NASONEX Nasal spray (2020)

Βιβλιογραφική αναφορά

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Merck Sharp & Dohme Corp.

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1. Indications and Usage

1.1 Treatment of Allergic Rhinitis NASONEX 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 ...

2. Dosage and Administration

2.1 Preparation and Administration Administer NASONEX by the nasal route only. Initial Priming Prior to initial use of NASONEX, the pump must be primed by actuating ten times or until a fine spray appears. ...

3. Dosage Forms and Strengths

Nasal spray: 50 mcg, metered-dose, manual pump spray. After initial priming (10 actuations), each actuation of the pump delivers a metered spray containing 50 mcg of mometasone furoate.

4. Contraindications

NASONEX is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients.

5. Warnings and Precautions

5.1 Local Nasal Effects Epistaxis In clinical studies, epistaxis was observed more frequently in patients with allergic rhinitis with NASONEX than those who received placebo [see Adverse Reactions ...

6. Adverse Reactions

Systemic and local corticosteroid use may result in the following: Epistaxis, ulcerations, Candida albicans infection, impaired wound healing [see Warnings and Precautions (5.1)] Glaucoma ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during the post-marketing period for NASONEX: nasal burning and irritation, anaphylaxis and angioedema, disturbances in taste and smell, nasal septal ...

7. Drug Interactions

No formal drug-drug interaction studies have been conducted with NASONEX. Inhibitors of Cytochrome P450 3A4 Studies have shown that mometasone furoate is primarily and extensively metabolized in the liver ...

8.1. Pregnancy

Risk Summary There are no adequate and well-controlled clinical studies of NASONEX in pregnant women. In animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased ...

8.2. Lactation

Risk Summary There are no available data on the presence of NASONEX in human milk, the effects on the breastfed child, or the effects on milk production. Other corticosteroids are excreted in human milk. ...

8.4. Pediatric Use

The safety and effectiveness of NASONEX for allergic rhinitis in children 12 years of age and older have been established [see Adverse Reactions (6.1) and Clinical Studies (14.1)]. Use of NASONEX ...

8.5. Geriatric Use

A total of 280 patients above 64 years of age with allergic rhinitis or nasal polyps (age range 64 to 86 years) have been treated with NASONEX for up to 3 or 4 months, respectively. The adverse reactions ...

8.7. Hepatic Impairment

Concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see Clinical Pharmacology (12.3)].

10. Overdosage

There are no data available on the effects of acute or chronic overdosage with NASONEX. Because of low systemic bioavailability, and an absence of acute drug-related systemic findings in clinical studies, ...

11. Description

Mometasone furoate monohydrate, the active component of NASONEX 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 ...

12.1. Mechanism of Action

NASONEX 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 ...

12.2. Pharmacodynamics

Adrenal Function in Adults: Four clinical pharmacology studies have been conducted in humans to assess the effect of NASONEX at various doses on adrenal function. In one study, daily doses of 200 ...

12.3. Pharmacokinetics

Absorption Mometasone furoate monohydrate administered as a nasal spray suspension has very low bioavailability (<1%) in plasma using a sensitive assay with a lower quantitation limit (LOQ) of 0.25 pcg/mL. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 67 mcg/kg (approximately ...

13.2. Animal Toxicology and/or Pharmacology

Reproduction Toxicology Studies In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above (less than the MRDID in adults on a mcg/m2 basis). Fetal survival ...

14. Clinical Studies

14.1 Allergic Rhinitis in Adults and Adolescents The efficacy and safety of NASONEX in the prophylaxis and treatment of seasonal allergic rhinitis and the treatment of perennial allergic rhinitis have ...

16.1. How Supplied

NASONEX Nasal Spray: 50 mcg mometasone furoate monohydrate is supplied in a white, high-density, polyethylene bottle fitted with a white metered-dose, manual spray pump, and blue cap contains 17 g of product ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light. When NASONEX Nasal Spray, 50 mcg is removed from its cardboard container, prolonged ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). 17.1 Local Nasal Effect Patients should be informed that treatment with NASONEX may be associated with adverse reactions ...