Corhidron 25

Leaflet accompanying the packaging: information for the user

Corhydron 25

25 mg powder and solvent for solution for injection or infusion

Corhydron 100

100 mg powder and solvent for solution for injection or infusion

Hydrocortisone

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Corhydron and what is it used for
• 2. Important information before using Corhydron
• 3. How to use Corhydron
• 4. Possible side effects
• 5. How to store Corhydron
• 6. Package contents and other information

1. What is Corhydron and what is it used for

Corhydron contains a synthetic derivative of hydrocortisone: hydrocortisone sodium succinate in the form of a sodium salt.
Hydrocortisone is a glucocorticosteroid (hormone) that occurs in the human body. It has a strong anti-inflammatory, anti-rheumatic, anti-allergic, anti-shock, and immunosuppressive effect.
Corhydron is used to treat patients in severe conditions that require rapid administration of a glucocorticosteroid, such as:

• primary or secondary adrenal insufficiency,
• shock states (post-traumatic, postoperative, cardiogenic, anaphylactic, post-transfusion, post-burn),
• sepsis and septic shock,
• severe bronchospastic conditions (asthmatic status),
• acute allergic conditions (Quincke's edema),
• severe form of erythema multiforme (Stevens-Johnson syndrome),
• acute forms of autoimmune diseases,
• acute hypersensitivity reactions to drugs.

Prophylactic use:

• endocrine diseases, with the aim of preventing the development of acute adrenal insufficiency, where additional glucocorticoid administration may be required due to increased cortisol demand (e.g., surgery in a patient with adrenal insufficiency or thyroiditis; adrenal insufficiency due to chronic steroid therapy).

Use in chronic conditions:
may occur after considering the indications by a doctor and may concern conditions/diseases such as:

• allergic conditions,
• dermatological diseases responding to corticosteroids,
• endocrine diseases,
• gastrointestinal diseases (in certain situations - treatment of inflammatory exacerbations),
• hematological diseases,
• oncological diseases,
• respiratory system diseases,
• rheumatic diseases.

Adrenal insufficiency with secondary adrenal cortex insufficiency (Sheehan's syndrome).
Nelson's syndrome after adrenalectomy (adrenal removal).
Adrenal-genital syndrome.

2. Important information before using Corhydron

When not to use Corhydron:

In acute, life-threatening conditions, there are no contraindications, especially if the medicine is to be used for a short period (24-36 hours).

Warnings and precautions

The risk of side effects during the use of glucocorticosteroids increases with the increase in dose and duration of treatment, therefore, the benefits and risks of the treatment will be carefully evaluated during the determination of the dose and duration of treatment.
Before starting the use of Corhydron, the patient should discuss with their doctor if they have or have had:

• allergy to other medicines in the past,
• active or latent peptic ulcer,
• osteoporosis (especially in postmenopausal women),
• hypertension, congestive heart failure,
• diabetes,
• ongoing or past severe manic-depressive psychosis (especially with a history of steroid psychosis),
• past tuberculosis,
• glaucoma (also if it occurred in family members),
• liver damage or cirrhosis,
• renal insufficiency,
• epilepsy,
• ulceration of the mucous membrane of the gastrointestinal tract,
• recently formed intestinal anastomosis (surgical procedure in the intestines),
• predisposition to thrombophlebitis,
• purulent infections,
• ulcerative colitis, diverticulitis,
• myasthenia,
• ophthalmic herpes threatening corneal perforation,
• hypothyroidism,

After the administration of Corhydron, severe allergic reactions may occur, especially in patients who have had allergic reactions in the past.
Hydrocortisone may mask the symptoms of fungal, viral, or bacterial infections. During the use of hydrocortisone, new infections may develop.
During the use of hydrocortisone, the patient should avoid exposure to viral diseases (chickenpox, shingles), especially if they have not had these diseases in the past. In case of contact with an infected person, the patient should immediately inform their doctor, who will take appropriate action.
During the administration of glucocorticosteroids, the patient should not be vaccinated, due to the weakened immune system.
Side effects can be minimized by using the smallest effective dose for the shortest possible period. During long-term use of hydrocortisone, adrenal insufficiency may occur, which may persist for several months after the end of treatment.
After long-term treatment, the medicine should not be suddenly discontinued, as this may lead to symptoms of acute adrenal insufficiency.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.

Elderly patients

During treatment, the doctor will carefully monitor the patient's condition.
Side effects may be more severe in elderly patients, especially those with osteoporosis, hypertension, hypokalemia (low potassium levels in the blood), diabetes, susceptibility to infections, and skin thinning.

Children and adolescents

Hydrocortisone causes growth retardation. Treatment should be limited to the use of the minimum dose for the shortest possible period. If long-term treatment is necessary, the doctor may decide to administer the medicine every other day to reduce side effects. The doctor will carefully monitor the growth and development of children.
If hydrocortisone is administered to premature infants, it may be necessary to monitor cardiac function and cardiac muscle image.

Corhydron and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those that are available without a prescription. Some medicines may enhance the effect of Corhydron, and the doctor may want to carefully monitor the patient's condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat).
In particular, the patient should inform their doctor if they are taking any of the following medicines, due to their potential impact on the effect of Corhydron or modification of the effect of these medicines by Corhydron:

• cyclosporine (a medicine that suppresses the immune system, used, among other things, after organ transplantation),
• medicines used to treat myasthenia,
• digoxin (a medicine used in heart failure),
• estrogens (found in, among other things, oral contraceptives),
• phenytoin, carbamazepine, primidone, barbiturates (medicines used to treat epilepsy),
• rifampicin, rifabutin, isoniazid (medicines used to treat tuberculosis),
• aminoglutethimide (a medicine used in cancer treatment),
• erythromycin (a medicine used to treat bacterial infections),
• ketoconazole (an antifungal medicine),
• oral anticoagulants, including coumarin derivatives
• antihypertensive and diuretic medicines, such as furosemide, thiazides, ethacrynic acid
• medicines used to treat diabetes, including insulin
• muscle relaxants, such as pancuronium,
• non-steroidal anti-inflammatory medicines, such as ibuprofen, acetylsalicylic acid (aspirin), diclofenac,
• vaccines, anatoxins.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Pregnancy
The medicine should only be used if the doctor believes that the benefits to the mother outweigh the potential risk to the fetus. Hydrocortisone passes through the placental barrier. Newborns born to mothers who received significant doses of hydrocortisone during pregnancy should be monitored for the risk of adrenal insufficiency.
Breastfeeding
Hydrocortisone passes into breast milk and may inhibit the production of glucocorticosteroids in the breastfed child, slow down the child's growth, and cause other side effects. In breastfeeding mothers taking high doses of hydrocortisone, it is recommended to stop breastfeeding during the treatment period.

Driving and operating machinery

The medicine does not affect the ability to drive and operate machinery.

Corhydron contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per vial, which means the medicine is considered "sodium-free".

3. How to use Corhydron

This medicine should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The medicine can be administered by intravenous injection, infusion, or intramuscular injection.
If repeated intramuscular administration is necessary, the injection site should be changed.
If the product is administered intravenously, the injection should be slow, lasting from 1 to 10 minutes.
Rapid intravenous injection may increase the risk of side effects.
Instructions for preparing the medicine:

To obtain a solution ready for intravenous or intramuscular injection

the patient should, following aseptic procedures, dissolve the contents of the vial in the solvent provided with the packaging (ampoule with water for injections).
To do this, the patient should use a syringe to draw 2 ml of solvent from the ampoule and introduce it into the vial with the powder (lyophilized substance). The powder should be gently dissolved with slow, circular motions to obtain a uniform solution.
The vial should not be shaken vigorously, as this may cause the formation of gas bubbles.
The prepared solution is ready for intravenous or intramuscular injection or can be used to prepare a solution for infusion. If the solution is foamy or contains visible particles after dissolution, it should not be administered.
To prepare an infusion solution, the patient should first prepare the solution as described above, and then, following aseptic procedures, add it to 100-1000 ml of 5% glucose solution for injection. If the patient does not require sodium restriction, the medicine can be dissolved in 0.9% sodium chloride solution for injection or a mixture of 5% glucose solution for injection and 0.9% sodium chloride solution for injection.
The solution should be used immediately after preparation, and any unused residue should be discarded.
Any remaining unused product or waste should be disposed of in accordance with local regulations.
The Corhydron solution should not be mixed with other products, except for:

• water for injections,
• 0.9% sodium chloride solution,
• 5% glucose solution. Corhydron should be administered as a separate injection or infusion, separate from other medicines.

Recommended dose:
The dose of the medicine is determined individually, depending on the indication, the patient's condition, and their response to the medicine.
Usually, the initial doses are higher, and after achieving the desired therapeutic effect, the smallest possible doses are used to maintain the therapeutic effect.

