Elocon Topical: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash. Mometasone decreases swelling (inflammation), itching, and redness. Mometasone is a medium-strength corticosteroid. This medication is available in several forms including cream, ointment, and lotion (solution). Your doctor will choose the type of product based on the skin condition/area of the body being treated.

How to use Elocon 0.1 % Topical Cream

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is for use only on certain areas of skin: do not use it on the face, groin, or underarms, or for diaper rash, unless directed to do so by your doctor.

Wash and dry your hands before using. Clean and dry the affected area. Apply as directed by your doctor, usually a thin film of medication to the affected area once daily. Gently rub in. Do not cover the treated area with bandages or other dressings unless instructed to do so by your doctor.

Do not wash or rinse the medication off immediately after applying it. Wash your hands with soap and water after each use unless you are using this medication to treat the hands. Avoid getting this medication in your eyes, nose, or mouth. If this occurs, rinse thoroughly with water and call your doctor if irritation lasts.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Do not apply large amounts of this medication, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase.

Tell your doctor if your condition does not improve after 2 weeks of treatment or if it worsens.

Side Effects

Burning, itching, or stinging may occur when you apply this medication, but usually only lasts a short time. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, small red bumps on the skin (folliculitis).

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using mometasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, immune system problems.

Corticosteroids can make skin infections worse and more difficult to treat. Tell your doctor if you have a skin infection so it can be treated. Tell your doctor promptly if your condition does not improve or if you have worsening skin symptoms.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Though it is unlikely, this medication may temporarily slow down a child’s growth if used for a long time. See the doctor regularly so your child’s height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Does Elocon 0.1 % Topical Cream interact with other drugs you are taking?

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Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.

Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for an extended period of time or apply it over large areas of the body. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Mometasone Topical (Elocon) – Side Effects, Interactions, Uses, Dosage, Warnings

Reviewed: June 23, 2020

Mometasone topical is a potent steroid. It reduces the actions of chemicals in the body that cause inflammation.

Mometasone topical (for the skin) is used to treat the symptoms of certain skin conditions, such as pain, redness, warmth, swelling, or itching.

Mometasone topical may also be used for purposes not listed in this medication guide.

uses

What is Mometasone Topical (Elocon) used for?

• Dermatitis
• Dermatitis Herpetiformis
• Eczema
• Psoriasis
• Sunburn
• Dermatitis – Drug-Induced
• Autoimmune Disorder
• Psoriatic Arthropathy
• Diaper Rash

warnings

What is the most important information I should know about Mometasone Topical (Elocon)?

You should not use this medicine if you are allergic to mometasone.

Do not use mometasone topical to treat diaper rash.

Do not use this medicine on any child without a doctor’s advice. Children can absorb larger amounts of this medication through the skin and may be more likely to have side effects. Mometasone topical may not be safe to use on a child for longer than 3 weeks.

Mometasone topical is not approved for use by anyone younger than 2 years old.

Tell your doctor if you have any type of skin infection.

Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk. If you apply mometasone topical to your chest, avoid areas that may come into contact with the baby’s mouth.

Side Effects

What are the side effects of Mometasone Topical (Elocon)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe skin irritation;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights; or
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor.

Mometasone topical can affect growth in children and should not be used long-term.

Common side effects may include:

• red or pus-filled bumps on your skin;
• acne; or
• mild itching, tingling, or burning.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pregnancy & Breastfeeding

Can I take Mometasone Topical (Elocon) if I’m pregnant or breastfeeding?

C

Risk cannot be ruled out

Based on FDA pregnancy categories

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk. If you apply mometasone topical to your chest, avoid areas that may come into contact with the baby’s mouth.

Interactions

What drugs and food should I avoid while taking Mometasone Topical (Elocon)?

Rinse with water if this medicine gets in your eyes.

Avoid applying mometasone topical to the skin of your face, underarms, or groin area unless your doctor has told you to.

Do not use mometasone topical to treat any condition that has not been checked by your doctor.

Dosage Guidelines & Tips

How to take Mometasone Topical (Elocon)?

Use Mometasone Topical (Elocon) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

What should I do if I missed a dose of Mometasone Topical (Elocon)?

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Overdose Signs

What happens if I overdose on Mometasone Topical (Elocon)?

