Mometasone furoate

Uses and Indications

Mometasone Furoate Ointment 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 Ointment 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 observed, 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. Regular eye examinations may be warranted to monitor for these potential complications.

Side Effects

Patients using Mometasone Furoate Ointment 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, including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which can lead to glucocorticosteroid insufficiency following the withdrawal of treatment. Patients applying the ointment to large surface areas or under occlusion should be monitored periodically for signs of HPA axis suppression. If such suppression is detected, it is advised to modify the treatment regimen accordingly. Additionally, there is a potential risk of developing Cushing's syndrome and hyperglycemia due to systemic absorption of the medication.

Pediatric patients may be particularly susceptible to systemic toxicity associated with topical corticosteroids. Reports indicate that children receiving these treatments may experience HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension. Symptoms of adrenal suppression in this population can include low plasma cortisol levels and a lack of response to adrenocorticotropic hormone (ACTH) stimulation. Intracranial hypertension may manifest as bulging fontanelles, headaches, and bilateral papilledema.

Furthermore, the use of Mometasone Furoate Ointment 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 Ointment 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 Ointment. Therefore, the potential for drug interactions remains undefined. Clinicians are advised to exercise caution when prescribing this medication in conjunction with other therapies, 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 Ointment may be used with caution in pediatric patients aged 2 years and older; however, the safety and efficacy of prolonged use beyond 3 weeks have not been established. Its use is not recommended in pediatric patients under 2 years of age due to insufficient safety and efficacy data.

In clinical observations, approximately 27% of pediatric subjects aged 6 to 23 months experienced HPA axis suppression after treatment with Mometasone Furoate Ointment for about 3 weeks, despite having normal adrenal function prior to treatment. Pediatric patients are at an increased risk of HPA axis suppression and Cushing's syndrome when treated with topical corticosteroids, attributed to their higher skin surface area-to-body mass ratio. Additionally, they are more susceptible to glucocorticosteroid insufficiency during and after treatment withdrawal.

The risk of skin atrophy, including striae, is also heightened in pediatric patients compared to adults. Those applying topical corticosteroids to more than 20% of their body surface area face an elevated 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. Manifestations 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.

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

Geriatric Use

Clinical trials of Mometasone Furoate Ointment 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 their younger counterparts. Additionally, other reported clinical experiences have not identified significant differences in responses between geriatric patients and younger individuals.

It is important to note, however, that greater sensitivity to 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 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 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, administration of mometasone furoate to rats during the end of pregnancy resulted in dystocia and related complications.

In mice, subcutaneous doses of 60 mcg/kg and above led to the occurrence of 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 resulted in umbilical hernias, while a dose of 300 mcg/kg caused delays in ossification without producing 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 at 700 mcg/kg, mometasone furoate increased resorptions and caused 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 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 ointment 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 Ointment, 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 Ointment 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 these patients to ensure safety and efficacy.

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

Topically applied Mometasone Furoate Ointment 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 indicative of systemic corticosteroid effects. These may include, but are not limited to, adrenal suppression, Cushing's syndrome, and other related complications.

Management of overdosage should focus on symptomatic treatment and supportive care. It is essential to monitor the patient closely for any adverse reactions and to provide appropriate interventions as necessary. If systemic effects are observed, the healthcare provider may consider tapering any ongoing corticosteroid therapy and implementing measures to mitigate the effects of overdosage.

Healthcare professionals are advised to report any cases of overdosage to the appropriate regulatory authorities to contribute to ongoing safety monitoring and risk assessment.

Nonclinical Toxicology

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Mometasone Furoate Ointment. However, long-term carcinogenicity studies of mometasone furoate were 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 from Mometasone Furoate Ointment 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 Ointment 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 impairment of fertility was not observed 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 Ointment on a mcg/m² basis.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Patients should be advised to read the FDA-approved patient labeling (Patient Information) prior to using Mometasone Furoate Ointment. It is essential that the ointment is used strictly as directed by the physician and is intended for external use only. Patients must be cautioned to avoid contact with the eyes and to report any visual symptoms to their healthcare providers immediately.

Healthcare providers should instruct patients not to apply Mometasone Furoate Ointment to the face, underarms, or groin areas. It is important to emphasize that the ointment should only be used for the specific disorder for which it was prescribed. Patients should also be informed not to bandage or cover the treated skin area in a manner that is occlusive unless directed by their physician.

Patients must be made aware of the need to report any signs of local adverse reactions to their physician. Additionally, they should be advised against using Mometasone Furoate Ointment for the treatment of diaper dermatitis, as applying it in the diaper area may lead to occlusive dressing due to the use of 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 guidance. Lastly, it is crucial to inform patients not to use other corticosteroid-containing products in conjunction with Mometasone Furoate Ointment without prior consultation with their physician.

Storage and Handling

Mometasone Furoate Ointment USP is available in two package configurations: 15-gram tubes and 45-gram tubes.

For optimal storage, the ointment should be maintained at a temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F), in accordance with USP Controlled Room Temperature guidelines. Proper handling and storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be advised to read the FDA-approved patient labeling for Mometasone Furoate Ointment and to use the medication strictly as directed by their physician, as it is intended for external use only. It is important to avoid contact with the eyes and to report any visual symptoms to healthcare providers. The ointment should not be applied to the face, underarms, or groin areas, nor should it be used for any condition other than that for which it was prescribed.

Patients should refrain from bandaging or covering the treated area in an occlusive manner unless instructed by their physician. Any signs of local adverse reactions should be reported to the physician. Mometasone Furoate Ointment is not recommended for the treatment of diaper dermatitis, as the use of diapers or plastic pants may create an occlusive environment. Therapy should be discontinued once control is achieved, and if no improvement is observed within two weeks, patients should contact their physician. Additionally, patients should not use other corticosteroid-containing products concurrently with Mometasone Furoate Ointment without prior consultation with their physician.

FDA Insert (PDF)

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

View full prescribing information (PDF)