Mometasone furoate

Description

Mometasone Furoate Cream USP, 0.1% contains mometasone furoate, USP, a synthetic corticosteroid with anti-inflammatory properties, intended for topical use. The chemical structure of mometasone furoate, USP 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 521.43. The compound appears as a white to off-white powder and is soluble in acetone and methylene chloride.

Each gram of Mometasone Furoate Cream USP, 0.1% contains 1 mg of mometasone furoate, USP, formulated in a cream base that includes aluminum starch octenyl succinate (Dry-Flo Plus (Pure)), hexylene glycol, phospholipon 90 H, phosphoric acid, purified water, titanium dioxide, white petrolatum, and white wax.

Uses and Indications

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

Limitations of Use: The safety and efficacy of mometasone furoate cream in pediatric patients under 2 years of age have not been established. There are no reported 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 only be undertaken if specifically directed by a physician.

Contraindications

Mometasone furoate cream, 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 periodically evaluate patients who apply a topical steroid over large surface areas or under occlusive dressings for signs of HPA axis suppression. Should any evidence of suppression be identified, it is recommended to modify the treatment regimen accordingly.

Pediatric patients are particularly vulnerable to systemic toxicity associated with this medication. Therefore, careful monitoring and consideration of the risk-benefit profile are advised when prescribing to this population.

Additionally, there is an increased risk of developing cataracts and glaucoma 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. Regular eye examinations may be warranted to monitor for these potential complications.

Side Effects

Patients using mometasone furoate cream may experience a range of adverse reactions. The most common adverse reactions reported include burning, pruritus, and skin atrophy.

Serious adverse reactions may occur, particularly with prolonged use or inappropriate application. There is a risk of reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which can lead to glucocorticosteroid insufficiency following the withdrawal of treatment. This risk is heightened in pediatric patients, who may be more susceptible to systemic toxicity due to a higher ratio of skin surface area to body mass. In clinical studies, HPA axis suppression was observed in approximately 16% of pediatric subjects aged 6 to 23 months, who had normal adrenal function prior to treatment. These subjects were treated for an average of three weeks over a mean body surface area of 41%. Follow-up testing indicated that one subject continued to exhibit suppressed HPA axis function after treatment cessation.

Patients applying topical steroids to large surface areas or under occlusion should be monitored periodically for signs of HPA axis suppression. If such suppression is detected, modification of treatment is advised. Additionally, the use of mometasone furoate cream may increase the risk of cataracts and glaucoma; therefore, if visual symptoms arise, referral to an ophthalmologist should be considered.

In pediatric patients, the use of topical corticosteroids has been associated with various adverse effects, including Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension. Symptoms of adrenal suppression in children may manifest as low plasma cortisol levels and a lack of response to ACTH stimulation. Intracranial hypertension may present with bulging fontanelles, headaches, and bilateral papilledema.

It is important to note that mometasone furoate cream can be absorbed systemically, potentially leading to significant effects. As such, careful consideration and monitoring are essential when prescribing this medication, particularly in pediatric populations and in cases of extensive application.

Drug Interactions

No drug-drug interaction studies have been conducted with mometasone furoate cream. Therefore, the potential for drug interactions remains undefined. Clinicians are advised to exercise caution when prescribing this medication in conjunction with other treatments, and to monitor patients for any unexpected effects.

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 may be used with caution in pediatric patients aged 2 years and older. However, the safety and efficacy of this medication for durations longer than 3 weeks have not been established. Its use is not recommended in pediatric patients under 2 years of age due to insufficient data.

In a clinical trial involving 24 subjects with atopic dermatitis, including 19 patients aged 2 to 12 years, the majority achieved clearance within 3 weeks of once-daily treatment with mometasone furoate cream. Despite this, caution is warranted as approximately 16% of pediatric subjects aged 6 to 23 months experienced HPA axis suppression after treatment, with a mean body surface area of 41% treated. The criteria for HPA axis suppression included a basal cortisol level of ≤5 mcg/dL and a 30-minute post-stimulation level of ≤18 mcg/dL. Follow-up testing indicated that 1 of 5 subjects continued to show suppressed HPA axis function.

Pediatric patients are at a higher risk of HPA axis suppression and Cushing’s syndrome due to their greater skin surface area relative to body mass. This population may also experience increased susceptibility to skin atrophy, including striae, particularly when topical corticosteroids are applied to more than 20% of the body surface. Adverse effects associated with topical corticosteroid use in children include HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension. Symptoms of adrenal suppression may manifest as low plasma cortisol levels and a lack of response to ACTH stimulation, while signs of intracranial hypertension can include bulging fontanelles, headaches, and bilateral papilledema.

Mometasone furoate cream is contraindicated for the treatment of diaper dermatitis.

Geriatric Use

Clinical studies of mometasone furoate cream included 190 subjects aged 65 years and older, with 39 subjects aged 75 years and older. The data from these studies indicated 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 to the effects of the medication 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 and the need for careful monitoring of treatment responses.

Pregnancy

Mometasone furoate cream is classified as a Pregnancy Category C medication. There are no adequate and well-controlled studies in pregnant women; therefore, the use of mometasone furoate during pregnancy should only be considered if the potential benefits justify the potential risks to the fetus.

Corticosteroids, including mometasone furoate, have demonstrated teratogenic effects in laboratory animals when administered systemically at relatively low dosages. Specifically, studies have shown that mometasone furoate can lead to increased fetal malformations in pregnant rats, rabbits, and mice. These malformations were 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 late pregnancy.

