Mometasone furoate

Description

Mometasone Furoate Cream USP, 0.1% is formulated for topical application and contains mometasone furoate, a synthetic corticosteroid known for its anti-inflammatory properties. The chemical designation of mometasone furoate is 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 Cream USP, 0.1% contains 1 mg of mometasone furoate, incorporated into a cream base consisting of aluminum starch octenylsuccinate, ceteareth-20, phosphoric acid, propylene glycol, propylene glycol stearate, purified water, stearyl alcohol, titanium dioxide, white petrolatum, and white wax.

Uses and Indications

Mometasone Furoate Cream 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 cream is contraindicated in patients with a history of hypersensitivity to any of the components in the preparation. This contraindication is essential to prevent potential allergic reactions that may occur upon application.

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 apply a topical steroid over large surface areas or under occlusive dressings periodically 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 associated with this medication. Therefore, careful monitoring and consideration of the risk-benefit profile are advised when prescribing to this population.

Additionally, there is an increased risk of developing cataracts and glaucoma 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. Regular eye examinations may be warranted to monitor for these potential complications.

Side Effects

Patients using mometasone furoate cream may experience a range of adverse reactions. Common adverse reactions reported include burning, pruritus, and skin atrophy.

Serious adverse reactions may arise from the systemic absorption of the medication. These include reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which can lead to glucocorticosteroid insufficiency upon withdrawal of treatment. Additionally, Cushing's syndrome and hyperglycemia have been associated with systemic absorption of the topical steroid. Patients applying the cream to large surface areas or under occlusion should be evaluated periodically for signs of HPA axis suppression, and modifications to treatment should be made if such suppression is detected.

Pediatric patients are particularly susceptible to systemic toxicity, with reports indicating that they may experience HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension. Manifestations of adrenal suppression in children may include low plasma cortisol levels and a lack of response to ACTH stimulation. Symptoms of intracranial hypertension can present as bulging fontanelles, headaches, and bilateral papilledema. It is important to note that pediatric patients applying topical corticosteroids to more than 20% of their body surface area are at an increased risk for HPA axis suppression.

Furthermore, the use of mometasone furoate cream may elevate the risk of cataracts and glaucoma; therefore, if patients experience visual symptoms, a referral to an ophthalmologist should be considered.

Mometasone furoate cream is contraindicated in individuals with a history of hypersensitivity to any of its components. It is crucial to recognize that topically applied mometasone furoate can be absorbed in sufficient quantities to produce systemic effects, necessitating careful monitoring of patients during treatment.

Drug Interactions

No drug-drug interaction studies have been conducted with mometasone furoate cream. Therefore, the potential for pharmacodynamic or pharmacokinetic interactions with other medications remains undefined. Clinicians are advised to exercise caution when prescribing mometasone furoate cream in conjunction with other therapies, and to monitor patients for any unexpected clinical 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 cream 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 cream is not recommended in pediatric patients under 2 years of age due to insufficient data on safety and efficacy.

In a clinical trial involving 24 subjects with atopic dermatitis, including 19 children aged 2 to 12 years, the majority achieved clearance within 3 weeks of once-daily treatment with mometasone furoate cream. However, caution is warranted as approximately 16% of pediatric subjects aged 6 to 23 months experienced HPA axis suppression after treatment for about 3 weeks, with a mean body surface area of 41% treated.

Pediatric patients are at a higher risk of HPA axis suppression and Cushing's syndrome due to their greater skin surface area relative to body mass. Those applying topical corticosteroids to more than 20% of their body surface area are particularly susceptible. Additionally, pediatric patients may experience increased skin atrophy, including striae, when treated with topical corticosteroids.

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 cream is contraindicated for the treatment of diaper dermatitis.

Geriatric Use

Clinical studies of mometasone furoate cream included 190 subjects aged 65 years and older, with 39 subjects aged 75 years and older. The data from these studies indicated no overall differences in safety or effectiveness between elderly patients and younger patients. 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 cream to elderly patients, considering the potential for increased sensitivity. Monitoring for adverse effects and therapeutic efficacy is recommended to ensure optimal treatment outcomes in this population.