An overdose of mometasone topical is not expected to produce life threatening symptoms. Long term use of high doses can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

If you think you or someone else may have overdosed on: Mometasone Topical (Elocon),  call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn’t breathing after taking Mometasone Topical (Elocon), call 911

911

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Drugs A-Z provides drug information from Everyday Health and our partners, as well as ratings from our members, all in one place. Cerner Multum™ provides the data within some of the Overview, Uses, Warnings, Side Effects, Pregnancy, Interactions, Dosage, Overdose, and Images sections. The information within all other sections is proprietary to Everyday Health. 

cream for external use, ointment for external use, 0.1%, 0.1% visualization:

04/13/2021

Contents

• Active substance
• ATX
• RU owner
• Storage conditions
• Best before date
• Information sources
• Pharmacological group
• Characteristic
• Pharmacology
• Indications for use
• Nosological classification (ICD-10)
• Contraindications
• Use during pregnancy and lactation
• Side effects
• Interaction
• Overdose
• Dosage and administration
• Precautionary measures
• Reviews

Active ingredient

Mometasone* (Mometasone*)

ATX

D07AC13 Mometasone

Owner RU

Schering-Plow Labo N. V.

Storage conditions

At a temperature not higher than 25 °C.

Keep out of reach of children.

Expiry date

3 years.

Do not use after the expiry date which is stated on the packaging.

www.rxlist.com , 2021.

Pharmacological group

Glucocorticoid for topical use

Characteristics

Synthetic GCS with anti-inflammatory action for dermatological use.

Mometasone furoate is a white to off-white powder, practically insoluble in water, readily soluble in acetone and methylene chloride, sparingly soluble in octanol, and sparingly soluble in ethyl alcohol and heptane; the molecular weight is 521.4.

Pharmacology

Mechanism of action

Like other local corticosteroids, mometasone has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of anti-inflammatory action of topical steroids is generally unclear. It is believed that corticosteroids act by inducing proteins that inhibit phospholipase A ₂ , collectively known as lipocortins. These proteins are thought to control the biosynthesis of strong inflammatory mediators such as PG and LT by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A ₂ .

Pharmacokinetics

The degree of percutaneous absorption of local GCS is determined by many factors, including the carrier and the integrity of the epidermal barrier. Hydrocortisone occlusive dressings applied for up to 24 hours did not increase penetration, but hydrocortisone occlusion for 96 hours markedly increased penetration. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Carcinogenicity, mutagenicity, effects on fertility

Long-term animal studies to evaluate the carcinogenic potential of mometasone ointment or lotion have not been conducted. Such studies were carried out with inhalation use in rats and mice. In a two-year carcinogenicity study in Sprague Dawley rats, mometasone did not show a statistically significant increase in tumor incidence at inhaled doses up to 67 mcg/kg, which is approximately 0.04 times the MRDH of mometasone ointment on a body surface area basis. . During 191-month carcinogenicity study in Swiss CD-1 mice, mometasone showed no statistically significant increase in tumor incidence at inhaled doses up to 160 µg/kg (approximately 0.05-fold higher than mometasone’s MRH when applied topically on a surface area basis) bodies).

Mometasone increased the number of chromosome aberrations in in vitro”> in vitro test in Chinese hamster ovary cells, but did not increase the number of chromosome aberrations in in vitro”> in vitro test in Chinese hamster lung cells. Mometasone did not show mutagenicity in the Ames test or in mouse lymphoma cells and clastogenicity in the in vivo mouse micronucleus test”> in vivo , in the analysis of chromosomal aberrations in rat bone marrow or mouse male germ cells. Mometasone also did not induce unscheduled DNA synthesis in vivo “> in vivo in rat hepatocytes.

In reproductive studies in male or female rats, no impairment of fertility was observed at s.c. doses up to 15 µg/kg (approximately 0.01 times the MRDH of topical mometasone on a body surface area basis).

Clinical studies

Studies conducted with mometasone ointment show that it is in the middle range of efficacy compared to other topical corticosteroids.

In a study evaluating the effect of mometasone ointment on the hypothalamic-pituitary-adrenal (HPA) axis, 15 g of the ointment was applied twice daily for 7 days in 6 adult patients with psoriasis or atopic dermatitis. The ointment was applied without occlusion to at least 30% of the body surface. The results showed that mometasone caused a slight decrease in the secretion of corticosteroids by the adrenal glands.

In a study evaluating the effect of mometasone lotion on the HPA axis, 15 ml of lotion was applied without occlusion 2 times a day (30 ml per day) for 7 days in 4 adult patients with psoriasis of the scalp and body. At the end of treatment, plasma cortisol levels in each of the 4 patients remained within the normal range and changed little compared to baseline.

In a study of 24 children with atopic dermatitis, of whom 19 were between 2 and 12 years of age, mometasone 0.01% cream was applied once daily. Most patients recovered within 3 weeks.

