MOMETASONE FUROATE LOTION, (MOMETASONE FUROATE TOPICAL SOLUTION USP 0.1%)

/MOMETASONE FUROATE LOTION, (MOMETASONE FUROATE TOPICAL SOLUTION USP 0.1%)
MOMETASONE FUROATE LOTION, (MOMETASONE FUROATE TOPICAL SOLUTION USP 0.1%)2018-09-06T09:12:40+00:00

Prescription Drug Name:

MOMETASONE FUROATE LOTION, (MOMETASONE FUROATE TOPICAL SOLUTION USP 0.1%)

ID:

02247f29-7afe-46dd-a5f6-ef8f8eeec7a3

Code:

34391-3

DESCRIPTION


id: 1681edb6-4c2e-4ef4-b4d1-aaf84369dfd4
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) contains mometasone furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α, 21-dichloro-11β ,17-dihydroxy-16α-methylpregna-1,4-diene-3, 20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula: Mometasone furoate is a white to off-white powder insoluble in water, freely soluble in acetone and in methylene chloride and sparingly soluble in heptane. Each gram of Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) contains: 1 mg of mometasone furoate, USP in a lotion base of isopropyl alcohol (40%), propylene glycol, hydroxypropyl-cellulose, sodium phosphate monobasic monohydrate and water. May also contain phosphoric acid and sodium hydroxide used to adjust the pH to approximately 4.5.

CLINICAL PHARMACOLOGY


id: 3fee25af-4896-4f1a-b8b3-8e34b90a6d62
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Like other topical corticosteroids, mometasone furoate has anti-inflammatory, anti-pruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

INDICATIONS AND USAGE


id: 1ea96d87-04db-40d8-bcbf-c120f52f30f4
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Since safety and efficacy of Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended. (see PRECAUTIONS – Pediatric Use ).

CONTRAINDICATIONS


id: da210e31-d1d9-4116-bcd2-af8dfdecae63
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

ADVERSE REACTIONS


id: 5922e6c1-e310-4936-bd53-8297f2e57006
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

In clinical studies involving 209 patients, the incidence of adverse reactions associated with the use of Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) was 3%. Reported reactions included acneiform reaction, 2; burning, 4; and itching, 1. In an irritation/sensitization study involving 156 normal subjects, the incidence of folliculitis was 3% (4 subjects). The following adverse reactions were reported to be possibly or probably related to treatment with Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) during a clinical study, in 14% of 65 pediatric patients 6 months to 2 years of age: decreased glucocorticoid levels, 4; paresthesia, 2; dry mouth, 1; an unspecified endocrine disorder, 1; pruritus, 1; and an unspecified skin disorder, 1. The following signs of skin atrophy were also observed among 65 patients treated with Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) in a clinical study: shininess 4, telangiectasia 2, loss of elasticity 2, and loss of normal skin markings 3. Striae, thinness and bruising were not observed in this study. The following local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: irritation, dryness, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae and miliaria.

OVERDOSAGE


id: 4f1e5713-0f8b-4c88-b68f-85c115c67759
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Topically applied Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS .)

DOSAGE AND ADMINISTRATION


id: 1a832f72-7dfb-43ef-a59c-407f6682a27f
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Apply a few drops of Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) to the affected areas once daily and massage lightly until it disappears. For the most effective and economical use, hold nozzle of the bottle very close to the affected areas and gently squeeze. Since safety and efficacy of Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended. (see PRECAUTIONS -Pediatric Use ). As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate Lotion (Mometasone Furoate Topical Solution USP 0.1%) should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.

HOW SUPPLIED


id: ec3a434a-e90c-49c6-b610-f80560abe784
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Mometasone Furoate Lotion (Mometasone Furoate Topical Solution
USP 0.1%) is supplied in:
30 mL (27.5 g) NDC 54868-3757-1

60 mL (55 g) NDC
54868-3757-0

Store between 2° and 30°C (36° and 86°F). January 2008 E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville. NEW YORK
11747
I2272A-
R1/08
Relabeling of “Additional Barcode Label” by:

Physicians Total Care,
Inc.
Tulsa, OK      74146

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 mL CARTON


id: 882d11b5-9ed2-4304-a760-41f563cea3f6
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Fougera® MOMETASONE FUROATE LOTION (MOMETASONE FUROATE
TOPICAL SOLUTION USP 0.1%)
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
Rx only 60 mL DO NOT USE IN EYES