Nasal preparations

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)

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)

(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]

The precise mechanism through which ciclesonide affects allergic rhinitis symptoms is not known. 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 allergic inflammation.
Pharmacokinetics.

INDICATIONS AND USAGE:
Seasonal Allergic Rhinitis
OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.
Perennial Allergic Rhinitis

OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older.

DOSAGE AND ADMINISTRATION:
Seasonal Allergic Rhinitis
Adults and Children (6 Years of Age and Older): The recommended dose of OMNARIS Nasal Spray is 200 mcg per day administered as 2 sprays (50 mcg/spray) in each nostril once daily.

Perennial Allergic Rhinitis
Adults and Adolescents (12 Years of Age and Older): The recommended dose of OMNARIS Nasal Spray is 200 mcg per day administered as 2 sprays (50 mcg/spray) in each nostril once daily.

The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day).

Prior to initial use, OMNARIS Nasal Spray must be gently shaken and then the pump must be primed by actuating eight times. If the product is not used for four consecutive days, it should be gently shaken and reprimed with one spray or until a fine mist appears.

Directions for Use
Illustrated patient's instructions for proper use accompany each package of OMNARIS Nasal Spray.

DOSAGE FORMS AND STRENGTHS:
OMNARIS is supplied in an amber glass bottle and provides for nasal delivery with a manual metered pump. OMNARIS Nasal Spray is supplied with an oxygen absorber sachet and enclosed in a foil pouch. OMNARIS Nasal Spray provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. The OMNARIS Nasal Spray bottle has been filled with an excess to accommodate the priming activity. The bottle should be discarded after removal from the foil pouch either after 120 sprays following initial priming (since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose) or after 4 months. Patient instructions are also provided.

OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g.

CONTRAINDICATIONS:
OMNARIS Nasal Spray is contraindicated in patients with a hypersensitivity to any of its ingredients.

DOSAGE AND ADMINISTRATION:
For Intranasal use only
1 actuation per nostril once daily. (74 mcg per day)

DOSAGE FORMS AND STRENGTHS:
Nasal Aerosol: 37 mcg of ciclesonide per actuation.
Supplied in a 6.1 g canister containing 60 actuations.

CONTRAINDICATIONS:
Patients with a known hypersensitivity to ciclesonide or any of the ingredients of ZETONNA Nasal Aerosol.

WARNINGS AND PRECAUTIONS
Epistaxis, ulceration, nasal septal perforations, Candida albicans infection impaired wound healing. Prior to initiating therapy, examine patients for evidence of septal perforation, erosions, ulceration, nasal surgery, and trauma. Avoid spraying ZETONNA Nasal Aerosol directly onto the nasal septum. Avoid use in patients with recent septal perforation, nasal erosion, nasal ulcers, nasal surgery, or nasal trauma. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Discontinue ZETONNA Nasal Aerosol if erosions, ulcerations or perforations occur.

Development of glaucoma or cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, or cataracts.

Cases of hypersensitivity reactions following administration of ciclesonide with manifestations such as angioedema, with swelling of the lips, tongue and pharynx have been reported.

Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chicken pox or measles in susceptible individuals. Use caution in patients with the above because of the potential for worsening of these infections.

Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue ZETONNA Nasal Aerosol slowly.

Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving ZETONNA Nasal Aerosol.

ADVERSE REACTIONS
The most common adverse reactions (>/=2% incidence) included nasal discomfort, headache and epistaxis.

To report SUSPECTED ADVERSE REACTIONS, contact Sunovion Pharmaceuticals Inc. at 1-877-737-7226 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

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)

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.

USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm

DOSAGE AND ADMINISTRATION:
For intranasal use only.
Recommended dose is 1 spray per nostril twice daily in adults and adolescents 12 years of age and older.
Prime before initial use and when it has not been used for 14 or more days.

DOSAGE FORMS AND STRENGTHS:
Dymista Nasal Spray: 137 mcg of azelastine hydrochloride and 50 mcg of fluticasone propionate (137 mcg/50 mcg) in each 0.137 mL spray.

CONTRAINDICATIONS:
None.

WARNINGS AND PRECAUTIONS
Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking Dymista Nasal Spray.
Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with Dymista Nasal Spray because further decreased alertness and impairment of CNS performance may occur.
Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound healing, Candida albicans infection. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.
Development of glaucoma or posterior subcapsular cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections.
Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Dymista Nasal Spray slowly.
Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving Dymista Nasal Spray.

ADVERSE REACTIONS
The most common adverse reactions (>/=2% incidence) are: dysgeusia, epistaxis, and headache.
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-888-939-6478 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
Potent inhibitors of cytochrome P450 (CYP) 3A4: May increase blood levels of fluticasone propionate.
Ritanovir: Coadministration is not recommended.
Other potent CYP3A4 inhibitors, such as ketoconazole: use caution with coadministration.

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

The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day).

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]

Initial U.S. Approval:  2016

Mechanism of Action:

INDICATIONS AND USAGE:  KOVANAZE contains tetracaine HCl, an ester local anesthetic, and oxymetazoline HCl, a vasoconstrictor. KOVANAZE is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more.

DOSAGE AND ADMINISTRATION:
2.1 Important Dosage and Administration Instructions
KOVANAZE is for intranasal use only.
Administer ipsilateral (same side) to the maxillary tooth on which the dental procedure will be performed.
Wait 10 minutes after administration of KOVANAZE to perform a test drill to confirm that the tooth involved is anesthetized. A patient may not experience the same sensations of numbness or tingling of the lips and cheeks associated with injectable dental anesthetics.

2.2 Dosing in Adults (>/= 18 years old)
2 sprays (0.2 mL each) administered 4 to 5 minutes apart in the nostril ipsilateral to the maxillary tooth on which the dental procedure will be performed. Initiate the dental procedure 10 minutes after the second spray.
1 additional spray (0.2 mL) if adequate anesthesia to initiate the dental procedure has not been achieved 10 minutes after the second spray.

2.3 Dosing in Children (who weigh 40 kg or more)
2 sprays (0.2 mL each) administered 4 to 5 minutes apart in the nostril ipsilateral to the maxillary tooth on which the dental procedure will be performed. Initiate the dental procedure 10 minutes after the second spray.

HOW SUPPLIED:
KOVANAZE Nasal Spray is supplied as pre-filled, single-use sprayers containing a clear aqueous solution of 30 mg/mL of tetracaine hydrochloride (equivalent to 26.4 mg/mL tetracaine) and 0.5 mg/mL of oxymetazoline hydrochloride (equivalent to 0.44 mg/mL oxymetazoline). Each sprayer delivers 0.2 mL.

The product is available as:

NDC 69803-100-10: Box of 30 sprayers

Store between 2° and 8°C (36° and 46°F); excursions permitted between 0° and 15°C (32° and 59°F) [see USP controlled cold temperature].

Discard any unused solution. DO NOT use if drug is left out at room temperature for more than 5 days.

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

Dosage
Intranasal:
Children >/= 6 years and Adults: 0.05% solution: Instill 2-3 drops or 2-3 sprays into each nostril twice daily

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)

Dosing:  Use 1-3 sprays in each nostril as needed.

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.

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.

Children >/= 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)