enzymes to its active metabolite beclomethasone-17-monopropionate (B-17-MP), which has high topical anti-inflammatory activity. INDICATIONS AND USAGE BECONASE AQ Nasal Spray is indicated for the relief of the symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis. Results from 2 clinical trials have shown that significant symptomatic relief was obtained within 3 days. However, symptomatic relief may not occur in some patients for as long as 2 weeks. BECONASE AQ Nasal Spray should not be continued beyond 3 weeks in the absence of significant symptomatic improvement. BECONASE AQ Nasal Spray should not be used in the presence of untreated localized infection involving the nasal mucosa. BECONASE AQ Nasal Spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal. Clinical studies have shown that treatment of the symptoms associated with nasal polyps may have to be continued for several weeks or more before a therapeutic result can be fully assessed. Recurrence of symptoms due to polyps can occur after stopping treatment, depending on the severity of the disease. CONTRAINDICATIONS Hypersensitivity to any of the ingredients of this preparation contraindicates its use Dosing: Aqueous inhalation, nasal (Beconase® AQ): Children >/= 6 years and Adults: 1-2 inhalations each nostril twice daily; total dose 168-336 mcg/day Intranasal (Beconase®): Children >/= 12 years and Adults: 1 inhalation in each nostril 2-4 times/day or 2 inhalations each nostril twice daily (total dose 168-336 mcg/day); usual maximum maintenance: 1 inhalation in each nostril 3 times/day (252 mcg/day) |
budesonide (Rhinocort ® )
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Allergic Rhinitis - Dosing: Two sprays twice daily or 4
sprays once daily. (Rhinocort Aqua Nasal Spray®): - Recommended starting dose (adults): 1 spray in each nostril once daily. Maximum recommended dose for adults (12 years of age and older): 256 mcg per day administered as four sprays per nostril once daily [Supplied: Nasal Spray- 32 mcg/spray] |
cromolyn (NasalCrom ® )
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Purpose Nasal Allergy Symptom Controller Uses To prevent and relieve nasal symptoms of hay fever and other nasal allergies: runny nose, sneezing, allergic stuffy nose Dosing Allergic rhinitis (treatment and prophylaxis): Children >/= 2 years and Adults: 1 spray into each nostril 3-4 times/day; may be increased to 6 times/day (symptomatic relief may require 2-4 weeks) |
desmopressin acetate (DDAVP®) Nasal Spray
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Synthetic analogue of the pituitary hormone
vasopressin (ADH). DDAVP Nasal Spray delivers 0.1 L (10 µg) of DDAVP (desmopressin
acetate) per spray. Dosage (adults): Primary Nocturnal Enuresis: Dosage should be adjusted according to the individual. Initial dose: > 6 years of age: 20 µg (0.2 mL) solution intranasally at bedtime. Adjustment up to 40 µg is suggested if the patient does not respond. Some patients may respond to 10 µg and adjustment to that lower dose may be done if the patient has shown a response to 20 µg. It is recommended that one-half of the dose be administered per nostril. Adequately controlled studies with intranasal DDAVP in primary nocturnal enuresis have not been conducted beyond 4-8 weeks. Diabetes Insipidus: Dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. The usual dosage range in adults is 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses. |
flunisolide (Nasalide ®)
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General Pharmacology Flunisolide nasal spray has demonstrated potent glucocorticoid and weak mineralocorticoid activity in classical animal test systems. As a glucocorticoid it was 180 times more potent than the cortisol standard in a rat anti-granuloma assay. INDICATIONS AND USAGE: Flunisolide is indicated for the management of the nasal symptoms of seasonal or perennial rhinitis. CONTRAINDICATIONS: Hypersensitivity to any of the ingredients. Flunisolide should not be used in the presence of untreated localized infection involving the nasal mucosa. Dosing Adults: 2 sprays each nostril twice daily (morning and evening); maximum dose: 8 sprays/day in each nostril |
fluticasone (Flonase ® )
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Seasonal & perennial allergic rhinitis: Adults: Start: 2
sprays (50 mcg of ticasone propionate each) in each nostril qd.
