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Basic Drug Info
Drug Name:Hydrocortisone
Manufacturer:Glades Pharmaceuticals, LLC
Other Info:RX only



Clinical Trials:


Indications and Usage
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement
TUBERCULOUS MENINGITIS -- A form of bacterial meningitis caused by MYCOBACTERIUM TUBERCULOSIS or rarely MYCOBACTERIUM BOVIS. The organism seeds the meninges and forms microtuberculomas which subsequently rupture. The clinical course tends to be subacute, with progressions occurring over a period of several days or longer. Headache and meningeal irritation may be followed by SEIZURES, cranial neuropathies, focal neurologic deficits, somnolence, and eventually COMA. The illness may occur in immunocompetent individuals or as an OPPORTUNISTIC INFECTION in the ACQUIRED IMMUNODEFICIENCY SYNDROME and other immunodeficiency syndromes. (From Adams et al., Principles of Neurology, 6th ed, pp717-9)

Trichinosis -- A disease due to infection with TRICHINELLA SPIRALIS. It is caused by eating undercooked meat, usually pork.

Contraindications
Systemic fungal infections and known hypersensitivity to components.
Systemic mycosis --

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.

Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.

Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.

These effects are less likely to occur with the synthetic derivatives except when used in large doses.

Dietary salt restriction and potassium supplementation may be necessary.

All corticosteroids increase calcium excretion.

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.

Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished.

Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids.

The use of Hydrocortisone Tablets in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur.

During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals.

Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids.

In such children or adults who have not had these diseases, particular care should be taken to avoid exposure.

How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known.

The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known.

If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated.

If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated.

(See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents may be considered.

Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation.

In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
Branded Drugs
The following US Branded drugs contain Hydrocortisone


ACETASOL HC -- ACTAVIS MID ATLANTIC LLC

ACETIC ACID W/ HYDROCORTISONE -- KV PHARMACEUTICAL CO

HYDROCORTISONE AND ACETIC ACID -- BAUSCH AND LOMB PHARMACEUTICALS INC

HYDROCORTISONE AND ACETIC ACID -- MORTON GROVE PHARMACEUTICALS INC

HYDROCORTISONE AND ACETIC ACID -- TARO PHARMACEUTICALS USA INC

HYDROCORTISONE AND ACETIC ACID -- VINTAGE PHARMACEUTICALS LLC

ORLEX HC -- PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO

VOSOL HC -- HI TECH PHARMACAL CO INC

NEO-CORT-DOME -- BAYER PHARMACEUTICALS CORP

CORTISPORIN -- MONARCH PHARMACEUTICALS INC

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE -- BAUSCH AND LOMB PHARMACEUTICALS INC

ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE -- PHARMAFAIR INC

NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE -- PHARMAFAIR INC

CIPRO HC -- ALCON INC

AEROSEB-HC -- ALLERGAN HERBERT DIV ALLERGAN INC

ALA-CORT -- DEL RAY LABORATORIES INC

ANUSOL HC -- SALIX PHARMACEUTICALS INC

CORT-DOME -- BAYER PHARMACEUTICALS CORP

DERMACORT -- MONARCH PHARMACEUTICALS INC

ELDECORT -- VALEANT PHARMACEUTICALS INTERNATIONAL

FLEXICORT -- WESTWOOD SQUIBB PHARMACEUTICALS INC

HC #1 -- BAYER PHARMACEUTICALS CORP

HC #4 -- BAYER PHARMACEUTICALS CORP

HC (HYDROCORTISONE) -- C AND M PHARMACAL INC

H-CORT -- PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS

HI-COR -- C AND M PHARMACAL INC

HYTONE -- SANOFI AVENTIS US LLC

NOGENIC HC -- IVAX PHARMACEUTICALS INC

NUTRACORT -- CORIA LABORATORIES LTD

PENECORT -- ALLERGAN HERBERT DIV ALLERGAN INC

PROCTOCORT -- MONARCH PHARMACEUTICALS INC

SYNACORT -- MEDICIS PHARMACEUTICAL CORP

COLOCORT -- PADDOCK LABORATORIES INC

CORTENEMA -- ANI PHARMACEUTICALS INC

NUTRACORT -- HEALTHPOINT LTD

PENECORT -- ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC

CORTEF -- PHARMACIA AND UPJOHN CO

ACTICORT -- BAKER NORTON PHARMACEUTICALS INC

ALA-SCALP -- DEL RAY LABORATORIES INC

BALNEOL-HC -- SOLVAY PHARMACEUTICALS

BETA-HC -- BETA DERMACEUTICALS INC

CETACORT -- CORIA LABORATORIES LTD

DERMACORT -- SOLVAY PHARMACEUTICALS

EPICORT -- BLULINE LABORATORIES INC

GLYCORT -- HERAN PHARMACEUTICAL INC

STIE-CORT -- PERRIGO CO

CORTRIL -- PFIZER GLOBAL RESEARCH DEVELOPMENT

HYDROCORTISONE IN ABSORBASE -- CAROLINA MEDICAL PRODUCTS CO

HYTONE -- DERMIK LABORATORIES DIV AVENTIS PHARMACEUTICALS INC

H-CORT -- TORCH LABORATORIES INC

HYDRO-RX -- X GEN PHARMACEUTICALS INC

TEXACORT -- SIRIUS LABORATORIES INC

CORTRIL -- PFIZER LABORATORIES DIV PFIZER INC

HYDROCORTONE -- MERCK AND CO INC

CORTRIL -- PFIPHARMECS DIV PFIZER INC

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE -- ALCON LABORATORIES INC

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE -- BAUSCH AND LOMB PHARMACEUTICALS INC

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE -- PHARMAFORCE INC

NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE -- PHARMAFAIR INC

OTOCORT -- WATSON LABORATORIES INC

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE -- ALCON UNIVERSAL LTD

NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE -- PHARMAFAIR INC

OTICAIR -- BAUSCH AND LOMB PHARMACEUTICALS INC

OTICAIR -- PHARMAFAIR INC

OTOBIONE -- SCHERING CORP SUB SCHERING PLOUGH CORP

PEDIOTIC -- MONARCH PHARMACEUTICALS INC

OTOBIOTIC -- SCHERING CORP SUB SCHERING PLOUGH CORP

PYOCIDIN -- FOREST LABORATORIES INC

ACHROMYCIN -- LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO

ALPHADERM -- BIOGLAN LABORATORIES LTD

CALMURID HC -- PHARMACIA AND UPJOHN CO


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