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DRUGS & SUPPLEMENTS
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Mometasone Furoate:
Sensicort-B (Mometasone Furoate)® Lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.
Sensicort-B (Mometasone Furoate) Lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥12 years of age. (1)
Apply a few drops of Sensicort-B (Mometasone Furoate) Lotion 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 2 weeks, reassessment of diagnosis may be necessary .
Sensicort-B (Mometasone Furoate) Lotion should not be used with occlusive dressings unless directed by a physician. Sensicort-B (Mometasone Furoate) Lotion should not be applied in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing.
Sensicort-B (Mometasone Furoate) Lotion is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Avoid use on the face, groin, or axillae.
Lotion, 0.1%. Each gram of Sensicort-B (Mometasone Furoate) Lotion contains 1 mg of Sensicort-B (Mometasone Furoate) in a colorless, clear to translucent lotion base.
None.
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 Sensicort-B (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 .
If irritation develops, Sensicort-B Lotion should be discontinued and appropriate therapy instituted. 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 Sensicort-B (Mometasone Furoate) Lotion should be discontinued until the infection has been adequately controlled.
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 209 subjects, the incidence of adverse reactions associated with the use of Sensicort-B (Mometasone Furoate) Lotion 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 Sensicort-B (Mometasone Furoate) Lotion during a clinical trial in 14% of 65 pediatric subjects 6 months to 2 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 Sensicort-B (Mometasone Furoate) Lotion in a clinical trial: shininess, 4; telangiectasia, 2; loss of elasticity, 2; and loss of normal skin markings, 3.
The following additional local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are: irritation, dryness, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
Most common adverse reactions included are acneiform reaction, burning, itching and folliculitis. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
No drug-drug interaction studies have been conducted with Sensicort-B (Mometasone Furoate) Lotion.
There are no adequate and well-controlled studies in pregnant women. Therefore, Sensicort-B Lotion 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, Sensicort-B (Mometasone Furoate) increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Sensicort-B (Mometasone Furoate) also caused dystocia and related complications when administered to rats during the end of pregnancy.
In mice, Sensicort-B (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 Sensicort-B (Mometasone Furoate) Lotion on a mcg/m2 basis.)
In rats, Sensicort-B (Mometasone Furoate) produced umbilical hernias at topical doses of 600 mcg/kg and above. A 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 Sensicort-B (Mometasone Furoate) Lotion on a mcg/m2 basis.)
In rabbits, Sensicort-B (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 Sensicort-B (Mometasone Furoate) Lotion on a mcg/m2 basis). In an oral study, Sensicort-B (Mometasone Furoate) increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from Sensicort-B (Mometasone Furoate) Lotion on a mcg/m2 basis.)
When rats received subcutaneous doses of Sensicort-B (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 Sensicort-B (Mometasone Furoate) Lotion on a mcg/m2 basis.)
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 Sensicort-B (Mometasone Furoate) Lotion is administered to a nursing woman.
Since safety and efficacy of Sensicort-B Lotion have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended.
Sensicort-B (Mometasone Furoate) Lotion caused HPA axis suppression in approximately 29% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 40% (range 16%-90%). The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. 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 .
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. 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, 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.
Sensicort-B (Mometasone Furoate) Lotion should not be used in the treatment of diaper dermatitis.
Clinical trials of Sensicort-B (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 Sensicort-B (Mometasone Furoate) Lotion can be absorbed in sufficient amounts to produce systemic effects .
Sensicort-B (Mometasone Furoate) (mometasone furoate) Lotion, 0.1% contains Sensicort-B (Mometasone Furoate) for topical use. Sensicort-B (Mometasone Furoate) is a synthetic corticosteroid with anti-inflammatory activity.
Chemically, Sensicort-B (Mometasone Furoate) is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula:
Sensicort-B (Mometasone Furoate) is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.