(total: 200 mcg/day). Alternatively: 1 spray each nostril bid. After the first few days, patients may be able to reduce their dosage to 100 mcg (1 spray in each nostril) once daily for maintenance therapy. The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). |
Ipratropium bromide (Atrovent Nasal ®)
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Dosage (adults):
2 sprays 2 to 4 times per day. [rhinitis: 0.03%,
colds:0.06%] Common cold rhinorrhea: Recommended dose (Nasal Spray 0.06%): 2 sprays (84 mcg) per nostril 3-4 times daily in adults and children age 12 years and older. Seasonal Allergic Rhinitis: 2 sprays (84 mcg) per nostril 2 to 4 times daily in adults and children age 5 years and older. The safety and effectiveness of the use of Atrovent Nasal ® Spray 0.06% beyond 4 days in patients with the common cold or beyond 3 weeks in patients with seasonal allergic rhinitis has not been established. MOA: Anticholinergic agent - inhibits secretions from the serous and seromucous glands lining the nasal mucosa. [Supplied: 0.03% and 0.06% Nasal Spray] |
mometasone (Nasonex ® )
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Nasal spray: Allergic rhinitis: Children 2-11 years: 1 spray (50 mcg) in each nostril daily Children >/= 12 years and Adults: 2 sprays (100 mcg) in each nostril daily; when used for the prevention of allergic rhinitis, treatment should begin 2-4 weeks prior to pollen season Nasal polyps: Adults: 2 sprays (100 mcg) in each nostril twice daily; 2 sprays (100 mcg) once daily may be effective in some patients |
oxymetazoline (Afrin ®)
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Nasal decongestant.
Use Adjunctive therapy of middle ear infections, associated with acute or chronic rhinitis, the common cold, sinusitis, hay fever, or other allergies. Dosage Intranasal: Children >/= 6 years and Adults: 0.05% solution: Instill 2-3 drops or 2-3 sprays into each nostril twice daily |
phenylephrine (Neo-Synephrine ®)
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Nasal decongestant. Dosage Nasal decongestant (therapy should not exceed 3 continuous days): Children: 2-6 years: Instill 1 drop every 2-4 hours of 0.125% solution as needed 6-12 years: Instill 1-2 sprays or instill 1-2 drops every 4 hours of 0.25% solution as needed Adults: Children >12 years and Adults: Instill 1-2 sprays or instill 1-2 drops every 4 hours of 0.25% to 0.5% solution as needed; 1% solution may be used in adult in cases of extreme nasal congestion; do not use nasal solutions more than 3 days Supplied Solution, intranasal spray, as hydrochloride: Neo-Synephrine® Extra Strength: 1% (15 mL) Neo-Synephrine® Mild: 0.25% (15 mL) Neo-Synephrine® Regular Strength: 0.5% (15 mL) |
Saline nasal spray (Ocean ®, SeaMist ® )
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USE: Restores moisture to nasal membranes. Dosing: Use 1-3 sprays in each nostril as needed. |
Sumatriptan (Imitrex ®)
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May increase blood pressure and should not be given to patients with
uncontrolled hypertension. The safety of treating an average of more than 4 headaches in a 30-day period has not been established. Serotonin (5-HT 1) agonist --> vasoconstriction of cranial arteries. Dosing (Adults): Acute treatment of migraine: Nasal spray: Single doses of 5, 10, or 20 mg administered into 1 nostril are effective for the acute treatment of migraine in adults. Individualize dose based on response. A 10-mg dose may be achieved by the administration of a single 5-mg dose in each nostril. There is evidence that doses above 20 mg do not provide a greater effect than 20 mg. If the headache returns, the dose may be repeated once after 2 hours, not to exceed a total daily dose of 40 mg. Supplied: Nasal Spray 5 mg and 20 mg are each supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 5 and 20 mg, respectively, of sumatriptan. |
triamcinolone (Nasacort ®)