63 patients aged 6 to 23 months with atopic dermatitis were included in an open label HPA axis safety study. Mometasone ointment and lotion was applied once daily for approximately 3 weeks on an average body surface area of ​​39% (range 15–99%). Approximately 27% of patients who had normal adrenal function before treatment as determined by the Cortrosyn test had adrenal suppression at the end of treatment. Evaluation criteria were basal cortisol levels ≤5 µg/dl, levels of 18 µg/dl after 30 minutes of stimulation, or elevation <7 µg/dl. Follow-up testing 2–4 weeks after discontinuation of treatment using the same criteria in 8 patients demonstrated suppression of the HPA axis in 3 (ointment) and 1 (lotion) patients.

Indications for use

Relief of inflammatory and itching manifestations of GCS-dependent dermatoses in patients over 2 years of age (ointment) and over 12 years of age (lotion).

Nosological classification (ICD-10)

ICD-10 code list

• L20 Atopic dermatitis
• L21 Seborrheic dermatitis
• L23 Allergic contact dermatitis
• L28 Lichen simplex chronicus and pruritus
• L29Itching
• L30. 1 Dyshidrosis [pompholyx]
• L40 Psoriasis
• L43 Lichen red flat
• L56.2 Photocontact dermatitis [berloque dermatitis]
• L56.3 Solar urticaria
• L58 Radiation dermatitis, radiation

Contraindications

Hypersensitivity; children’s age up to 2 years (ointment) and up to 12 years (lotion).

Pregnancy and Lactation Use

FDA Fetal Category – C

There are no adequate and well controlled studies in pregnant women. Therefore, mometasone ointment should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low doses. Some corticosteroids are teratogenic after dermatological use in laboratory animals.

When administered to pregnant rats, rabbits and mice, mometasone aggravated fetal malformations. Malformative doses also reduced embryonic development as measured by lower fetal weight and/or delayed bone formation. When administered to rats at the end of pregnancy, mometasone also caused dystocia and associated complications.

In mice, mometasone caused the development of cleft palate at s.c. doses of 60 µg/kg and above. Fetal survival was reduced at a dose of 180 mcg/kg. No toxicity was observed at a dose of 20 µg/kg. Doses of 20, 60, and 180 μg/kg in mice are approximately 0.01, 0.02, and 0.05 times the MRDH for topical mometasone on a body surface area basis.

In rats, mometasone caused the development of umbilical hernia when applied topically at doses of 600 µg/kg and above. A dose of 300 μg/kg caused a delay in the formation of bone substance, but without signs of malformations. Doses of 300 and 600 µg/kg in rats are approximately 0.2 and 0.4 times the MRDH of mometasone when applied topically on a body surface area basis.

In rabbits, mometasone caused multiple malformations (eg, flexed forepaws, gallbladder agenesis, umbilical hernia, hydrocephalus) when applied topically at doses of 150 µg/kg and above (approximately 0.2 times the MRHD of mometasone when applied topically in in terms of body surface area). When administered orally, mometasone increased resorption and caused the development of a cleft palate and/or malformations of the head (hydrocephalus and domed head) at a dose of 700 mcg/kg. At a dose of 2800 mcg/kg, most offspring were miscarried or resolved. No toxicity was observed at a dose of 140 µg/kg. Doses of 140, 700 and 2800 mcg/kg for rabbits are approximately 0.2, 0.9and 3.6 times the MRDH of mometasone when applied topically in terms of body surface area.

When rats received s.c. mometasone throughout pregnancy or late in pregnancy, a dose of 15 µg/kg caused prolonged and difficult labor and reduced live births, birth weight, and early offspring survival. Similar effects were not observed at a dose of 7.5 mcg/kg. Doses of 7.5 and 15 µg/kg in rats are approximately 0.005 and 0.01 times the MRDH of mometasone when applied topically on a body surface area basis.

Systemic corticosteroids are found in human milk and may suppress growth, interfere with the production of endogenous corticosteroids, or cause other undesirable effects. It is not known whether topical application of corticosteroids leads to systemic absorption sufficient to obtain detectable amounts of corticosteroids in breast milk. Since many drugs are excreted in breast milk, caution should be exercised when topical mometasone is administered to nursing women.

Side effects

Clinical trial experience

Because clinical trials are conducted in a variety of settings, the frequency of adverse reactions observed in drug clinical trials cannot be directly compared with rates in other clinical trials and may not reflect rates observed in clinical practice.

Ointment

In controlled clinical studies involving 812 patients, the frequency of adverse reactions associated with the use of mometasone ointment was 4.8%. Adverse reactions reported included burning, itching, skin atrophy, tingling/stinging and furunculosis. There have been reports of cases of rosacea associated with the use of mometasone ointment.

In clinical studies involving pediatric patients aged 6 months to 2 years, the following adverse reactions were reported in 5% of 63 children, which could be or are likely to be associated with the use of mometasone ointment: a decrease in the level of corticosteroids in the blood – 1 case, unspecified skin disease – 1 case; and bacterial skin infection – 1 case. Other signs of skin atrophy were luster – 4 cases, telangiectasia – 1 case, loss of elasticity – 4 cases, loss of normal skin – 4 cases, and thinning of the skin – 1 case.

