Hidrocortison Vuab

Leaflet attached to the packaging: Patient information

Hydrocortison VUAB

100 mg, powder for solution for injection/infusion
Hydrocortisone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 you experience any side effects, including any not listed in this leaflet, tell your doctor. See section 4.

Table of contents of the leaflet

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

1. What is Hydrocortison VUAB and what is it used for

The active substance of Hydrocortison VUAB, hydrocortisone, is a glucocorticoid (a natural hormone) produced in the human adrenal cortex. The main action of hydrocortisone is to reduce inflammatory and immune reactions (reactions of the immune system to foreign substances). Additionally, it affects, among other things, sugar and protein metabolism.
Hydrocortison VUAB is used in the following cases:
Use in emergency/severe conditions:

• treatment of shock caused by adrenal insufficiency (adrenal crisis caused by acute adrenal insufficiency)*
• treatment of other types of shock that do not respond to conventional treatment, especially when adrenal insufficiency is suspected
• non-allergic shock (anaphylactoid reactions)
• severe, life-threatening exacerbation of respiratory diseases (asthma, COPD) - as an adjunct in the case of severe anaphylactic reactions
• other emergency/severe conditions requiring steroid therapy (including, for example, drug hypersensitivity reactions, Quincke's edema, severe erythema multiforme (Stevens-Johnson syndrome))

* Acute adrenal insufficiency is a syndrome of symptoms that develop as a result of a sudden - relative or absolute - deficiency of cortisol, where there is a disruption of the balance between increased demand for hydrocortisone and the possibility of its delivery (endogenous or exogenous).
Prophylactic use:

• endocrine diseases, with the aim of preventing the development of acute adrenal insufficiency, where additional glucocorticoid supply 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 careful consideration of indications by the 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 diseases
• rheumatic diseases.

2. Important information before using Hydrocortison VUAB

When not to use Hydrocortison VUAB

• If the patient is allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
• If the patient has acute viral, bacterial, fungal or tropical parasitic infections. Before starting treatment with Hydrocortison VUAB, such an infection should be cured first.
• Hydrocortison VUAB should not be used in doses that weaken the immune system if the patient has been or is to be vaccinated with a live or attenuated virus.
• General rules regarding the non-use of adrenal cortex hormones (glucocorticoids) and precautions that should be taken during systemic glucocorticoid therapy also apply to Hydrocortison VUAB.

NOTE: In life-threatening conditions, there are no absolute contraindications, especially if the drug is to be used for a short time (24-36 hours).

Warnings and precautions

The risk of side effects during glucocorticoid therapy increases with increasing dose and duration of treatment, so the benefits and risks of the treatment will be carefully weighed against each other when determining the dose and duration of treatment.
Hydrocortison VUAB should not be stopped abruptly, but rather gradually withdrawn.
Before starting treatment, discuss it with your doctor or pharmacist:

• Patients undergoing surgery during or after treatment with Hydrocortison VUAB, who have had an accident, or who have an infection, may require treatment with fast-acting glucocorticoids.
• Glucocorticoids can mask infection symptoms, and new infections may occur during their use, as the patient's immunity may decrease. In the case of bacterial infections, the doctor will first determine the type of bacteria and cure the infection before using glucocorticoid therapy.
• While taking immunosuppressive drugs, the patient may be more susceptible to infections than healthy individuals.
• If the patient has already had a risk factor for cardiovascular disease, they may be at increased risk of additional cardiovascular diseases after high doses and long-term use of Hydrocortison VUAB. Examples include elevated blood pressure and increased and/or decreased levels of one or more fats in the blood (such as cholesterol, triglycerides).
• If the patient has congestive heart failure.
• Hydrocortisone may increase blood pressure, as salt and water are retained. The doctor may recommend a low-sodium diet with additional potassium content for the patient.
• In patients with septic shock. This is a condition caused by infection, characterized by a sudden drop in blood pressure, paleness, anxiety, weak and rapid pulse, moist skin, and decreased level of consciousness. Routine use of Hydrocortison VUAB is not recommended in this case.
• During treatment with high doses of hydrocortisone, patients should not be vaccinated with live virus vaccines.
• If the patient has active tuberculosis or is being treated for tuberculosis, the doctor should closely monitor the patient's condition during treatment with Hydrocortison VUAB.
• If the patient has ever had hypersensitivity reactions due to medication, the doctor will take necessary precautions before starting treatment.
• If the patient has eye infections caused by herpes, regular eye exams should be performed during treatment.
• Corticosteroid therapy can cause retinal detachment and cataracts. If blurred vision or other vision disturbances occur, contact a doctor.
• During treatment, psychological changes may occur, such as excessive joy, insomnia, irritability, personality changes, and depression.
• There have been reports of fat accumulation in the spinal canal during long-term use of corticosteroids in high doses.
• If the patient has a history of stomach or intestinal inflammation, high blood pressure, active or inactive ulcers, impaired kidney function, adrenal gland tumors, Kaposi's sarcoma (a type of skin cancer), osteoporosis, myasthenia (some muscle diseases), or thrombosis or has an increased risk of thrombosis, the doctor prescribing Hydrocortison VUAB should exercise particular caution.
• If the patient has liver disease, the doctor may prescribe a lower dose of the medicine, as hydrocortisone may have an increased effect on the patient.
• If the patient has Cushing's disease (a disease caused by an excess of cortisol hormone in the blood).
• If the patient has reduced thyroid function (hypothyroidism).
• If the patient has diabetes.
• If the patient has a disease accompanied by seizures or attacks (e.g., epilepsy).
• In the case of using certain painkillers with anti-inflammatory and antipyretic effects (NSAIDs).
• If the patient has pancreatitis, which is accompanied by severe abdominal pain radiating to the back, nausea, and vomiting.

