Mometasone furoate

Description

Mometasone Furoate Ointment USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, it is identified 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 g/mol. The compound appears as a white to off-white powder and is practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of Mometasone Furoate Ointment USP, 0.1% contains 1 mg of mometasone furoate in a white to off-white uniform ointment base composed of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), purified water, white wax, and white petrolatum.

Uses and Indications

Mometasone Furoate Ointment, 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 Ointment in patients younger than 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 be avoided unless specifically directed by a physician.

Contraindications

Mometasone Furoate Ointment, 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. Healthcare professionals are advised to periodically evaluate patients who apply a topical steroid over large surface areas or under occlusive dressings 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 during treatment.

Additionally, there is an increased risk of developing cataracts and glaucoma associated with the use of this medication. If patients experience any visual symptoms, a referral to an ophthalmologist should be considered for further evaluation and management.

Side Effects

Patients using Mometasone Furoate Ointment, 0.1% may experience a range of adverse reactions. Common adverse reactions reported include burning, pruritus, skin atrophy, tingling or stinging sensations, and furunculosis.

Serious adverse reactions may occur, particularly concerning the hypothalamic-pituitary-adrenal (HPA) axis. Reversible HPA axis suppression has been observed, with potential consequences such as glucocorticosteroid insufficiency following treatment withdrawal, Cushing’s syndrome, and hyperglycemia due to systemic absorption. Patients applying the ointment over large surface areas or under occlusion should be monitored periodically for signs of HPA axis suppression, and treatment should be modified if such suppression is detected.

Pediatric patients are particularly vulnerable to systemic toxicity. In clinical studies, HPA axis suppression was noted in approximately 27% of pediatric subjects aged 6 to 23 months, who initially exhibited normal adrenal function prior to treatment. Follow-up assessments indicated that three subjects continued to show suppressed HPA axis function after discontinuation of the ointment. The risk of HPA axis suppression and Cushing’s syndrome is greater in children compared to adults, and they may also experience glucocorticosteroid insufficiency during or after treatment withdrawal. Additional manifestations of adrenal suppression in children may include low plasma cortisol levels and a lack of response to ACTH stimulation. Symptoms of intracranial hypertension, such as bulging fontanelles, headaches, and bilateral papilledema, have also been reported in this population.

Furthermore, the use of Mometasone Furoate Ointment, 0.1% may increase the risk of cataracts and glaucoma; therefore, if patients experience visual symptoms, a referral to an ophthalmologist should be considered.

It is important to note that Mometasone Furoate Ointment, 0.1% is contraindicated in individuals with a history of hypersensitivity to any of its components. Additionally, the topical application of this ointment can lead to systemic effects due to sufficient absorption.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 Ointment, 0.1% may be used with caution in pediatric patients aged 2 years and older; however, the safety and efficacy of its use for longer than 3 weeks have not been established. The use of this medication is not recommended in pediatric patients under 2 years of age due to insufficient safety and efficacy data.

In clinical studies, Mometasone Furoate Ointment, 0.1% was associated with HPA axis suppression in approximately 27% of pediatric subjects aged 6 to 23 months, who had normal adrenal function prior to treatment. These subjects were treated for about 3 weeks, covering a mean body surface area of 39% (range 15%-99%). Pediatric patients are at a higher risk of HPA axis suppression and Cushing’s syndrome compared to adults, primarily due to their greater skin surface area relative to body mass.

Additionally, pediatric patients may be more susceptible to skin atrophy, including striae, when treated with topical corticosteroids. Those applying topical corticosteroids to more than 20% of their body surface area are at an increased risk of HPA axis suppression. Adverse effects associated with topical corticosteroid use in children may include HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension. Signs of adrenal suppression can manifest as low plasma cortisol levels and a lack of response to ACTH stimulation, while symptoms of intracranial hypertension may include bulging fontanelles, headaches, and bilateral papilledema.

Mometasone Furoate Ointment, 0.1% is contraindicated for the treatment of diaper dermatitis.

Geriatric Use

Clinical trials of mometasone furoate ointment, 0.1%, included 310 subjects aged 65 years and older, with 57 subjects aged 75 years and older. The data from these trials indicated no overall differences in safety or effectiveness between elderly patients and younger subjects. 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 ointment to elderly patients, considering the potential for increased sensitivity and the need for careful monitoring of therapeutic responses.

Pregnancy

Mometasone Furoate Ointment, 0.1% is classified as Pregnancy Category C. 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, when administered to pregnant rats, rabbits, and mice, resulted in increased fetal malformations. The doses that produced these 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 toxicity was 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 exhibited multiple malformations, including flexed front paws, gallbladder agenesis, umbilical hernia, and hydrocephaly, at topical doses of 150 mcg/kg and above. In oral studies, doses of 700 mcg/kg resulted in increased resorptions and cleft palate, as well as head malformations such as hydrocephaly and domed head. At 2800 mcg/kg, most litters were either aborted or resorbed, while no toxicity was observed at 140 mcg/kg.

