Hidrocortisone Pharmline

Leaflet attached to the packaging: information for the user

Hydrocortisone PHARMLINE, 100 mg, powder for solution for injection/infusion

for injection/infusion
Hydrocortisone(as sodium succinate)

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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.
• 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 Hydrocortisone and what is it used for
• 2. Important information before using Hydrocortisone
• 3. How to use Hydrocortisone
• 4. Possible side effects
• 5. How to store Hydrocortisone
• 6. Contents of the packaging and other information

1. What is Hydrocortisone and what is it used for

The active substance of Hydrocortisone, hydrocortisone, is a glucocorticoid (a natural hormone) produced in the adrenal cortex of humans. The main action of hydrocortisone is to suppress inflammatory and immune reactions (reactions of the immune system to foreign substances). Additionally, it affects, among other things, sugar and protein metabolism.
Hydrocortisone can be used in combination with other adrenal cortex hormones when the adrenal cortex does not function properly, for example in Addison's disease or adrenogenital syndrome. It can also be used if the adrenal cortex does not function due to another disease.
Additionally, Hydrocortisone can be used for a short time when other measures do not help or do not help enough:

• in cases of severe asthma exacerbations, chronic bronchitis, or pulmonary emphysema;
• in status asthmaticus (persistent asthma attack);
• in combination with other medications in cases of severe allergic reactions.

2. Important information before using Hydrocortisone

When not to use Hydrocortisone

• 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, fungal, or tropical parasitic infections. Before starting treatment with Hydrocortisone, bacterial infections must be cured first.
• in case of stomach or duodenal ulcer disease.
• if the patient has received or is going to receive live or attenuated virus vaccines, Hydrocortisone should not be used in a dose that suppresses the immune system.

This medicine should not be injected:

• into the spinal cord (intrathecally) or epidurally.

General rules for not using adrenal cortex hormones (glucocorticoids) and precautions that should be taken when using systemic glucocorticoid therapy also apply to Hydrocortisone.

Warnings and precautions

The risk of side effects when using glucocorticoids 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.
Hydrocortisone should not be stopped suddenly, but the dose should be gradually reduced.
Before starting treatment, the patient should discuss it with their doctor or pharmacist:

• Patients undergoing surgery, patients who have had an accident, or those with an infection during or after hydrocortisone treatment may require rapid-acting glucocorticoid therapy.
• Glucocorticoids can mask symptoms of infection, and new infections may occur during their use, as the patient's immunity may decrease. In case of bacterial infections, the doctor will first determine the type of bacteria and cure the infection before using glucocorticoid therapy.
• When 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 Hydrocortisone. Examples include high blood pressure and increased and/or decreased levels of one or more lipids in the blood (lipids, cholesterol, triglycerides).
• If the patient has reduced heart function (congestive heart failure).
• Hydrocortisone may cause high blood pressure, sodium and water retention, and increased potassium excretion. The doctor may recommend a low-sodium diet with potassium supplementation. It may be necessary to limit sodium in the diet and supplement with potassium. All corticosteroids increase calcium excretion.
• 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 Hydrocortisone is not recommended in this case.
• When treating 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 Hydrocortisone.
• If the patient has ever had allergic reactions to medications, 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 the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
• Corticosteroid therapy can lead to retinal detachment and cataracts.
• During treatment, the patient may experience mental changes, such as excessive cheerfulness, 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 stomach or intestinal inflammatory condition, high blood pressure, active or inactive ulcers, kidney function disorders, adrenal gland tumors, Kaposi's sarcoma (a type of skin cancer), osteoporosis, myasthenia (some muscle diseases), or thrombosis or is at increased risk of thrombosis, the doctor prescribing Hydrocortisone should exercise particular caution.
• If the patient has liver disease, the doctor may prescribe a lower dose of the medicine, as hydrocortisone may have increased effects in 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 fits (e.g., epilepsy).
• When 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

Long-term treatment with glucocorticoids can inhibit growth in children. Therefore, the doctor usually uses intermittent dosing in children.
Particularly in infants and children who are treated long-term with corticosteroids, there is an increased risk of increased intracranial pressure.
High doses of corticosteroids can cause pancreatitis in children.
If hydrocortisone is administered to premature infants, it may be necessary to monitor heart function and cardiac muscle image.

Hydrocortisone and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those available without a prescription.
Tell your doctor about any medications you are taking, such as:

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

Hydrocortisone with food and drink

Grapefruit juice may change the effect of Hydrocortisone. 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
Hydrocortisone can be used as indicated.
Whenever possible, avoid chronic use of higher doses.
Breastfeeding
Corticosteroids pass into breast milk. Therefore, breastfeeding is not recommended during corticosteroid therapy, unless it is done after consulting a doctor.
Fertility
There is no evidence that corticosteroids affect fertility.

Driving and using machines

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

Hydrocortisone contains sodium

The medicine contains 9.46 mg of sodium (the main component of table salt) in each vial. Patients controlling their sodium intake should take this into account.

3. How to use Hydrocortisone

Hydrocortisone is 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 disease and situation.

Using a higher dose of Hydrocortisone than recommended

There is no data on acute overdose of Hydrocortisone.
Hydrocortisone can be removed using 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 Hydrocortisone

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

Stopping treatment with Hydrocortisone

If treatment with Hydrocortisone is stopped suddenly or if surgery is necessary during treatment, the adrenal cortex may become less effective. This may cause the symptoms of the disease being treated to recur. Especially in children, seizures, dizziness, and headaches may occur if treatment is stopped too quickly. Therefore, the doctor will usually gradually reduce the dose of Hydrocortisone.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Hydrocortisone 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):

• Hydrocortisone suppresses the symptoms of inflammation, which can make it difficult to diagnose an infection, and may lead to the manifestation of latent infections and the occurrence of new infections.
• Infections that usually occur rarely (opportunistic infections) may occur.
• Skin cancer (Kaposi's sarcoma).
• Significant increase in blood pressure due to adrenal gland tumor (pheochromocytoma).
• Increased white blood cell count in the blood (leukocytosis).
• Severe allergic reaction to certain substances, 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 reaction).
• Hypersensitivity to medications.
• 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 that may occur after stopping corticosteroid therapy (steroid withdrawal syndrome).
• Acidosis (metabolic acidosis).
• Sodium retention by the kidneys (sodium retention).
• Fluid retention in the body (fluid retention).
• Lipid metabolism disorders (dyslipidemia).
• Disrupted acid-base balance of the blood due to excessive potassium loss (hypokalemic alkalosis).
• Decreased ability to tolerate glucose (decreased glucose tolerance).
• Disrupted blood sugar regulation, allowing the detection of latent diabetes or increasing the need for insulin or other medications that lower blood sugar levels.
• Increased appetite.
• Fat accumulation in various parts of the body (lipomatosis).
• Psychiatric disorders, such as excessive cheerfulness associated with having a lot of energy (mania), delusions, perceiving things that are not there (hallucinations), and severe mental illness (schizophrenia) characterized by gradual personality changes.
• Mood disorders, such as low mood, extreme feeling of joy (euphoria), emotional instability, drug dependence, suicidal thoughts.
• Psychiatric 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 swelling of the mucous membranes (benign intracranial hypertension).
• Loss of consciousness with muscle tremors (seizures).
• Memory loss (amnesia).
• Cognitive function disorders, such as perception, attention, concentration, memory, orientation, language skills, and abilities (cognitive disorders).
• Dizziness.
• Headache.
• Retinal and choroidal disorders (chorioretinopathy).
• Visual disturbances.
• Clouding of the lens (cataract).
• Increased eye pressure (glaucoma).
• Abnormal protrusion of the eyeballs (exophthalmos).
• Dizziness with balance disorders (vertigo).
• In patients at risk, there may be a decrease in the heart's ability to pump blood (congestive heart failure).
• Increased blood clotting (thrombosis).
• Low blood pressure (hypotension).
• High blood pressure (hypertension).
• Pulmonary embolism.
• Persistent hiccups.
• Stomach and/or duodenal ulcers with possible perforation and bleeding.
• Bleeding and intestinal wall damage (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.
• Digestive disorders with a feeling of fullness in the upper abdomen, stomach pain, belching, nausea.
• Vomiting and heartburn (indigestion).
• Nausea.
• Sudden accumulation of fluid in the skin and mucous membranes (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash, often as an allergic reaction (angioedema).
• Excessive hair growth in women (hirsutism).
• Small bruises under the skin (ecchymoses).
• Small bruises on the mucous membrane (ecchymoses).
• Thin, fragile, and wrinkled skin (skin atrophy).
• Redness of the skin (erythema).
• Excessive sweating.
• Scars on the skin (striae).
• Skin rash.
• Itching (pruritus).
• Skin rash with severe itching and nodules (urticaria).
• "Juvenile" acne on the skin (acne).
• Muscle weakness.
• Muscle pain (myalgia).
• Muscle diseases (myopathy).
• Decreased muscle mass due to muscle disuse or inability to use the muscle due to a nervous system disease (muscle atrophy).
• Bone necrosis.
• Bone decalcification (osteoporosis).
• Bone fracture (pathological fracture).
• Joint diseases caused by nerve disorders (neuropathic arthropathy).
• Joint pain (arthralgia).
• Growth retardation.
• Vertebral collapse (compressive spinal fracture).
• Tendon rupture.
• Irregular menstrual cycles.
• Difficulty healing wounds.
• Fluid retention in the limbs (peripheral edema).
• Fatigue.
• General malaise, nausea.
• Reactions at the injection site after injection.
• Increased eye pressure.
• Decreased ability to metabolize sugars (carbohydrates), which may lead to increased insulin or other medications that lower blood sugar levels.
• Decreased potassium levels in the blood, in severe cases manifesting as 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).
• Disrupted skin test results.
• Weight gain.

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

In children, growth inhibition may occur. In premature infants, cardiac hypertrophy (hypertrophic cardiomyopathy) may occur.

Reporting side effects

If side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 provide more information on the safety of this medicine.

5. How to store Hydrocortisone

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after EXP.
The expiry date refers to the last day of the month stated.
Do not store above 25°C. Store the vial in the outer packaging to protect from light.
After mixing the medicine with water for injections, the solution should be used immediately.
Unused liquid should be disposed of in a safe way.
The doctor will check before administration that the solution does not contain solid particles and is not discolored.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Hydrocortisone contains

• The active substance is hydrocortisone. One vial contains 100 mg of hydrocortisone, in the form of hydrocortisone sodium succinate.
• The other ingredients are: sodium dihydrogen phosphate dihydrate, sodium dihydrogen phosphate anhydrous, sodium hydroxide.

What Hydrocortisone looks like and contents of the pack

Hydrocortisone is a white or almost white powder for solution for injection/infusion. It is in a vial made of colorless type I glass, containing 100 mg of hydrocortisone, closed with a rubber stopper and sealed with an aluminum cap.
Hydrocortisone is available in packs containing 1 or 10 vials.
A vial or 2 protective trays with 5 vials each, made of PVC coated with PET/PE film, are packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Pharmline Company Sp. z o. o.
Juliana Ursyna Niemcewicza 17/11
02-306 Warsaw
phone: +48 780 008 085
email: office@pharmline.pl

Manufacturer

S.C. Rompharm Company S.R.L.
1A Eroilor street
075100 Otopeni, Ilfov County
Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria
Hydrocortisone Inresa 100 mg powder for solution for injection/infusion
Bulgaria
Хидрокортизон Ромфарм 100 mg прах за инжекционен/инфузионен разтвор
Spain
Hidrocortisona Lorien 100 mg powder for solution for injection and perfusion EFG
Germany
Hydrocortison Inresa 100 mg powder for solution for injection/infusion
Poland
Hydrocortisone
Romania
Hidrocortizon Rompharm 100 mg pulbere pentru soluție injectabilă/perfuzabilă
Hungary
100 mg oldatos injekcióhoz vagy infúzióhoz

Date of last revision of the leaflet: --------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Dosage and administration

Hydrocortisone can be administered intravenously, intramuscularly, or by intravenous infusion. The preferred method of initial administration in emergency situations is intravenous injection. After initial intervention in an emergency situation, consider using a longer-acting injection form or oral form. The duration of the infusion depends on the dose; it can range from 30 seconds (e.g., 100 mg) to 10 minutes (e.g., 500 mg or more).
Essentially, treatment with high doses of corticosteroids should be continued until the patient's condition stabilizes (usually no longer than 48 to 72 hours).
Although side effects associated with short-term use of high doses of corticosteroids are not very common, stomach ulcers may occur. Prophylactic treatment with medications that neutralize stomach acid may be indicated.
When treating with high doses of hydrocortisone, it is better to replace Hydrocortisone with a corticosteroid such as methylprednisolone sodium succinate, after which there is little sodium retention in the body or no sodium retention at all.
The initial dose of Hydrocortisone is 100 mg to 500 mg or more, depending on the severity of the disease. This dose can be repeated at intervals of 2, 4, or 6 hours, depending on the patient's clinical condition. Corticosteroid therapy is a supplement to conventional therapy, but it cannot replace it.
Hydrocortisone may have a stronger effect in patients with liver disease. Therefore, a dose reduction should be considered (see section 4.4).
Children and adolescents
The dose of Hydrocortisone in children should be determined based on the severity of the disease and the patient's response, rather than on the child's weight and age. In these patients, the dose may be reduced, but it should not be less than 25 mg per day (see section 4.4).

Preparation of the solution

Medicines for parenteral use must be visually inspected for particles and color change before administration.
After reconstitution, the solution is clear, without visible particles or sediment.
The preparation does not contain a preservative and is intended for single use only.
After opening the vial, its contents should be used immediately (see section 6.3).
Instructions:
Add no more than 2 mL of water for injections to one vial containing sterile powder, under aseptic conditions.
For intravenous or intramuscular injections:
Prepare the solution as described above. For intravenous or intramuscular injection, no further dilution is required; shake and draw up for use.
Intravenous infusion:
First, prepare the solution as described above, adding no more than 2 mL of water for injections to the vial. The resulting solution containing 100 mg of hydrocortisone can then be added to 100-1000 mL (but not less than 100 mL) of one of the following solutions:

• 5% glucose solution in water
• 0.9% sodium chloride solution.

If the patient is on a sodium diet, a 5% glucose solution can be used.
After dissolution according to the instructions, the pH value of the solution is between 7.0 and 8.0.

Shelf life

Unopened vial:
2 years
The stability of the solution after reconstitution with 2 mL of water for injections has not been tested. Therefore, the solution after reconstitution should be used immediately.
After reconstitution and dilution:
After reconstitution and subsequent dilution in 100 mL and 1000 mL of 0.9% sodium chloride injection solution, chemical and physical stability has been demonstrated for 4 hours at 25°C.
After reconstitution and subsequent dilution in 100 mL and 1000 mL of 5% glucose injection solution, chemical and physical stability has been demonstrated for 4 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage time and conditions.

Special precautions for storage

Do not store above 25°C.
Store the vial in the outer packaging to protect from light.

More information can be found in the Summary of Product Characteristics.