Lotion

In clinical studies involving 209 patients, the incidence of adverse reactions associated with the use of mometasone lotion was 3%. Acneform reaction was noted – 2 cases, burning sensation – 4 cases and itching – 1 case. In an irritation/sensitization study involving 156 healthy volunteers, the incidence of folliculitis was 3% (4 patients).

In a clinical study in children aged 6 months to 2 years who received mometasone lotion, adverse reactions possibly or likely related to its use were observed in 14% of 65 patients and included a decrease in the level of GCS – 4 cases, paresthesia 2 cases, dry mouth 1 case, endocrine disease unspecified 1 case, pruritus 1 case, and skin disease unspecified 1 case. There were also signs of skin atrophy such as pallor – 4 cases, telangiectasia – 2 cases, loss of elasticity – 2 cases and loss of normal skin pattern – 3 cases. Stretch marks, skin thinning, and hematomas were not observed in this study.

Post-marketing experience

Because adverse reactions have been reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Post-marketing reports of local adverse reactions to corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. These adverse reactions may occur more frequently with occlusive dressings.

Interactions

Information for healthcare professionals only.
Are you a healthcare professional?

The study of the interaction of external dosage forms of mometasone with other drugs has not been conducted.

Overdose

When applied topically, mometasone ointment may be absorbed in an amount sufficient to develop systemic effects.

Dosage and Administration

Information for healthcare professionals only.
Are you a healthcare professional?

Topically, a thin layer of ointment or a few drops of lotion is applied to the affected area of ​​the skin 1 time per day.

Precautions

General

When control is achieved, mometasone should be discontinued. If no improvement is seen within 2 weeks, a reassessment of the diagnosis may be required.

Do not use mometasone with occlusive dressings unless directed by a physician. You can not apply it to the diaper area, because. diapers or plastic pants are an occlusive dressing. Avoid application to the face, groin or underarms. Avoid contact with eyes.

Mometasone ointment and lotion is for external use only. These forms of mometasone are not intended for oral, ophthalmic, or intravaginal use.

Effects on the endocrine system

Systemic absorption of local corticosteroids can cause reversible suppression of the HPA axis with the possible development of glucocorticosteroid insufficiency. This can happen during treatment or after it has been discontinued. Manifestations of Cushing’s syndrome, hyperglycemia and glucosuria can also be caused in some patients by systemic absorption of local corticosteroids during treatment. Factors predisposing to suppression of the HPA axis include the use of highly active corticosteroids, a large surface area to be treated, prolonged use, the use of occlusive dressings, impaired skin barrier function, liver failure, and young age.

Due to the possibility of systemic absorption, the use of topical corticosteroids may require periodic examination of patients for signs of suppression of the HPA axis. This can be done with an ACTH stimulation test.

In a study evaluating the effect of mometasone ointment on the HPA axis, 15 g ointment was applied twice daily for 7 days to 6 adult patients with psoriasis or atopic dermatitis. The results showed that the use of mometasone caused a slight decrease in the secretion of corticosteroids by the adrenal glands.

In a study evaluating the effect of mometasone lotion on the HPA axis, a lotion of 15 ml was applied without occlusion 2 times a day (30 ml per day) for 7 days in 4 adult patients with psoriasis of the scalp and body. At the end of treatment, plasma cortisol levels in each of the 4 patients remained within the normal range and changed little compared to baseline.

If the HPA axis suppression is confirmed by the results of the examination, an attempt should be made to gradually withdraw mometasone, reduce the frequency of use, or replace it with a less active GCS. The restoration of the function of the HPA axis usually occurs immediately after the abolition of local corticosteroids. Infrequently, signs and symptoms of corticosteroid insufficiency may occur, which requires additional use of systemic corticosteroids. Children may be more susceptible to systemic manifestations of the action of topical corticosteroids when used in similar doses due to the greater ratio of skin surface area to body weight.

Ophthalmic adverse reactions

The use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in the post-registration period with the use of local corticosteroids, including mometasone (see “Adverse reactions”). Avoid getting mometasone in the eyes. The patient should be informed of any symptoms of visual impairment and, if present, consideration should be given to referring the patient to an ophthalmologist for evaluation.

Allergic contact dermatitis

If irritation occurs, mometasone should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed in the absence of healing, and not in clinical exacerbation. Such a diagnosis must be confirmed by appropriate diagnostic tests.

Concomitant skin infections

In the presence or development of concomitant skin infections, an appropriate antifungal or antibacterial drug should be prescribed. If a positive response does not occur within a short period of time, topical mometasone should be discontinued until adequate infection control is achieved.