Adults and adolescents over 14 years old

Typically, the single dose is 100-250 mg; up to 1500 mg per day.
In severe conditions, 100-500 mg is administered by slow intravenous injection, lasting from 1 to 10 minutes. If necessary, the dose may be repeated after 2, 4, or 6 hours.
Septic shock in adults
200 mg per day intravenously in a dose of 50 mg every 6 hours or as a continuous infusion.
Based on literature data on the treatment of adrenal insufficiency with secondary adrenal cortex insufficiency (Sheehan's syndrome), the most commonly used intravenous dose of hydrocortisone is 300-600 mg per day, administered in 3-4 divided doses or as a continuous infusion.
Usually, treatment with high doses of glucocorticosteroids is not used for more than 48 to 72 hours.
If treatment with high doses must be continued, it is recommended to replace the sodium salt of hydrocortisone succinate with the sodium salt of methylprednisolone succinate, which does not cause sodium retention in the body.
If possible, it is recommended to reduce the dose and limit the duration of glucocorticosteroid use due to the possibility of complications.

Use in children and adolescents under 14 years old

The dose of the medicine is determined individually, depending on the patient's clinical condition, age, and weight.
Typically, the following doses are used:
in children under 12 months: 8-10 mg/kg body weight,
in children from 2 to 14 years: 4-8 mg/kg body weight per day.
In justified cases, higher doses may be used. Doses less than 25 mg per day should not be used in children.
If possible, the use of hydrocortisone or other glucocorticosteroids should not be prolonged in newborns and children, as these medicines may slow down growth. If continued treatment with glucocorticosteroids is necessary, the doctor may consider administering the medicine every other day to reduce side effects. During treatment with glucocorticosteroids, the growth and development of the child should be monitored.
The use of hydrocortisone for more than 72 hours may lead to an increase in sodium levels in the blood, so in children, it is also recommended to consider replacing the sodium salt of hydrocortisone succinate with the sodium salt of methylprednisolone succinate, which does not cause sodium retention in the body.

Use in elderly patients

The use of the medicine in elderly patients does not require special dosing. However, elderly patients are more susceptible to side effects.

Warning!

It is recommended that the division of the daily dose takes into account the biological rhythm of hormone secretion. The morning dose, administered between 6 and 8 am, should be 50%; the afternoon dose 20%, and the evening dose 30% of the daily dose.

Use of a higher than recommended dose of Corhydron

Acute overdose is rarely dangerous. Long-term use of high doses requires careful reduction of the dose to prevent the occurrence of acute adrenal insufficiency. Hydrocortisone is removed during dialysis.
Anaphylactic reactions and hypersensitivity reactions, depending on their severity, can be treated with antihistamines and, if necessary, with adrenaline.

Missing a dose of Corhydron

The patient should not take a double dose to make up for a missed dose.

Discontinuing Corhydron

The medicine should always be used according to the scheme prescribed by the doctor. The patient should not stop using Corhydron without consulting their doctor.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Corhydron can cause side effects, although not everybody gets them.
In the case of long-term use of hydrocortisone, the treatment should not be suddenly discontinued, as this may lead to acute adrenal insufficiency.
The following side effects may occur during the use of hydrocortisone:

Frequency not known (cannot be estimated from the available data):

