Mometasone Furoate Monohydrate (Nasonex)

Trade Name : NASONEX

Merck Sharp & Dohme Corp.

SPRAY, METERED

Strength 50 ug/1

MOMETASONE FUROATE MONOHYDRATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]

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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 Mometasone Furoate Monohydrate (Nasonex) which is also known as NASONEX and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 50 ug/1 per ml. Read more

Mometasone Furoate Monohydrate (Nasonex) 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

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No data

NASONEX is a corticosteroid indicated for:

Treatment of Nasal Symptoms of Allergic Rhinitis in patients u22652 years of age ()
Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis in patients u22652 years of age ()
Prophylaxis of Seasonal Allergic Rhinitis in patients u226512 years of age ()
Treatment of Nasal Polyps in patients u226518 years of age ()

Administer NASONEX Nasal Spray 50 mcg by the intranasal route only. Prior to initial use of NASONEX Nasal Spray, 50 mcg, the pump must be primed by actuating ten times or until a fine spray appears. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by actuating two times, or until a fine spray appears.
For Intranasal Use Only

Treatment of Nasal Symptoms of Allergic Rhinitis ()Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril once dailyChildren (2-11 yrs.): 1 spray in each nostril once daily
Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis ()Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril once dailyChildren (2-11 yrs.): 1 spray in each nostril once daily
Prophylaxis of Seasonal Allergic Rhinitis ()Adults & Adolescents (12 yrs. and older): 2 sprays in each nostril once daily
Treatment of Nasal Polyps ()Adults (18 yrs. and older): 2 sprays in each nostril twice daily. 2 sprays in each nostril once daily may also be effective in some patients.

NASONEX Nasal Spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/w mometasone furoate calculated on the anhydrous basis.
After initial priming (10 actuations), each actuation of the pump delivers a metered spray containing 100 mg or 100 microliter of suspension containing mometasone furoate monohydrate equivalent to 50 mcg of mometasone furoate calculated on the anhydrous basis. Each bottle of NASONEX Nasal Spray 50 mcg provides 120 sprays.
Nasal Spray: 50 mcg of mometasone furoate in each 100-microliter spray ()

NASONEX Nasal Spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients.
Patients with known hypersensitivity to mometasone furoate or any of the ingredients of NASONEX. ()

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Epistaxis, nasal ulceration, infection, nasal septal perforation, impaired wound healing. 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. ()
Glaucoma and cataracts. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use NASONEX long term. ()
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 higher than recommended dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue NASONEX Nasal Spray slowly. ()
Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving NASONEX Nasal Spray. (, )

Systemic and local corticosteroid use may result in the following:
The most common adverse reactions (u22655%) included headache, viral infection, pharyngitis, epistaxis and cough. ()
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No formal drug-drug interaction studies have been conducted with NASONEX Nasal Spray 50 mcg.
Inhibitors of Cytochrome P450 3A4:
In vitro
Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate and potentially increase the risk for systemic corticosteroid side effects. Caution should be exercised when considering the coadministration of NASONEX Nasal Spray 50 mcg with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) . Consider the benefit of coadministration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects.

No data

There are no data available on the effects of acute or chronic overdosage with NASONEX Nasal Spray 50 mcg. Because of low systemic bioavailability, and an absence of acute drug-related systemic findings in clinical studies, overdose is unlikely to require any therapy other than observation. Intranasal administration of 1600 mcg (4 times the recommended dose of NASONEX Nasal Spray 50 mcg for the treatment of nasal polyps in patients 18 years of age and older) daily for 29 days, to healthy human volunteers, showed no increased incidence of adverse events. Single intranasal doses up to 4000 mcg and oral inhalation doses up to 8000 mcg have been studied in human volunteers with no adverse effects reported. Chronic over dosage with any corticosteroid may result in signs or symptoms of hypercorticism . Acute overdosage with this dosage form is unlikely since one bottle of NASONEX Nasal Spray 50 mcg contains approximately 8500 mcg of mometasone furoate.

Mometasone furoate monohydrate, the active component of NASONEX Nasal Spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11u00df,17-dihydroxy-16u03b1-methylpregna-1,4-diene-3,20-dione17-(2 furoate) monohydrate, and the following chemical structure:
Mometasone furoate monohydrate is a white powder, with an empirical formula of CHCOu2219HO, and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is greater than 5000.
NASONEX Nasal Spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/w mometasone furoate calculated on the anhydrous basis; in an aqueous medium containing glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The pH is between 4.3 and 4.9.

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NASONEX (mometasone furoate monohydrate) Nasal Spray, 50 mcg is supplied in a white, high-density, polyethylene bottle fitted with a white metered-dose, manual spray pump, and blue cap. It contains 17 g of product formulation, 120 sprays, each delivering 50 mcg of mometasone furoate per actuation.
(NDC 0085-1288-01).
Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature]. Protect from light.
When NASONEX Nasal Spray, 50 mcg is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided. Brief exposure to light, as with normal use, is acceptable.
SHAKE WELL BEFORE EACH USE.
Keep out of reach of children.

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
Manufactured by: MSD International GmbH (Singapore Branch), Singapore 638414, Singapore
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 1997-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
uspi-mk0887-ns-1907r015

No data

For use in your nose only.
Read the Patient Instructions for Use carefully before you start to use your NASONEX Nasal Spray. If you have any questions, ask your healthcare provider.
Shake the bottle well before each use.
Each bottle of NASONEX Nasal Spray contains enough medicine for you to spray medicine from the bottle 120 times. Do not use the bottle of NASONEX Nasal Spray after 120 sprays. Additional sprays after the 120 sprays may not contain the right amount of medicine, and throw away the bottle even if it has medicine still left in. Talk with your healthcare provider before your supply runs out to see if you should get a refill of your medicine.
Pediatric Use:n- Patient Instructions for Use
Cleaning: Do not try to unblock the nasal applicator with a sharp object. n- Array
Patient Instructions for Cleaning Applicator

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
Manufactured by: MSD International GmbH (Singapore Branch), Singapore 638414, Singapore
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 1997-2018 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 06/2018
usppi-mk0887-ns-1806r009

NDC 0085-1288-01
Scent-Free Mist
Net Contents: 17 g
120 Metered Sprays
For Intranasal Use OnlyRx only
NASONEXn
(mometasone furoate monohydrate)Nasal Spray, 50mcg**calculated on the anhydrous basis
For more NASONEX information log on towww.nasonex.com

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Mometasone Furoate Monohydrate (Nasonex)

Trade Name : NASONEX

SPRAY, METERED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Mometasone Furoate Monohydrate (Nasonex)

Trade Name : NASONEX

SPRAY, METERED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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