In murine studies, 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, which is approximately 0.01 times the estimated maximum clinical topical dose based on mcg/m². In rats, topical doses of 600 mcg/kg and above produced umbilical hernias, while a dose of 300 mcg/kg caused delays in ossification without malformations, corresponding to approximately 0.2 and 0.4 times the estimated maximum clinical topical dose, respectively.

Rabbits exposed to 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 led to increased resorptions and cleft palate or head malformations, with significant adverse outcomes, including abortion or resorption of most litters at 2800 mcg/kg. No toxicity was noted at 140 mcg/kg, which is approximately 0.2 times the estimated maximum clinical topical dose.

Furthermore, when administered subcutaneously throughout pregnancy or during the later stages, a dose of 15 mcg/kg resulted in prolonged and difficult labor, reduced live births, lower birth weights, and decreased early pup survival in rats. These effects were not observed at a lower dose of 7.5 mcg/kg, which is approximately 0.005 times the estimated maximum clinical topical dose.

Given these findings, healthcare professionals should carefully weigh the potential risks and benefits when considering the use of mometasone furoate cream in pregnant patients.

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 to lactating mothers.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 has the potential to be absorbed in sufficient quantities to elicit systemic effects. In cases of overdosage, healthcare professionals should be vigilant for signs and symptoms indicative of systemic corticosteroid effects, which may include but are not limited to adrenal suppression, Cushing's syndrome, and other related complications.

Management of overdosage should focus on the immediate assessment of the patient's clinical status. If systemic effects are suspected, it is recommended to monitor the patient closely for any adverse reactions. Supportive care should be provided as necessary, and specific interventions may be required based on the severity of symptoms observed.

In the event of significant overdosage, discontinuation of the topical application is advised, and further evaluation may be warranted to determine the need for additional therapeutic measures. It is essential for healthcare professionals to remain alert to the potential for systemic absorption, particularly in patients using the cream over large surface areas or under occlusive dressings.

Nonclinical Toxicology

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

In terms of mutagenicity, mometasone furoate increased chromosomal aberrations in an in vitro assay using Chinese hamster ovary cells; however, it did not induce chromosomal aberrations in an in vitro assay using Chinese hamster lung cells. Mometasone furoate was found to be non-mutagenic in the Ames test and the mouse lymphoma assay. Additionally, 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. Furthermore, mometasone furoate did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

Reproductive studies conducted in rats indicated that subcutaneous doses of mometasone furoate up to 15 mcg/kg, approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate cream on a mcg/m² basis, did not result in impairment of fertility in either male or female rats.

Postmarketing Experience

Postmarketing experience with mometasone furoate cream has identified several serious side effects reported voluntarily or through surveillance programs. Patients have experienced burning, itching, and thinning of the skin (atrophy) during treatment.

Additionally, there is a potential risk for vision problems associated with the use of topical corticosteroids, including an increased likelihood of developing cataracts and glaucoma. Patients are advised to inform their healthcare provider if they experience blurred vision or other vision-related issues while using mometasone furoate cream.

Skin-related adverse events have also been reported, including allergic reactions such as contact dermatitis and skin infections at the site of application. Patients should discontinue use and consult their healthcare provider if they notice any skin reactions, including pain, tenderness, swelling, or difficulties in healing.

For any side effects experienced, patients are encouraged to seek medical advice and may report these events to the FDA at 1-800-FDA-1088.

Patient Counseling

Advise patients to read the FDA-approved patient labeling (Patient Information) prior to using mometasone furoate cream. It is essential that patients use the cream as directed by their physician, emphasizing that it is for external use only. Patients should be instructed to avoid contact with the eyes and to report any visual symptoms to their healthcare providers immediately.

Inform patients that mometasone furoate cream should not be applied to the face, underarms, or groin areas unless specifically directed by their physician. They should also be cautioned against using the cream for any condition other than that for which it was prescribed. Additionally, patients should not bandage or cover the treated skin area in a manner that is occlusive unless directed by their physician.

Patients must be advised not to use mometasone furoate cream for the treatment of diaper dermatitis and to avoid applying it in the diaper area, as diapers or plastic pants may create an occlusive dressing. They should discontinue therapy once control is achieved and contact their physician if no improvement is observed within two weeks.

It is important to inform patients not to use other corticosteroid-containing products in conjunction with mometasone furoate cream without first consulting their physician. Patients should be reminded that the cream is intended for use on the skin only and must not be applied to the eyes, mouth, or vagina. They should also be advised against using the cream if they are allergic to mometasone furoate or any of its ingredients.

Before initiating treatment, patients should inform their healthcare provider about all medical conditions and any medications they are currently taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Special attention should be given to informing the healthcare provider if they are taking other corticosteroid medications orally or using other corticosteroid products on their skin or scalp.

Mometasone furoate cream is not recommended for use in children under 2 years of age, and its safety and efficacy in children beyond 3 weeks of use have not been established. Patients should wash their hands after applying the cream to prevent unintentional exposure.

Patients should be made aware that excessive absorption of mometasone furoate cream through the skin can lead to adrenal gland suppression. Their healthcare provider may conduct blood tests to monitor for potential adrenal gland issues. They should also report any development of blurred vision or other vision problems during treatment.

Patients must stop using mometasone furoate cream and notify their healthcare provider if they experience any skin reactions, such as pain, tenderness, swelling, or issues with healing. Finally, advise patients to store mometasone furoate cream at room temperature, between 68°F to 77°F (20°C to 25°C), and to keep it and all medications out of the reach of children.

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°C to 30°C (59°F to 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 Glenmark Pharmaceuticals Inc. , USA. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)