mometasone furoate 1 MG/ML Topical Cream
Generic Name: MOMETASONE FUROATE
Brand Name: Mometasone Furoate
- Substance Name(s):
- MOMETASONE FUROATE
DRUG INTERACTIONS
7 No drug-drug interaction studies have been conducted with mometasone furoate cream.
OVERDOSAGE
10 Topically applied mometasone furoate cream can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions ( 5.1 )] .
DESCRIPTION
11 Mometasone Furoate Cream USP, 0.1% contains mometasone furoate, USP for topical use.
Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity.
Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27 H 30 Cl 2 O 6 , a molecular weight of 521.43 and the following structural formula: Mometasone furoate, USP is a white to off-white powder, soluble in acetone and methylene chloride.
Each gram of Mometasone Furoate Cream USP, 0.1% contains: 1 mg mometasone furoate, USP in a cream base of aluminum starch octenyl succinate (Dry-Flo Plus (Pure)), hexylene glycol, phospholipon 90 H, phosphoric acid, purified water, titanium dioxide, white petrolatum, and white wax.
mometasone-furoate-structure
CLINICAL STUDIES
14 The safety and efficacy of the mometasone furoate cream for the treatment of corticosteroid-responsive dermatoses were evaluated in two randomized, double-blind, vehicle-controlled clinical trials, one in psoriasis and one in atopic dermatitis.
A total 366 subjects (12 to 81 years of age), of whom 177 received mometasone furoate cream and 181 subjects received vehicle cream, were evaluated in these trials.
Mometasone furoate cream or the vehicle cream were applied once daily for 21 days.
The two trials showed mometasone furoate cream is effective in the treatment of psoriasis and atopic dermatitis.
HOW SUPPLIED
16 /STORAGE AND HANDLING Mometasone furoate cream USP, 0.1% is a white to off-white, uniform and smooth cream and is supplied in 15 g (NDC 68462-192-17) and 45 g (NDC 68462-192-55) tubes.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59 to86°F) [see USP Controlled Room Temperature].
Avoid excessive heat.
RECENT MAJOR CHANGES
Warnings and Precautions Ophthalmic Adverse Reactions ( 5.2 ) 05/2018
GERIATRIC USE
8.5 Geriatric Use Clinical studies of mometasone furoate cream included 190 subjects who were 65 years of age and over and 39 subjects who were 75 years of age and over.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
However, greater sensitivity of some older individuals cannot be ruled out.
DOSAGE FORMS AND STRENGTHS
3 Cream, 0.1%.
Each gram of Mometasone Furoate Cream USP, 0.1% contains 1 mg of mometasone furoate, USP in a white to off-white, uniform and smooth cream.
• Cream, 0.1%.
( 3 )
MECHANISM OF ACTION
12.1 Mechanism of Action Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, 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 A 2 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 A 2 .
INDICATIONS AND USAGE
1 Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.
Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥ 2 years of age.
( 1 )
PEDIATRIC USE
8.4 Pediatric Use Mometasone furoate cream may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established.
Since safety and efficacy of mometasone furoate cream have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended.
In a pediatric trial, 24 atopic dermatitis subjects, of whom 19 subjects were age 2 to 12 years, were treated with mometasone furoate cream once daily.
The majority of subjects cleared within 3 weeks.
Mometasone furoate cream caused HPA axis suppression in approximately 16% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 41% (range 15% to 94%).
The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL.
Follow-up testing 2 to 4 weeks after trial completion, available for 5 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria.
Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology ( 12.2 )] .
Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids.
They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment.
Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids.
Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.
HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids.
Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Mometasone furoate cream should not be used in the treatment of diaper dermatitis.
PREGNANCY
8.1 Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women.
Therefore, mometasone furoate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations.
The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification.
Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.
In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above.
Fetal survival was reduced at 180 mcg/kg.
No toxicity was observed at 20 mcg/kg.
(Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis.) In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above.
A dose of 300 mcg/kg produced delays in ossification, but no malformations.
(Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis.) In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis).
In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg.
At 2800 mcg/kg most litters were aborted or resorbed.
