DROTIS
DROTIS
Hydrocortisone Sodium Succinate For Injection USP 100 mg
For IM/IV Use only
INDICATIONS
Hydrocortisone is used to treat certain medical conditions, such as;
Dosage and Administration
For intravenous injection or intramuscular injection 100 mg Hydrocortisone Sodium Succinate for injection is dissolved in 2 ml Sterile Water for Injection USP immediately before administration. Hydrocortisone Sodium Succinate for Injection may also be given as an intravenous infusion, First Prepare the Solution by adding not more than 2 mi of sterile water for injection USP to the vial 100 mg, This solution may be added to 100 ml - 1000 ml (but not less than 100 ml) of 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution it patient is not on sodium restriction) The constituted solution should preferably be used immediately after preparation. The prepared solution should be used only if clear. A clinical effect is seen in two to four hours and it persists for up to eight hours after intravenous injection. Systemic therapy in adults: 100 to 500 mg administered by slow intravenous injection taking half to one minute. This dose can be repeated three or four times in 24 hours depending upon the conditions being treated and the patient's response. Systemic therapy in children: Infants up to 1 year may be given 25 mg hydrocortisone intravenously: children 1 to 5 years, 50 mg; 6 to 12 years, 100 mg. This dose can be repeated 3 or 4 times in 24 hours depending upon the conditions being treated and the patient's response. Other Uses: Local treatment of soft tissue lesions 100 up to 200 mg of Hydrocortisone Sodium Succinate for Injection can be used. This daily dose can be repeated on 2 or 3 occasions depending on the patient's response. OR As Directed by the Physician.
Direction For Use:
Reconstitute using requisite amount of Sterile Water for Injection USP, Shake Well.
Contra-Indications:
Systemic infections, unless specific anti-infective therapy is employed. Live virus immunization. Hypersensitivity to any component of the injection. Hydrocortisone Sodium Succinate for Injection should injected directly into tendons.
Warning:
Precautions:
Administration of corticosteroids may impair the ability to resist and counteract infection; in addition, clinical signs and symptoms of infection are suppressed.
Systemic administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established.
Side-Effects:
In the short term, high dosage of hydrocortisone involve little risk of adverse reactions, except that peptic ulceration may occur, or be aggravated and there may be a small but significant increase in the risk of infection. With continued use, signs of hypercorticism may become apparent. Unwanted mineral corticoid and glucocorticoid effects especially with prolonged or excessive dosing rare reports of anaphylaxis.
Interactions:
Steroids may reduce the effects of anticholinesterases in myasthenia gravis, cholecystographic X-ray media and salicylates. The effect of steroids may be reduced by Phenobaribitone, Ephedrine and Rifampicin.
Overdosage:
Acute over dosage is very unlike to occur, however in the case of chronic Overdosage or misuse the features of hypercorticism may appear and in this situation the product should be discontinued slowly.
Pregnancy & Lactation:
Consult your doctor if you are pregnant, think you might be pregnant as this medicine could slow the baby's growth. Lactation: Consult your doctor, if you are breast feeding as small amount of corticosteroid medicine may get into breast milk.
- Inflammation (swelling)
- Severe allergic reactions
- Kidney diseases
- Adrenal problems
- Asthma
- Blood or bone marrow problems
- Eye or vision problems
- Lupus
- Skin conditions
- Ulcerative colitis.
Dosage and Administration
For intravenous injection or intramuscular injection 100 mg Hydrocortisone Sodium Succinate for injection is dissolved in 2 ml Sterile Water for Injection USP immediately before administration. Hydrocortisone Sodium Succinate for Injection may also be given as an intravenous infusion, First Prepare the Solution by adding not more than 2 mi of sterile water for injection USP to the vial 100 mg, This solution may be added to 100 ml - 1000 ml (but not less than 100 ml) of 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution it patient is not on sodium restriction) The constituted solution should preferably be used immediately after preparation. The prepared solution should be used only if clear. A clinical effect is seen in two to four hours and it persists for up to eight hours after intravenous injection. Systemic therapy in adults: 100 to 500 mg administered by slow intravenous injection taking half to one minute. This dose can be repeated three or four times in 24 hours depending upon the conditions being treated and the patient's response. Systemic therapy in children: Infants up to 1 year may be given 25 mg hydrocortisone intravenously: children 1 to 5 years, 50 mg; 6 to 12 years, 100 mg. This dose can be repeated 3 or 4 times in 24 hours depending upon the conditions being treated and the patient's response. Other Uses: Local treatment of soft tissue lesions 100 up to 200 mg of Hydrocortisone Sodium Succinate for Injection can be used. This daily dose can be repeated on 2 or 3 occasions depending on the patient's response. OR As Directed by the Physician.
Direction For Use:
Reconstitute using requisite amount of Sterile Water for Injection USP, Shake Well.
Contra-Indications:
Systemic infections, unless specific anti-infective therapy is employed. Live virus immunization. Hypersensitivity to any component of the injection. Hydrocortisone Sodium Succinate for Injection should injected directly into tendons.
Warning:
- Do not use, if any particle is visible after dissolving the content.
- The reconstituted solution should be used immediately after preparation.
Precautions:
Administration of corticosteroids may impair the ability to resist and counteract infection; in addition, clinical signs and symptoms of infection are suppressed.
Systemic administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established.
Side-Effects:
In the short term, high dosage of hydrocortisone involve little risk of adverse reactions, except that peptic ulceration may occur, or be aggravated and there may be a small but significant increase in the risk of infection. With continued use, signs of hypercorticism may become apparent. Unwanted mineral corticoid and glucocorticoid effects especially with prolonged or excessive dosing rare reports of anaphylaxis.
Interactions:
Steroids may reduce the effects of anticholinesterases in myasthenia gravis, cholecystographic X-ray media and salicylates. The effect of steroids may be reduced by Phenobaribitone, Ephedrine and Rifampicin.
Overdosage:
Acute over dosage is very unlike to occur, however in the case of chronic Overdosage or misuse the features of hypercorticism may appear and in this situation the product should be discontinued slowly.
Pregnancy & Lactation:
Consult your doctor if you are pregnant, think you might be pregnant as this medicine could slow the baby's growth. Lactation: Consult your doctor, if you are breast feeding as small amount of corticosteroid medicine may get into breast milk.