When administered subcutaneously to rats throughout pregnancy or during the later stages, a dose of 15 mcg/kg of mometasone furoate caused 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 potential risks and benefits of using mometasone furoate 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. It is not known whether topical administration of corticosteroids, such as Mometasone Furoate Ointment, 0.1%, could result in sufficient systemic absorption to produce detectable quantities in human milk. Therefore, caution should be exercised when this medication is administered to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

Nonclinical Toxicology

There are no adequate and well-controlled studies in pregnant women; therefore, Mometasone Furoate Ointment, 0.1% 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 also demonstrated teratogenic effects following dermal application in laboratory animals.

In studies involving pregnant rats, rabbits, and mice, mometasone furoate was associated with an increase in fetal malformations. The doses that produced these malformations also resulted in decreased fetal growth, as indicated by lower fetal weights and/or delayed ossification. Additionally, mometasone furoate caused dystocia and related complications when administered to rats 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 observed at 180 mcg/kg. No toxicity was noted at a dose of 20 mcg/kg. In rats, topical doses of 600 mcg/kg and above produced umbilical hernias, while a dose of 300 mcg/kg led to delays in ossification without causing malformations. In rabbits, multiple malformations, including flexed front paws, gallbladder agenesis, umbilical hernia, and hydrocephaly, were observed at topical doses of 150 mcg/kg and above. An oral study indicated that mometasone furoate increased resorptions and caused cleft palate and/or head malformations at 700 mcg/kg, with most litters aborted or resorbed at 2800 mcg/kg. No toxicity was observed at 140 mcg/kg. Furthermore, when rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages, a dose of 15 mcg/kg resulted in prolonged and difficult labor, as well as reduced live births, birth weight, and early pup survival; similar effects were not observed at 7.5 mcg/kg.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate ointment, 0.1%. However, long-term carcinogenicity studies conducted via inhalation in rats and mice showed no statistically significant increase in tumors at inhalation doses up to 67 mcg/kg in a 2-year study in Sprague Dawley rats and up to 160 mcg/kg in a 19-month study in Swiss CD-1 mice. Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. It was not mutagenic in the Ames test or mouse lymphoma assay and 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.

In reproductive studies involving rats, no impairment of fertility was observed in male or female rats at subcutaneous doses up to 15 mcg/kg.

Postmarketing Experience

Mometasone Furoate Ointment, 0.1% has been associated with various serious side effects reported through voluntary channels and surveillance programs. Notably, the ointment may be absorbed through the skin, potentially leading to adrenal gland suppression. Healthcare providers may conduct blood tests to monitor adrenal function in patients using this medication.

Additionally, there is a risk of vision problems, including cataracts and glaucoma, associated with the use of topical corticosteroids. Patients are advised to inform their healthcare provider if they experience 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. Patients should discontinue use and consult their healthcare provider if they notice any skin reactions, including pain, tenderness, swelling, or issues with healing.

Commonly reported side effects include burning, itching, skin atrophy, tingling, stinging, and the formation of boils.

Patients are encouraged to report any side effects 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 Ointment, 0.1%. It is essential that patients use the ointment as directed by their physician, emphasizing that it is for external use only. Patients should be cautioned to avoid contact with the eyes and to report any visual symptoms to their healthcare providers immediately.

Instruct patients not to apply Mometasone Furoate Ointment, 0.1% on the face, underarms, or groin areas, and to refrain from using it for any disorder other than that for which it was prescribed. Patients should also be advised against bandaging or otherwise covering the treated skin area in an occlusive manner unless specifically directed by their physician. Any signs of local adverse reactions should be reported to the physician promptly.

It is important to inform patients that Mometasone Furoate Ointment, 0.1% should not be used in the treatment of diaper dermatitis, as the use of diapers or plastic pants may create an occlusive dressing. Patients should discontinue therapy once control is achieved and should contact their physician if no improvement is observed within 2 weeks.

Patients must be cautioned not to use other corticosteroid-containing products in conjunction with Mometasone Furoate Ointment, 0.1% without prior consultation with their physician. The ointment is intended for use on the skin only and should not be applied to the eyes, mouth, or vagina. Additionally, it should not be used 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 be advised to avoid using Mometasone Furoate Ointment, 0.1% if they are allergic to mometasone furoate or any of its ingredients. Before initiating treatment, patients should inform their healthcare provider of all medical conditions, particularly if they have a skin infection at the site to be treated. It is also crucial for patients to disclose all medications they are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements, especially if they are using other corticosteroid medications orally or topically.

Patients should use Mometasone Furoate Ointment, 0.1% exactly as instructed by their healthcare provider, applying a thin film to the affected skin area once daily. They should continue using the ointment until the affected area improves and should inform their healthcare provider if there is no improvement after 2 weeks. After application, patients should wash their hands thoroughly. It is important to remind patients that medications may be prescribed for purposes other than those listed in the Patient Information leaflet, and they should not use Mometasone Furoate Ointment, 0.1% for any condition for which it was not prescribed. Furthermore, patients should not share this medication with others, even if they exhibit similar symptoms, as it may cause harm.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in compliance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients may require periodic evaluation for hypothalamic-pituitary-adrenal (HPA) axis suppression, which can be assessed using the adrenocorticotropic hormone (ACTH) stimulation test. Clinicians should advise patients to report any visual symptoms and consider referral to an ophthalmologist for further evaluation.

In postmarketing experience, cataracts and glaucoma have been reported in patients using topical corticosteroid products, including those containing mometasone.

FDA Insert (PDF)

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

View full prescribing information (PDF)