Children and adolescents up to 18 years of age

Long-term glucocorticoid therapy may inhibit growth in children. Therefore, doctors usually use intermittent dosing in children.
In particular, infants and children who are long-term treated with corticosteroids are at risk of increased intracranial pressure.
High doses of corticosteroids may cause pancreatitis in children.
If hydrocortisone is administered to premature infants, it may be necessary to monitor heart function and cardiac muscle image.

Hydrocortison VUAB and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Inform your doctor about any medications you are taking, such as:

• Isoniazid: used to treat bacterial infections.
• Rifampicin: an antibiotic used to treat tuberculosis.
• Anticoagulant medicines (oral anticoagulants).
• Barbiturates, carbamazepine, and/or phenytoin used to treat epilepsy.
• Medicines used to treat certain nervous system diseases (anticholinergic medicines).
• Medicines used to treat muscle diseases - myasthenia (anticholinesterases).
• Medicines used to treat diabetes (antidiabetic medicines).
• Aprepitant and fosaprepitant: used to prevent nausea and vomiting.
• Itraconazole or ketoconazole: used to treat fungal infections.
• Some medicines may enhance the effect of Hydrocortison VUAB, and the doctor will monitor the patient's condition when taking these medicines (including some HIV medicines: indinavir, ritonavir, cobicistat).
• Aminoglutethimide and/or cyclophosphamide: used to treat cancer.
• Tacrolimus: a medicine used after organ transplantation to prevent rejection.
• Diltiazem: used to treat heart diseases or high blood pressure.
• Digoxin: heart medicines belonging to the group of cardiac glycosides.
• Estrogens (including oral contraceptives containing estrogens).
• Cyclosporine; used to treat, among other things, severe joint inflammation (rheumatoid arthritis), severe skin disorders with peeling, rash (psoriasis), and to prevent organ rejection.
• Clarithromycin, erythromycin, and/or troleandomycin: medicines that prevent or control certain infections.
• Aspirin (acetylsalicylic acid) and/or certain painkillers that also have anti-inflammatory and antipyretic effects (NSAIDs).
• Medicines that lower potassium levels, such as diuretics.

Hydrocortison VUAB with food and drink

Grapefruit juice may change the effect of Hydrocortison VUAB. Consult your doctor or pharmacist before using this medicine and consuming grapefruit juice.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Hydrocortison VUAB may be used in case of absolute indication. It is recommended to avoid long-term use of high doses.
Breastfeeding
Adrenal hormones pass into breast milk. Therefore, breastfeeding is not recommended during corticosteroid therapy, unless it is done after consulting a doctor who will assess the benefit-risk ratio for both the mother and the child.
Fertility
There is no evidence that corticosteroids affect fertility.

Driving and using machines

Many possible side effects of Hydrocortison VUAB, such as blurred vision, mood changes, muscle weakness, and involuntary muscle contractions, may negatively affect the ability to drive vehicles and operate machines.

Hydrocortison VUAB contains sodium

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

3. How to use Hydrocortison VUAB

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Hydrocortison VUAB will be administered by a doctor or nurse. It can be administered intravenously (using a syringe or infusion) or intramuscularly (using a syringe).
The doctor will determine the appropriate dose based on the patient's condition.

