Looking for:
Mometasone furoate topical solution dosage. Mometasone Topical |
- Mometasone (Topical Application Route) Proper Use - Mayo Clinic
Mometasone Topical: MedlinePlus Drug Information
Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. Titrate after 2 weeks if needed for control. Titrate to the lowest effective dose once asthma stability is achieved. If asthma is not controlled after 2 weeks, the higher strength may provide additional control. Choose dose based on previous asthma therapy including the previous inhaled corticosteroid dosage and the patient's current control of asthma symptoms and risk of future exacerbation.
Reduce the oral corticosteroid no faster than 2. Carefully monitor for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency. Once oral corticosteroid reduction is complete, titrate to the lowest effective inhaled mometasone dose.
After at least 1 week of inhaled therapy, consider slow reduction of the oral corticosteroid. Monitor patients for signs of asthma instability or adrenal insufficiency during withdrawal. In patients with a known seasonal allergen that precipitates nasal symptoms, initiation of mometasone nasal spray 2 to 4 weeks prior to the anticipated start of the pollen season is recommended. One implant, which contains 1, mcg of mometasone furoate that is gradually released over time, inserted into the ethmoid sinus by a physician under endoscopic visualization.
One implant, which contains mcg of mometasone furoate that is gradually released over time, inserted into the sinus by a physician under endoscopic visualization.
In clinical trials, use of the Propel mometasone sinus implants reduced polyposis and edema, and reduced ethmoid sinus obstruction following surgery. Apply a thin layer topically to the affected skin area s once daily. If no response is seen within 2 weeks, reassess treatment options. Safety and efficacy of treatment for more than 3 weeks in pediatric patients have not been established.
Apply a few drops to the affected skin area s once daily. Titrate to lowest effective dose. Titrate to the lowest effective dose. In general, corticosteroid dosage must be individualized and is highly variable depending on the nature and severity of the disease, route and product of administration, and on patient age and response. For some products maximum dosage limits have not been specified. Safety and efficacy have not been established for inhaler products or lotion.
Younger than 2 years: Safety and efficacy have not been established. Specific guidelines for dosage adjustments in hepatic impairment are not available; however, caution is recommended in those with severe hepatic impairment. Inhalational and intranasal mometasone undergo extensive first-pass metabolism in the liver. For topical dermatologic use only.
Not for ophthalmic, oral, or intravaginal use. Avoid contact with the eyes. Avoid use on face, groin, or axillae. Patients who fail to respond to topical mometasone treatment after 2 weeks should be re-evaluated. Mometasone preparations should generally not be used with occlusive dressings.
Instruct patients and caregivers not to bandage, cover, or wrap area in any way that may be occlusive unless recommended by their physician. Do not use in the diaper area of patients who require diapers or plastic pants; these garments may act as an occlusive dressing. Wash hands before and after mometasone application.
Use gloves if required by universal precautions. Restrict application to the active lesions or affected areas and try to avoid normal surrounding skin. Lotion: Apply a few drops to the affected areas and massage lightly until it disappears. Cream and ointment: Apply a thin film to affected areas.
Patients should be instructed to rinse their mouth with water and spit out contents without swallowing after administration. Most children less than 4 years of age may not generate sufficient inspiratory flow to activate dry powder inhalers. After administration, gently wipe the mouthpiece with a drug cloth or tissue as needed. Do not wash the inhaler. The digital dose counter on the inhaler displays the doses remaining. When the counter indicates '00', the cap will lock and the unit must be discarded.
If the dose counter is not working correctly, the unit should not be used. When the foil pouch is opened, write the date on the cap label. Discard the unit when the counter reads '00' or 45 days after the foil pouch has been opened, whichever comes first. To avoid the spread of infection, do not use the inhaler in more than 1 person. Instruct patient on proper inhalation technique.
Asmanex HFA should be primed prior to the initial use by releasing 4 sprays into the air, away from the face and other people. Shake the inhaler well before each use. This process should be repeated if the inhaler has not been used for more than 5 days.
The canister contains a dose counter. Initially the dose counter will display '''' actuations. After the initial priming with 4 actuations, the dose counter will read '''' and the inhaler is now ready for use.
The inhaler should be discarded after the counter reads 0. Although the canister is still operational and may contain medication, the accuracy of medication delivery cannot be assured. Each canister is supplied with a blue oral actuator along with patient instructions. The actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the Asmanex HFA canister.
Following administration, instruct patient to rinse mouth thoroughly with water or mouthwash to remove mometasone deposited in the mouth and to minimize dry mouth or throat, throat irritation, and hoarseness.
