Brand name: Solu-Cortef

Active ingredient (generic name): Hydrocotisone Sodium succinate

Manufacturer: Pfizer

Importer: Behestan Darou

Pharmacotherapeutic group: glucocorticosteroid

Pharmaceutical form: 100mg Vials

Pharmacodynamic:

Hydrocortisone sodium succinate has the same metabolic and anti-inflammatory actions as hydrocortisone. It is a glucocorticosteroid. Used in pharmacological doses, its actions suppress the clinical manifestations of disease in a wide range of disorders.

Pharmacokinetic:

Hydrocortisone is mainly metabolized in the liver. 22 to 30% of the I.V. or I.M. administered doses are excreted through the urine in 24 hours.

Elimination of the administered dose is nearly complete within 12 hours. Thus if constantly high blood levels are required, I.V. or I.M. injections should be made every 4 to 6 hours.

Therapeutic indication:

Solu-Cortef is indicated for any condition in which rapid and intense corticosteroid effect is required such as:

1. Endocrine disorders: Primary or secondary adrenocortical insufficiency

2. Collagen diseases: Systemic lupus erythematosus

3. Dermatological diseases: Severe erythema multiforme (Stevens-Johnson syndrome)

4. Allergic states: Bronchial asthma, anaphylactic reactions

5. Gastro-intestinal diseases: Ulcerative colitis, Crohn's disease

6. Respiratory diseases: Aspiration of gastric contents

7. Medical emergencies: Solu-Cortef is indicated in the treatment of shock secondary to adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenocortical insufficiency may be present.

Dosage and administration:

Dosage usually ranges from 100 mg to 500 mg depending on the severity of the condition, administered by intravenous injection over a period of one to ten minutes. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient's response and clinical condition.

In general high-dose corticosteroid therapy should be continued only until the patient's condition has stabilised - usually not beyond 48 to 72 hours. If hydrocortisone therapy must be continued beyond 48 to 72 hours hypernatraemia may occur, therefore it may be preferable to replace Solu-Cortef with a corticosteroid such as methylprednisolone sodium succinate as little or no sodium retention occurs.

While the dose may be reduced for infants and children, it is governed more by the severity of the condition and response of the patient than by age or body weight but should not be less than 25 mg daily.

Adverse reaction:

The undesirable effects are as following:

GASTRO-INTESTINAL - Dispepsia, gastric hemorrhage; MUSCULOSKELETAL; FLUID AND ELECTROLYTE; DISTURBANCE - Sodium and water retention; DERMATOLOGICAL - Impaired healing; ENDOCRINE/METABOLIC - negative nitrogen and calcium balance; NEUROPSYCHIATRIC – headache and confusion; OPHTHALMIC - glaucoma

Contraindication:

Solu-Cortef is contra-indicated where there is known hypersensitivity to components and in systemic fungal infection unless specific anti-infective therapy is employed.

Pharmacokinetic interactions:

Drugs which inhibit the CYP3A4 enzyme, such as cimetidine, erythromycin, itraconazole, and mibefradil, may decrease the rate of metabolism of corticosteroids and hence increase the serum concentration.

Drugs that induce hepatic enzymes, such as rifampicin, phenobarbitone and phenytoin enhance the metabolism of corticosteroids and its therapeutic effects may be reduced.

Pregnancy and lactation:

Pregnancy category is C. during breast-feeding it can be administered only under physician supervision.

In first three months of pregnancy, it is categorized in group D.

Storage temperature:

Room temperature (15-25 C)

 

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