ADVERSE REACTIONS SECTION.

6ADVERSE REACTIONS. Most common adverse reactions included are acneiform reaction, burning, itching and folliculitis. (6)To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.In clinical trials involving 209 subjects, the incidence of adverse reactions associated with the use of mometasone furoate lotion (mometasone furoate topical solution 0.1%) was 3%. Reported reactions included acneiform reaction, 2; burning, 4; and itching, 1. In an irritation/sensitization study involving 156 normal subjects, the incidence of folliculitis was 3% (4 subjects).The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate lotion (mometasone furoate topical solution 0.1%) during clinical trial in 14% of 65 pediatric subjects months to years of age: decreased glucocorticoid levels, 4; paresthesia, 2; dry mouth,1; an unspecified endocrine disorder, 1; pruritus, 1; and an unspecified skin disorder, 1. The following signs of skin atrophy were also observed among 65 subjects treated with mometasone furoate lotion (mometasone furoate topical solution 0.1%) in clinical trial: shininess, 4; telangiectasia, 2; loss of elasticity, 2; and loss of normal skin markings, 3.. 6.2Postmarketing Experience Because adverse reactions are reported voluntarily from population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings.Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility. Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate lotion (mometasone furoate topical solution 0.1%). Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis). In 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis).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. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, rat bone marrow chromosomal aberration assay, or mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis).

INDICATIONS & USAGE SECTION.

1INDICATIONS AND USAGE. Mometasone furoate lotion (mometasone furoate topical solution 0.1%) is corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.. Mometasone furoate lotion (mometasone furoate topical solution 0.1%) is corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients >=12 years of age. (1).

CLINICAL PHARMACOLOGY SECTION.

12CLINICAL PHARMACOLOGY. 12.1Mechanism of Action. Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. 12.2Pharmacodynamics. Studies performed with mometasone furoate lotion (mometasone furoate topical solution 0.1%) indicate that it is in the medium range of potency as compared with other topical corticosteroids.In study evaluating the effects of mometasone furoate lotion (mometasone furoate topical solution 0.1%) on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for days to adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the subjects remained within the normal range and changed little from baseline [see Warnings and Precautions (5.1)].Sixty-five pediatric subjects ages to 23 months, with atopic dermatitis, were enrolled in an open-label, HPA axis safety trial. Mometasone furoate lotion (mometasone furoate topical solution 0.1%) was applied once daily for approximately weeks over mean body surface area of 40% (range 16% to 90%). In approximately 29% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with mometasone furoate lotion (mometasone furoate topical solution, 0.1%). The criteria for suppression were: basal cortisol level of <= mcg/dL, 30-minute post-stimulation level of <= 18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing to weeks after stopping treatment, available for of the subjects, demonstrated suppressed HPA axis function in subject, using these same criteria [see Use in Specific Populations (8.4)].. 12.3Pharmacokinetics. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.7% of the applied dose of mometasone furoate lotion (mometasone furoate topical solution 0.1%) enters the circulation after hours of contact on normal skin without occlusion. similar minimal degree of absorption of the corticosteroid from the lotion formulation would be anticipated. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

CLINICAL STUDIES SECTION.

14CLINICAL STUDIES. The safety and efficacy of mometasone furoate lotion (mometasone furoate topical solution 0.1%) for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. total of 405 subjects (age range: 12 to 95 years) received mometasone furoate lotion (mometasone furoate topical solution 0.1%) (205 subjects) or the vehicle lotion applied once daily for 21 days.

CONTRAINDICATIONS SECTION.

4CONTRAINDICATIONS. Mometasone furoate lotion (mometasone furoate topical solution 0.1%) is contraindicated in those patients with history of hypersensitivity to any of the components in the preparation.. Mometasone furoate lotion (mometasone furoate topical solution 0.1%) is contraindicated in those patients with history of hypersensitivity to any of the components in the preparation. (4). Mometasone furoate lotion (mometasone furoate topical solution 0.1%) is contraindicated in those patients with history of hypersensitivity to any of the components in the preparation. (4).

DESCRIPTION SECTION.