Infections and infestations: exacerbation or masking of infection symptoms, occurrence of opportunistic infections, infection (induction of infection, reactivation of tuberculosis).
Benign, malignant, and unspecified tumors (including cysts and polyps): Kaposi's sarcoma, tumor lysis syndrome.
Blood and lymphatic system disorders: leukocytosis, thrombocytopenia, lymphopenia.
Immune system disorders: anaphylactic reactions.
Endocrine disorders: menstrual disorders, Cushing's syndrome symptoms, growth retardation in children, secondary adrenal cortex insufficiency, unmasking of latent diabetes, increased insulin or oral antidiabetic requirements in diabetic patients, steroid withdrawal syndrome.
Metabolic and nutritional disorders: negative nitrogen balance due to increased protein catabolism, sodium retention, hypokalemic alkalosis, dyslipidemia, impaired glucose tolerance, increased appetite.
Psychiatric disorders: psychotic disorders (including mania, delusions, hallucinations, and worsening of schizophrenia), mood disorders (including depression, euphoria, mood swings, drug dependence, suicidal thoughts), psychiatric disorders, personality changes, confusion, anxiety, behavioral disorders, insomnia, irritability.
Nervous system disorders: dizziness and headaches, seizures, increased intracranial pressure with papilledema (pseudotumor cerebri), neuropathy, paresthesia, epidural lipomatosis (excessive fat accumulation in the epidural space, causing compression of the spinal canal), amnesia, cognitive impairment.
Eye disorders: central serous chorioretinopathy (a disease that impairs central vision), secondary glaucoma, exophthalmos, optic nerve damage, posterior subcapsular cataract, blurred vision.
Cardiac disorders: arrhythmias or ECG changes related to hypokalemia, syncope, worsening of hypertension, cardiac rupture as a consequence of recent myocardial infarction, reports of sudden cardiac arrest, hypertrophic cardiomyopathy (in premature infants), congestive heart failure (in susceptible patients).
Vascular disorders: thromboembolism, fat embolism, hypercholesterolemia, accelerated atherosclerosis, necrotizing vasculitis, thrombophlebitis, hypotension, hypertension.
Respiratory, thoracic, and mediastinal disorders: pulmonary embolism, acute respiratory distress syndrome, hiccups.
Gastrointestinal disorders: nausea, vomiting, loss of appetite, which may lead to weight loss, diarrhea or constipation, abdominal distension, gastric irritation, and esophagitis with ulcers, gastric ulcer with possible perforation and bleeding, perforation of the small and large intestine, especially in inflammatory bowel diseases, gastrointestinal bleeding, pancreatitis, esophagitis, abdominal pain, dyspepsia.
Skin and subcutaneous tissue disorders: impaired wound healing, skin thinning, which becomes prone to damage and sensitive, bruising and petechiae, facial flushing, striae, hirsutism, acne-like eruptions, decreased skin test reactivity, hypersensitivity reactions such as allergic dermatitis, urticaria, angioedema, excessive sweating, pruritus. Treatment with glucocorticosteroids administered parenterally can cause hypo- or hyperpigmentation, scleroderma, skin and subcutaneous tissue atrophy, decreased pain sensation, and sterile abscesses at the injection site.
Musculoskeletal and connective tissue disorders: aseptic necrosis of the femoral and humeral heads, muscle weakness, muscle pain, steroid myopathy, muscle mass loss, osteoporosis, spontaneous fractures, including compression fractures of the spine and pathological fractures of long bones, arthropathy, tendon rupture.
Reproductive system and breast disorders: irregular menstruation.
General disorders and administration site conditions: fluid retention, congestive heart failure, hypokalemia, hypocalcemia, burning and tingling, which may occur after intravenous administration of glucocorticosteroids, impaired wound healing, peripheral edema, fatigue, malaise.
Investigations: weight gain, increased intraocular pressure, increased urine calcium levels, increased alanine aminotransferase activity, increased aspartate aminotransferase activity, increased alkaline phosphatase activity in the blood, increased blood urea levels.
If any of the side effects worsen or any side effects not listed in this leaflet occur, the patient should inform their doctor or pharmacist.
Withdrawal syndrome
Occurs after rapid discontinuation of hydrocortisone after long-term use. It is caused by acute adrenal insufficiency and can be life-threatening.
In withdrawal syndrome, the following may also occur: fever, muscle pain, joint pain, rhinitis, conjunctivitis, painful skin nodules, and weight loss.
Children and adolescents
Infections, which can be severe and even life-threatening, during the use of glucocorticosteroids, occur more frequently in children than in adults. Long-term treatment with glucocorticosteroids can slow down growth.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Corhydron

Store at a temperature below 25°C. Store in the original packaging to protect from light. Do not freeze.
The medicine should be stored in a place that is inaccessible to children.
Do not use this medicine after the expiry date stated on the carton and vial after: EXP. The expiry date refers to the last day of the month.
The abbreviation "Lot" means batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Corhydron contains

Corhydron 25: The active substance of the medicine is hydrocortisone in the form of buffered hydrocortisone sodium succinate 35.10 mg.
1 vial contains 25 mg of hydrocortisone.
Corhydron 100: The active substance of the medicine is hydrocortisone in the form of buffered hydrocortisone sodium succinate 140.4 mg.
1 vial contains 100 mg of hydrocortisone.
The other ingredients of the medicine are solvent: water for injections, phosphate buffer (in terms of disodium phosphate).

What Corhydron looks like and what the package contains

Corhydron is a white or almost white solid (lyophilized) mass.
Corhydron 25
Vials made of colorless glass, closed with a rubber stopper and a purple aluminum cap, and ampoules made of colorless glass in a cardboard box.
5 vials with powder + 5 ampoules with solvent
Corhydron 100
Vials made of colorless glass, closed with a rubber stopper and a green aluminum cap, and ampoules made of colorless glass in a cardboard box.
5 vials with powder + 5 ampoules with solvent

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Phone: +48 17 865 51 00

Manufacturer:

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Date of last revision of the leaflet: