Deksametazon Accord

Leaflet accompanying the packaging: patient information

Deksametazon Accord, 4 mg/mL, solution for injection/infusion

Dexamethasone phosphate

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, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Deksametazon Accord and what is it used for
• 2. Important information before using Deksametazon Accord
• 3. How to use Deksametazon Accord
• 4. Possible side effects
• 5. How to store Deksametazon Accord
• 6. Contents of the packaging and other information

1. What is Deksametazon Accord and what is it used for

Dexamethasone phosphate is a synthetic glucocorticosteroid (adrenal cortex hormone) affecting metabolism, electrolyte balance, and tissue function. Deksametazon Accord is used to treat diseases that require the use of glucocorticosteroids. Depending on the symptoms and severity, these include:

Systemic administration:

• Brain edema caused by brain tumors, neurosurgical interventions, brain abscess, bacterial meningitis.
• Shock after severe injuries, for preventive treatment of post-traumatic acute respiratory distress syndrome (ARDS).
• Use in the treatment of COVID-19 in adult patients and adolescents (aged 12 and older, weighing at least 40 kg), with breathing difficulties and requiring oxygen therapy.
• Severe acute asthma attack.
• Initial stage of treatment of widespread, severe skin diseases, such as erythroderma, pemphigus, acute eczema.
• Treatment of systemic rheumatic diseases (rheumatic diseases that can affect internal organs), such as systemic lupus erythematosus.
• Severe progressive rheumatoid arthritis, e.g., rapidly progressive forms of the disease leading to joint damage and/or extra-articular tissue damage.
• Severe infectious diseases with symptoms of intoxication (tuberculosis, typhoid fever, only in combination with appropriate anti-infective therapy).
• Prevention and treatment of post-operative or chemotherapy-induced vomiting.
• Supportive treatment of malignant tumors, when dexamethasone may be administered by injection or infusion into a vein or under the skin (subcutaneously) to alleviate some symptoms, including pain, fatigue, weight loss, and malaise.
• Use in adolescents: In children and adolescents (adolescents aged 12 and older, weighing at least 40 kg), 6 mg is recommended to be administered intravenously once a day for up to 10 days.

Local administration

• Intra-articular injection: persistent inflammation of one or more joints after systemic treatment of chronic inflammatory joint diseases, activated degenerative joint disease (in the progressive phase), acute forms of shoulder pain syndrome.
• Soft tissue injection (only when strictly indicated): non-bacterial tendon or bursa inflammation, periarticular disorders, tendon disorders.

2. Important information before using Deksametazon Accord

When not to use Deksametazon Accord

• If the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).

In individual cases, during the use of dexamethasone phosphate, severe hypersensitivity reactions (anaphylactic reactions) with circulatory collapse, cardiac arrest, arrhythmia, dyspnea (bronchospasm), and/or decreased or increased blood pressure have been observed.
If the patient has a systemic infection, including fungal infections (e.g., candidiasis), that is not being treated with antibiotics or appropriate anti-infective therapy.
Injection into a joint is contraindicated in cases of:

• Infections within or near the joint, requiring treatment
• Bacterial arthritis
• Joint instability
• Bleeding tendency (spontaneous or caused by anticoagulant medications)
• Calcifications in the joint area
• Avascular necrosis of bone
• Tendon rupture
• Charcot joint

Do not administer by soft tissue injection without additional causal treatment in case of infections at the injection site.
Do not stop taking any other steroid medications without consulting a doctor.

Warnings and precautions

Before starting treatment with this medicine, discuss it with your doctor, pharmacist, or nurse.
If during treatment with dexamethasone phosphate, special physical stress situations occur (accident, surgery, childbirth, etc.), it may be necessary to temporarily increase the dose.
Dexamethasone phosphate may mask the symptoms of an existing or developing infection, making diagnosis difficult. Inactive infections may recur.
Treatment with dexamethasone phosphate should only be considered when absolutely necessary in cases of concomitant use of other medicines that affect the pathogens causing the following diseases:

