Trade Name: Hydrocortisone

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals,Inc.

Presentation: CREAM, HUMAN PRESCRIPTION DRUG

Strength: 25 mg/g

Storage and handling

HYDROCORTISONE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Rx Only
  • Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol.
  • Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of hydrocortisone in ointment base of light mineral oil and white petrolatum.
  • Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11u03b2)-] with the molecular formula (Cn n n Hn n n 0n n n ) and is represented by the following structural formula:n nn
  • Its molecular weight is 362.47 and its CAS Registery Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
  • Topical corticosteroids share anti-inflammatory, antipruritic, and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
  • The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION).
  • Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systematically 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 and their metabolites are also excreted into the bile.
  • Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.
  • Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
  • Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, 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 or under an occlusive dressing 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 - Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
  • In the presence of dermatological 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.
  • Patients using topical corticosteroids should receive the following information and instructions:
  • 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  • 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
  • 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
  • 4. Patients should report any signs of local adverse reactions, especially under occlusive dressing.
  • 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
  • The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate 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.
  • Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
  • Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
  • Hydrocortisone Cream USP, 2.5% is available as follows:n nNDC 66267-967-01 Box of 30gn
  • Store at 20-25u00b0C (68-77u00b0F) [see USP Controlled Room Temperature].
  • Keep out of the reach of children.
  • Manufactured By Perrigo
  • Bronx, NY 10457
  • Distributed By Perrigo
  • Allegan, MI 49010 u00b7 www.perrigo.com
  • Rev. 08-15
  • :1F300 RC JX1
  • No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Hydrocortisone (Hydrocortisone) which is also known as Hydrocortisone and Manufactured by NuCare Pharmaceuticals,Inc.. It is available in strength of 25 mg/g.

Hydrocortisone (Hydrocortisone) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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