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| INDIVIDUALIZATION OF DOSAGE Individual patients will experience a variable time to onset and degree of symptom relief when using Nasacort. It is recommended that dosing be started at 220 mcg once a day and the effect be assessed in four to seven days. Adults and Children 12 years of age and older Some relief can be expected in approximately two-thirds of patients within four to seven days. If greater effect is desired an increase of dose to 440 mcg once a day can be tried. If adequate relief has not been obtained by the third week of Nasacort treatment, alternate forms of treatment should be considered. A dose-response between 110 mcg/day (one spray/nostril/day) and 440 mcg/day (four sprays/nostril/day) is not clearly discernible. In general, in the clinical trials the highest dose tended to provide relief sooner. This suggests an alternative approach to starting therapy with Nasacort, e.g., starting treatment with 440 mcg (four sprays/nostril/day) and then, depending on the patient's response, decreasing the dose by one spray per day every four to seven days. Although Nasacort may be used at 220 mcg/day or 440 mcg/day divided into two or four times a day, the degree of relief does not seem to be significantly different compared to once-a-day dosing. As with other nasal corticosteroids, the vehicle used to deliver the corticosteroid, may cause symptoms that are difficult to distinguish from the patient's rhinitis symptoms. Thus, depending upon the balance between these vehicle side effects and the benefits of treatment, in determining the optimal dose for the relief of symptoms, individual patients may need to have a trial of high and low doses. Children 6 through 11 years of age In children 6 through 11 years of age, it is recommended that dosing be started at 220 mcg given as two sprays (55 mcg/spray) in each nostril once a day. In clinical trials, significant relief of rhinitis symptoms in children was observed as early as the fourth day of treatment and generally, it took one to two weeks to achieve maximum benefit. If adequate relief has not been obtained by the third week of Nasacort treatment, alternate forms of treatment should be considered. In general, it is always desirable to titrate an individual patient to the minimum effective dose to reduce the possibility of side effects. In clinical trials, after symptoms have been brought under control at the recommended starting doses, reducing the daily dose to 110 mcg (one spray in each nostril once per day) has been shown to be effective in controlling symptoms in approximately one-half of adult patients being treated long-term for allergic rhinitis INDICATIONS AND USAGE Nasacort Nasal Inhaler is indicated for the nasal treatment of seasonal and perennial allergic rhinitis symptoms in adults and children 6 years of age and older. CONTRAINDICATIONS Hypersensitivity to any of the ingredients of this preparation contraindicates its use. Dosing (Adults): Use 2 sprays in each nostril once or twice daily. Maximum: 8 sprays/day. Nasacort AQ ® Use 2 sprays in each nostril once daily. Use: Nasal inhalation: Management of seasonal and perennial allergic rhinitis in patients >/= 6 years of age Dosage Nasal spray: Shake well prior to use. Gently blow nose to clear nostrils. Children 6-11 years: 110 mcg/day as 1 spray in each nostril once daily. CChildren >/= 12 years and Adults: 220 mcg/day as 2 sprays in each nostril once daily Nasal inhaler: Children 6-11 years: Initial: 220 mcg/day as 2 sprays in each nostril once daily Children >/= 12 years and Adults: Initial: 220 mcg/day as 2 sprays in each nostril once daily; may increase dose to 440 mcg/day (given once daily or divided and given 2 or 4 times/day) |
Zolmitriptan (Zomig ® )
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Serotonin agonist: (5-HT1B and 5-HT1D receptors) -->
vasoconstriction in cranial. Dosing (Adults): Nasal spray: Initial: 1 spray (5 mg) at the onset of migraine headache. If the headache returns, the dose may be repeated after 2 hours; do not exceed 10 mg within a 24-hour period. Controlled trials have not established the effectiveness of a second dose if the initial one was ineffective. |
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any diagnosis or treatment made in reliance thereon. David F. McAuley, Pharm.D., R.Ph. GlobalRPh Inc. |
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