Special patient groups

Children. Mometasone ointment may be used with caution in children 2 years of age and older, although safety and efficacy for use beyond 3 weeks has not been established. Since the safety and efficacy of mometasone ointment in children under 2 years of age have not been established, its use in this age group is not recommended.

Because the safety and efficacy of mometasone lotion in children under 12 years of age have not been established, its use in this age group is not recommended.

Mometasone ointment or lotion induced suppression of the HPA axis in approximately 27% to 29% of patients aged 6 to 23 months in whom normal adrenal function was confirmed by the Cortrosyn test prior to treatment and who were treated for approximately 3 weeks on a mean body surface area of ​​39% (range 15–99%). Criteria for suppression included a basal cortisol level of ≤5 μg dl, a level of ≤18 μg/dl after 30 minutes of stimulation, or an increase of <7 μg/dl. Follow-up testing 2 to 4 weeks after discontinuation of treatment, performed in 8 patients using the same criteria, demonstrated suppression of the HPA axis in 3 patients using the ointment and 1 patient using the lotion. Long-term use of topical corticosteroids in this population has not been studied.

Because of their greater skin surface area to body weight ratio, children treated with topical corticosteroids are at a higher risk of HPA axis suppression and Cushing’s syndrome than adults. Therefore, they are also at a higher risk of developing glucocorticoid deficiency during and/or after discontinuation of treatment. Pediatric patients, more than adults, may be more susceptible to developing skin atrophy, including striae, when treated with topical corticosteroids. A higher risk of suppression of the HPA axis in children is observed with the use of topical corticosteroids on a surface exceeding more than 20% of the body area.

In children treated with topical corticosteroids, suppression of the HPA axis, the development of Cushing’s syndrome, linear growth retardation, delayed weight gain and the development of intracranial hypertension have been reported. Manifestations of adrenal insufficiency in children include low plasma cortisol levels and lack of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Mometasone ointment and lotion should not be used in the treatment of diaper rash.

Old age. Clinical studies of mometasone ointment included 310 patients aged 65 years and older and 57 patients aged 75 years and older. Overall, there were no differences in safety or efficacy between these and younger patients. However, hypersensitivity in some older people cannot be ruled out.

Clinical studies of mometasone lotion did not include sufficient numbers of patients aged 65 years or older to determine differences from younger subjects. In general, there were no differences in responses between older and younger patients. Caution should be exercised when choosing a dose for an elderly patient.

cream for external use, ointment for external use, 0.1%, 0.1% – Encyclopedia of drugs RLS

Generalized scientific materials on the active substance of the drug Elocom ^® (ointment for external use, 0.1%)

900 02 Last update date : 04/13/2021

Contents

• Active substance
• ATX
• RU owner
• Storage conditions
• Best before date
• Information sources
• Pharmacological group
• Characteristic
• Pharmacology
• Indications for use
• Nosological classification (ICD-10)
• Contraindications
• Use during pregnancy and lactation
• Side effects
• Interaction
• Overdose
• Dosage and administration
• Precautionary measures
• Reviews

Active ingredient

Mometasone* (Mometasone*)

ATX

D07AC13 Mometasone

Owner RU

Schering-Plow Labo N. V.

Storage conditions

At a temperature not higher than 25 °C.

Keep out of reach of children.

Expiry date

3 years.

Do not use after the expiry date which is stated on the packaging.

www.rxlist.com , 2021.

Pharmacological group

Glucocorticoid for topical use

Characteristics

Synthetic GCS with anti-inflammatory action for dermatological use.

Mometasone furoate is a white to off-white powder, practically insoluble in water, readily soluble in acetone and methylene chloride, sparingly soluble in octanol, and sparingly soluble in ethyl alcohol and heptane; the molecular weight is 521.4.

Pharmacology

Mechanism of action

Like other local corticosteroids, mometasone has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of anti-inflammatory action of topical steroids is generally unclear. It is believed that corticosteroids act by inducing proteins that inhibit phospholipase A ₂ , collectively known as lipocortins. These proteins are thought to control the biosynthesis of strong inflammatory mediators such as PG and LT by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A ₂ .

Pharmacokinetics

The degree of percutaneous absorption of local GCS is determined by many factors, including the carrier and the integrity of the epidermal barrier. Hydrocortisone occlusive dressings applied for up to 24 hours did not increase penetration, but hydrocortisone occlusion for 96 hours markedly increased penetration. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Carcinogenicity, mutagenicity, effects on fertility

Long-term animal studies to evaluate the carcinogenic potential of mometasone ointment or lotion have not been conducted. Such studies were carried out with inhalation use in rats and mice. In a two-year carcinogenicity study in Sprague Dawley rats, mometasone did not show a statistically significant increase in tumor incidence at inhaled doses up to 67 mcg/kg, which is approximately 0.04 times the MRDH of mometasone ointment on a body surface area basis. . During 191-month carcinogenicity study in Swiss CD-1 mice, mometasone showed no statistically significant increase in tumor incidence at inhaled doses up to 160 µg/kg (approximately 0.05-fold higher than mometasone’s MRH when applied topically on a surface area basis) bodies).