• Acute viral infections (hepatitis B virus, chickenpox, shingles, Herpes simplex infection, Herpes virus keratitis)
• Chronic active hepatitis with a positive HBsAg test result (infectious hepatitis)
• Approximately 8 weeks before and up to 2 weeks after vaccinations with live vaccines
• Acute and chronic bacterial infections
• Systemic fungal infections
• Certain parasitic diseases (amebiasis or worm infestations). In the case of infestation or suspected infestation with threadworms (Strongyloides), Deksametazon Accord may lead to activation and massive multiplication of these parasites

During treatment with dexamethasone phosphate, carefully monitor the course of the following diseases and apply appropriate treatment:

• Stomach or intestinal ulcers
• Bone density loss (osteoporosis)
• Poorly controlled hypertension
• Poorly controlled diabetes
• Psychiatric disorders (also in the past), including suicidal tendencies. In such cases, neurological or psychiatric supervision is recommended.
• Increased intraocular pressure (glaucoma with closed or open angle); ophthalmological supervision and appropriate treatment are recommended.
• Corneal damage and ulcers; ophthalmological supervision and appropriate treatment are recommended.

The use of this medicine may cause a crisis in the course of a pheochromocytoma (a rare adrenal gland tumor), which can be life-threatening. A pheochromocytoma crisis may manifest as headache, excessive sweating, palpitations, and increased blood pressure. If these symptoms occur, the patient should immediately contact their doctor.
Before starting treatment with Deksametazon Accord, discuss it with your doctor if there is a suspicion or diagnosis of a pheochromocytoma (adrenal gland tumor).
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
Due to the risk of intestinal perforation, Deksametazon Accord should only be used in emergency situations and under appropriate control:

• in severe colitis (ulcerative colitis) with a risk of perforation, with ulcerative or abscessing inflammation that may occur without peritoneal irritation
• in diverticulitis (inflammation of intestinal diverticula)
• after certain intestinal surgeries (intestinal anastomosis), immediately after surgery.

Signs of peritoneal irritation after gastrointestinal perforation may not occur in patients receiving high doses of glucocorticosteroids.
In diabetic patients, blood glucose levels should be regularly monitored, and the increased need for diabetes medications (insulin, oral hypoglycemic agents) should be considered.
Due to the risk of exacerbating the disease, patients with very high blood pressure and/or severe heart failure should be closely monitored.
During the use of high doses of the medicine, the pulse may be lower than usual.
Severe anaphylactic reactions (hypersensitivity of the immune system) may occur.
The risk of tendon diseases, tendonitis, and tendon rupture increases in patients treated concurrently with fluoroquinolones (a type of antibiotic) and Deksametazon Accord.
During the treatment of a certain type of muscle paralysis (myasthenia gravis), the symptoms may initially worsen.
Vaccination with vaccines containing killed pathogens (inactivated vaccines) is generally possible. However, it should be noted that after administration of high doses of corticosteroids, the immune response may be weakened, and thus the effectiveness of the vaccine.
When used concurrently with medications used to treat malaria or rheumatic diseases (chloroquine, hydroxychloroquine, and mefloquine), Deksametazon Accord may increase the risk of muscle or heart diseases (myopathy and cardiomyopathy).

Effect on diagnostic tests

Glucocorticosteroids may suppress skin reactions in allergy tests.
Due to interactions with these medications, the doctor may need to adjust the dose of the medication administered to the patient.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
The doctor will then decide whether the medicine is suitable for the patient and may order additional tests during treatment.
Dexamethasone crosses the placenta. During pregnancy, especially in the first three months, the medicine should only be used after careful assessment of the benefit-risk ratio.
In case of prolonged or repeated use of dexamethasone during pregnancy, growth disturbances in the unborn child cannot be excluded. If glucocorticosteroids are used in the late stages of pregnancy, the newborn may experience adrenal insufficiency, which may require replacement therapy in the newborn. In newborns of mothers who received Deksametazon Accord at the end of pregnancy, low blood sugar may occur after birth.
Glucocorticosteroids, including dexamethasone, pass into breast milk. No harmful effects on the infant have been reported; however, if high doses are necessary, breastfeeding should be discontinued.