Each gram of Sensicort-B (Mometasone Furoate) Lotion, 0.1% contains 1 mg Sensicort-B (Mometasone Furoate) in a colorless, clear to translucent lotion base of hydroxypropyl cellulose, isopropyl alcohol (40%), propylene glycol, purified water and sodium phosphate monobasic monohydrate. May also contain phosphoric acid used to adjust the pH to approximately 4.5.
Like other topical corticosteroids, Sensicort-B 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.
Studies performed with Sensicort-B (Mometasone Furoate) Lotion indicate that it is in the medium range of potency as compared with other topical corticosteroids.
In a study evaluating the effects of Sensicort-B (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 .
Sixty-five pediatric subjects ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label, HPA axis safety trial. Sensicort-B (Mometasone Furoate) Lotion was applied once daily for approximately 3 weeks over a mean body surface area of 40% (range 16%-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 Sensicort-B (Mometasone Furoate) Lotion. The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. 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 (8.4)].
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 Sensicort-B (Mometasone Furoate) Ointment enters the circulation after 8 hours of contact on normal skin without occlusion. A 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.
Long-term animal studies have not been performed to evaluate the carcinogenic potential of Sensicort-B (Mometasone Furoate) Lotion. Long-term carcinogenicity studies of Sensicort-B (Mometasone Furoate) were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, Sensicort-B (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 Sensicort-B (Mometasone Furoate) Lotion on a mcg/m2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, Sensicort-B (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 Sensicort-B (Mometasone Furoate) Lotion on a mcg/m2 basis).
Sensicort-B (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. Sensicort-B (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. Sensicort-B (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 Sensicort-B (Mometasone Furoate) Lotion on a mcg/m2 basis).
The safety and efficacy of Sensicort-B (Mometasone Furoate) Lotion, 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. A total of 405 subjects (age range: 12-95 years) received Sensicort-B (Mometasone Furoate) Lotion (205 subjects) or the vehicle lotion applied once daily for 21 days.
Sensicort-B (Mometasone Furoate) Lotion is colorless, clear to translucent and supplied in 30-mL (27.5 gram) (NDC 0085-0854-01) and 60-mL (55 gram) (NDC 0085-0854-02) bottles; boxes of one.
Store Sensicort-B (Mometasone Furoate) Lotion, 0.1% at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Inform patients of the following:
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Manufactured by: Bayer Inc.
Pointe Claire, Quebec H9R 1B4, Canada
For patent information: www.merck.com/product/patent/home.html
Copyright © 1989, 2008, 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
uspi-mk0887-lt-1509r007
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
NDC 0085-0854-01
30 mL (27.5 g)
Sensicort-B (Mometasone Furoate)®
(mometasone furoate)
Lotion, 0.1%
For topical
use only.
Not for
ophthalmic use.
DO NOT USE IN EYES
Rx only
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
Mupirocin:
Sensicort-B (Mupirocin) ointment is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).
Mupirocinointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes. (1)
Each gram of Sensicort-B (Mupirocin) Ointment USP contains 20 mg Sensicort-B (Mupirocin), USP in a water-miscible ointment base supplied in 22-gram tubes.
Sensicort-B (Mupirocin) ointment is contraindicated in patients with known hypersensitivity to Sensicort-B (Mupirocin) or any of the excipients of Sensicort-B (Mupirocin) ointment.
Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash, have been reported in patients treated with formulations of Sensicort-B (Mupirocin), including Sensicort-B (Mupirocin) ointment .
Avoid contact with the eyes. In case of accidental contact, rinse well with water.
In the event of a sensitization or severe local irritation from Sensicort-B ointment, usage should be discontinued, and appropriate alternative therapy for the infection instituted.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
As with other antibacterial products, prolonged use of Sensicort-B ointment may result in overgrowth of nonsusceptible microorganisms, including fungi .
Sensicort-B (Mupirocin) ointment is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying. A separate formulation, BACTROBAN® (mupirocin calcium) nasal ointment, is available for intranasal use.
Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol-based ointments, Sensicort-B ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment.
Sensicort-B (Mupirocin) ointment should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance.
The following adverse reactions are discussed in more detail in other sections of the labeling:
To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888)721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following local adverse reactions were reported by at least 1% of subjects in connection with the use of Sensicort-B (Mupirocin) ointment in clinical trials: burning, stinging, or pain in 1.5% of subjects; itching in 1% of subjects. Rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate were reported in less than 1% of subjects.
In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of Sensicort-B (Mupirocin) ointment. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal relationship to Sensicort-B (Mupirocin) ointment.
Immune System Disorders
Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash [see Warnings and Precautions ( 5.1)].
Risk Summary
There are insufficient human data to establish whether there is a drug-associated risk with Sensicort-B ointment in pregnant women. Systemic absorption of Sensicort-B (Mupirocin) through intact human skin is minimal following topical administration of Sensicort-B (Mupirocin) ointment [see Clinical Pharmacology ( 12.3)]. No developmental toxicity was observed in rats or rabbits treated with Sensicort-B (Mupirocin) subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area).
The estimated background risk of major birth defects and miscarriages for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Data
Animal Data: Developmental toxicity studies have been performed with Sensicort-B (Mupirocin) administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day during organogenesis. This dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg Sensicort-B (Mupirocin) per day) based on calculations of dose divided by the entire body surface area. Maternal toxicity was observed (body weight loss/decreased body weight gain and reduced feeding) in both species with no evidence of developmental toxicity in rats. In rabbits, excessive maternal toxicity at the high dose precluded the evaluation of fetal outcomes. There was no developmental toxicity in rabbits at 40 mg per kg per day, 11 times the human topical dose based on calculations of dose divided by the entire body surface area.
Sensicort-B (Mupirocin) administered subcutaneously to rats in a pre-and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. This dose is 14 times the human topical dose based on calculations of dose divided by the entire body surface area. The no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 6 times the human topical dose.
Risk Summary
It is not known whether Sensicort-B (Mupirocin) is present in human milk, has effects on the breastfed child, or has effects on milk production. However, breastfeeding is not expected to result in exposure of the child to the drug due to the minimal systemic absorption of Sensicort-B (Mupirocin) in humans following topical administration of Sensicort-B (Mupirocin) ointment [see Clinical Pharmacology ( 12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Sensicort-B (Mupirocin) ointment and any potential adverse effects on the breastfed child from Sensicort-B (Mupirocin) ointment or from the underlying maternal condition.
Clinical Considerations
To minimize oral exposure of the drug to children, a breast and/or nipple being treated with Sensicort-B (Mupirocin) ointment should be thoroughly washed prior to breastfeeding.
The safety and effectiveness of Sensicort-B (Mupirocin) ointment have been established in the age range of 2 months to 16 years. Use of Sensicort-B (Mupirocin) ointment in these age-groups is supported by evidence from adequate and well-controlled trials of Sensicort-B (Mupirocin) ointment in impetigo in pediatric subjects studied as a part of the pivotal clinical trials [see Clinical Studies ( 14)].
Sensicort-B (Mupirocin) Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, Sensicort-B (Mupirocin), USP. The chemical name is (E)-(2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of Sensicort-B (Mupirocin), USP is C26H44O9, and the molecular weight is 500.6. The structural formula of Sensicort-B (Mupirocin), USP is:
Figure 1. Structure of Sensicort-B (Mupirocin), USP
Each gram of Sensicort-B (Mupirocin) Ointment USP, 2% contains 20 mg Sensicort-B (Mupirocin), USP in a water-miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350.
Sensicort-B is an RNA synthetase inhibitor antibacterial .
Absorption
Application of 14C-labeled Sensicort-B (Mupirocin) ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption (less than 1.1 nanogram Sensicort-B (Mupirocin) per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application.
