Mometasone furoate

Description

Mometasone Furoate Ointment USP, 0.1% contains mometasone furoate, a synthetic corticosteroid with anti-inflammatory properties, intended for topical use. The chemical structure of mometasone furoate 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 521.4.

Mometasone furoate appears as a white to off-white powder that 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, formulated in a white to off-white uniform ointment base consisting of hexylene glycol, propylene glycol stearate, white petrolatum, and white wax.

Uses and Indications

Mometasone Furoate Ointment USP, 0.1% 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 individuals 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 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 professionals 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 include burning, pruritus, skin atrophy, tingling or stinging sensations, and furunculosis.

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 the withdrawal of treatment. Cushing's syndrome and hyperglycemia may also 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 the use of the medication should be modified if such suppression is detected.

Pediatric patients are noted to be at an increased risk for systemic toxicity. Clinical data indicate that mometasone furoate ointment caused 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 an average of three weeks, covering a mean body surface area of 39%. Follow-up testing revealed that three out of eight subjects continued to show signs of HPA axis suppression after treatment cessation. Due to their higher ratio of skin surface area to body mass, pediatric patients are more susceptible to HPA axis suppression and Cushing's syndrome when treated with topical corticosteroids. They are also at greater risk for glucocorticosteroid insufficiency during and after treatment withdrawal.

In addition, pediatric patients may experience increased susceptibility to skin atrophy, including striae, when treated with topical corticosteroids. Those applying the medication to more than 20% of their body surface area are at an elevated risk of HPA axis suppression. Reports have indicated that children receiving topical corticosteroids may experience HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension. Symptoms of adrenal suppression in children can include low plasma cortisol levels and a lack of response to ACTH stimulation, while manifestations of intracranial hypertension may present as bulging fontanelles, headaches, and bilateral papilledema.

It is important to note that mometasone furoate ointment is contraindicated in patients with a history of hypersensitivity to any of its components. Additionally, the use of this medication may increase the risk of cataracts and glaucoma; therefore, if visual symptoms arise, a referral to an ophthalmologist should be considered.

Drug Interactions

Mometasone furoate ointment has not undergone any drug-drug interaction studies. Therefore, the potential for interactions with other medications remains undefined. Clinicians should exercise caution when prescribing this medication alongside other treatments, as the absence of specific interaction data necessitates careful monitoring of the patient's overall therapeutic regimen.

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 its use for longer than 3 weeks have not been established. The use of mometasone furoate ointment is not recommended in pediatric patients under 2 years of age, as safety and efficacy in this age group have not been determined.

In a study involving pediatric subjects aged 6 to 23 months, approximately 27% experienced HPA axis suppression after treatment for about 3 weeks, despite having normal adrenal function prior to treatment. 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. Additionally, pediatric patients may be more susceptible to skin atrophy, including striae, when treated with topical corticosteroids.

Pediatric patients applying topical corticosteroids to more than 20% of their body surface area are at 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. 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 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 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 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 doses. Specifically, studies have shown that mometasone furoate can increase fetal malformations in pregnant rats, rabbits, and mice. Notably, doses that resulted in malformations also correlated with decreased fetal growth, as evidenced by lower fetal weights and 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 adverse effects were 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 resulted in increased resorptions and cleft palate or head malformations, while doses of 2800 mcg/kg led to significant abortion or resorption of litters. No toxicity was noted at a dose of 140 mcg/kg.

When administered subcutaneously throughout pregnancy or during the later stages, a dose of 15 mcg/kg of mometasone furoate in rats 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 weigh the potential risks and benefits when considering the use of 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. 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 ointment to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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.

Symptoms of Overdosage

Healthcare professionals should be vigilant for signs of systemic corticosteroid effects, which may include but are not limited to adrenal suppression, Cushing's syndrome, and other related symptoms.

Recommended Actions

In the event of suspected overdosage, it is imperative to assess the patient for any systemic effects. Monitoring should include evaluating the patient's clinical status and considering the need for supportive care.

Management Procedures

Management of overdosage primarily involves discontinuation of the topical application of mometasone furoate ointment. If systemic effects are observed, appropriate medical intervention should be initiated based on the severity of the symptoms. Consultation with a poison control center or a medical toxicologist may be warranted for further guidance on management strategies.

Healthcare professionals are encouraged to report any cases of overdosage to the relevant authorities to contribute to ongoing safety monitoring and risk assessment.

Nonclinical Toxicology

Pregnancy Category C indicates that there are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate ointment 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 evidenced by lower fetal weights and/or delayed ossification. Additionally, administration of mometasone furoate to rats during the later stages of pregnancy led to dystocia and related complications. In mice, subcutaneous 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 20 mcg/kg. 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. 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 aborted or resorbed at 2800 mcg/kg; no toxicity was observed at 140 mcg/kg. Furthermore, subcutaneous doses of 15 mcg/kg administered throughout pregnancy or during the later stages 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. 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 do so 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

Postmarketing experience with mometasone furoate ointment has identified several important considerations.

Mometasone furoate ointment is known to permeate the skin, and excessive absorption may lead to adrenal gland suppression. Healthcare providers may conduct blood tests to monitor adrenal function in patients using this medication.

There is an association between the use of topical corticosteroids and an increased risk of ocular complications, including 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 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 delayed healing.

Common side effects associated with mometasone furoate ointment 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

Healthcare providers should instruct patients to use mometasone furoate ointment strictly as directed, emphasizing that it is intended for external use only. Patients should be advised to avoid contact with the eyes and to report any visual symptoms to their healthcare provider promptly.

It is important to inform patients that mometasone furoate ointment should not be applied to the face, underarms, or groin areas, and that it should only be used for the specific condition for which it was prescribed. Patients should be cautioned against bandaging or covering the treated area in a manner that could be occlusive unless directed by their physician.

Patients must be made aware that mometasone furoate ointment is not suitable for treating diaper dermatitis and should not be applied in the diaper area, as diapers or plastic pants may create an occlusive environment. They should also be advised to discontinue therapy once control is achieved and to contact their physician if no improvement is observed within two weeks.

Healthcare providers should remind patients not to use other corticosteroid-containing products concurrently with mometasone furoate ointment without prior consultation. Additionally, it should be emphasized that the ointment is for skin use only and must not be applied to the eyes, mouth, or vagina.

Patients should be informed that mometasone furoate ointment is not recommended for children under 2 years of age, and its safety and efficacy in children beyond three weeks of use have not been established. They should also be advised to avoid using the ointment if they have a known allergy to mometasone furoate or any of its ingredients.

Before initiating treatment, patients should disclose all medical conditions to their healthcare provider, including any plans for pregnancy or breastfeeding. They should be instructed to apply a thin film of the ointment to the affected area once daily and to wash their hands after application.

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

No further data are available.

FDA Insert (PDF)

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

View full prescribing information (PDF)