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uncomplicated Cormax Cream Generic Name: clobetasol propionate Dosage Form: cream Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A For Dermatologic Use Only - Not for Ophthalmic Use. Cormax Cream Description Cormax Cream (Clobetasol Propionate Cream, USP) contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione,17-propionate and it has the following structural formula: Clobetasol propionate has the molecular formula C 25 H 3 CIFO 5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Each gram of Cormax Cream contains 0.5 mg clobetasol propionate in a base composed of white petrolatum, cetyl alcohol, stearyl alcohol, lanolin oil, PEG-8 stearate, polysorbate 60, glycol stearate, propylparaben, propylene glycol, methylparaben, sodium citrate, citric acid and purified water. Cormax Cream - Clinical Pharmacology The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid- responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteris tic of this class of drugs. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids, including clobetasol propionate, is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION ). As with all topical corticosteroids, clobetasol propionate can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similarly to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids, including clobetasol propionate and its metabo lites, are also excreted into the bile. Clobetasol propionate cream has been shown to depress the plasma levels of adrenal cortical hormones following repeated nonocclusive application to diseased skin in patients with psoriasis and eczematous dermatitis. These effects have been shown to be transient and reversible upon completion of a two-week course of treatment. Indications and Usage for Cormax Cream Cormax Cream (Clobetasol Propionate Cream, USP) is indicated for short-term treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. This product is not recommended for use in children under 12 years of age. Contraindications Cormax Cream (Clobetasol Propionate Cream, USP) is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation. Precautions General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g per day. Systemic absorption of topical corticosteroids has resulted in reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions that augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS: Pedi atric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Certain areas of the body, such as the face, groin, and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids. Frequent observation of the patient is important if these areas are to be treated. As with other potent topical corticosteroids, Cormax Cream (Clobetasol Pro pionate Cream, USP) should not be used in the treatment of rosacea and perioral dermatitis. Topical corticosteroids in general should not be used in the treatment of acne or as sole therapy in widespread plaque psoriasis. Information for Patients Patients using Cormax Cream should receive the following information and instructions: This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes. This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive. Patients should report any signs of local adverse reactions to the physician. Laboratory Tests The following tests may be helpful in evaluating HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone have revealed nega tive results. Pregnancy Teratogenic Effects: Pregnancy Category C: The more potent corticosteroids have been shown to be teratogenic in animals after dermal application. Clobetasol propionate has not been tested for teratogenicity by this route; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent. There are no adequate and well-controlled studies of the teratogenic effects of topically applied corticosteroids, including clobetasol, in pregnant women. Therefore, clobetasol and other topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and they should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are prescribed for a nursing woman. Pediatric Use Use of Cormax Cream (Clobetasol Propionate Cream, USP) in children under 12 years of age is not recommended. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Adverse Reactions Cormax Cream (Clobetasol Propionate Cream, USP) is generally well tolerated when used for two-week treatment periods. The most frequent adverse reactions reported for clobetasol propionate cream have been local and have included burning sensation and stinging sensation in approximately 1% of the patients. Less frequent adverse reactions were itching, skin atrophy, and cracking and fissuring of the skin. The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended. Overdosage Topically applied Cormax Cream (Clobetasol Propionate Cream, USP) can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ). Cormax Cream Dosage and Administration A thin layer of Cormax Cream (Clobetasol Propionate Cream, USP) should be applied with gentle rubbing to the affected skin areas twice daily, once in the morning and once at night. Cormax Cream is potent; therefore, treatment must be limited to two consecutive weeks, and amounts greater than 50 g per week should not be used. Cormax Cream is not to be used with occlusive dressings. How is Cormax Cream Supplied Cormax Cream (Clobetasol Propionate Cream, USP) is supplied in 15 g (NDC 55515-420-15), 30 g (NDC 55515-420-30), and 45 g (NDC 55515-420-45) tubes. Store at controlled room temperature 15 -30 C (59 -86 F). Do not refrigerate. Rx only Mfd. for Oclassen DERMATOLOGICS A Division of Watson Pharma, Inc., Corona, CA 92880 USA by DPT Labs. Ltd., San Antonio, TX 78215 Revised: May 2005 128254-0505 Principal Display Panel Cormax 0.05% Cream (Clobetasol Propionate Cream, USP) 45 g NDC 55515-420-45 Oclassen DERMATOLOGICS Rx only CORMAX clobetasol propionate cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63094-5420 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOBETASOL PROPIONATE (CLOBETASOL) CLOBETASOL PROPIONATE 0.5 mg in 1 g Packaging # Item Code Package Description 1 NDC:63094-5420-1 15 g in 1 TUBE 2 NDC:63094-5420-3 30 g in 1 TUBE 3 NDC:63094-5420-4 45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074220 08/05/1998 06/30/2010 Labeler - DPT Laboratories, Ltd. (832224526) Revised: 06/2010 DPT Laboratories, Ltd. Next Interactions Print this page Add to My Med List More about Cormax (clobetasol topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: topical steroids Consumer resources Cormax Cormax (Advanced Reading) Professional resources Cormax (FDA) Cormax Solution (FDA) Clobetasol Propionate (AHFS Monograph) Other brands: Temovate , Clobex , Olux , Temovate E , ... +2 more Other Formulations Cormax Scalp Application Related treatment guides Atopic Dermatitis Dermatitis Dermatological Disorders Eczema ... +3 more} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Topical steroids Related Drugs topical steroids fluticasone topical , triamcinolone topical , hydrocortisone topical , clobetasol topical Lichen Sclerosus prednisone , triamcinolone , clobetasol topical , betamethasone topical , tretinoin topical , Deltasone , More... Psoriasis Humira , methotrexate , cyclosporine , Remicade , adalimumab , infliximab , More... Atopic Dermatitis prednisone , fluticasone topical , triamcinolone topical , hydrocortisone topical , dexamethasone , methylprednisolone , More... 4 more conditions... Cormax Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } continual


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