Hybrisil

Before taking methylprednisolone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to methylprednisolone, aspirin (Ecotrin), or any ingredient within this medication product
• have a history of liver, kidney, intestinal, or heart disease
• have diabetes, an underactive thyroid gland, high blood pressure, or mental illness
• have myasthenia gravis (disease of weak muscles), osteoporosis, seizures, or ulcers
• have or have had tuberculosis or any other type of ongoing infection
• have a history of ulcers (holes in the stomach)
• have a history of alcohol use or abuse
• have are or about to receive a vaccine, especially a live one such as the nasal influenza, MMR, or varicella vaccines
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

DESCRIPTION: The topical corticosteroids constitute a class of primary synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hybrisil™ Topical Silicone Gel contains methylpremethylprednisolone acetate, USP (CAS 53-36-1)
Chemical Name: Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß)-,11ß,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione 21-acetate.  It has a molecular formula of C24H32O6 and a molecular weight of 416.51.

Contains: Methylpremethylprednisolone acetate 1.0% in a base of: silicone cross-polymers, alcohol, cyclomethicones, propylene glycol, PEG-12 glyceryl dimyristate, and benzyl alcohol.

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. 

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 is prescribed.
3.    Treated skin areas 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 urinary free cortisol test and the ACTH suppression test may be helpful in evaluating the HPA axis suppression.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of the effect of topical corticosteroids on fertility.
Studies to determine mutagenicity with prednisolone and hydrocortisone may have revealed negative results.

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.

Hybrisil™ (methylpremethylprednisolone 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.
Occlusive dressings may be used for management of recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.