EXICORT 100

Vial Hydrocortisone 100 mg ( contains strile powder for injection)

Generic Name of ProductBrand NameDosage Form StrengthPharmacologic GroupTherapeutic GroupUnit Per Pack
Hydrocortisone Sodium SuccinateExicort®Vial100 mg/1 mlGlucocorticoidCorticosteroids25

Indications And Usage

When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramusculat use of Hydrocortisone Sodium Succinate  Sterile Powder is indicated as follows:

Allergic states, Dermatologic diseases, Endocrine disorders, Gastrointestinal diseases,

 Hematologic disorders, Miscellaneous, Neoplastic diseases, Nervous System, Ophthalmic diseases, Renal diseases, Respiratory diseases, Rheumatic disorders

Administration

For intravenous or intramuscular injection, prepare solution by aseptically adding not more than 2 mL of Bacteriostatic Water for Injection or Bacteriostatic Sodium Chloride Injection to the contents of one vial. For intravenous infusion, first prepare solution by adding not more than 2 mL of Bacteriostatic Water for Injection to the vial; this solution may then be added to 100 to 1000 mL of the following: 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction).

Contraindications

Hydrocortisone Sodium Succinate Sterile Powder is contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents.

Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

Sterile Powder is contraindicated for intrathecal administration. Reports of severe medical events have been associated with this route of administration

Precautions

Cardio-renal, Endocrine, Gastrointestinal, Musculoskeletal, Neurologic-psychiatric, Ophthalmic.                                                                                        Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. In patients with suspected pheochromocytoma, consider the risk of pheochromocytoma crisis prior to administering corticosteroids.

Adverse Reactions

Allergic reactions, Blood and lymphatic system disorders, Cardiovascular, Dermatologic, Endocrine, Fluid and electrolyte disturbances, Gastrointestinal, Metabolic, Musculoskeletal, Ophthalmic

Pregnancy and lactation

Pregnancy: Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Breast feeding: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to continue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Renal and liver Impairment

As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.

Laboratory Tests
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