Hydrocortisone Sodium Succinate Injection USP 500 mg

Hydrocortisone sodium succinate use:

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

Endocrine disorders
Primary or secondary adrenocortical insufficiency

Collagen diseases
Systemic lupus erythematosus

Dermatological diseases
Severe erythema multiforme (Stevens-Johnson syndrome)

Allergic states
Bronchial asthma, anaphylactic reactions

Gastro-intestinal diseases
Ulcerative colitis, Crohn’s disease

Respiratory diseases
Aspiration of gastric contents

Medical emergencies
Solnac is indicated in the treatment of shock secondary to adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenocortical insufficiency may be present.

Hydrocortisone sodium succinate dosages administration:

• Solnac may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer-acting injectable preparation or an oral preparation.
• 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.
• Dosage requirements are variable and must be individualized on the basis of the disease under treatment, its severity and the response of the patient over the entire duration of treatment. A risk/benefit decision must be made in each individual case on an ongoing basis.
• The proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage, which will maintain an adequate clinical response, is reached.
• In general high-dose corticosteroid therapy should be continued only until the patient’s condition has stabilized – 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 Solnac with a corticosteroid such as methylprednisolone sodium succinate as little or no sodium retention occurs.
• If after long-term therapy the drug is to be stopped, it needs to be withdrawn gradually rather than abruptly.
• Undesirable effects may be minimized by using the lowest effective dose for the minimum period.
• Corticosteroid therapy is an adjunct to, and not a replacement for, conventional therapy.
• In patients with liver disease, there may be an increased effect and reduced dosing may be considered.

Paediatric population:

• Dosage should be reduced for infants and children, but should be governed more by the severity of the condition and response of the patient, than by age of size.
• Dosage should not be less than 25 mg daily.

Elderly patients:

• Solnac is primarily used in acute short-term conditions. When used according to instructions, there is no information to suggest that a change in dosage is warranted in the elderly. However, treatment of elderly patients, particularly if long-term, should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age and close clinical supervision is required.

The incidence of predictable undesirable side effects associated with the use of corticosteroids, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and duration of treatment.

Such side-effects include:

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Frequency: Not Known

Infections and infestations
Opportunistic infections, infections

Blood and lymphatic system disorders
Leucocytosis

Immune system disorders
Drug hypersensitivity Anaphylactic reaction, Anaphylactoid reaction

Endocrine disorders
Cushingoid facies, Hypopituitarism, Steroid withdrawal syndrome

Metabolism and nutrition disorders
Metabolic acidosis, Sodium retention, Fluid retention, Alkalosis hypokalaemic, Dyslipidaemia

Psychiatric disorders
Affective disorders, Psychotic disorder, Mental disorder

Eye disorders
Central serous chorioretinopathy, Cataracts, Glaucoma, Exophthalmos, Vision blurred

Cardiac disorders
Congestive heart failure

Respiratory, thoracic and mediastinal disorders
Pulmonary embolism, Hiccups

Gastrointestinal disorders
Peptic ulcer, abdominal distension, oesophageal ulceration, acute pancreatitis

Reproductive system and breast disorders
Irregular menstruation, Amenorrhoea

Particular care is required when considering the use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary.

1. Osteoporosis is generally associated with long‑term use and large doses of glucocorticoids. Corticosteroids should be used with caution in patients with osteoporosis (post-menopausal females are particularly at risk).
2. Hypertension.
3. Existing or previous history of severe affective disorders (especially previous steroid psychosis).
4. Corticosteroids, including hydrocortisone, can increase blood glucose, worsen pre‑existing diabetes, and predispose those on long‑term corticosteroid therapy to diabetes mellitus (or a family history of diabetes).
5. History of tuberculosis.
6. Glaucoma (or a family history of glaucoma).
7. Previous corticosteroid-induced myopathy.
8. Liver failure or cirrhosis.
9. Corticosteroids should be used with caution in patients with renal insufficiency.
10. Epilepsy.
11. Peptic ulceration.
12. Fresh intestinal anastomoses.
13. Predisposition to thrombophlembitis.
14. Abscess or other pyogenic infections.
15. Ulcerative colitis.
16. Diverticulitis.
17. Myasthenia gravis.
18. Exanthematous diseases.

• Store below 30°C. Protected from light.
• The reconstituted solution to be used immediately. If not used, can be stored for 24 hours at 2°C to 8°C an aseptic condition. If not used immediately, in-use storage times and conditions are the responsibility of the user.
• Keep the medicine out of reach of children.

• 10 ml Clear molded Glass Vial with a grey bromobutyl rubber stopper, sealed with an orange flip-off aluminum seal.
• Hydrocortisone Sodium Succinate for Injection USP 500 mg powder for solution for injection is supplied in a glass vial in the unit carton with a pack insert.