The mouthpiece should be cleaned using a dry wipe after every 7 days of use; do not wash any of the inhaler parts in water. To avoid the spread of infection, do not use the inhaler for more than 1 person. Instruct patient or caregiver on the proper use of the nasal spray. Shake well before each use. Before using for the first time, the unit must be primed. Keep the sprayer pointed away from people and pets. Pump the activator 10 times or until a fine spray appears. If the unit has not been used for 1 week, re-prime by pumping the activator twice or until a fine spray appears.
After administration, wipe the nasal applicator with a clean tissue. Replace the cap right after cleaning. To avoid the spread of infection, do not use the inhaler in more than one person.
Sinus Implant Administration Propel, Propel Contour, and Propel Mini The Propel implants should be inserted into the ethmoid sinus surgical cavity by a physician under endoscopic visualization; a delivery system is provided. The implant is designed for single patient use; do not reprocess or reuse. Special care should be taken to avoid bending, twisting, or damaging the implant. Do not compress or load the implant into the delivery system more than 2 times.
The implant is designed to accommodate each patient's unique anatomy; it is not designed to be modified. Once inserted, the system is self-retaining against the mucosa of the surgically enlarged sinus. Proper placement of the implant is confirmed by endoscopic visualization. There is no need for removal; the implant is made of a synthetic bioabsorbable co-polymer that will eventually dissolve.
Sinuva The implant should be inserted into the ethmoid sinus surgical cavity by a physician under endoscopic visualization; a delivery system is provided.
Do not use if the package is open, the package or product is damaged, or has evidence of gross contamination. The implant is not designed to be modified. Remove the crimper and the delivery system from their protective packaging using sterile technique.
Inspect the sinus implant located inside of the crimper; however, do not remove the implant from the crimper. Prior to use, the sinus implant must be crimped and loaded into the delivery system. If the sinus implant is not fully seated inside of the crimper, secure the sinus implant before proceeding.
See manufacturer instructions to secure, prepare and place the sinus implant for insertion. The sinus implant is made from bioabsorbable polymers designed to gradually soften over time; the implant may be left in the sinus to gradually release the corticosteroid over 90 days. Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to mometasone should not receive any form of mometasone.
It is possible, though also rare, that such patients will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and following the administration of any corticosteroid.
Mometasone is contraindicated in any patient with a known hypersensitivity to any ingredients in the preparation. Rare cases of immediate hypersensitivity reactions have been reported after the intranasal or respiratory administration of mometasone. Asmanex Twisthaler contains anhydrous lactose, which in turn contains trace amounts of milk protein; as such, use of this formulation is contraindicated in patients with known milk protein hypersensitivity. Anaphylactic reactions have been reported in patients with milk protein allergy following use of this product.
❾-50%}- DailyMed - MOMETASONE FUROATE solution
It is important to note that pediatric patients may be more susceptible than adults to skin atrophy, including striae, when treated with topical corticosteroids. The topical lotion solution is not recommended in children less than 12 years of age. Sinus implants of mometasone are not FDA-approved in pediatric patients less than 18 years of age.
Topical and inhaled corticosteroids, like mometasone, should be used with caution in patients with diabetes mellitus. Hyperglycemia and exacerbation of diabetes may occur with systemic absorption of the topical or inhaled corticosteroid. Use of topical corticosteroids may further delay healing of skin ulcers in diabetic patients or patients with markedly impaired circulation e.
As with any long-term topical treatment of the nasal cavity, patients using mometasone intranasally over several months or longer should be examined periodically for possible changes in the nasal mucosa. Further, because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal perforation or ulcer, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.
Take care to avoid ocular exposure and use of mometasone around the eyes; cases of visual impairment, cataracts, glaucoma, increased intraocular pressure, central serous chorioretinopathy, and ocular hypertension have been reported with topical corticosteroids. These ophthalmic side effects have also occurred during use of nasal and inhaled corticosteroids. Patients receiving corticosteroids chronically should be periodically assessed for increased intraocular pressure, cataract formation, glaucoma, or any other visual disturbance.
Consider referring patients who develop ocular symptoms to an ophthalmologist for evaluation. Corticosteroid therapy may result in immunosuppression and an increased susceptibility to infection.
The normal inflammatory response to infections can be masked by mometasone. The use of mometasone in the presence of infection, including tuberculosis of the skin, active or latent tuberculosis of the respiratory tract, fungal infections, systemic parasitic infection, untreated bacterial infections, ocular herpes simplex, and cutaneous or systemic viral infection e.
Because of the potential for worsening infection, mometasone therapy may need to be interrupted during some active infections. Chickenpox and measles can have a more serious or even fatal course in susceptible children using corticosteroids; the exact risk associated with inhaled or topical mometasone is unclear.
If an unimmunized patient is exposed to chickenpox or measles, proper prophylaxis may be indicated. Corticosteroid therapy can reactivate tuberculosis and should not be used except when chemoprophylaxis is instituted concomitantly. Although patients receiving systemic corticosteroid therapy are more susceptible to secondary infection than patients not receiving corticosteroids, administration via the inhaled route minimizes this risk.
