12.Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Trichinosis with neurologic or myocardial involvement.
Medical Emergencies:
Shock secondary to adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenal cortical insufficiency may be present.
Acute allergic disorders (status asthmaticus, anaphylactic reactions, insect stings, etc.) following epinephrine.
Although there are no well controlled (double-blind, placebo) clinical trials, data from experimental animal models indicate that corticosteroids may be useful in hemorrhagic, traumatic and surgical shock in which standard therapy (e.g. fluid replacement) has not been effective (see Warningis and Precautions)
Contraindications
Systemic fungal infections and known hypersensitivity to the drug or any component of formulation. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.
Warnings
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, drug, 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. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections. In any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity or neutrophil function.
These infections may be mild, but can be severe, and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.
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.
Usage in Pregnancy
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 benefit of the drug be carefully weighed against the potential risks 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 adrenal insufficiency. There are no known effects of corticosteroids on labor and delivery.
Hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. 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 non-immunosuppressive doses of corticosteroids.
The use of Hydrocortisone sodium succinate Sterile Powder 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 appropriate antitubercular 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.
Because rare instances of anaphylactoid reactions (eg. Bronchospasm) have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal “Gasping syndrome” in premature infants.
Although recent studies have not been conducted with hydrocortisone or other corticosteroids, studies of meethylprednisolone sodium succinate in septic shock suggest that increased mortality may occur in some subgroups of patients at higher risk (i.e. elevated creatinine greater than 2.0mg% or with secondary infections).