11DESCRIPTION. Mometasone furoate lotion (mometasone furoate topical solution USP, 0.1%) contains mometasone furoate, USP for topical use. Mometasone furoate, USP is synthetic corticosteroid with anti-inflammatory activity.Chemically, mometasone furoate is 9,21-dichloro-11,17-dihydroxy-16-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the molecular formula C27H30Cl2O6, molecular weight of 521.4 and the following structural formula:Mometasone furoate,USP is white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.Each gram of mometasone furoate lotion (mometasone furoate topical solution USP, 0.1%) contains mg mometasone furoate, USP in colorless, clear lotion base of isopropyl alcohol (40%), propylene glycol, hydroxypropyl cellulose, monobasic sodium phosphate (monohydrate) and purified water. May also contain phosphoric acid used to adjust the pH to approximately 4.5.. mometasonechemicalstructure.jpg.

DOSAGE & ADMINISTRATION SECTION.

2DOSAGE AND ADMINISTRATION. Apply few drops of mometasone furoate lotion (mometasone furoate topical solution 0.1%) to the affected skin areas once daily and massage lightly until it disappears.Therapy should be discontinued when control is achieved. If no improvement is seen within weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].Do not use mometasone furoate lotion (mometasone furoate topical solution 0.1%) with occlusive dressings unless directed by physician. Do not apply mometasone furoate lotion (mometasone furoate topical solution 0.1%) in the diaper area if the patient requires diapers or plastic pants, as these garments constitute occlusive dressing.Mometasone furoate lotion (mometasone furoate topical solution 0.1%) is for topical use only. It is not for oral, ophthalmic, or intravaginal use.Avoid use on the face, groin, or axillae. Avoid contact with eyes. Wash hands after each application.. oApply few drops to the affected skin areas once daily and massage lightly until it disappears. (2)oDiscontinue therapy when control is achieved. (2)oIf no improvement is seen within weeks, reassess diagnosis. (2)oDo not use with occlusive dressings unless directed by physician. (2). oApply few drops to the affected skin areas once daily and massage lightly until it disappears. (2). oDiscontinue therapy when control is achieved. (2). oIf no improvement is seen within weeks, reassess diagnosis. (2). oDo not use with occlusive dressings unless directed by physician. (2).

DOSAGE FORMS & STRENGTHS SECTION.

3DOSAGE FORMS AND STRENGTHS. Lotion, 0.1%. Each gram of mometasone furoate lotion (mometasone furoate topical solution USP, 0.1%) contains mg of mometasone furoate, USP in colorless, clear lotion base.. Lotion, 0.1%. (3). Lotion, 0.1%. (3).

DRUG INTERACTIONS SECTION.

7DRUG INTERACTIONS. No drug-drug interaction studies have been conducted with mometasone furoate lotion (mometasone furoate topical solution 0.1%).

GERIATRIC USE SECTION.

8.5Geriatric Use. Clinical trials of mometasone furoate lotion (mometasone furoate topical solution 0.1%) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range.

HOW SUPPLIED SECTION.

16HOW SUPPLIED/STORAGE AND HANDLING. Mometasone furoate lotion (mometasone furoate topical solution USP, 0.1%) is supplied in: NDC 0168-0272-30, 30 mL (27.5 g) NDC 0168-0272-60, 60 mL (55 g) Mometasone furoate lotion (mometasone furoate topical solution USP, 0.1%) is supplied in: NDC 0168-0272-30, 30 mL (27.5 g) NDC 0168-0272-60, 60 mL (55 g) Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) [see USP Controlled Room Temperature].

INFORMATION FOR PATIENTS SECTION.