Use in children up to 14 years of age

For each child, the dose of the medicine is selected individually based on the child's clinical condition, age, and body weight. Usually, the following doses are used:

• in children up to 12 months: doses of 8-10 mg/kg body weight per day
• 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 are not used in children.

Using a higher dose of Hydrocortison VUAB than recommended

There is no data on acute overdose of Hydrocortison VUAB. Hydrocortisone can be removed by dialysis. This means that in case of overdose, excess hydrocortisone can be removed from the blood using an artificial kidney. After long-term repeated use (daily or several times a week), the patient may experience Cushing's syndrome (characterized by, among other things, the appearance of a moon face).

Missing a dose of Hydrocortison VUAB

The doctor will ensure that the patient receives the next dose at the right time. Do not use a double dose to make up for a missed dose.

Stopping treatment with Hydrocortison VUAB

If treatment with Hydrocortison VUAB is stopped abruptly or if surgery is necessary during treatment, the adrenal cortex may become less effective.
This may exacerbate the symptoms of the disease being treated.
Especially in children, seizures, dizziness, and headaches may occur if treatment is stopped too quickly.
Therefore, the doctor usually gradually withdraws treatment with Hydrocortison VUAB.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with an unknown frequency (frequency cannot be estimated from the available data):

• Hydrocortison VUAB may mask symptoms of inflammation, which can make it difficult to diagnose an infection.
• Opportunistic infection (characteristic of people with weakened immunity).
• Skin cancer (Kaposi's sarcoma).
• Significant increase in blood pressure due to the occurrence of a pheochromocytoma in the adrenal glands.
• Increased white blood cell count in the blood (leukocytosis).
• Severe allergic reaction, including a sudden drop in blood pressure, paleness, anxiety, weak and rapid pulse, moist skin, and decreased level of consciousness due to sudden, severe vasodilation (anaphylactic or anaphylactoid reaction).
• Hypersensitivity to medicines.
• Development of obesity (head, trunk), moon face, and high blood pressure (Cushing's syndrome).
• Deficiency of one or more hormones produced by the pituitary gland (suppression of the hypothalamic-pituitary-adrenal axis).
• Syndrome associated with withdrawal symptoms, which may occur after stopping corticosteroid therapy (steroid withdrawal syndrome).
• Metabolic acidosis.
• Sodium retention by the kidneys.
• Fluid retention in the body.
• Lipid metabolism disorders (dyslipidemia).
• Disturbed acid-base balance of the blood due to excessive potassium loss (hypokalemic alkalosis).
• Decreased glucose tolerance.
• Glucose metabolism disorder, which may lead to the detection of diabetes or may cause patients with diabetes to require higher doses of insulin or other medicines that lower blood sugar levels.
• Increased appetite.
• Fat accumulation in different parts of the body (lipomatosis).
• Psychological disorders, such as excessive joy associated with having a lot of energy (mania), delusions, perception of things that are not there (hallucinations), and severe mental illness (schizophrenia) characterized by gradual personality changes.
• Mood disorders, such as low mood, excessive joy (euphoria), emotional instability, drug dependence, suicidal thoughts.
• Psychological disorder.
• Disorientation, anxiety.
• Personality change, mood swings.
• Abnormal behavior.
• Insomnia, irritability.
• Worsening of existing psychotic behaviors.
• Fat accumulation in the spinal canal (spinal epidural lipomatosis).
• Increased intracranial pressure.
• Increased intracranial pressure with papilledema (benign intracranial hypertension).
• Loss of consciousness with tremors (seizures).
• Memory loss (amnesia).
• Cognitive function disorders, such as perception, attention, concentration, memory, orientation, language skills, and abilities (cognitive disorders).
• Dizziness, headaches.
• Retinal and choroidal disorders (chorioretinopathy).
• Visual disturbances, cataract (cataract).
• Increased eye pressure (glaucoma).
• Protrusion of the eyeballs (exophthalmos).
• Dizziness with balance disorders (vertigo).
• Congestive heart failure.
• Increased blood clotting (thrombosis).
• Low blood pressure (hypotension).
• High blood pressure (hypertension).
• Pulmonary embolism.
• Respiratory disorders (severe respiratory distress syndrome).
• Hiccup.
• Stomach and duodenal ulcers with possible complications such as perforation and bleeding.
• Bleeding and damage to the intestinal wall (intestinal perforation).
• Gastric bleeding.
• Pancreatitis with symptoms of severe abdominal pain radiating to the back, nausea, and vomiting.
• Esophageal inflammation with or without ulcers.
• Abdominal pain, abdominal distension.
• Diarrhea.
• Feeling of fullness or pain in the abdominal area, reflux, nausea, vomiting, and/or heartburn (indigestion).
• Sudden swelling of the skin and mucous membranes (e.g., throat or tongue), causing difficulty breathing and/or itching and rash, often as an allergic reaction (angioedema).
• Excessive hair growth in women (hirsutism).
• Small pinpoint bleeding under the skin (petechiae).
• Small pinpoint bleeding in the mucous membrane (ecchymosis).
• Thin, fragile, and wrinkled skin (skin atrophy).
• Redness of the skin (erythema).
• Excessive sweating.
• Scars on the skin (striae).
• Skin rash, itching.
• Skin rash with severe itching and nodules (urticaria).
• "Juvenile" acne on the skin (acne).
• Muscle weakness, muscle pain.
• Muscle diseases (myopathy).
• Decrease in muscle mass due to muscle disuse or inability to use the muscle due to a nervous system disease (muscle atrophy).
• Bone necrosis, bone demineralization (osteoporosis).
• Bone fracture (pathological fracture).
• Joint diseases caused by nervous system disorders (neuropathic arthropathy).
• Joint pain.
• Growth retardation.
• Vertebral collapse (compressive spinal fracture).
• Tendon rupture.
• Irregular menstrual cycles.
• Difficulty in wound healing.
• Fluid retention in the limbs (peripheral edema).
• Fatigue; general malaise.
• Reaction at the injection site.
• Increased eye pressure.
• Decreased carbohydrate metabolism, which may lead to increased insulin requirements or other medicines that lower blood sugar levels (decreased carbohydrate tolerance).
• Decreased potassium levels in the blood, in severe cases manifested by muscle cramps or weakness and fatigue (hypokalemia).
• Increased calcium levels in the urine.
• Abnormal blood test results (increased alanine aminotransferase activity, increased aspartate aminotransferase activity, increased alkaline phosphatase activity in the blood).
• Increased levels of protein breakdown products in the blood (increased urea levels in the blood).
• Disorders of skin test results.
• Weight gain.