The incidence or course of acute bacterial or viral infection is probably minimally affected by inhaled corticosteroids in immunocompetent individuals. The use of nasal or inhaled mometasone may also result in localized fungal infection of the nose, mouth, and pharynx with Candida albicans. Instruct patients to rinse mouth after each use of inhaled mometasone to minimize risk. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic therapy; in most cases, treatment with mometasone can continue during antifungal therapy.
Also, patients using mometasone nasal spray for extended periods i. If concomitant skin infections are present or develop during topical mometasone therapy, an appropriate antifungal or antibacterial agent should be used.
If clinical improvement does not occur promptly, discontinue topical mometasone until the infection has been properly treated. Topical corticosteroids should not be used to treat acne vulgaris, acne rosacea, or perioral dermatitis as they may exacerbate these conditions.
Inhalational, nasal, and sinus implant forms of mometasone should be used with caution during pregnancy. Fetal abnormalities have been reported in the off-spring of mice, rats, and rabbits exposed to the medications during gestation. Infants born to mothers taking substantial corticosteroid doses during pregnancy should be monitored for signs of hypoadrenalism.
Low-dose inhaled corticosteroids are considered first line therapy for control of mild persistent asthma during pregnancy according to the guidelines of the National Asthma Education and Prevention Program NAEPP Asthma and Pregnancy Working Group.
Data on the use of medium to high dose inhaled corticosteroid use during pregnancy are limited. However, dose titration may be considered for those with moderate to severe persistent asthma, preferably using budesonide. Budesonide is preferred over other inhaled corticosteroids due to availability of more safety information during pregnancy.
However, there are no data to indicate safety concerns with other inhaled corticosteroids, and maintaining a previously established treatment regimen may be more beneficial to the patient. Selection of any pharmacologic treatment for asthma control during pregnancy should include the specific needs of the patient, based on an individual evaluation, and consideration of the potential benefits or risks to the fetus.
Topical use of mometasone during pregnancy should also be approached with caution. Topical corticosteroids, including mometasone, should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women.
Guidelines recommend mild to moderate potency agents over potent corticosteroids, which should be used in short durations. Fetal growth restriction and a significantly increased risk of low birthweight has been reported with use of potent or very potent topical corticosteroids during the third trimester, particularly when using more than grams.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
The manufacturer of mometasone inhalation and nasal spray recommend caution during use while breast-feeding. However, experts consider inhaled and oral corticosteroids acceptable to use during breast-feeding.
Mometasone via inhalation typically results in low systemic concentrations; therefore, the amount excreted into breast-milk after inhalation is expected to be very low. Consideration should be given in the use of inhalational products to the developmental and health benefits of breast-feeding, the mother's clinical need for mometasone inhalation aerosol, and any potential adverse effects on the breast-fed infant.
Budesonide is preferred over other inhaled corticosteroids due to availability of more safety information during pregnancy and lactation. However, there are no data to indicate safety concerns with other inhaled corticosteroids and maintaining a previously established treatment regimen may be more beneficial to the patient. It is not known whether mometasone from the sinus stent implant is excreted in human milk.
It is not known whether topical administration of mometasone to the skin could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, most dermatologists stress that topical corticosteroids can be safely used during lactation and breast-feeding.
If applied topically, care should be used to ensure the infant will not come into direct contact with the area of application, such as the breast. Increased blood pressure has been reported in an infant whose mother applied a high potency topical corticosteroid ointment directly to the nipples. Consider therapy with less-potent topical agents, like hydrocortisone or triamcinolone, in nursing mothers requiring long-term therapy with a topical corticosteroid.
Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA. Marked decrease in skin thickness and delayed skin recovery have been noted in cutaneous areas exposed to sun after the topical application of corticosteroids.
Patients that apply mometasone topical formulations to exposed portions of the body should avoid excessive sunlight UV exposure, both natural and artificial. Use mometasone cautiously in patients with severe hepatic disease.
Liver failure may predispose patients to HPA axis suppression; clearance of the drug is reduced in this population. Detrimental effects on bone metabolism are expected to be much lower with inhaled corticosteroids compared to systemically-administered corticosteroids.
However, some data suggest that high-dose inhaled steroids may also decrease bone formation and increase resorption, and decreases in bone mineral density have been reported in patients receiving long-term therapy of inhaled corticosteroids. Patients receiving inhaled steroids, such as mometasone, may be at increased risk of bone loss compared to healthy individuals; compounding risk factors include preexisting osteopenia, prolonged immobilization, family history of osteoporosis, tobacco smoking, malnutrition, and use of other medications that may reduce bone mass.
Clinical studies and other reported clinical experience with topical mometasone products has not identified differences in responses between geriatric and younger adults.