17PATIENT COUNSELING INFORMATION. Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following:oUse mometasone furoate lotion (mometasone furoate topical solution 0.1%) as directed by the physician. It is for external use only.oAvoid contact with the eyes.oAdvise patients to report any visual symptoms to their healthcare providers.oDo not use mometasone furoate lotion (mometasone furoate topical solution 0.1%) on the face, underarms, or groin areas.oDo not use mometasone furoate lotion (mometasone furoate topical solution 0.1%) for any disorder other than that for which it was prescribed.oDo not bandage or otherwise cover or wrap the treated skin area so as to be occlusive, unless directed by the physician.oReport any signs of local adverse reactions to the physician.oAdvise patients not to use mometasone furoate lotion (mometasone furoate topical solution 0.1%) in the treatment of diaper dermatitis. Do not apply mometasone furoate lotion (mometasone furoate topical solution 0.1%) in the diaper area, as diapers or plastic pants may constitute occlusive dressing.oDiscontinue therapy when control is achieved. If no improvement is seen within weeks, contact the physician.oDo not use other corticosteroid-containing products with mometasone furoate lotion (mometasone furoate topical solution 0.1%) without first consulting with the physician.. oUse mometasone furoate lotion (mometasone furoate topical solution 0.1%) as directed by the physician. It is for external use only.. oAvoid contact with the eyes.. oAdvise patients to report any visual symptoms to their healthcare providers.. oDo not use mometasone furoate lotion (mometasone furoate topical solution 0.1%) on the face, underarms, or groin areas.. oDo not use mometasone furoate lotion (mometasone furoate topical solution 0.1%) for any disorder other than that for which it was prescribed.. oDo not bandage or otherwise cover or wrap the treated skin area so as to be occlusive, unless directed by the physician.. oReport any signs of local adverse reactions to the physician.. oAdvise patients not to use mometasone furoate lotion (mometasone furoate topical solution 0.1%) in the treatment of diaper dermatitis. Do not apply mometasone furoate lotion (mometasone furoate topical solution 0.1%) in the diaper area, as diapers or plastic pants may constitute occlusive dressing.. oDiscontinue therapy when control is achieved. If no improvement is seen within weeks, contact the physician.. oDo not use other corticosteroid-containing products with mometasone furoate lotion (mometasone furoate topical solution 0.1%) without first consulting with the physician.

MECHANISM OF ACTION SECTION.

12.1Mechanism of Action. Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

NONCLINICAL TOXICOLOGY SECTION.

13NONCLINICAL TOXICOLOGY. 13.1Carcinogenesis, Mutagenesis, Impairment of Fertility. Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate lotion (mometasone furoate topical solution 0.1%). Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis). In 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis).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. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, rat bone marrow chromosomal aberration assay, or mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis).

NURSING MOTHERS SECTION.

8.3Nursing Mothers. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when mometasone furoate lotion (mometasone furoate topical solution 0.1%) is administered to nursing woman.

OVERDOSAGE SECTION.

10OVERDOSAGE. Topically applied mometasone furoate lotion (mometasone furoate topical solution 0.1%) can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) ].

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

NDC 0168-0272-30 Fougera(R) Mometasone FuroateTopical Solution USP,0.1% (Lotion)FOR DERMATOLOGIC USE ONLY.NOT FOR OPHTHALMIC USE.Rx Only DO NOT USE IN EYES 30 mL. bottlelabel.jpg.

PATIENT MEDICATION INFORMATION SECTION.

