Mometasone furoate

Description

Mometasone Furoate Topical Solution USP, 0.1% (Lotion) is formulated for topical use and contains mometasone furoate, USP, a synthetic corticosteroid exhibiting anti-inflammatory properties. 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 g/mol.

Mometasone furoate, USP appears as a white to off-white powder and is soluble in acetone and methylene chloride. Each gram of Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains 1 mg of mometasone furoate, USP, incorporated into a lotion base consisting of hydroxypropyl cellulose, isopropyl alcohol (40%), propylene glycol, sodium phosphate monobasic monohydrate, and purified water. Phosphoric acid is included to adjust the pH to approximately 4.5.

Uses and Indications

Mometasone furoate topical solution (lotion) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 12 years and older.

Limitations of Use: The safety and efficacy of mometasone furoate topical solution in patients under 12 years of age have not been established. There are no teratogenic or nonteratogenic effects reported in the available data.

Dosage and Administration

Healthcare professionals are advised to apply a few drops of the medication to the affected skin areas once daily. The application should be followed by a light massage until the product is fully absorbed.

Therapy should be discontinued once adequate control of the condition is achieved. In cases where no improvement is observed within 2 weeks of treatment 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 topical solution is contraindicated in patients with a history of hypersensitivity to any of the components in the preparation. 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 are applying 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 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 mometasone furoate topical solution may experience a range of adverse reactions. Common adverse reactions reported include acneiform reactions, burning, itching, and folliculitis.

Serious warnings associated with the use of this medication include the potential for reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may lead to glucocorticosteroid insufficiency following withdrawal of treatment. Additionally, Cushing’s syndrome and hyperglycemia may occur due to systemic absorption, particularly in patients applying the topical steroid over 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 observed.

Pediatric patients may be particularly susceptible to systemic toxicity, with reports indicating that they are at an increased risk for HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension when receiving topical corticosteroids. 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. Notably, pediatric patients applying topical corticosteroids to more than 20% of their body surface area are at an elevated risk for HPA axis suppression.

Furthermore, the use of mometasone furoate topical solution 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 this medication is contraindicated in individuals with a history of hypersensitivity to any of its components.

Drug Interactions

No drug-drug interaction studies have been conducted with mometasone furoate topical solution. Therefore, the potential for pharmacodynamic or pharmacokinetic interactions with other medications remains undefined. Clinicians are advised to exercise caution when prescribing mometasone furoate in conjunction with other therapies, and to monitor patients for any unexpected effects or changes in therapeutic response.

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

The safety and efficacy of mometasone furoate topical solution have not been established in pediatric patients below 12 years of age; therefore, its use in this age group is not recommended. In a study involving pediatric subjects aged 6 to 23 months, approximately 29% experienced HPA axis suppression after treatment for about 3 weeks, with a mean body surface area of 40% (range 16% to 90%). Due to a higher ratio of skin surface area to body mass, pediatric patients are at an increased risk of HPA axis suppression and Cushing’s syndrome when treated with topical corticosteroids.

Pediatric patients are also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Additionally, they may be more susceptible to skin atrophy, including striae, when using topical corticosteroids. Those applying topical corticosteroids to more than 20% of their body surface area face a heightened risk of HPA axis suppression. Reports have indicated that pediatric patients receiving topical corticosteroids may experience adverse effects such as HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension.

Manifestations of adrenal suppression in children can include low plasma cortisol levels and an absence of response to ACTH stimulation. Symptoms of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema. Mometasone furoate topical solution is contraindicated for the treatment of diaper dermatitis.

Geriatric Use

Clinical trials of mometasone furoate topical solution did not include a sufficient number of subjects aged 65 and over to determine whether they respond differently from younger patients. However, other reported clinical experiences have not identified any significant differences in responses between elderly patients and their younger counterparts.

In general, dose selection for geriatric patients should be approached with caution. It is advisable to start at the low end of the dosing range to minimize the risk of adverse effects and to ensure safety in this population. Regular monitoring may be warranted to assess efficacy and tolerability in elderly patients receiving treatment.

Pregnancy

There are no adequate and well-controlled studies in pregnant women regarding the use of mometasone furoate topical solution. Therefore, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids, including mometasone furoate, have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. In studies involving pregnant rats, rabbits, and mice, mometasone furoate was associated with increased fetal malformations. The doses that produced these malformations also resulted in decreased fetal growth, as evidenced by lower fetal weights and/or delayed ossification. Additionally, dystocia and related complications were observed in rats when mometasone furoate was administered during the later stages of pregnancy.