Driving and using machines

There is no evidence that Deksametazon Accord affects the ability to drive or operate machinery, or perform work in hazardous conditions.

Deksametazon Accord contains sodium

This medicine contains 1.4 mg of sodium (the main component of common salt/table salt) per 1 mL of solution.
This corresponds to 0.07% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Deksametazon Accord

This medicine will be administered by a nurse or doctor.

The doctor will determine the dose of the medicine suitable for the patient and the method and duration of treatment.
This medicine is a solution for injection/infusion administered intravenously (i.v.), intramuscularly (i.m.), subcutaneously (s.c.), or into tissues.
Dosage depends on the indication, severity of symptoms, individual patient response, and, in the case of joint injection, on the size of the joint.
Deksametazon Accord should be administered slowly (over 2-3 minutes) by intravenous injection. Deksametazon Accord may be administered into a muscle if intravenous administration is not possible and if circulatory function is not impaired. Deksametazon Accord may also be administered by injection or continuous infusion under the skin (subcutaneously).
Deksametazon Accord may also be administered by soft tissue injection or into a joint.
The duration of treatment is determined based on the underlying disease and its course. The doctor will determine the treatment schedule, which should be strictly followed. After achieving a satisfactory treatment result, the dose should be reduced to a maintenance dose or treatment should be discontinued. Abrupt discontinuation of treatment after approximately 10 days may cause acute adrenal insufficiency; therefore, if treatment is to be discontinued, the dose should be gradually reduced. In cases of adrenal insufficiency or liver cirrhosis, smaller doses may be sufficient or the dose may need to be reduced.

COVID-19 treatment:

Adult patients are recommended to receive 6 mg intravenously once a day for up to 10 days.

Use of a higher than recommended dose of Deksametazon Accord or omission of a dose

This medicine will be administered by a doctor or nurse, so it is unlikely that the patient will receive too much or too little of the medicine. In case of doubts, consult a doctor or nurse.
Generally, Deksametazon Accord is well-tolerated in high doses without complications, even during short-term use. No special precautions are necessary. If more severe or unusual side effects are observed, consult a doctor.
A missed dose can be taken later on the same day, and the next scheduled dose should be taken the next day as usual. If more than one dose is missed, the disease symptoms may recur or worsen. In such cases, consult a doctor, who will review and possibly adjust the treatment.

Discontinuation of Deksametazon Accord

Follow the doctor's instructions regarding dosage. Never stop taking Deksametazon Accord on your own, especially since long-term use of the medicine may lead to suppression of the body's own glucocorticosteroid production (adrenal insufficiency). Increased stress on the body without sufficient glucocorticosteroids could be life-threatening. If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Deksametazon Accord can cause side effects, although not everybody gets them.
During short-term treatment with dexamethasone, the risk of side effects is low.
The following side effects may occur:

• stomach or duodenal ulcers;
• reduced defense against infections;
• increased blood sugar levels (decreased glucose tolerance).

The following side effects may occur, which to a large extent depend on the dose and duration of treatment, and therefore their frequency is not known (frequency cannot be estimated from available data):

Infections and infestations:

Masking of infection symptoms, occurrence or exacerbation of viral, fungal, bacterial, parasitic, or opportunistic infections, activation of threadworm infestation.

Blood and lymphatic system disorders:

Changes in blood cell count (increased white blood cell count or all blood cell counts, decreased count of certain white blood cells).

Immune system disorders:

Hypersensitivity reactions (e.g., drug rash), severe anaphylactic reactions, such as arrhythmia, bronchospasm, high or low blood pressure, circulatory collapse, cardiac arrest, immunosuppression.

Endocrine disorders:

Cushing's syndrome (typical symptoms: moon face, central obesity, facial flushing), adrenal insufficiency or atrophy.

Metabolic and nutritional disorders:

Weight gain, increased blood sugar levels, diabetes, increased blood lipid levels (cholesterol and triglycerides), sodium retention with tissue edema (edema), potassium deficiency due to increased potassium excretion (may lead to arrhythmias), increased appetite.

Psychiatric disorders:

Depression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, mood changes, anxiety, sleep disturbances, suicidal tendencies.

