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Basic Drug Info
Drug Name:Hydrocortisone
Manufacturer:TEVA PHARMACEUTICALS USA
Other Info:

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

Neonates born of mothers who have received substantial doses of corticosteroid 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.While on corticosteroid therapy, patients should not be vaccinated against smallpox.

Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.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 pediatric patients or adults on corticosteroids.

In such pediatric patients 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.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.



Clinical Trials:


Indications and Usage

Hydrocortisone rectal suspension is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis.

It has proved useful also in some cases involving the transverse and ascending colons.
Ulcerative Colitis -- Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.

ULCERATIVE PROCTITIS --

Ulcerative (chronic) proctosigmoiditis --

Left-sided ulcerative (chronic) colitis --

Contraindications
Systemic fungal infections; and ileocolostomy during the immediate or early postoperative period.
Systemic mycosis --

Warnings

In severe ulcerative colitis, it is hazardous to delay needed surgery while awaiting response to medical treatment.Damage to the rectal wall can result from careless or improper insertion of a rectal suspension tip.In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.Corticosteroids may mask some signs of infection, and new infections may appear during their use.

There may be decreased resistance and inability to localize infection when corticosteroids are used.Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
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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