Mometasone furoate

Description

Mometasone furoate topical solution USP, 0.1% (lotion) contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, it is identified as 9,21-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 soluble in acetone and methylene chloride. Each gram of the topical solution contains 1 mg of mometasone furoate. The lotion base is colorless, clear to light hazy, and includes hydroxypropyl cellulose, isopropyl alcohol (40%), propylene glycol, purified water, and sodium phosphate monobasic monohydrate. Phosphoric acid is incorporated to adjust the pH to approximately 4.5.

Uses and Indications

Mometasone furoate topical solution USP, 0.1% (lotion) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 12 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 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 initiating treatment, 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 USP, 0.1% (lotion) 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 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 associated with this medication. Therefore, careful monitoring and consideration of the risk-benefit profile are advised when prescribing to this population.

Additionally, the use of this medication may elevate the risk of developing cataracts and glaucoma. 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 adverse reactions warranting caution include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may lead to glucocorticosteroid insufficiency following the withdrawal of treatment. This condition, along with Cushing's syndrome and hyperglycemia, can occur due to systemic absorption, particularly in patients applying the topical steroid over large surface areas or under occlusion. Regular evaluations for evidence of HPA axis suppression are recommended, and modifications to treatment should be made if suppression is detected.

Pediatric patients may be at an increased risk for systemic toxicity. Clinical data indicate that mometasone furoate lotion caused HPA axis suppression in approximately 29% of pediatric subjects aged 6 to 23 months, who initially exhibited normal adrenal function prior to treatment. Follow-up assessments revealed suppressed HPA axis function in one subject. Additional manifestations of HPA axis suppression in children may include Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension. Symptoms of adrenal suppression can present as low plasma cortisol levels and a lack of response to ACTH stimulation, while signs of intracranial hypertension may include bulging fontanelles, headaches, and bilateral papilledema.

Furthermore, the use of this medication may increase the risk of cataracts and glaucoma. Patients experiencing visual symptoms should be referred to an ophthalmologist for further evaluation.

It is important to note that mometasone furoate topical solution is contraindicated in individuals with a history of hypersensitivity to any of its components.

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

The safety and efficacy of mometasone furoate lotion have not been established in pediatric patients under 12 years of age; therefore, its use in this population is not recommended. In a study involving pediatric subjects aged 6 to 23 months, approximately 29% experienced hypothalamic-pituitary-adrenal (HPA) axis suppression after treatment for about three weeks, with a mean body surface area of 40% affected. Due to the higher ratio of skin surface area to body mass in pediatric patients, there is an increased risk of HPA axis suppression and Cushing's syndrome compared to adults.

Pediatric patients may also 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 elevated risk for HPA axis suppression. Adverse effects associated with topical corticosteroid use in this population include HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension. Signs of adrenal suppression in children may manifest as low plasma cortisol levels and a lack of response to ACTH stimulation, while symptoms of intracranial hypertension can include bulging fontanelles, headaches, and bilateral papilledema.

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

Geriatric Use

Clinical trials of mometasone furoate lotion 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 experience has 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 with mometasone furoate lotion.

Pregnancy

There are no adequate and well-controlled studies in pregnant women regarding the use of mometasone furoate lotion, which is classified as Pregnancy Category C. 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 increased fetal malformations in pregnant rats, rabbits, and mice. 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 when mometasone furoate was administered 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 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 increased resorptions and caused cleft palate and/or head malformations, such as hydrocephaly and domed head, 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 use in pregnant patients.

Lactation

Systemically administered corticosteroids appear in human milk and may suppress growth, interfere with endogenous corticosteroid production, or cause other adverse effects in breastfed infants. The potential for topical administration of corticosteroids, such as mometasone furoate lotion, 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 lotion to lactating mothers.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding 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.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with any medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient and may involve supportive care, including monitoring vital signs, administering activated charcoal if appropriate, and providing symptomatic treatment as necessary.