Mometasone increased the number of chromosome aberrations in in vitro”> in vitro test in Chinese hamster ovary cells, but did not increase the number of chromosome aberrations in in vitro”> in vitro test in Chinese hamster lung cells. Mometasone did not show mutagenicity in the Ames test or in mouse lymphoma cells and clastogenicity in the in vivo mouse micronucleus test”> in vivo , in the analysis of chromosomal aberrations in rat bone marrow or mouse male germ cells. Mometasone also did not induce unscheduled DNA synthesis in vivo “> in vivo in rat hepatocytes.

In reproductive studies in male or female rats, no impairment of fertility was observed at s.c. doses up to 15 µg/kg (approximately 0.01 times the MRDH of topical mometasone on a body surface area basis).

Clinical studies

Studies conducted with mometasone ointment show that it is in the middle range of efficacy compared to other topical corticosteroids.

In a study evaluating the effect of mometasone ointment on the hypothalamic-pituitary-adrenal (HPA) axis, 15 g of the ointment was applied twice daily for 7 days in 6 adult patients with psoriasis or atopic dermatitis. The ointment was applied without occlusion to at least 30% of the body surface. The results showed that mometasone caused a slight decrease in the secretion of corticosteroids by the adrenal glands.

In a study evaluating the effect of mometasone lotion on the HPA axis, 15 ml of lotion was applied without occlusion 2 times a day (30 ml per day) for 7 days in 4 adult patients with psoriasis of the scalp and body. At the end of treatment, plasma cortisol levels in each of the 4 patients remained within the normal range and changed little compared to baseline.

In a study of 24 children with atopic dermatitis, of whom 19 were between 2 and 12 years of age, mometasone 0.01% cream was applied once daily. Most patients recovered within 3 weeks.

63 patients aged 6 to 23 months with atopic dermatitis were included in an open label HPA axis safety study. Mometasone ointment and lotion was applied once daily for approximately 3 weeks on an average body surface area of ​​39% (range 15–99%). Approximately 27% of patients who had normal adrenal function before treatment as determined by the Cortrosyn test had adrenal suppression at the end of treatment. Evaluation criteria were basal cortisol levels ≤5 µg/dl, levels of 18 µg/dl after 30 minutes of stimulation, or elevation <7 µg/dl. Follow-up testing 2–4 weeks after discontinuation of treatment using the same criteria in 8 patients demonstrated suppression of the HPA axis in 3 (ointment) and 1 (lotion) patients.

Indications for use

Relief of inflammatory and itching manifestations of GCS-dependent dermatoses in patients over 2 years of age (ointment) and over 12 years of age (lotion).

Nosological classification (ICD-10)

ICD-10 code list

• L20 Atopic dermatitis
• L21 Seborrheic dermatitis
• L23 Allergic contact dermatitis
• L28 Lichen simplex chronicus and pruritus
• L29Itching
• L30. 1 Dyshidrosis [pompholyx]
• L40 Psoriasis
• L43 Lichen red flat
• L56.2 Photocontact dermatitis [berloque dermatitis]
• L56.3 Solar urticaria
• L58 Radiation dermatitis, radiation

Contraindications

Hypersensitivity; children’s age up to 2 years (ointment) and up to 12 years (lotion).

Pregnancy and Lactation Use

FDA Fetal Category – C

There are no adequate and well controlled studies in pregnant women. Therefore, mometasone ointment should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low doses. Some corticosteroids are teratogenic after dermatological use in laboratory animals.

When administered to pregnant rats, rabbits and mice, mometasone aggravated fetal malformations. Malformative doses also reduced embryonic development as measured by lower fetal weight and/or delayed bone formation. When administered to rats at the end of pregnancy, mometasone also caused dystocia and associated complications.

In mice, mometasone caused the development of cleft palate at s.c. doses of 60 µg/kg and above. Fetal survival was reduced at a dose of 180 mcg/kg. No toxicity was observed at a dose of 20 µg/kg. Doses of 20, 60, and 180 μg/kg in mice are approximately 0.01, 0.02, and 0.05 times the MRDH for topical mometasone on a body surface area basis.

In rats, mometasone caused the development of umbilical hernia when applied topically at doses of 600 µg/kg and above. A dose of 300 μg/kg caused a delay in the formation of bone substance, but without signs of malformations. Doses of 300 and 600 µg/kg in rats are approximately 0.2 and 0.4 times the MRDH of mometasone when applied topically on a body surface area basis.

