Mometasone furoate

Description

Mometasone furoate cream, USP, 0.1% is formulated for topical use and contains mometasone furoate, a synthetic corticosteroid exhibiting anti-inflammatory properties. The chemical structure of mometasone furoate is defined as 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with an empirical formula of C27H30Cl2O6 and a molecular weight of 521.4.

The compound appears as a white to off-white powder that is practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of the cream contains 1 mg of mometasone furoate, USP, incorporated into a cream base consisting of hexylene glycol, phosphoric acid, propylene glycol stearate, stearyl alcohol, ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate, white wax, white petrolatum, and purified water.

Uses and Indications

Mometasone furoate cream, USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 2 years and older.

There are no teratogenic or nonteratogenic effects associated with the use of this medication.

Dosage and Administration

Healthcare professionals are advised to apply a thin film of the medication to the affected skin areas once daily. Treatment should be discontinued once adequate control of the condition is achieved. In cases where no improvement is observed within 2 weeks of initiation, a reassessment of the diagnosis is recommended.

It is important to note that the use of occlusive dressings with this medication should be avoided unless specifically directed by a physician.

Contraindications

Mometasone furoate cream, USP, 0.1% is contraindicated in patients with a history of hypersensitivity to any of the components in the formulation. Use in these patients may lead to severe allergic reactions.

Warnings and Precautions

Reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur with the use of this medication, particularly following withdrawal of treatment. This suppression can lead to glucocorticosteroid insufficiency, Cushing's syndrome, and hyperglycemia due to systemic absorption. It is essential for healthcare professionals to evaluate patients who are applying a topical steroid over large surface areas or under occlusive dressings periodically for signs of HPA axis suppression. Should evidence of suppression be identified, it is recommended to modify the treatment regimen accordingly.

Pediatric patients are particularly vulnerable to systemic toxicity and may require closer monitoring when treated with this medication.

Additionally, there is an increased risk of developing cataracts and glaucoma associated with the use of this medication. Healthcare providers should remain vigilant for any visual symptoms in patients and consider referral to an ophthalmologist for further evaluation if such symptoms arise.

Side Effects

Patients using topical corticosteroids may experience a range of adverse reactions. Common adverse reactions include burning, pruritus, and skin atrophy.

Serious warnings associated with the use of these medications include the potential for reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may lead to glucocorticosteroid insufficiency following the withdrawal of treatment. Additionally, Cushing's syndrome and hyperglycemia may occur due to systemic absorption, particularly in patients applying the steroid to large surface areas or under occlusion. It is recommended that these patients be evaluated periodically for signs of HPA axis suppression, and modifications to treatment should be made if such suppression is detected.

Pediatric patients may be at an increased risk for systemic toxicity, and specific adverse effects such as HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in this population. Manifestations of adrenal suppression in children can include low plasma cortisol levels and a lack of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

Furthermore, there is an increased risk of cataracts and glaucoma associated with the use of topical corticosteroids. If patients experience visual symptoms, a referral to an ophthalmologist should be considered.

Drug Interactions

No drug-drug interaction studies have been conducted with mometasone furoate cream, USP, 0.1%. Therefore, the potential for drug interactions remains undefined. Clinicians are advised to exercise caution when prescribing this medication in conjunction with other treatments, as the absence of specific interaction data necessitates careful monitoring of the patient's overall therapeutic regimen.

Packaging & NDC

The table below lists all NDC Code configurations of Mometasone Furoate, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Mometasone furoate cream, USP, 0.1% may be used with caution in pediatric patients aged 2 years and older; however, the safety and efficacy of treatment beyond 3 weeks have not been established. The use of this medication is not recommended in pediatric patients under 2 years of age, as safety and efficacy in this age group have not been determined.

In a clinical trial involving 24 subjects with atopic dermatitis, including 19 children aged 2 to 12 years, the majority achieved clearance within 3 weeks of once-daily application of mometasone furoate cream, USP, 0.1%. Despite these positive outcomes, pediatric patients are at an increased risk of hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome due to their higher skin surface area-to-body mass ratio. Approximately 16% of pediatric subjects aged 6 to 23 months experienced HPA axis suppression after treatment for about 3 weeks, with a mean body surface area involvement of 41% (range 15%-94%).