Specific findings from animal studies indicate that in mice, subcutaneous 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 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, topical doses of 150 mcg/kg and above caused multiple malformations, including flexed front paws, gallbladder agenesis, umbilical hernia, and hydrocephaly. An oral study in rabbits indicated that at 700 mcg/kg, there was an increase in resorptions and the occurrence of cleft palate and/or head malformations, with most litters being 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 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 mometasone furoate topical solution in pregnant patients and women of childbearing potential.

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 for topical administration of corticosteroids to result in sufficient systemic absorption to produce detectable quantities in human milk is not known. Therefore, caution should be exercised when administering mometasone furoate topical solution 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 patients 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 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 topical solution has the potential to be absorbed in sufficient quantities to elicit systemic effects.

In the event of an overdosage, healthcare professionals should be vigilant for signs and symptoms associated with systemic corticosteroid effects. These may include, but are not limited to, adrenal suppression, Cushing's syndrome, and other corticosteroid-related adverse effects.

Management of overdosage should focus on symptomatic treatment and supportive care. It is essential to monitor the patient closely for any signs of systemic corticosteroid effects and to provide appropriate interventions as necessary. If significant symptoms arise, consultation with a medical toxicologist or poison control center may be warranted to guide further management.

Healthcare professionals are advised to educate patients on the importance of adhering to prescribed dosages to minimize the risk of overdosage and its associated complications.

Nonclinical Toxicology

Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate topical solution. However, long-term carcinogenicity studies have been conducted via the inhalation route in 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 based on mcg/m². 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.

In terms of mutagenicity, mometasone furoate increased chromosomal aberrations in an in vitro assay using Chinese hamster ovary cells; however, it did not increase chromosomal aberrations in an in vitro assay using Chinese hamster lung cells. 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, it did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.

Reproductive studies in rats indicated that mometasone furoate did not impair 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 based on mcg/m².

Postmarketing Experience

Postmarketing experience with mometasone furoate topical solution has identified several serious side effects. Vision problems, including the potential development of cataracts and glaucoma, have been reported. Patients are advised to inform their healthcare provider if they experience blurred vision or other vision-related issues during treatment.

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

Commonly reported side effects include burning, itching, and inflammation of the hair follicle (folliculitis). It is important to note that these are not all possible side effects associated with mometasone furoate topical solution. Patients are encouraged to seek medical advice regarding any side effects and may report adverse events to the FDA at 1-800-FDA-1088.

Patient Counseling

Patients should be advised to read the FDA-approved patient labeling (Patient Information) prior to using mometasone furoate topical solution. It is essential that patients use this medication strictly as directed by their healthcare provider, emphasizing that it is 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.

Patients must be informed that mometasone furoate topical solution should not be applied to the face, underarms, or groin areas, and it should only be used for the specific disorder for which it was prescribed. Additionally, patients should not bandage or cover the treated skin area in a manner that is occlusive unless specifically directed by their physician.

It is important to counsel patients against using mometasone furoate topical solution for diaper dermatitis, as the use of diapers or plastic pants may create an occlusive dressing. Patients should be instructed to discontinue therapy once control is achieved and to contact their healthcare provider if no improvement is observed within two weeks.

Healthcare providers should advise patients not to use other corticosteroid-containing products concurrently with mometasone furoate topical solution without prior consultation. This medication is not recommended for use in children under 12 years of age, and patients should be cautioned against using it if they have a known allergy to mometasone furoate or any of its ingredients.

Before initiating treatment, patients should inform their healthcare provider of all existing medical conditions. The proper application technique involves applying a few drops of the solution to the affected skin area once daily and rubbing it in lightly until it disappears. Patients should wash their hands after application.

Patients should be made aware that mometasone furoate topical solution can be absorbed through the skin, potentially affecting adrenal gland function. Healthcare providers may conduct blood tests to monitor for any adrenal gland issues. Patients should report any development of blurred vision or other vision problems during treatment, as well as any skin reactions such as pain, tenderness, swelling, or issues with healing.

Common side effects include burning, itching, and inflammation of the hair follicle (folliculitis). Patients should be encouraged to seek medical advice regarding any side effects and may report them to the FDA at 1-800-FDA-1088.

Finally, patients should be instructed to store mometasone furoate topical solution 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

Mometasone Furoate Topical Solution USP, 0.1% (Lotion) is supplied in a container that meets the necessary specifications for pharmaceutical products. 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) in accordance with USP 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 avoid contact of mometasone furoate topical solution with the eyes and to report any visual symptoms, considering a referral to an ophthalmologist for further evaluation if necessary.

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 Glenmark Pharmaceuticals Inc. , USA. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)