In all cases of suspected overdose, contacting a poison control center or a medical toxicologist for guidance on specific management strategies is recommended. Documentation of the incident and any interventions performed should be meticulously recorded in the patient's medical record.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide clear instructions regarding what to do in the event of a missed dose or suspected overdose.

Nonclinical Toxicology

Long-term animal studies have not been conducted to assess the carcinogenic potential of mometasone furoate lotion. However, long-term carcinogenicity studies 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 show 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 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.

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 with Chinese hamster lung cells. The compound was not found to be mutagenic in the Ames test or the mouse lymphoma assay, nor was it clastogenic 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 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 lotion has identified several adverse events reported voluntarily or through surveillance programs.

Mometasone furoate lotion is known to permeate the skin, and excessive absorption may lead to adrenal gland dysfunction. Healthcare providers may conduct blood tests to monitor for potential adrenal issues in patients using this medication.

Vision-related problems have also been reported, with topical corticosteroids potentially increasing the risk of conditions such as cataracts and glaucoma. Patients are advised to inform their healthcare provider if they experience blurred vision or other visual disturbances during treatment.

Skin-related adverse events have been noted, including allergic reactions, such as contact dermatitis, and localized skin infections at the application site. Patients should 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 associated with mometasone furoate lotion include burning, itching, and inflammation of hair follicles (folliculitis).

This summary does not encompass all possible side effects. Patients are encouraged to seek medical advice regarding any adverse effects and may report side effects to the FDA at 1-800-FDA-1088.

Patient Counseling

Advise patients to read the FDA-approved patient labeling (Patient Information) carefully before using mometasone furoate lotion. It is essential that patients use the lotion as directed by their healthcare provider, 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 provider immediately.

Inform patients that mometasone furoate lotion 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. Patients must not bandage or cover the treated skin area in a manner that is occlusive unless directed by their physician. They should also report any signs of local adverse reactions to their healthcare provider.

Patients should be cautioned against using mometasone furoate lotion for the treatment of diaper dermatitis, as applying it in the diaper area may lead to occlusive dressing due to diapers or plastic pants. Advise patients to discontinue therapy once control is achieved and to 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 lotion without prior consultation with their healthcare provider. Additionally, patients should be reminded that the lotion is intended for use on the skin only and must not be applied to the eyes, mouth, or vagina.

Patients under 12 years of age should not use mometasone furoate lotion. Before starting treatment, patients should disclose all medical conditions to their healthcare provider, particularly if they have a skin infection at the treatment site. Pregnant patients or those planning to become pregnant should inform their healthcare provider, as the effects of mometasone furoate lotion on an unborn baby are not fully understood. Similarly, breastfeeding patients should discuss their plans with their healthcare provider, as it is unknown if the lotion passes into breast milk.

Patients should use mometasone furoate lotion exactly as instructed by their healthcare provider, applying a few drops to the affected skin area once daily and rubbing it in lightly until it disappears. They should continue using the lotion until the affected area improves and notify their healthcare provider if there is no improvement after two weeks. It is also important for patients to wash their hands after applying the lotion.

Finally, remind patients that medications may be prescribed for purposes other than those listed in the Patient Information leaflet. They should not use mometasone furoate lotion for any condition other than that for which it was prescribed and should not share it with others, even if they have similar symptoms, as it may cause harm.

Storage and Handling

Mometasone furoate topical solution USP, 0.1% (lotion) is available in two package configurations: 30-mL (27.5 gram) and 60-mL (55 gram) bottles.

This product should be stored at a temperature range of 20°C to 25°C (68°F to 77°F). Temporary excursions are permissible between 15°C to 30°C (59°F to 86°F) in accordance 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. If irritation occurs, mometasone furoate lotion should be discontinued, and appropriate therapy should be initiated. It is important to note that allergic contact dermatitis associated with corticosteroids is typically diagnosed by observing a failure to heal, rather than a clinical exacerbation, and should be confirmed with diagnostic patch testing.

In postmarketing experience, there have been reports of cataracts and glaucoma associated with the use of 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 Encube Ethicals, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)