Adverse effects associated with topical corticosteroid use in pediatric patients include adrenal insufficiency during and/or after treatment withdrawal, skin atrophy, and increased susceptibility to striae. Pediatric patients applying topical corticosteroids to more than 20% of their body surface area are at a heightened risk for HPA axis suppression. Reports have indicated that manifestations of adrenal suppression may include low plasma cortisol levels and a lack of response to ACTH stimulation, while signs of intracranial hypertension can present as bulging fontanelles, headaches, and bilateral papilledema.

Mometasone furoate cream, USP, 0.1% is contraindicated for the treatment of diaper dermatitis.

Geriatric Use

Clinical studies of mometasone furoate cream, USP, 0.1% included 190 subjects aged 65 years and older, with 39 subjects aged 75 years and older. The data from these studies indicate that there are no overall differences in safety or effectiveness between elderly patients and younger patients. Additionally, other reported clinical experiences have not identified significant differences in responses between geriatric patients and their younger counterparts.

It is important to note, however, that greater sensitivity in some older individuals cannot be ruled out. Therefore, healthcare providers should exercise caution when prescribing mometasone furoate cream to elderly patients, considering the potential for increased sensitivity. Monitoring for adverse effects and therapeutic efficacy is recommended to ensure optimal treatment outcomes in this population.

Pregnancy

Mometasone furoate cream, USP, 0.1% is classified as a Pregnancy Category C medication. There are no adequate and well-controlled studies in pregnant women; therefore, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids, including mometasone furoate, have demonstrated teratogenic effects in laboratory animals when administered systemically at relatively low dosage levels. Specifically, studies have shown that mometasone furoate increases the incidence of fetal malformations in pregnant rats, rabbits, and mice. The doses that resulted in malformations were also associated with decreased fetal growth, as evidenced by lower fetal weights and/or delayed ossification. Additionally, dystocia and related complications were observed in rats treated with mometasone furoate during the later stages of pregnancy.

In mice, subcutaneous administration of mometasone furoate at doses of 60 mcg/kg and above resulted in cleft palate, with reduced fetal survival noted at 180 mcg/kg. No adverse effects were observed at a dose of 20 mcg/kg. In rats, topical application of mometasone furoate at doses of 600 mcg/kg and above led to the development of umbilical hernias, while a dose of 300 mcg/kg caused delays in ossification without producing malformations.

Rabbits treated with mometasone furoate at topical doses of 150 mcg/kg and above exhibited multiple malformations, including flexed front paws, gallbladder agenesis, umbilical hernia, and hydrocephaly. In oral studies, doses of 700 mcg/kg resulted in increased resorptions and cleft palate or head malformations, while doses of 2800 mcg/kg led to the majority of litters being aborted or resorbed. No toxicity was noted at a dose of 140 mcg/kg.

Furthermore, when administered subcutaneously to rats throughout pregnancy or during the later stages, a dose of 15 mcg/kg resulted in prolonged and difficult labor, as well as a reduction in the number of live births, birth weight, and early pup survival. Similar adverse effects were not observed at a lower dose of 7.5 mcg/kg.

Given these findings, healthcare professionals should carefully consider the risks and benefits of using mometasone furoate in pregnant patients and monitor for potential adverse fetal outcomes.

Lactation

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects in breastfed infants. The potential effects of topical administration of corticosteroids on breast milk are not well understood, as it is not known whether such administration could result in sufficient systemic absorption to produce detectable quantities in human milk. Given that many drugs are excreted in human milk, caution should be exercised when administering mometasone furoate cream, USP, 0.1% to lactating mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Topically applied mometasone furoate cream, USP, 0.1% has the potential for systemic absorption, which may lead to overdosage effects. Healthcare professionals should be aware that excessive application or use of this medication can result in significant systemic effects due to its pharmacological properties.