In clinical trials of nasal and inhaled mometasone, no efficacy differences have been noted; the adverse reactions reported with nasal spray usage in geriatric patients were similar in type and incidence to those reported by younger patients. However, greater sensitivity of some elderly patients cannot be ruled out when using inhaled mometasone.
The OBRA guidelines caution that orally inhaled corticosteroids, such as mometasone, can cause throat irritation and oral candidiasis, particularly if the mouth is not rinsed after administration. Abatacept: Moderate Concomitant use of immunosuppressives, as well as long-term corticosteroids, may potentially increase the risk of serious infection in abatacept treated patients.
Advise patients taking abatacept to seek immediate medical advice if they develop signs and symptoms suggestive of infection. Acetaminophen; Aspirin, ASA; Caffeine: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Concomitant use increases the risk of GI bleeding. In patients receiving concomitant corticosteroids and chronic use of salicylates, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
Acetaminophen; Aspirin: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Acetaminophen; Aspirin; Diphenhydramine: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use.
Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Monitor patients for increased pressor effect if these agents are administered concomitantly. Acetaminophen; Chlorpheniramine; Phenylephrine : Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Acetaminophen; Dextromethorphan; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Acetaminophen; Guaifenesin; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Acetazolamide: Moderate Corticosteroids may increase the risk of hypokalemia if used concurrently with acetazolamide. Hypokalemia may be especially severe with prolonged use of corticotropin, ACTH. Acetohexamide: Moderate Monitor blood glucose during concomitant corticosteroid and sulfonylurea use; a sulfonylurea dose adjustment may be necessary. Corticosteroids may increase blood glucose concentrations.
Risk factors for impaired glucose tolerance due to corticosteroids include the corticosteroid dose and duration of treatment. Corticosteroids stimulate hepatic glucose production and inhibit peripheral glucose uptake into muscle and fatty tissues, producing insulin resistance. Decreased insulin production may occur in the pancreas due to a direct effect on pancreatic beta cells.
Adalimumab: Moderate Closely monitor for the development of signs and symptoms of infection if coadministration of a corticosteroid with adalimumab is necessary.
Adalimumab treatment increases the risk for serious infections that may lead to hospitalization or death. Patients taking concomitant immunosuppressants including corticosteroids may be at greater risk of infection. Albiglutide: Moderate Monitor blood glucose during concomitant corticosteroid and incretin mimetic use; an incretin mimetic dose adjustment may be necessary. Alemtuzumab: Moderate Concomitant use of alemtuzumab with immunosuppressant doses of corticosteroids may increase the risk of immunosuppression.
Monitor patients carefully for signs and symptoms of infection. Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary.
Both corticosteroids and thiazide diuretics cause increased renal potassium loss. Aliskiren; Hydrochlorothiazide, HCTZ: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Alogliptin; Metformin: Moderate Monitor blood glucose during concomitant corticosteroid and metformin use; a metformin dose adjustment may be necessary.
Alpha-glucosidase Inhibitors: Moderate Monitor patients receiving antidiabetic agents closely for worsening glycemic control when corticosteroids are instituted and for signs of hypoglycemia when corticosteroids are discontinued.
Systemic and inhaled corticosteroids are known to increase blood glucose and worsen glycemic control in patients taking antidiabetic agents. The main risk factors for impaired glucose tolerance due to corticosteroids are the dose of steroid and duration of treatment. Altretamine: Minor Concurrent use of altretamine with other agents which cause bone marrow or immune suppression such as corticosteroids may result in additive effects.
Ambenonium Chloride: Moderate Concomitant use of anticholinesterase agents, such as ambenonium chloride, and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents used to treat myasthenia should be withdrawn at least 24 hours before initiating corticosteroid therapy. Amifampridine: Moderate Carefully consider the need for concomitant treatment with systemic corticosteroids and amifampridine, as coadministration may increase the risk of seizures.
If coadministration occurs, closely monitor patients for seizure activity. Seizures have been observed in patients without a history of seizures taking amifampridine at recommended doses. Systemic corticosteroids may increase the risk of seizures in some patients. Amiloride; Hydrochlorothiazide, HCTZ: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary.
Aminolevulinic Acid: Minor Corticosteroids administered prior to or concomitantly with photosensitizing agents used in photodynamic therapy may decrease the efficacy of the treatment. Aminosalicylate sodium, Aminosalicylic acid: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary.
Amoxicillin; Clarithromycin; Omeprazole: Moderate Concomitant administration of clarithromycin and mometasone may increase systemic exposure to mometasone, increasing the risk of corticosteroid-related adverse events. Exercise caution when administering mometasone with clarithromycin long-term and monitor closely for hypercorticism and adrenal suppression.