Additional side effects that may occur in children and adolescents up to 18 years of age

In children, growth inhibition may occur.
In premature infants, hypertrophic cardiomyopathy (cardiomyopathy) may occur - frequency unknown.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
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, you can help gather more information on the safety of this medicine.

5. How to store Hydrocortison VUAB

Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label, box, and bottle after: EXP. The expiry date refers to the last day of the specified month.
Before opening: There are no special storage instructions for the medicinal product.
After opening: Use immediately.
After dilution: Use immediately, discard any leftovers.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Hydrocortison VUAB contains

• The active substance is hydrocortisone. One vial for injection contains hydrocortisone in a dose of 100 mg, in the form of hydrocortisone sodium succinate.
• The other ingredients are: sodium dihydrogen phosphate monohydrate, disodium phosphate.

What Hydrocortison VUAB looks like and what the package contains

White or almost white dry powder.
Hydrocortison VUAB is packaged in a 10 ml vial made of type II colorless glass, closed with a bromobutyl rubber stopper with an aluminum seal or a "flip-off" closure in a cardboard box.
Package size: 1 x 100 mg.

Marketing authorization holder and manufacturer

Marketing authorization holder

VUAB Pharma a.s.
Vltavská 53
252 63 Roztoky
Czech Republic
phone: +420 220 394 504
e-mail: office@vuab.cz

Manufacturer

VUAB Pharma a.s.
Vltavská 53
252 63 Roztoky
Czech Republic

Date of last revision of the leaflet:

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Information intended only for healthcare professionals:
Preparation of the solution
For intravenous or intramuscular use, the solution should be aseptically prepared by adding no more than 2 ml of sterile water for injection to the contents of one vial of Hydrocortison VUAB, shaking, and drawing up for use.
For intravenous infusion, first prepare the solution by adding no more than 2 ml of sterile water for injection to the vial. Then, this solution may be added to 100 ml - 1000 ml (but not less than 100 ml) of 5% dextrose solution in water (or isotonic saline solution or 5% glucose in isotonic saline solution, when sodium restriction is not necessary for the patient).
After dissolution, the pH value of the solution is between 7.0 and 8.0. The prepared solution is practically clear, colorless, and essentially free of particles.