You are here: Home > Prescription(RX) Drugs > H > Hybrisil (Biozone Laboratories, Inc.)|
methylprednisolone acetate gel
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
DESCRIPTION: The topical corticosteroids constitute a class of primary synthetic steroids used as anti-inflammatory and anti-pruritic agents. HybriSil™ Topical Silicone Gel contains methylprednisolone acetate, USP (CAS 53-36-1)
Contains: Methylprednisolone acetate 1.0% in a base of: silicone cross-polymers, alcohol, cyclomethicones, propylene glycol, PEG-12 glyceryl dimyristate, and benzyl alcohol.
CLINICAL PHARMACOLOGYTopical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstriction 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 vasoconstrictive 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.
INDICATIONS AND USAGE
HybriSil™ topical gel is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, including those associated with the formation of scar tissue.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
General: 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.
Information for the Patient
Patients using topical corticosteroids should receive the following information and instructions:
The urinary free cortisol test and the ACTH suppression test may be helpful in evaluating the HPA axis suppression.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential of the effect of topical corticosteroids on fertility.
Pregnancy Category C
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. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients in large amounts or for prolonged periods of time.
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 administered to nursing women.
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. Hypothalamic-pituitary-adrenal (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. Manifestation of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.
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:
topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS)
DOSAGE AND ADMINISTRATION
HybriSil™ (methylprednisolone acetate 1%) silicone gel should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.
If medication accidentally gets in the eyes, wash thoroughly with water and contact a physician immediately. Keep out of the reach of children.
Image: Bottle Label
Image: Carton Label
Revised: 04/2011 BioZone Laboratories, Inc.
Reproduced with permission of U.S. National Library of Medicine
Copyright © 2018
|Over-the-counter (OTC) Drugs|