In rabbits, mometasone caused multiple malformations (eg, flexed forepaws, gallbladder agenesis, umbilical hernia, hydrocephalus) when applied topically at doses of 150 µg/kg and above (approximately 0.2 times the MRHD of mometasone when applied topically in in terms of body surface area). When administered orally, mometasone increased resorption and caused the development of a cleft palate and/or malformations of the head (hydrocephalus and domed head) at a dose of 700 mcg/kg. At a dose of 2800 mcg/kg, most offspring were miscarried or resolved. No toxicity was observed at a dose of 140 µg/kg. Doses of 140, 700 and 2800 mcg/kg for rabbits are approximately 0.2, 0.9and 3.6 times the MRDH of mometasone when applied topically in terms of body surface area.

When rats received s.c. mometasone throughout pregnancy or late in pregnancy, a dose of 15 µg/kg caused prolonged and difficult labor and reduced live births, birth weight, and early offspring survival. Similar effects were not observed at a dose of 7.5 mcg/kg. Doses of 7.5 and 15 µg/kg in rats are approximately 0.005 and 0.01 times the MRDH of mometasone when applied topically on a body surface area basis.

Systemic corticosteroids are found in human milk and may suppress growth, interfere with the production of endogenous corticosteroids, or cause other undesirable effects. It is not known whether topical application of corticosteroids leads to systemic absorption sufficient to obtain detectable amounts of corticosteroids in breast milk. Since many drugs are excreted in breast milk, caution should be exercised when topical mometasone is administered to nursing women.

Side effects

Clinical trial experience

Because clinical trials are conducted in a variety of settings, the frequency of adverse reactions observed in drug clinical trials cannot be directly compared with rates in other clinical trials and may not reflect rates observed in clinical practice.

Ointment

In controlled clinical studies involving 812 patients, the frequency of adverse reactions associated with the use of mometasone ointment was 4.8%. Adverse reactions reported included burning, itching, skin atrophy, tingling/stinging and furunculosis. There have been reports of cases of rosacea associated with the use of mometasone ointment.

In clinical studies involving pediatric patients aged 6 months to 2 years, the following adverse reactions were reported in 5% of 63 children, which could be or are likely to be associated with the use of mometasone ointment: a decrease in the level of corticosteroids in the blood – 1 case, unspecified skin disease – 1 case; and bacterial skin infection – 1 case. Other signs of skin atrophy were luster – 4 cases, telangiectasia – 1 case, loss of elasticity – 4 cases, loss of normal skin – 4 cases, and thinning of the skin – 1 case.

Lotion

In clinical studies involving 209 patients, the incidence of adverse reactions associated with the use of mometasone lotion was 3%. Acneform reaction was noted – 2 cases, burning sensation – 4 cases and itching – 1 case. In an irritation/sensitization study involving 156 healthy volunteers, the incidence of folliculitis was 3% (4 patients).

In a clinical study in children aged 6 months to 2 years who received mometasone lotion, adverse reactions possibly or likely related to its use were observed in 14% of 65 patients and included a decrease in the level of GCS – 4 cases, paresthesia 2 cases, dry mouth 1 case, endocrine disease unspecified 1 case, pruritus 1 case, and skin disease unspecified 1 case. There were also signs of skin atrophy such as pallor – 4 cases, telangiectasia – 2 cases, loss of elasticity – 2 cases and loss of normal skin pattern – 3 cases. Stretch marks, skin thinning, and hematomas were not observed in this study.

Post-marketing experience

Because adverse reactions have been reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Post-marketing reports of local adverse reactions to corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. These adverse reactions may occur more frequently with occlusive dressings.

Interactions

Information for healthcare professionals only.
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The study of the interaction of external dosage forms of mometasone with other drugs has not been conducted.

Overdose

When applied topically, mometasone ointment may be absorbed in an amount sufficient to develop systemic effects.

Dosage and Administration

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Topically, a thin layer of ointment or a few drops of lotion is applied to the affected area of ​​the skin 1 time per day.

Precautions

General

When control is achieved, mometasone should be discontinued. If no improvement is seen within 2 weeks, a reassessment of the diagnosis may be required.

Do not use mometasone with occlusive dressings unless directed by a physician. You can not apply it to the diaper area, because. diapers or plastic pants are an occlusive dressing. Avoid application to the face, groin or underarms. Avoid contact with eyes.

Mometasone ointment and lotion is for external use only. These forms of mometasone are not intended for oral, ophthalmic, or intravaginal use.