Amphotericin B cholesteryl sulfate complex ABCD : Moderate The potassium-wasting effects of corticosteroid therapy can be exacerbated by concomitant administration of other potassium-depleting drugs including amphotericin B.
Serum potassium levels should be monitored in patients receiving these drugs concomitantly. Amphotericin B lipid complex ABLC : Moderate The potassium-wasting effects of corticosteroid therapy can be exacerbated by concomitant administration of other potassium-depleting drugs including amphotericin B. Amphotericin B liposomal LAmB : Moderate The potassium-wasting effects of corticosteroid therapy can be exacerbated by concomitant administration of other potassium-depleting drugs including amphotericin B.
Amphotericin B: Moderate The potassium-wasting effects of corticosteroid therapy can be exacerbated by concomitant administration of other potassium-depleting drugs including amphotericin B. Arsenic Trioxide: Moderate Caution is advisable during concurrent use of arsenic trioxide and corticosteroids as electrolyte imbalance caused by corticosteroids may increase the risk of QT prolongation with arsenic trioxide. Articaine; Epinephrine: Moderate Monitor potassium concentrations during concomitant corticosteroid and epinephrine use due to risk for additive hypokalemia; potassium supplementation may be necessary.
Corticosteroids may potentiate the hypokalemic effects of epinephrine. Asparaginase Erwinia chrysanthemi: Moderate Concomitant use of L-asparaginase with corticosteroids can result in additive hyperglycemia.
L-Asparaginase transiently inhibits insulin production contributing to hyperglycemia seen during concurrent corticosteroid therapy. Insulin therapy may be required in some cases. Administration of L-asparaginase after rather than before corticosteroids reportedly has produced fewer hypersensitivity reactions.
Aspirin, ASA: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Aspirin, ASA; Butalbital; Caffeine: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Aspirin, ASA; Caffeine: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use.
Aspirin, ASA; Caffeine; Dihydrocodeine: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Aspirin, ASA; Caffeine; Orphenadrine: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use.
Aspirin, ASA; Carisoprodol: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Aspirin, ASA; Carisoprodol; Codeine: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use.
Aspirin, ASA; Dipyridamole: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Aspirin, ASA; Omeprazole: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Aspirin, ASA; Oxycodone: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use.
Aspirin, ASA; Pravastatin: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Atazanavir: Moderate Coadministration of mometasone with atazanavir may cause elevated mometasone serum concentrations, potentially resulting in Cushing's syndrome and adrenal suppression. Corticosteroids, such as beclomethasone and prednisolone, whose concentrations are less affected by strong CYP3A4 inhibitors, should be considered, especially for long-term use.
Atazanavir; Cobicistat: Moderate Coadministration of mometasone with atazanavir may cause elevated mometasone serum concentrations, potentially resulting in Cushing's syndrome and adrenal suppression. Moderate Coadministration of mometasone with cobicistat may cause elevated mometasone serum concentrations, potentially resulting in Cushing's syndrome and adrenal suppression.
Atenolol; Chlorthalidone: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Atracurium: Moderate Limit the period of use of neuromuscular blockers and corticosteroids and only use when the specific advantages of the drugs outweigh the risks for acute myopathy. An acute myopathy has been observed with the use of high doses of corticosteroids in patients receiving concomitant long-term therapy with neuromuscular blockers.
Clinical improvement or recovery after stopping therapy may require weeks to years. Azilsartan; Chlorthalidone: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Benazepril; Hydrochlorothiazide, HCTZ: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary.
Bendroflumethiazide; Nadolol: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary.
Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Bismuth Subsalicylate: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Bismuth Subsalicylate; Metronidazole; Tetracycline: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Bisoprolol; Hydrochlorothiazide, HCTZ: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary.
Boceprevir: Moderate Concomitant administration of boceprevir and mometasone may increase systemic exposure to mometasone, increasing the risk of corticosteroid-related adverse events. Exercise caution when administering mometasone with boceprevir long-term and monitor closely for hypercorticism and adrenal suppression.
Brompheniramine; Carbetapentane; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Brompheniramine; Dextromethorphan; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Brompheniramine; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Bupivacaine; Epinephrine: Moderate Monitor potassium concentrations during concomitant corticosteroid and epinephrine use due to risk for additive hypokalemia; potassium supplementation may be necessary. Bupropion: Moderate Monitor for seizure activity during concomitant bupropion and corticosteroid use.
Bupropion is associated with a dose-related seizure risk; concomitant use of other medications that lower the seizure threshold, such as systemic corticosteroids, increases the seizure risk.
Bupropion; Naltrexone: Moderate Monitor for seizure activity during concomitant bupropion and corticosteroid use. Caffeine; Sodium Benzoate: Moderate Corticosteroids may cause protein breakdown, which could lead to elevated blood ammonia concentrations, especially in patients with an impaired ability to form urea. Corticosteroids should be used with caution in patients receiving treatment for hyperammonemia.
Canagliflozin; Metformin: Moderate Monitor blood glucose during concomitant corticosteroid and metformin use; a metformin dose adjustment may be necessary.
Candesartan; Hydrochlorothiazide, HCTZ: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary.
Captopril; Hydrochlorothiazide, HCTZ: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Carbetapentane; Chlorpheniramine; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Carbetapentane; Diphenhydramine; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Carbetapentane; Guaifenesin; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Carbetapentane; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Carbetapentane; Phenylephrine; Pyrilamine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Carbinoxamine; Hydrocodone; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Carbinoxamine; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Ceritinib: Moderate Coadministration of mometasone with ceritinib may cause elevated mometasone serum concentrations, potentially resulting in Cushing's syndrome and adrenal suppression. Chlophedianol; Guaifenesin; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Chloramphenicol: Moderate Coadministration of mometasone with chloramphenicol may cause elevated mometasone serum concentrations, potentially resulting in Cushing's syndrome and adrenal suppression. Chlorothiazide: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Chlorpheniramine; Dextromethorphan; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Chlorpheniramine; Dihydrocodeine; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Chlorpheniramine; Hydrocodone; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Chlorpheniramine; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Chlorpropamide: Moderate Monitor blood glucose during concomitant corticosteroid and sulfonylurea use; a sulfonylurea dose adjustment may be necessary. Chlorthalidone: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary.
Chlorthalidone; Clonidine: Moderate Monitor potassium concentrations during concomitant corticosteroid and thiazide diuretic use due to risk for additive hypokalemia; potassium supplementation may be necessary. Choline Salicylate; Magnesium Salicylate: Moderate Monitor for gastrointestinal toxicity during concurrent corticosteroid and salicylate use. Cisatracurium: Moderate Limit the period of use of neuromuscular blockers and corticosteroids and only use when the specific advantages of the drugs outweigh the risks for acute myopathy.
Clarithromycin: Moderate Concomitant administration of clarithromycin and mometasone may increase systemic exposure to mometasone, increasing the risk of corticosteroid-related adverse events. Cobicistat: Moderate Coadministration of mometasone with cobicistat may cause elevated mometasone serum concentrations, potentially resulting in Cushing's syndrome and adrenal suppression. Codeine; Phenylephrine; Promethazine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Dapagliflozin; Metformin: Moderate Monitor blood glucose during concomitant corticosteroid and metformin use; a metformin dose adjustment may be necessary. Darunavir: Moderate Coadministration of mometasone with darunavir may cause elevated mometasone serum concentrations, potentially resulting in Cushing's syndrome and adrenal suppression.
Darunavir; Cobicistat: Moderate Coadministration of mometasone with cobicistat may cause elevated mometasone serum concentrations, potentially resulting in Cushing's syndrome and adrenal suppression.
Moderate Coadministration of mometasone with darunavir may cause elevated mometasone serum concentrations, potentially resulting in Cushing's syndrome and adrenal suppression. Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide: Moderate Coadministration of mometasone with cobicistat may cause elevated mometasone serum concentrations, potentially resulting in Cushing's syndrome and adrenal suppression.
Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir: Moderate Coadministration of mometasone with ritonavir a strong CYP3A4 inhibitor may cause mometasone serum concentrations to increase, potentially resulting in Cushing's syndrome and adrenal suppression. Consider use of an alternative corticosteroid whose concentrations are less affected by strong CYP3A4 inhibitors, such as beclomethasone and prednisolone, especially during long-term treatment.
Delavirdine: Moderate Concomitant administration of delavirdine and mometasone may increase systemic exposure to mometasone, increasing the risk of corticosteroid-related adverse events. Exercise caution when administering mometasone with delavirdine long-term and monitor closely for hypercorticism and adrenal suppression.
Denosumab: Moderate The safety and efficacy of denosumab use in patients with immunosuppression have not been evaluated. Patients receiving immunosuppressives along with denosumab may be at a greater risk of developing an infection. Desmopressin: Major Desmopressin is contraindicated with concomitant inhaled or systemic corticosteroid use due to an increased risk of hyponatremia.
Desmopressin can be started or resumed 3 days or 5 half-lives after the corticosteroid is discontinued, whichever is longer. Dextromethorphan; Bupropion: Moderate Monitor for seizure activity during concomitant bupropion and corticosteroid use.
Dextromethorphan; Diphenhydramine; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Dextromethorphan; Guaifenesin; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Digoxin: Moderate Hypokalemia, hypomagnesemia, or hypercalcemia increase digoxin's effect.