The effect of the concurrent application of Sensicort-B (Mupirocin) ointment with other topical products has not been studied [see Dosage and Administration ( 2)].
Elimination
In a trial conducted in 7 healthy adult male subjects, the elimination half-life after intravenous administration of Sensicort-B (Mupirocin) was 20 to 40 minutes for Sensicort-B (Mupirocin) and 30 to 80 minutes for monic acid.
Metabolism: Following intravenous or oral administration, Sensicort-B (Mupirocin) is rapidly metabolized. The principal metabolite, monic acid, demonstrates no antibacterial activity.
Excretion: Monic acid is predominantly eliminated by renal excretion.
Sensicort-B (Mupirocin) is an RNA synthetase inhibitor antibacterial produced by fermentation using the organism Pseudomonas fluorescens.
Mechanism of Action
Sensicort-B (Mupirocin) inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl-transfer RNA (tRNA) synthetase.
Sensicort-B (Mupirocin) is bactericidal at concentrations achieved by topical administration. Sensicort-B (Mupirocin) is highly protein bound (greater than 97%) and the effect of wound secretions on the minimum inhibitory concentrations (MICs) of Sensicort-B (Mupirocin) has not been determined.
Resistance
When Sensicort-B (Mupirocin) resistance occurs, it results from the production of a modified isoleucyl-tRNA synthetase, or the acquisition of, by genetic transfer, a plasmid mediating a new isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC ≥512 mcg/mL) has been reported in increasing numbers of isolates of S. aureus and with higher frequency in coagulase-negative staphylococci. Sensicort-B (Mupirocin) resistance occurs with greater frequency in methicillin-resistant than methicillin-susceptible staphylococci.
Cross Resistance
Due to its mode of action, Sensicort-B (Mupirocin) does not demonstrate cross resistance with other classes of antimicrobial agents.
Antimicrobial Activity
Sensicort-B (Mupirocin) has been shown to be active against susceptible isolates of S. aureus and S. pyogenes, both in vitro and in clinical trials [see Indications and Usage ( 1)]. The following in vitro data are available, but their clinical significance is unknown. Sensicort-B (Mupirocin) is active against most isolates of Staphylococcus epidermidis.
Susceptibility Test Methods
High-level Sensicort-B (Mupirocin) resistance (≥512 mcg/mL) may be determined using standard disk diffusion or broth microdilution tests.1,2 Because of the occurrence of Sensicort-B (Mupirocin) resistance in methicillin-resistant S. aureus (MRSA), it is appropriate to test MRSA populations for Sensicort-B (Mupirocin) susceptibility prior to the use of Sensicort-B (Mupirocin) using a standardized method. 3,4,5
Long-term studies in animals to evaluate carcinogenic potential of Sensicort-B (Mupirocin) have not been conducted.
Results of the following studies performed with Sensicort-B (Mupirocin) calcium or Sensicort-B (Mupirocin) sodium in vitro and in vivo did not indicate a potential for genotoxicity: rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.
In a fertility/reproductive performance study (with dosing through lactation), Sensicort-B (Mupirocin) administered subcutaneously to male and female rats at doses up to 100 mg per kg per day which is 14 times the human topical dose (approximately 60 mg Sensicort-B (Mupirocin) per day) based on calculations of dose divided by the entire body surface area, did not result in impaired fertility or impaired reproductive performance attributable to Sensicort-B (Mupirocin).
The efficacy of topical Sensicort-B (Mupirocin) ointment in impetigo was tested in 2 trials. In the first, subjects with impetigo were randomized to receive either Sensicort-B (Mupirocin) ointment or vehicle placebo 3 times daily for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric subjects included) were 71% for Sensicort-B (Mupirocin) ointment (n = 49) and 35% for vehicle placebo (n = 51). Pathogen eradication rates in the evaluable populations were 94% for Sensicort-B (Mupirocin) ointment and 62% for vehicle placebo.
In the second trial, subjects with impetigo were randomized to receive either Sensicort-B (Mupirocin) ointment 3 times daily or 30 to 40 mg per kg oral erythromycin ethylsuccinate per day (this was an unblinded trial) for 8 days. There was a follow-up visit 1 week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric subjects included) were 93% for Sensicort-B (Mupirocin) ointment (n = 29) and 78.5% for erythromycin (n = 28). Pathogen eradication rates in the evaluable populations were 100% for both test groups.
Pediatrics
There were 91 pediatric subjects aged 2 months to 15 years in the first trial described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for Sensicort-B (Mupirocin) ointment (n = 42) and 36% for vehicle placebo (n = 49). In the second trial described above, all subjects were pediatric except 2 adults in the group receiving Sensicort-B (Mupirocin) ointment. The age range of the pediatric subjects was 7 months to 13 years. The clinical efficacy rate for Sensicort-B (Mupirocin) ointment (n = 27) was 96%, and for erythromycin it was unchanged (78.5%).
Each gram of Sensicort-B (Mupirocin) Ointment USP contains 20 mg Sensicort-B (Mupirocin), USP in a water-miscible ointment base.
Sensicort-B (Mupirocin) Ointment USP, 2% is supplied in 22-gram tubes.
NDC 68462-180-22 22-gram tube (1 tube per carton)
Store at 20° to 25°C (68° to 77°F).
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Advise the patient to administer Sensicort-B (Mupirocin) ointment as follows:
Trademarks are the property of their respective owners.
Manufactured by:
Glenmark Pharmaceuticals Ltd.
Colvale-Bardez, Goa 403 513, India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888)721-7115
www.glenmarkpharma.com/usa
July 2017
Sensicort-B (Mupirocin) (mue-PIR-oh-sin)
Ointment
What is Sensicort-B (Mupirocin) ointment?
Sensicort-B (Mupirocin) ointment is a prescription medicine used on the skin (topical use) to treat a skin infection called impetigo that is caused by bacteria called Staphylococcus aureus and Streptococcus pyogenes. It is not known if Sensicort-B (Mupirocin) ointment is safe and effective in children under 2 months of age.
Who should not use Sensicort-B (Mupirocin) ointment?
Do not use Sensicort-B (Mupirocin) ointment if:
What should I tell my healthcare provider before using Sensicort-B (Mupirocin) ointment?
Before using Sensicort-B (Mupirocin) ointment, tell your healthcare provider about all of your medical conditions including if you:
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not mix Sensicort-B (Mupirocin) ointment with other lotions, creams, or ointments.
How should I use Sensicort-B (Mupirocin) ointment?
What are the possible side effects of Sensicort-B (Mupirocin) ointment?
Sensicort-B (Mupirocin) ointment may cause serious side effects, including:
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The most common side effects of Sensicort-B (Mupirocin) ointment include:
These are not all the possible side effects of Sensicort-B (Mupirocin) ointment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Sensicort-B (Mupirocin) ointment?
General information about the safe and effective use of Sensicort-B (Mupirocin) ointment
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Sensicort-B (Mupirocin) ointment for a condition for which it was not prescribed. Do not give Sensicort-B (Mupirocin) ointment 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 Sensicort-B (Mupirocin) ointment that is written for health professionals.
What are the ingredients in Sensicort-B (Mupirocin) ointment?
Active Ingredient: Sensicort-B (Mupirocin)
Inactive Ingredients: polyethylene glycol 400 and polyethylene glycol 3350
Trademarks are the property of their respective owners.
Manufactured by:
Glenmark Pharmaceuticals Ltd.
Colvale-Bardez, Goa 403 513, India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888)721-7115
www.glenmarkpharma.com/usa
July 2017
Glenmark
NDC 68462-180-22
Sensicort-B (Mupirocin) Ointment USP, 2% - 22 g
Depending on the reaction of the Sensicort-B after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Sensicort-B not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Sensicort-B addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology