Aphatisone

Afatisone®

Hydrocortisone Sodium Succinate 100 mg

Powder for preparation of injectable solution for injection or infusion

This medicine has been prescribed for your current condition, so do not use it in similar cases or recommend its use to others.

General instructions:

Before using this medicine, consult your doctor in the following cases:

If you are allergic to this medicine or other medicines or any other substance such as food, preservatives, dyes, etc.

If you have other diseases or are taking other medicines.

Use during pregnancy and breastfeeding:

The use of this medicine during pregnancy is in category C and its use should be under the advice of a specialist.

This medicine is secreted in breast milk and its use during breastfeeding should be under the advice of a specialist.

Precautions and warnings:

This drug reduces the activity of the hypothalamic-pituitary-adrenal system, and after prolonged use of the drug, if it is suddenly discontinued or the patient is exposed to stress, symptoms of acute adrenal insufficiency may occur.

Injectable corticosteroids should be used with caution in the elderly, and they should be used at the lowest possible dose and for the shortest possible time.

Patients treated with this drug are more susceptible to viral, bacterial, and fungal infections due to a decrease in the body’s defense system.

Corticosteroids may worsen systemic fungal infections and should therefore not be used in the presence of such infections except in special circumstances and with the advice of a physician.

For the treatment of any case with this drug, the minimum effective dose and the shortest effective course of treatment should be used, and in the patient being treated, treatment should be reduced or discontinued gradually.

Due to sodium retention and edema and potassium excretion by the drug, it should be used with caution in patients with heart failure, patients with high blood pressure, and renal failure.

In patients with peptic ulcers, diverticulitis, and nonspecific ulcerative colitis, corticosteroids should be used with caution because they increase the risk of ulceration.

Corticosteroids reduce bone formation and increase bone resorption. In addition, by reducing the bone protein matrix (due to increased protein catabolism) by these drugs, they can inhibit bone growth in children and cause osteoporosis in adults, especially in postmenopausal women.

With the use of high doses (for example, in patients with MS), acute myopathy (especially in patients with myasthenia gravis or patients receiving drugs such as pancreatin) may be observed and can involve the eye and respiratory muscles.

Corticosteroids can cause mental disorders such as euphoria, insomnia, and personality changes, and can worsen emotional instability.

Intraocular pressure (IOP) may increase in some patients with this drug. IOP should be monitored if treatment is continued for more than 6 weeks. It should be used with caution in patients with glaucoma.

Corticosteroids can mask the symptoms of infection, and new infections may appear during treatment. Corticosteroids may decrease the body’s resistance and reduce the ability to control infection.

Infections or infestations by various pathogens, such as viruses, bacteria, fungi, protozoa, or worms, in any part of the body may occur with corticosteroids (alone or in combination with other immunosuppressive drugs that affect cellular, humoral, or neutrophil function). These infections may be mild or severe. The rate of infectious complications increases with increasing corticosteroid doses.

Prolonged use of corticosteroids may cause cataracts, glaucoma, with possible optic nerve damage, and may increase the likelihood of secondary ocular infections due to fungi or viruses.

Drug Interactions:

Drugs that increase liver enzyme activity (such as barbiturates, phenytoin, and rifampin) when used concomitantly with hydrocortisone may increase hydrocortisone metabolism, requiring an increase in hydrocortisone dosage.

Drugs that inhibit hydrocortisone metabolism (such as ketoconazole and erythromycin) may increase blood concentrations of hydrocortisone, requiring dosage adjustment.

Concomitant use of corticosteroids with aspirin or other NSAIDs may increase gastrointestinal side effects.

Concomitant use of hydrocortisone with oral anticoagulants (such as warfarin) may inhibit the response to warfarin.

Concomitant use of injectable amphotericin B and other potassium-sparing drugs with hydrocortisone may increase the risk of hypokalemia.

Concomitant use of cardiac glycosides (such as digoxin) and hydrocortisone may increase the risk of arrhythmia due to hypokalemia.

Corticosteroids may increase blood sugar, so the dose of drugs for diabetic patients who use corticosteroids simultaneously should be adjusted.

Dosage:

The dosage of the drug is determined by the attending physician for each patient. However, the usual dosage of this drug is as follows.

The usual dose for adults and adolescents

100 to 500 mg (base) intramuscularly or intravenously. This dose can be repeated every 2 to 6 hours depending on the patient’s condition and response to treatment.

Note: The initial intravenous dose of hydrocortisone is 100 mg, which should be injected over 30 seconds to several minutes.

The maintenance dose, if necessary, should not be less than 25 mg per day.

Usual dosage for children

In adrenal insufficiency: 0.19 to 0.28 mg (base) per kilogram of body weight or 10 to 12 mg per square meter of body surface area intramuscularly or intravenously in three divided doses per day.

Other cases: 0.67 to 4 mg per kilogram of body weight or 20 to 120 mg per square meter of body surface area every 12 to 24 hours as an intramuscular injection.

How to prepare the medicine:

For intramuscular or intravenous injection, add 2 ml of sterile water for injection to the contents of the vial and shake well until completely dissolved and a clear solution is obtained.

For intravenous infusion, dilute the resulting solution with a volume of 100 to 1000 ml of 5% dextrose injection solution or 0.9% sodium chloride injection or 5% dextrose in 0.9% sodium chloride injection.

Direct intravenous injection should be performed within 30 seconds to several minutes.

Intravenous infusion of the drug at a dilution of 1 mg/ml is performed over 20 to 30 minutes.

The resulting solutions for injection should be colorless, clear, and free of any foreign particles. Otherwise, avoid injection.

It is recommended that the resulting solutions be injected immediately after preparation.

If the patient is on a salt-free diet, saline solution should not be used for dilution.

Prepared solutions should be protected from light.

Side effects:

Every drug, along with its desired therapeutic effects, may cause some unwanted side effects. If these side effects occur, consult your doctor.

Hydrocortisone can cause sodium and water retention, potassium excretion, alkalosis, hypotension, muscle weakness and decreased muscle mass, osteoporosis, tendon rupture (especially in the Achilles or Achilles tendon), peptic ulcer with possible bleeding, impaired wound healing in the skin, hirsutism and increased sweating, increased intracranial pressure and headache, Cushing’s syndrome, growth retardation in children, decreased carbohydrate and glucose tolerance, revealing latent diabetes and increasing the need for insulin or oral antidiabetics in diabetic patients, posterior subcapsular cataract, increased intraocular pressure and glaucoma. In addition, it can cause negative nitrogen balance due to increased protein catabolism.

Storage conditions:

Store the dry product at a temperature below 25°C, away from light, and in the original box until use.

Inject the resulting solution immediately after preparation and discard the remaining drug after a single use.

Do not use expired medicine.

Keep the medicine out of the reach of children.

Dosage forms and packaging:

Powder for preparation of injectable solution for injection or infusion.

Each vial contains 100 mg of white powder of hydrocortisone (as sodium succinate) and is packaged in a box of 10 with an instruction sheet.

Hydrocortisone belongs to the group of corticosteroid drugs, which are also called cortisone. This medicine is used in people whose adrenal glands are impaired for any reason and do not produce steroid hormones (such as cortisol) in normal amounts. This can happen in people with adrenal gland defects (Addison’s disease) or in people whose adrenal glands have been surgically removed.