Corticosteroids can precipitate digoxin toxicity via their effect on electrolyte balance. It is recommended that serum potassium, magnesium, and calcium be monitored regularly in patients receiving digoxin. Dipeptidyl Peptidase-4 Inhibitors: Moderate Monitor blood glucose during concomitant corticosteroid and dipeptidyl peptidase-4 DPP-4 inhibitor use; a DPP-4 dose adjustment may be necessary.
Diphenhydramine; Hydrocodone; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Diphenhydramine; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone.
Dofetilide: Major Corticosteroids can cause increases in blood pressure, sodium and water retention, and hypokalemia, predisposing patients to interactions with certain other medications. Corticosteroid-induced hypokalemia could also enhance the proarrhythmic effects of dofetilide. Doxacurium: Moderate Limit the period of use of neuromuscular blockers and corticosteroids and only use when the specific advantages of the drugs outweigh the risks for acute myopathy.
Droperidol: Moderate Caution is advised when using droperidol in combination with corticosteroids which may lead to electrolyte abnormalities, especially hypokalemia or hypomagnesemia, as such abnormalities may increase the risk for QT prolongation or cardiac arrhythmias. Dulaglutide: Moderate Monitor blood glucose during concomitant corticosteroid and incretin mimetic use; an incretin mimetic dose adjustment may be necessary. Echinacea: Moderate Echinacea possesses immunostimulatory activity and may theoretically reduce the response to immunosuppressant drugs like corticosteroids.
For some patients who are using corticosteroids for serious illness, such as cancer or organ transplant, this potential interaction may result in the preferable avoidance of Echinacea. Although documentation is lacking, coadministration of echinacea with immunosuppressants is not recommended by some resources. Econazole: Minor In vitro studies indicate that corticosteroids inhibit the antifungal activity of econazole against C. When the concentration of the corticosteroid was equal to or greater than that of econazole on a weight basis, the antifungal activity of econazole was substantially inhibited.
When the corticosteroid concentration was one-tenth that of econazole, no inhibition of antifungal activity was observed. Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide: Moderate Coadministration of mometasone with cobicistat may cause elevated mometasone serum concentrations, potentially resulting in Cushing's syndrome and adrenal suppression.
Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with 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. Clinical trials of mometasone furoate lotion 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. Topically applied Mometasone Furoate Topical Solution 0. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Mometasone furoate is a white to off-white powder insoluble in water, freely soluble in acetone and in methylene chloride and sparingly soluble in heptane.
May also contain phosphoric acid used to adjust the pH to approximately 4. 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 A 2 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 A 2. Studies performed with mometasone furoate lotion indicate that it is in the medium range of potency as compared with other topical corticosteroids.
At the end of treatment, the plasma cortisol levels for each of the 4 subjects remained within the normal range and changed little from baseline [see Warnings and Precautions 5. Sixty-five pediatric subjects ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label, HPA axis safety trial.
Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria [see Use in Specific Populations 8.
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.
A similar minimal degree of absorption of the corticosteroid from the lotion formulation would be anticipated. Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate lotion.
Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay.
Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.
The safety and efficacy of mometasone furoate lotion for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in scalp psoriasis and one in seborrheic dermatitis.
A total of subjects age range: years received mometasone furoate lotion subjects or the vehicle lotion applied once daily for 21 days. Store Mometasone Furoate Topical Solution, 0. Important information: Mometasone Furoate Topical Solution, 0. See the end of this leaflet for a complete list of ingredients in Mometasone Furoate Topical Solution, 0. Before using Mometasone Furoate Topical Solution, 0. 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. What are the possible side effects of Mometasone Furoate Topical Solution, 0. The most common side effects of Mometasone Furoate Topical Solution, 0. Call your doctor for medical advice about side effects. General information about the safe and effective use of Mometasone Furoate Topical Solution, 0.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not give Mometasone Furoate Topical Solution, 0. It may harm them. You can ask your pharmacist or healthcare provider for information about Mometasone Furoate Topical Solution, 0.
Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water. This medicine should only be used for skin conditions that your doctor is treating.
Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.
Do not use this medicine on the face, groin, or underarms unless directed to do so by your doctor. Do not use this medicine in the diaper area of an infant. Diapers or plastic pants will increase the amount of medicine absorbed through the skin and cause unwanted side effects. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine.
If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. If you miss a dose of this medicine, apply it as soon as possible.
If you are a consumer or patient please visit this version. Warnings and Precautions Ophthalmic Adverse Reactions 5. Mometasone furoate topical solution USP, 0. Most common adverse reactions included are acneiform reaction, burning, itching and folliculitis. Apply a few drops of mometasone furoate topical solution USP, 0.
Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions 5. Do not use mometasone furoate topical solution USP, 0. Do not apply mometasone furoate topical solution USP, 0. 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. Lotion, 0. Each gram of mometasone furoate topical solution USP, 0. 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 Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
Factors that predispose a patient using a 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 a 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 7 days to 4 adult subjects with scalp and body psoriasis.