Effects on the endocrine system

Systemic absorption of local corticosteroids can cause reversible suppression of the HPA axis with the possible development of glucocorticosteroid insufficiency. This can happen during treatment or after it has been discontinued. Manifestations of Cushing’s syndrome, hyperglycemia and glucosuria can also be caused in some patients by systemic absorption of local corticosteroids during treatment. Factors predisposing to suppression of the HPA axis include the use of highly active corticosteroids, a large surface area to be treated, prolonged use, the use of occlusive dressings, impaired skin barrier function, liver failure, and young age.

Due to the possibility of systemic absorption, the use of topical corticosteroids may require periodic examination of patients for signs of suppression of the HPA axis. This can be done with an ACTH stimulation test.

In a study evaluating the effect of mometasone ointment on the HPA axis, 15 g ointment was applied twice daily for 7 days to 6 adult patients with psoriasis or atopic dermatitis. The results showed that the use of mometasone caused a slight decrease in the secretion of corticosteroids by the adrenal glands.

In a study evaluating the effect of mometasone lotion on the HPA axis, a lotion of 15 ml was applied without occlusion 2 times a day (30 ml per day) for 7 days in 4 adult patients with psoriasis of the scalp and body. At the end of treatment, plasma cortisol levels in each of the 4 patients remained within the normal range and changed little compared to baseline.

If the HPA axis suppression is confirmed by the results of the examination, an attempt should be made to gradually withdraw mometasone, reduce the frequency of use, or replace it with a less active GCS. The restoration of the function of the HPA axis usually occurs immediately after the abolition of local corticosteroids. Infrequently, signs and symptoms of corticosteroid insufficiency may occur, which requires additional use of systemic corticosteroids. Children may be more susceptible to systemic manifestations of the action of topical corticosteroids when used in similar doses due to the greater ratio of skin surface area to body weight.

Ophthalmic adverse reactions

The use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in the post-registration period with the use of local corticosteroids, including mometasone (see “Adverse reactions”). Avoid getting mometasone in the eyes. The patient should be informed of any symptoms of visual impairment and, if present, consideration should be given to referring the patient to an ophthalmologist for evaluation.

Allergic contact dermatitis

If irritation occurs, mometasone should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed in the absence of healing, and not in clinical exacerbation. Such a diagnosis must be confirmed by appropriate diagnostic tests.

Concomitant skin infections

In the presence or development of concomitant skin infections, an appropriate antifungal or antibacterial drug should be prescribed. If a positive response does not occur within a short period of time, topical mometasone should be discontinued until adequate infection control is achieved.

Special patient groups

Children. Mometasone ointment may be used with caution in children 2 years of age and older, although safety and efficacy for use beyond 3 weeks has not been established. Since the safety and efficacy of mometasone ointment in children under 2 years of age have not been established, its use in this age group is not recommended.

Because the safety and efficacy of mometasone lotion in children under 12 years of age have not been established, its use in this age group is not recommended.

Mometasone ointment or lotion induced suppression of the HPA axis in approximately 27% to 29% of patients aged 6 to 23 months in whom normal adrenal function was confirmed by the Cortrosyn test prior to treatment and who were treated for approximately 3 weeks on a mean body surface area of ​​39% (range 15–99%). Criteria for suppression included a basal cortisol level of ≤5 μg dl, a level of ≤18 μg/dl after 30 minutes of stimulation, or an increase of <7 μg/dl. Follow-up testing 2 to 4 weeks after discontinuation of treatment, performed in 8 patients using the same criteria, demonstrated suppression of the HPA axis in 3 patients using the ointment and 1 patient using the lotion. Long-term use of topical corticosteroids in this population has not been studied.

Because of their greater skin surface area to body weight ratio, children treated with topical corticosteroids are at a higher risk of HPA axis suppression and Cushing’s syndrome than adults. Therefore, they are also at a higher risk of developing glucocorticoid deficiency during and/or after discontinuation of treatment. Pediatric patients, more than adults, may be more susceptible to developing skin atrophy, including striae, when treated with topical corticosteroids. A higher risk of suppression of the HPA axis in children is observed with the use of topical corticosteroids on a surface exceeding more than 20% of the body area.

In children treated with topical corticosteroids, suppression of the HPA axis, the development of Cushing’s syndrome, linear growth retardation, delayed weight gain and the development of intracranial hypertension have been reported. Manifestations of adrenal insufficiency in children include low plasma cortisol levels and lack of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Mometasone ointment and lotion should not be used in the treatment of diaper rash.

Old age. Clinical studies of mometasone ointment included 310 patients aged 65 years and older and 57 patients aged 75 years and older. Overall, there were no differences in safety or efficacy between these and younger patients. However, hypersensitivity in some older people cannot be ruled out.

Clinical studies of mometasone lotion did not include sufficient numbers of patients aged 65 years or older to determine differences from younger subjects.