Patient Information. Mometasone Furoate Lotion (Mometasone Furoate Topical Solution, USP 0.1%)(moe-MEH-tah-zone)Important information: Mometasone furoate lotion (mometasone furoate topical solution 0.1%) is for use on skin only. Do not use mometasone furoate lotion (mometasone furoate topical solution 0.1%) in your eyes, mouth, or vagina. What is mometasone furoate lotion (mometasone furoate topical solution 0.1%) oMometasone furoate lotion (mometasone furoate topical solution 0.1%) is prescription medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 12 years of age and older. oIt is not known if mometasone furoate lotion (mometasone furoate topical solution 0.1%) is safe and effective for use in children under 12 years of age. oMometasone furoate lotion (mometasone furoate topical solution 0.1%) should not be used in children under 12 years of age. Do not use mometasone furoate lotion (mometasone furoate topical solution 0.1%) if you are allergic to mometasone furoate or any of the ingredients in mometasone furoate lotion (mometasone furoate topical solution 0.1%). See the end of this leaflet for complete list of ingredients in mometasone furoate lotion (mometasone furoate topical solution 0.1%). Before usingmometasone furoate lotion (mometasone furoate topical solution 0.1%),tell your healthcare provider about all your medical conditions, including if you: ohave skin infection at the site to be treated. You may also need medicine to treat the skin infection. oare pregnant or plan to become pregnant. It is not known if mometasone furoate lotion (mometasone furoate topical solution 0.1%) will harm your unborn baby. oare breastfeeding or plan to breastfeed. It is not known if mometasone furoate lotion (mometasone furoate topical solution 0.1%) passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. How should use mometasone furoate lotion (mometasone furoate topical solution 0.1%)oUse mometasone furoate lotion (mometasone furoate topical solution 0.1%) exactly as your healthcare provider tells you to use it.oApply few drops of mometasone furoate lotion (mometasone furoate topical solution 0.1%) to the affected skin area time each day and rub it in lightly until it disappears. oUse mometasone furoate lotion (mometasone furoate topical solution 0.1%) until the affected skin area is improved. Tell your healthcare provider if the treated skin area does not get better after weeks of treatment.oDo not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.oMometasone furoate lotion (mometasone furoate topical solution 0.1%) should not be used to treat diaper rash or redness. Avoid using mometasone furoate lotion (mometasone furoate topical solution 0.1%) in the diaper area if wearing diapers or plastic pants.oAvoid using mometasone furoate lotion (mometasone furoate topical solution 0.1%) on the face, groin, or underarms (armpits). Wash your hands after applying mometasone furoate lotion (mometasone furoate topical solution 0.1%). What are the possible side effects of (mometasone furoate topical solution 0.1%) Mometasone furoate lotion (mometasone furoate topical solution 0.1%)may cause serious side effects, including: oMometasone furoate lotion (mometasone furoate topical solution 0.1%) can pass through your skin. Too much mometasone furoate lotion (mometasone furoate topical solution 0.1%) passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems. oVision problems. Topical corticosteroids may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with mometasone furoate lotion (mometasone furoate topical solution 0.1%).oSkin problems. Skin problems may happen during treatment with mometasone furoate lotion (mometasone furoate topical solution 0.1%), including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using mometasone furoate lotion (mometasone furoate topical solution 0.1%) and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or problems healing during treatment with mometasone furoate lotion (mometasone furoate topical solution 0.1%). The most common side effects of mometasone furoate lotion (mometasone furoate topical solution 0.1%) include burning, itching, and inflammation of the hair follicle (folliculitis). These are not all the possible side effects of mometasone furoate lotion (mometasone furoate topical solution 0.1%). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should store mometasone furoate lotion (mometasone furoate topical solution 0.1%) oStore mometasone furoate lotion (mometasone furoate topical solution 0.1%) at room temperature between 68F to 77F (20C to 25C).oKeep mometasone furoate lotion (mometasone furoate topical solution 0.1%)and all medicines out of the reach of children. General information about the safe and effective use of mometasone furoate lotion (mometasone furoate topical solution 0.1%). Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflet. Do not use mometasone furoate lotion (mometasone furoate topical solution 0.1%) for condition for which it was not prescribed. Do not give mometasone furoate lotion (mometasone furoate topical solution 0.1%) to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mometasone furoate lotion (mometasone furoate topical solution 0.1%) that is written for health professionals. What are the ingredients in mometasone furoate lotion (mometasone furoate topical solution 0.1%) Active ingredient: mometasone furoate, USP Inactive ingredients: isopropyl alcohol (40%), propylene glycol, hydroxypropyl cellulose, monobasic sodium phosphate (monohydrate) and purified water. May also contain phosphoric acid used to adjust the pH to approximately 4.5. This Patient Information has been approved by the U.S. Food and Drug Administration. Revised 09/18. oMometasone furoate lotion (mometasone furoate topical solution 0.1%) is prescription medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 12 years of age and older. oIt is not known if mometasone furoate lotion (mometasone furoate topical solution 0.1%) is safe and effective for use in children under 12 years of age. oMometasone furoate lotion (mometasone furoate topical solution 0.1%) should not be used in children under 12 years of age. ohave skin infection at the site to be treated. You may also need medicine to treat the skin infection. oare pregnant or plan to become pregnant. It is not known if mometasone furoate lotion (mometasone furoate topical solution 0.1%) will harm your unborn baby. oare breastfeeding or plan to breastfeed. It is not known if mometasone furoate lotion (mometasone furoate topical solution 0.1%) passes into your breast milk. oare pregnant or plan to become pregnant. It is not known if mometasone furoate lotion (mometasone furoate topical solution 0.1%) will harm your unborn baby. oare breastfeeding or plan to breastfeed. It is not known if mometasone furoate lotion (mometasone furoate topical solution 0.1%) passes into your breast milk. oUse mometasone furoate lotion (mometasone furoate topical solution 0.1%) exactly as your healthcare provider tells you to use it.. oApply few drops of mometasone furoate lotion (mometasone furoate topical solution 0.1%) to the affected skin area time each day and rub it in lightly until it disappears. . oUse mometasone furoate lotion (mometasone furoate topical solution 0.1%) until the affected skin area is improved. Tell your healthcare provider if the treated skin area does not get better after weeks of treatment.. oDo not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to.. oMometasone furoate lotion (mometasone furoate topical solution 0.1%) should not be used to treat diaper rash or redness. Avoid using mometasone furoate lotion (mometasone furoate topical solution 0.1%) in the diaper area if wearing diapers or plastic pants.. oAvoid using mometasone furoate lotion (mometasone furoate topical solution 0.1%) on the face, groin, or underarms (armpits). Wash your hands after applying mometasone furoate lotion (mometasone furoate topical solution 0.1%). oMometasone furoate lotion (mometasone furoate topical solution 0.1%) can pass through your skin. Too much mometasone furoate lotion (mometasone furoate topical solution 0.1%) passing through your skin can cause your adrenal glands to stop working properly. Your healthcare provider may do blood tests to check for adrenal gland problems. oVision problems. Topical corticosteroids may increase your chance of developing vision problems such as cataract and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with mometasone furoate lotion (mometasone furoate topical solution 0.1%).. oSkin problems. Skin problems may happen during treatment with mometasone furoate lotion (mometasone furoate topical solution 0.1%), including allergic reactions (contact dermatitis) and skin infections at the treatment site. Stop using mometasone furoate lotion (mometasone furoate topical solution 0.1%) and tell your healthcare provider if you develop any skin reactions such as pain, tenderness, swelling, or problems healing during treatment with mometasone furoate lotion (mometasone furoate topical solution 0.1%). oStore mometasone furoate lotion (mometasone furoate topical solution 0.1%) at room temperature between 68F to 77F (20C to 25C).. oKeep mometasone furoate lotion (mometasone furoate topical solution 0.1%)and all medicines out of the reach of children.