At the end of treatment, the plasma cortisol levels for each of the 4 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 a 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.
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.
Avoid contact of mometasone furoate topical solution USP, 0. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. If irritation develops, mometasone furoate topical solution USP, 0. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of mometasone furoate topical solution USP, 0. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a 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 subjects, the incidence of adverse reactions associated with the use of mometasone furoate topical solution USP, 0. Reported reactions included acneiform reaction, 2; burning, 4; and itching, 1. The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate topical solution USP, 0.
The following signs of skin atrophy were also observed among 65 subjects treated with mometasone furoate topical solution USP, 0. Because adverse reactions are 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. 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. No drug-drug interaction studies have been conducted with mometasone furoate topical solution USP, 0. Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women.
Therefore, mometasone furoate topical solution USP, 0. 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. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.
In rabbits, mometasone furoate caused multiple malformations e. Similar effects were not observed at 7. Doses of 7. 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 topical solution USP, 0. Since safety and efficacy of mometasone furoate topical solution USP, 0. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria.
Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids.
Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. HPA axis suppression, Cushing's 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. Clinical trials of mometasone furoate topical solution USP, 0. 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.
Topically applied mometasone furoate topical solution USP, 0. Mometasone furoate topical solution, 0. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.
May also contain phosphoric acid used to adjust the pH to approximately 4. 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 A 2 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 A 2. Studies performed with mometasone furoate topical solution USP, 0.
At the end of treatment, the plasma cortisol levels for each of the 4 subjects remained within the normal range and changed little from baseline [see Warnings and Precautions 5. Sixty-five pediatric subjects ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label, HPA axis safety trial. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria [see Use in Specific Populations 8.
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.
A similar minimal degree of absorption of the corticosteroid from the lotion formulation would be anticipated. Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate topical solution USP, 0. Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay.
Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell hromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.
The safety and efficacy of mometasone furoate topical solution USP, 0. A total of subjects age range: years received mometasone furoate topical solution USP, 0. Store mometasone furoate topical solution, 0. It is for external use only.
If no improvement is seen within 2 weeks, contact the physician. Distributed by: Cosette Pharmaceuticals, Inc. Important information: Mometasone furoate topical solution, USP 0. Do not use mometasone furoate topical solution, USP 0.
Usual Pediatric Dose for Eczema. 2 years and older: Cream/ointment: Apply a thin layer to the affected area once a day 12 years and older. Apply a few drops of mometasone furoate topical solution, USP % (lotion) to the affected skin area 1 time each day and rub it in lightly until it disappears. Apply a few drops of mometasone furoate topical solution, USP % (lotion) to the affected skin area 1 time each day and rub it in lightly until it disappears. Mometasone Topical: learn about side effects, dosage, special precautions, and more on MedlinePlus. Adults, including elderly patients and children: A thin film of Mometasone Furoate 1mg/g Cream should be applied to the affected areas of skin once daily. Use. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. Do not use in the diaper area of patients who require diapers or plastic pants; these garments may act as an occlusive dressing. Diphenhydramine; Phenylephrine: Moderate The therapeutic effect of phenylephrine may be increased in patient receiving corticosteroids, such as hydrocortisone. Mometasone inhalation therapy is contraindicated in the primary treatment of status asthmaticus or other acute types of acute bronchospasm where intensive measures are required.Drug information provided by: IBM Micromedex. It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation. This medicine is for use on the skin only. Do not get it into your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.
This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present.
This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns. Do not use this medicine on the face, groin, or underarms unless directed to do so by your doctor.
Do not use this medicine in the diaper area of an infant. Diapers or plastic pants will increase the amount of medicine absorbed through the skin and cause unwanted side effects. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine.
Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. There is a problem with information submitted for this request.
Sign up for free, and stay up to date on research advancements, health tips and current health topics, like COVID, plus expertise on managing health. To provide you with the most relevant and helpful information, and understand which information is beneficial, we may combine your email and website usage information with other information we have about you. If you are a Mayo Clinic patient, this could include protected health information.
If we combine this information with your protected health information, we will treat all of that information as protected health information and will only use or disclose that information as set forth in our notice of privacy practices.
You may opt-out of email communications at any time by clicking on the unsubscribe link in the e-mail. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. All rights reserved. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Mayo Clinic does not endorse companies or products.
Advertising revenue supports our not-for-profit mission. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. This site complies with the HONcode standard for trustworthy health information: verify here. This content does not have an English version.
This content does not have an Arabic version. See more conditions. Products and services. Proper Use Drug information provided by: IBM Micromedex It is very important that you use this medicine only as directed by your doctor. Thank you for subscribing! Sorry something went wrong with your subscription Please, try again in a couple of minutes Retry.
No comments:
Post a Comment