Like all medications this medicine It can cause side effects, although not everyone suffers from them.
Adverse effects of glucocorticoids depend on the dose, timing of administration, and duration of treatment. Adverse reactions can be minimized by using the lowest effective dose for the shortest possible time.
The following adverse reactions of hydrocortisone drugs administered at high doses or at indications other than replacement therapy in adrenal insufficiency have been reported, although the frequency is unknown.
| Organs / Systems | Adverse event |
| Infections and infestations | Increased risk of infection |
| Blood and lymphatic system disorders | Impaired blood cells (Increased white blood cells and thrombocytes in the blood, decreased eosinophils and lymphocytes in the blood, thrombosis) |
| Immune system disorders | Allergic reactions |
| Endocrine disorders | Abstinence syndrome (headache, nausea, dizziness, decreased appetite, weakness, emotional changes, altered level of consciousness, and inappropriate reactions to stress situations) Delayed growth in children. Cushing's syndrome mainly characterized by an alteration in the arrangement of fat (moon face, central obesity, buffalo hump) Decreased potassium level High blood cholesterol High blood triglycerides Increased lipoproteins Thyroid disorder Increased ketone bodies in the blood Hyperosmolar hyperglycemic state Manifestation of latent hyperparathyroidism Tumor lysis syndrome |
| Psychiatric disorders | Euphoria, depression, corticosteroid-induced psychotic disorder, insomnia, mood swings, personality change, mania |
| Nervous system disorders | Epidural lipomatosis (deposition of fat around the spinal cord), increased pressure inside the skull in children, more frequent when withdrawing the medication. Worsening of epilepsy |
| Eye disorders | Cataract, increased eye pressure, glaucoma, papillary edema, posterior subcapsular cataracts, narrowing of the cornea, worsening of eye infections, central serous chorioretinopathy blurred vision |
| Cardiac disorders | Worsening of congestive heart failure, myocardial disorder, arrhythmia |
| Gastrointestinal disorders | Feeling of heaviness after meals, digestive ulcer, inflammation of the pancreas, infection by candida fungi |
| Skin and subcutaneous tissue disorders | Alterations in healing, skin atrophy, bruises, increased hair, stretch marks, acne, increased sweating, peeling on a large area of the skin greater than 30% of the body's surface (toxic epidermal necrolysis) disseminated rash with blisters and peeling of the skin that occurs especially around the mouth, nose, eyes and genitals (Steven-Johnson syndrome) . Redness and itching |
| Musculoskeletal and connective tissue disorders | Osteoporosis, bone fractures, muscle disorders, bone death, tear, and inflammation of tendons |
| Renal and urinary disorders | Need to urinate at night (nicturia), urinary calculus (stone) Hydroelectrolytic disturbances: fluid and salt retention |
| Metabolism and nutrition disorders | Weight gain, impaired diabetes control, increased appetite |
| Vascular disorders | Thromboembolism, hypertension |
| General disorders and administration site conditions | After intravenous administration, a tingling sensation may appear in some areas of the body, which usually disappears in a few minutes |
| Reproductive system disorders | Menstrual irregularities, including their absence |
Special caution in patients with renal or cardiac failure due to possible fluid retention and in patients with hepatic impairment as an elevation in blood corticosteroid levels may occur. These patients should be closely monitored by their doctor.
Symptoms and signs of suppression
Rapid corticosteroid removal after prolonged treatment can lead to a "abstinence syndrome," including fever, joint and muscle pain, nasal congestion, conjunctivitis, lumps on the skin that can be painful and / or cause itching, and weight loss.
Communication of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is possible side effects that do not appear in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicinal Products for Human Use : www.notificaRAM.es.
Your doctor will decide the injection site, the amount of medicine, and the number of injections to give you depending on the disease to be treated and its severity. Your doctor will you will administer the lowest dose for the shortest possible time necessary to relieve symptoms.
The recommended dose is as follows:
Adults
In general, the recommended dose ranges from 100 to 500 mg (1 to 5 ml) administered by slow intravenous injection, over a period of 1 to 10 minutes (for doses of 500 mg or higher). This dose can be repeated at intervals of 2, 4 or 6 hours, depending on the disease to be treated and the patient's response. Alternatively, this medication can be administered as an intravenous infusion. A clinical effect is observed in two to four hours and persists for up to eight hours after intravenous injection. The same dose can be administered by intramuscular injection, but the response is likely to be less rapid, especially in shock. They should not exceed 6g / day.
Use in children
Although the dose may be reduced for infants and children, it is governed more by the severity of the patient's condition and response than by age or body weight, but should not be less than 25 mg daily.
Elderly patients
Prolonged use of corticosteroids in these patients is associated with an increased risk of diabetes, hypertension, congestive heart failure, osteoporosis, and depression.
Close clinical supervision is required in order to avoid life-threatening reactions.
Altered Renal Function
No dose adjustment is necessary in patients with kidney failure.
Altered Liver Function
Patients with impaired liver function are more likely to experience serious unwanted effects as a consequence of a decrease in protein binding due to hypoalbuminemia and a reduction in hepatic hydrocortisone metabolism. Dose adjustments may be necessary.
The appearance of unwanted effects can be minimized by using the minimum effective dose for the minimum period of time required. Frequent review of the patient is required in order to properly titrate the dose.
Method of administration
Rules for the correct administration: Mix the powder contained in the vial with 5 ml of water for injection and apply by intramuscular injection, slow intravenous, drop by drop or by continuous infusion mixed with solutions for infusion.
If you use more Actocortin than you should
In prolonged treatments, there may be an increase in blood cortisol levels that subside in a few days with medication suppression.
No cases of overdose have been described. In case of overdose or accidental ingestion consult your doctor and / or hospital.
If you forgot to use Actocortin
Do not take a double dose to make up for a forgotten dose.
If you stop taking Actocortin
Your doctor will tell you the length of your treatment with this medicine.
Treatment should not be stopped abruptly. Your doctor will tell you how to do this since rapid corticosteroid removal after prolonged treatment can lead to major complications such as acute adrenal insufficiency and hypotension.
A "withdrawal syndrome" may also occur, including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful / pruritic skin nodules, and weight loss.