Nervous system disorders:

Increased intracranial pressure, appearance of previously undiagnosed epilepsy symptoms, increased frequency of seizures in diagnosed epilepsy.

Eye disorders:

Increased intraocular pressure (glaucoma), cataract (lens opacity), worsening of corneal ulcers, increased frequency of or worsening of viral, bacterial, or fungal infections; worsening of bacterial corneal infections, ptosis (drooping eyelid), mydriasis (pupil dilation), conjunctival edema, corneal perforation (perforation of the white part of the eye), vision disturbances, loss of vision.
In rare cases, transient exophthalmos (bulging eyes) occurred.

Cardiac disorders:

Hypertrophic cardiomyopathy in preterm infants, which usually returns to normal after treatment is discontinued.

Vascular disorders:

Hypertension, increased risk of atherosclerosis and thrombosis, vasculitis (also as a withdrawal syndrome after long-term treatment), increased capillary fragility.

Gastrointestinal disorders:

Gastrointestinal ulcers, gastrointestinal bleeding, pancreatitis, abdominal discomfort.

Skin and subcutaneous tissue disorders:

Stretch marks, skin thinning ("parchment-like" skin), telangiectasia, bruising, petechiae, hirsutism, acne, facial skin inflammation, especially around the mouth, nose, and eyes, skin pigmentation changes.

Musculoskeletal and connective tissue disorders:

Muscle diseases, muscle weakness and atrophy, bone density loss (osteoporosis) dependent on dose and duration of treatment, and possibly even after short-term therapy, other forms of bone necrosis (avascular necrosis), tendon-related symptoms, tendonitis, tendon rupture, fat deposits in the spine (epidural lipomatosis), growth retardation in children. If the dose of the medicine is reduced too quickly after long-term treatment, complications such as withdrawal syndrome may occur, which may manifest as muscle and joint pain.

Reproductive system and breast disorders:

Disorders of sex hormone secretion (manifested as irregular menstrual cycles or amenorrhea, hirsutism in women, impotence).

General disorders and administration site conditions:

Delayed wound healing.

Local administration:

Possible occurrence of irritation and hypersensitivity reactions (burning sensation, persistent pain). In case of incorrect intra-articular administration (outside the joint cavity), atrophy (wasting) of skin and subcutaneous tissue at the injection site cannot be excluded.
If the patient experiences any of the following, they should immediately consult a doctor:

• gastrointestinal symptoms,
• back, shoulder, or hip pain,
• mood changes,
• significant fluctuations in blood sugar levels in diabetic patients.

It is very important not to stop using this medicine abruptly (even in case of side effects), unless the doctor advises otherwise (see sections 2 and 3).

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. 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
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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Deksametazon Accord

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C.
Store the vial in the outer packaging to protect it from light.
Do not use this medicine after the expiry date stated on the vial label and carton after: EXP. The expiry date refers to the last day of the month.
For single use only. Any unused solution should be discarded.
Do not use this medicine if visible particles are observed in the solution.
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 Deksametazon Accord contains

The active substance is dexamethasone phosphate.
Each 1 mL of solution for injection/infusion contains 4.0 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
Each 2 mL of solution for injection/infusion contains 8.0 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
Each 5 mL of solution for injection/infusion contains 20.0 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
Other ingredients are creatinine, disodium edetate, sodium citrate, sodium hydroxide (for pH adjustment), water for injections.

What Deksametazon Accord looks like and contents of the pack

Clear, colorless, and sterile solution in a glass vial.
1 mL: 2 mL glass vial of type I with a chlorobutyl rubber stopper and a blue aluminum flip-off seal.
2 mL: 2 mL glass vial of type I with a chlorobutyl rubber stopper and a light blue aluminum flip-off seal.
5 mL: 6 mL glass vial of type I with a chlorobutyl rubber stopper and a light blue aluminum flip-off seal.
Pack sizes:
1 x 1 vial
1 x 3 vials
1 x 5 vials
1 x 10 vials
1 x 20 vials
1 x 25 vials
1 x 50 vials
1 x 100 vials
1 x 150 vials
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

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

Date of last revision of the leaflet: August 2024