PEDIATRIC USE SECTION.

8.4Pediatric Use. Since safety and efficacy of mometasone furoate lotion (mometasone furoate topical solution 0.1%) have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended.Mometasone furoate lotion (mometasone furoate topical solution 0.1%) caused HPA axis suppression in approximately 29% of pediatric subjects ages to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately weeks over mean body surface area of 40% (range 16% to 90%). The criteria for suppression were: basal cortisol level of <= mcg/dL, 30-minute post-stimulation level of <= 18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing to weeks after stopping treatment, available for of the subjects, demonstrated suppressed HPA axis function in subject, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology (12.2) ].Because of higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of HPA axis suppression and Cushings syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.HPA axis suppression, Cushings syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.Mometasone furoate lotion (mometasone furoate topical solution 0.1%) should not be used in the treatment of diaper dermatitis.

PHARMACODYNAMICS SECTION.

12.2Pharmacodynamics. Studies performed with mometasone furoate lotion (mometasone furoate topical solution 0.1%) indicate that it is in the medium range of potency as compared with other topical corticosteroids.In study evaluating the effects of mometasone furoate lotion (mometasone furoate topical solution 0.1%) on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for days to adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the subjects remained within the normal range and changed little from baseline [see Warnings and Precautions (5.1)].Sixty-five pediatric subjects ages to 23 months, with atopic dermatitis, were enrolled in an open-label, HPA axis safety trial. Mometasone furoate lotion (mometasone furoate topical solution 0.1%) was applied once daily for approximately weeks over mean body surface area of 40% (range 16% to 90%). In approximately 29% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with mometasone furoate lotion (mometasone furoate topical solution, 0.1%). The criteria for suppression were: basal cortisol level of <= mcg/dL, 30-minute post-stimulation level of <= 18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing to weeks after stopping treatment, available for of the subjects, demonstrated suppressed HPA axis function in subject, using these same criteria [see Use in Specific Populations (8.4)].

PHARMACOKINETICS SECTION.

12.3Pharmacokinetics. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.7% of the applied dose of mometasone furoate lotion (mometasone furoate topical solution 0.1%) enters the circulation after hours of contact on normal skin without occlusion. similar minimal degree of absorption of the corticosteroid from the lotion formulation would be anticipated. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

PREGNANCY SECTION.