No toxicity was observed at 140 mcg/kg.
(Doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis.) When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival.
Similar effects were not observed at 7.5 mcg/kg.
(Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m 2 basis.)
NUSRING MOTHERS
8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
Because many drugs are excreted in human milk, caution should be exercised when mometasone furoate cream is administered to a nursing woman.
WARNING AND CAUTIONS
5 WARNINGS AND PRECAUTIONS • Reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment, Cushing’s syndrome, and hyperglycemia may occur due to systemic absorption.
Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
Modify use should HPA axis suppression develop.
( 5.1 , 8.4 ) • Pediatric patients may be more susceptible to systemic toxicity.
( 5.1 , 8.4 ) • May increase the risk of cataracts and glaucoma.
If visual symptoms occur, consider referral to an ophthalmologist.
( 5.2 ) 5.1 Effects on Endocrine System Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency.
This may occur during treatment or after withdrawal of treatment.
Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age.
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.
This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.
In a study evaluating the effects of mometasone furoate cream on the HPA axis, 15 grams were applied twice daily for 7 days to six adult subjects with psoriasis or atopic dermatitis.
The results show that the drug caused a slight lowering of adrenal corticosteroid secretion.
If HPA axis suppression is noted, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.
Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.
Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations ( 8.4 )].
5.2 Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma.
Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroids, including the topical mometasone products [see Adverse Reactions (6.2)].
Avoid contact of mometasone furoate cream with eyes.
Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
5.3 Allergic Contact Dermatitis If irritation develops, mometasone furoate cream should be discontinued and appropriate therapy instituted.
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids.
Such an observation should be corroborated with appropriate diagnostic patch testing.
5.4 Concomitant Skin Infections If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used.
If a favorable response does not occur promptly, use of mometasone furoate cream should be discontinued until the infection has been adequately controlled.
INFORMATION FOR PATIENTS
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).
1.
Use mometasone furoate cream as directed by the physician.
It is for external use only.
2.
Avoid contact with the eyes.
3.
Advise patients to report any visual symptoms to their healthcare providers.
4.
Do not use mometasone furoate cream on the face, underarms, or groin areas unless directed by the physician.
5.
Do not use mometasone furoate cream for any disorder other than that for which it was prescribed.
6.
Do not bandage or otherwise cover or wrap the treated skin area so as to be occlusive, unless directed by the physician.
7.
Report any signs of local adverse reactions to the physician.
8.
Advise patients not to use mometasone furoate cream in the treatment of diaper dermatitis.
Do not apply mometasone furoate cream in the diaper area, as diapers or plastic pants may constitute occlusive dressing.
9.
Discontinue therapy when control is achieved.
If no improvement is seen within 2 weeks, contact the physician.
10.
Do not use other corticosteroid-containing products with mometasone furoate cream without first consulting with the physician.
Manufactured by: Glenmark Pharmaceuticals Ltd.
Village Kishanpura, Baddi Nalagarh Road District : Solan, Himachal Pradesh – 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma.com/usa July 2019 glenmark-logo
DOSAGE AND ADMINISTRATION
2 Apply a thin film of mometasone furoate cream, 0.1% to the affected skin areas once daily.
Mometasone furoate cream, 0.1% may be used in pediatric patients 2 years of age or older.
Since safety and efficacy of mometasone furoate cream, 0.1% have not been established in pediatric patients below 2 years of age; use in this age group is not recommended [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )].
Therapy should be discontinued when control is achieved.
If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1)].
Do not use mometasone furoate cream, 0.1% with occlusive dressings unless directed by a physician.
Do not apply mometasone furoate cream, 0.1% in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing.
Avoid contact with eyes.
Wash hands after each application.
Avoid use on the face, groin, or axillae.
Mometasone furoate cream, 0.1% is for topical use only.
It is not for oral, ophthalmic, or intravaginal use.
• Apply a thin film to the affected skin areas once daily.
( 2 ) • Discontinue therapy when control is achieved.
( 2 ) • If no improvement is seen within 2 weeks, reassess diagnosis.
( 2 ) • Do not use with occlusive dressings unless directed by a physician.
( 2 )