In the event of suspected overdosage, it is crucial to monitor the patient for potential symptoms associated with corticosteroid overexposure. These may include, but are not limited to, signs of adrenal suppression, Cushing's syndrome, or other systemic corticosteroid-related effects.

Management of overdosage should focus on discontinuation of the topical application and supportive care. If systemic effects are observed, appropriate interventions should be initiated based on the severity of the symptoms. Healthcare providers are advised to consult relevant clinical guidelines and consider referral to a specialist if necessary. Regular monitoring and assessment of the patient's condition are essential to ensure appropriate management and recovery.

Nonclinical Toxicology

Long-term animal studies have not been conducted to assess the carcinogenic potential of mometasone furoate cream, USP, 0.1%. However, long-term carcinogenicity studies of mometasone furoate have been performed via the inhalation route in both rats and mice. In a 2-year carcinogenicity study involving Sprague Dawley rats, mometasone furoate did not demonstrate a statistically significant increase in tumor incidence at inhalation doses up to 67 mcg/kg, which is approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate cream, USP, 0.1% on a mcg/m² basis. Similarly, a 19-month carcinogenicity study in Swiss CD-1 mice showed no statistically significant increase in tumor incidence at inhalation doses up to 160 mcg/kg, approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate cream, USP, 0.1% on a mcg/m² basis.

In terms of mutagenicity, mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay; however, it did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not found to be mutagenic in the Ames test or the mouse lymphoma assay, and it did not exhibit clastogenic effects in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Additionally, mometasone furoate did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

Reproductive studies in rats indicated that there was no impairment of fertility in either male or female rats at subcutaneous doses up to 15 mcg/kg, which is approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate cream, USP, 0.1% on a mcg/m² basis.

Postmarketing Experience

Postmarketing experience with mometasone furoate cream, USP, 0.1% has identified several events reported voluntarily or through surveillance programs.

There have been instances of adrenal gland dysfunction associated with excessive absorption of the cream through the skin, prompting healthcare providers to conduct blood tests to monitor adrenal function. Additionally, the use of topical corticosteroids, including mometasone furoate cream, USP, 0.1%, has been linked to an increased risk of vision-related issues, such as cataracts and glaucoma. Patients are advised to report any occurrences of blurred vision or other visual disturbances during treatment.

Skin-related adverse events have also been reported, including allergic reactions, such as contact dermatitis, and localized skin infections at the site of application. Patients are instructed to discontinue use and consult their healthcare provider if they experience symptoms such as pain, tenderness, swelling, or delayed healing.

The most frequently reported side effects of mometasone furoate cream, USP, 0.1% include burning, itching, and skin atrophy.

Patient Counseling

Patients should use mometasone furoate cream, USP, 0.1% strictly as directed by their physician, emphasizing that it is intended for external use only. Healthcare providers should instruct patients to avoid contact with the eyes and to report any visual symptoms that may arise during treatment.

It is important to advise patients against using mometasone furoate cream, USP, 0.1% on the face, underarms, or groin areas unless specifically directed by their physician. Patients should also be informed that this medication should not be used for any condition other than the one for which it was prescribed.

Healthcare providers should counsel patients not to bandage or cover the treated skin area in a manner that creates an occlusive dressing, unless directed by their physician. Patients must be made aware of the need to report any signs of local adverse reactions to their physician promptly.

Additionally, patients should be advised not to use mometasone furoate cream, USP, 0.1% for the treatment of diaper dermatitis, as applying it in the diaper area may lead to occlusion due to diapers or plastic pants.

Patients should discontinue therapy once control of the condition is achieved. If no improvement is observed within two weeks, they should contact their physician for further evaluation. Lastly, healthcare providers should remind patients not to use other corticosteroid-containing products concurrently with mometasone furoate cream, USP, 0.1% without prior consultation with their physician.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15-30°C (59-86°F) as outlined by USP guidelines. Care should be taken to avoid exposure to excessive heat to maintain product integrity.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Mometasone Furoate as submitted by Cosette Pharmaceuticals, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)