Mometasone Furoate Monohydrate

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Overview

What is Mometasone Furoate Monohydrate?

Mometasone furoate monohydrate, the active component of Mometasone Furoate Monohydrate Nasal Spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11ß,17-dihydroxy-16α-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 CHCO•HO, 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.

Mometasone Furoate Monohydrate 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.

What does Mometasone Furoate Monohydrate look like?

What are the available doses of Mometasone Furoate Monohydrate?

Nasal Spray: 50 mcg of mometasone furoate in each 100-microliter spray ()

What should I talk to my health care provider before I take Mometasone Furoate Monohydrate?

How should I use Mometasone Furoate Monohydrate?

Mometasone Furoate Monohydrate Nasal Spray 50 mcg is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older.

Administer Mometasone Furoate Monohydrate Nasal Spray 50 mcg by the intranasal route only. Prior to initial use of Mometasone Furoate Monohydrate 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.

What interacts with Mometasone Furoate Monohydrate?

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What are the warnings of Mometasone Furoate Monohydrate?

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What are the precautions of Mometasone Furoate Monohydrate?

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What are the side effects of Mometasone Furoate Monohydrate?

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What should I look out for while using Mometasone Furoate Monohydrate?

Mometasone Furoate Monohydrate Nasal Spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients.

What might happen if I take too much Mometasone Furoate Monohydrate?

There are no data available on the effects of acute or chronic overdosage with Mometasone Furoate Monohydrate 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 Mometasone Furoate Monohydrate 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 Mometasone Furoate Monohydrate Nasal Spray 50 mcg contains approximately 8500 mcg of mometasone furoate.

How should I store and handle Mometasone Furoate Monohydrate?

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20º to 25ºC (68º to 77ºF); that results in a mean kinetic temperature calculated to be not more than 25ºC; and that allows for excursions between 15º and 30ºC (59º and 86ºF) that are experienced in pharmacies, hospitals, and warehouses.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20º to 25ºC (68º to 77ºF); that results in a mean kinetic temperature calculated to be not more than 25ºC; and that allows for excursions between 15º and 30ºC (59º and 86ºF) that are experienced in pharmacies, hospitals, and warehouses.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 0781-6355-87).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 0781-6355-87).

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Mometasone Furoate Monohydrate Nasal Spray 50 mcg is a corticosteroid demonstrating potent anti-inflammatory properties. The precise mechanism of corticosteroid action on allergic rhinitis 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 inflammation.

In two clinical studies utilizing nasal antigen challenge, Mometasone Furoate Monohydrate Nasal Spray, 50 mcg decreased some markers of the early- and late-phase allergic response. These observations included decreases (vs. placebo) in histamine and eosinophil cationic protein levels, and reductions (vs. baseline) in eosinophils, neutrophils, and epithelial cell adhesion proteins. The clinical significance of these findings is not known.

The effect of Mometasone Furoate Monohydrate Nasal Spray, 50 mcg on nasal mucosa following 12 months of treatment was examined in 46 patients with allergic rhinitis. There was no evidence of atrophy and there was a marked reduction in intraepithelial eosinophilia and inflammatory cell infiltration (e.g., eosinophils, lymphocytes, monocytes, neutrophils, and plasma cells).

Non-Clinical Toxicology

Mometasone Furoate Monohydrate Nasal Spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients.

Use of phendimetrazine tartrate is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.

Concomitant use of alcohol with phendimetrazine tartrate may result in an adverse drug reaction.

Requirements may be altered

phendimetrazine tartrate may decrease the hypotensive effect of adrenergic neuron blocking drugs.

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. ()

Development of glaucoma or 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 higher than recommended dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Mometasone Furoate Monohydrate Nasal Spray slowly. ()

Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving Mometasone Furoate Monohydrate Nasal Spray. (, )

Systemic and local corticosteroid use may result in the following:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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