8.1 Pregnancy. Teratogenic Effects, Pregnancy Category C:There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate lotion (mometasone furoate topical solution 0.1%) 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 been shown to be teratogenic after dermal application in laboratory animals.When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis.)In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis.)In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2,800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2,800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis.)When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis.).

RECENT MAJOR CHANGES SECTION.

Warnings and PrecautionsOphthalmic Adverse Reactions (5.2) 05/2018.

SPL UNCLASSIFIED SECTION.

5.1Effects on Endocrine System. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushings syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Factors that predispose patient using topical corticosteroid to HPA axis suppression include the use of high potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure and young age.Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.In study evaluating the effects of mometasone furoate lotion on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for days to adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the subjects remained within the normal range and changed little from baseline.If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) ].

STORAGE AND HANDLING SECTION.

Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) [see USP Controlled Room Temperature].

TERATOGENIC EFFECTS SECTION.

Teratogenic Effects, Pregnancy Category C:There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate lotion (mometasone furoate topical solution 0.1%) 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 been shown to be teratogenic after dermal application in laboratory animals.When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis.)In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis.)In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2,800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2,800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis.)When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis.).

USE IN SPECIFIC POPULATIONS SECTION.

8USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Teratogenic Effects, Pregnancy Category C:There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate lotion (mometasone furoate topical solution 0.1%) 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 been shown to be teratogenic after dermal application in laboratory animals.When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis.)In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis.)In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2,800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2,800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis.)When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on mcg/m2 basis.). 8.3Nursing Mothers. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when mometasone furoate lotion (mometasone furoate topical solution 0.1%) is administered to nursing woman.. 8.4Pediatric Use. Since safety and efficacy of mometasone furoate lotion (mometasone furoate topical solution 0.1%) have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended.Mometasone furoate lotion (mometasone furoate topical solution 0.1%) caused HPA axis suppression in approximately 29% of pediatric subjects ages to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately weeks over mean body surface area of 40% (range 16% to 90%). The criteria for suppression were: basal cortisol level of <= mcg/dL, 30-minute post-stimulation level of <= 18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing to weeks after stopping treatment, available for of the subjects, demonstrated suppressed HPA axis function in subject, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology (12.2) ].Because of higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of HPA axis suppression and Cushings syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.HPA axis suppression, Cushings syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.Mometasone furoate lotion (mometasone furoate topical solution 0.1%) should not be used in the treatment of diaper dermatitis.. 8.5Geriatric Use. Clinical trials of mometasone furoate lotion (mometasone furoate topical solution 0.1%) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range.

WARNINGS AND PRECAUTIONS SECTION.

5WARNINGS AND PRECAUTIONS. oReversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment, Cushings syndrome, and hyperglycemia may occur due to systemic absorption. oPatients applying topical steroid to large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. Modify use should HPA axis suppression develop. Pediatric patients may be more susceptible to systemic toxicity. (5.1, 8.4)oMay increase the risk of cataracts and glaucoma. If visual symptoms occur,consider referral to an ophthalmologist. (5.2). oReversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment, Cushings syndrome, and hyperglycemia may occur due to systemic absorption. oPatients applying topical steroid to large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. Modify use should HPA axis suppression develop. Pediatric patients may be more susceptible to systemic toxicity. (5.1, 8.4). oMay increase the risk of cataracts and glaucoma. If visual symptoms occur,consider referral to an ophthalmologist. (5.2). 5.1Effects on Endocrine System. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushings syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Factors that predispose patient using topical corticosteroid to HPA axis suppression include the use of high potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure and young age.Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.In study evaluating the effects of mometasone furoate lotion on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for days to adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the subjects remained within the normal range and changed little from baseline.If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) ].. 5.2Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products, including the topical mometasone products [see Adverse Reactions (6.2)].Avoid contact of mometasone furoate lotion (mometasone furoate topical solution 0.1%) with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.. 5.3Allergic Contact Dermatitis. If irritation develops, mometasone furoate lotion (mometasone furoate topical solution 0.1%) should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.. 5.4Concomitant Skin Infections. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If favorable response does not occur promptly, use of mometasone furoate lotion (mometasone furoate topical solution 0.1%) should be discontinued until the infection has been adequately controlled.