Pregnancy

There are no adequate and well-controlled studies in pregnant women regarding the use of mometasone furoate cream. 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. Additionally, some corticosteroids have demonstrated teratogenic effects following dermal application in animal studies.

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. Furthermore, administration of mometasone furoate to rats during the end of pregnancy led to dystocia and related complications.

Specific findings from animal studies include that 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 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 caused delays in ossification without malformations. In rabbits, topical doses of 150 mcg/kg and above led to multiple malformations, including flexed front paws, gallbladder agenesis, umbilical hernia, and hydrocephaly. 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.

Additionally, 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 numbers 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 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 cream 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 of these patients.

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 cream has the potential to be absorbed in sufficient quantities to elicit systemic effects. In cases of overdosage, healthcare professionals should be vigilant for signs and symptoms that may arise due to excessive exposure.

Recommended Actions

In the event of suspected overdosage, it is crucial to assess the patient for any systemic effects that may manifest. Monitoring should include evaluating the patient's clinical status and any potential adverse reactions.

Potential Symptoms

Symptoms of overdosage may include, but are not limited to, signs of adrenal suppression, such as fatigue, weakness, and hypotension. Additionally, patients may exhibit signs of Cushing's syndrome, which can include weight gain, hypertension, and glucose intolerance.

Management Procedures

Management of overdosage should focus on symptomatic treatment and supportive care. If systemic effects are observed, it may be necessary to discontinue the use of mometasone furoate cream and initiate appropriate interventions to address the specific symptoms presented. Healthcare professionals are advised to consult relevant clinical guidelines and consider referral to a specialist if severe symptoms develop.

In all cases of overdosage, prompt medical attention is essential to ensure patient safety and effective management of any adverse effects.

Nonclinical Toxicology

There are no adequate and well-controlled studies in pregnant women; therefore, mometasone furoate cream 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 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 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 cream. 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 no statistically significant increase in tumor incidence at inhalation doses 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, 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. In reproductive studies in rats, no impairment of fertility was observed in male or female rats at subcutaneous doses up to 15 mcg/kg.

Postmarketing Experience

Mometasone furoate cream has been associated with various postmarketing experiences reported voluntarily or through surveillance programs.

Excessive absorption of mometasone furoate cream through the skin may lead to adrenal gland suppression, necessitating blood tests by healthcare providers to monitor adrenal function.

There is an increased risk of vision-related issues, such as 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 been reported, including allergic reactions (contact dermatitis) and localized skin infections at the site of application. Patients should discontinue use and consult their healthcare provider if they notice any skin reactions, such as pain, tenderness, swelling, or delayed healing.

The most frequently reported side effects include burning, itching, and skin atrophy.

Patients are encouraged to report any side effects to the FDA at 1-800-FDA-1088.

Patient Counseling

Healthcare providers should advise patients to read the FDA-approved patient labeling (Patient Information) thoroughly. It is essential to inform patients that mometasone furoate cream should be used strictly as directed by their 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 provider immediately. Additionally, they should be instructed not to apply mometasone furoate cream on the face, underarms, or groin areas unless specifically directed by their physician.

It is important to emphasize that mometasone furoate cream should not be used for any condition other than the one for which it was prescribed. Patients should also be advised against bandaging or covering the treated skin area in a manner that could be occlusive, unless directed by their physician.

Healthcare providers should encourage patients to report any signs of local adverse reactions to them. Furthermore, patients must be informed that mometasone furoate cream is not indicated for the treatment of diaper dermatitis and should not be applied in the diaper area, as diapers or plastic pants may create an occlusive dressing.

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 advise patients not to use other corticosteroid-containing products in conjunction with mometasone furoate cream without prior consultation with their physician.

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. It is essential to avoid exposure to excessive heat to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety 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)