Dexamethasone accord

Patient Information Leaflet

Dexamethasone Accord, 4 mg/mL, solution for injection/infusion
Dexamethasoni phosphas
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents

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

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

Dexamethasone sodium phosphate is a synthetic glucocorticoid (an adrenal cortex hormone)
affecting metabolism, electrolyte balance and tissue function.
Dexamethasone Accord is used in the treatment of diseases requiring glucocorticoid therapy. Depending on symptoms and severity, these include:

Systemic administration:

• Cerebral oedema caused by brain tumour, neurosurgical intervention, brain abscess, bacterial meningitis.
• Shock following severe trauma, for prophylactic treatment of post-traumatic acute respiratory distress syndrome (ARDS).
• Treatment of COVID-19 in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who have difficulty breathing and require oxygen therapy.
• Severe acute asthma attack.
• Initial stage of treatment of extensive, severe acute skin diseases such as erythroderma, pemphigus vulgaris, acute eczema.
• Treatment of systemic rheumatic diseases (rheumatic diseases which may affect internal organs), such as systemic lupus erythematosus.
• Severe progressive course of active rheumatoid arthritis, e.g. rapidly progressive forms leading to joint and/or extra-articular tissue damage.
• Severe infectious diseases with sepsis-like symptoms (e.g. tuberculosis, typhoid fever), only in conjunction with appropriate anti-infective therapy.
• Prevention and treatment of postoperative or chemotherapy-induced vomiting.
• Palliative treatment of malignant tumours, when dexamethasone may be administered by injection or infusion into a vein or subcutaneously to relieve certain symptoms, including pain, fatigue, weight loss and general malaise.
• Use in adolescents: In children and adolescents (aged 12 years and older with body weight at least 40 kg), a dose of 6 mg intravenously once daily for up to 10 days is recommended.

Local administration

• Intra-articular injection: persistent inflammation of one or more joints following systemic treatment of chronic inflammatory joint diseases, activated osteoarthritis (in progressive phase), acute forms of painful shoulder syndrome.
• Infiltrative administration (only when strictly indicated): non-bacterial tenosynovitis or bursitis, periarticular inflammation, tendon disorders.

2. Important information before using Dexamethasone Accord

When not to use Dexamethasone Accord

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

In isolated cases, severe hypersensitivity reactions (anaphylactic reactions) have been observed during the use of dexamethasone phosphate, including circulatory collapse, cardiac arrest, cardiac arrhythmia, dyspnoea (bronchospasm), and/or decreased or increased blood pressure.
If the patient has a systemic infection, including fungal infections (e.g. aspergillosis), which is not being treated with antibiotics or appropriate antimicrobial therapy.
Intra-articular injection is contraindicated in the following cases:

• Infections at or near the joint requiring treatment
• Bacterial arthritis
• Joint instability
• Tendency to bleeding (spontaneous or caused by anticoagulant drugs)
• Calcification in the joint area
• Avascular necrosis of bone
• Tendon rupture
• Charcot joint

Infiltrative administration should not be performed without additional causal treatment if there is an infection at the site of administration.
Do not discontinue any other steroid medications unless instructed by a physician.

Warnings and precautions

Before starting treatment with this medicine, discuss it with your doctor, pharmacist, or nurse.
If unusual physical stress situations occur during treatment with dexamethasone phosphate (e.g. accident, surgery, childbirth, etc.), a temporary increase in dose may be necessary.
Dexamethasone phosphate may mask symptoms of existing or developing infections, making diagnosis more difficult. Dormant infections may be reactivated.
Treatment with dexamethasone phosphate should only be considered when absolutely necessary in patients concurrently receiving drugs acting on pathogens causing the following diseases:

• Acute viral infections (hepatitis B virus, chickenpox, shingles, Herpes simplex infection, Herpes-induced keratitis)

• Chronic active hepatitis with positive HBsAg test (infectious hepatitis)

• From approximately 8 weeks before to 2 weeks after vaccination with live vaccines

• Acute and chronic bacterial infections

• Systemic fungal infections

• Certain parasitic diseases (infection with amoebae or worms). In case of infection or suspected infection with Strongyloides, Dexamethasone Accord may lead to activation and massive proliferation of these parasites

• Poliomyelitis

• Lymph node disorders after tuberculosis vaccination

• If the patient has had tuberculosis in the past

During treatment with dexamethasone phosphate, the following conditions should be carefully monitored and appropriate treatment initiated:

• Gastric or intestinal ulcers
• Bone mass loss (osteoporosis)
• Poorly controlled arterial hypertension
• Poorly controlled diabetes
• Psychiatric disorders (including history), including suicidal tendencies. In such cases, supervision by a neurologist or psychiatrist is recommended.
• Increased intraocular pressure (glaucoma with closed or open angle); ophthalmological supervision and appropriate treatment are recommended.
• Corneal damage and ulceration; ophthalmological supervision and appropriate treatment are recommended.

Use of this medicine may cause a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumour of the adrenal gland. A pheochromocytoma crisis may present with headache, excessive sweating, palpitations, and elevated blood pressure. If any of these symptoms occur, the patient should contact a doctor immediately.
Before starting treatment with Dexamethasone Accord, discuss with your doctor if there is suspicion or a confirmed diagnosis of pheochromocytoma (adrenal gland tumour).
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Due to the risk of intestinal perforation, Dexamethasone Accord should only be used in emergencies and under appropriate monitoring:

• In severe colitis (ulcerative colitis) with risk of perforation, with ulcerative or suppurative inflammation, which may occur without peritoneal irritation
• In diverticulitis (inflammation of intestinal diverticula)
• After certain intestinal surgeries (intestinal anastomosis), immediately post-operatively.

Signs of peritoneal irritation following gastrointestinal perforation may not appear in patients receiving high doses of glucocorticosteroids.
In patients with diabetes, blood glucose levels should be monitored regularly, and increased requirements for antidiabetic medications (insulin, oral antidiabetic drugs) should be considered.
Due to the risk of exacerbation of disease symptoms, patients with very high blood pressure and/or severe heart failure should remain under careful observation.
During treatment with high doses of the medicine, pulse rate may be lower than usual.
Severe anaphylactic reactions (immune system hypersensitivity) may occur.
The risk of tendon disorders, tendonitis, and tendon rupture increases in patients treated concomitantly with fluoroquinolones (a type of antibiotic) and Dexamethasone Accord.
During treatment of a specific type of muscle paralysis (myasthenia gravis), symptoms may initially worsen.
Vaccination with vaccines containing killed pathogenic microorganisms (inactivated vaccines) is generally possible. However, it should be noted that after administration of high doses of corticosteroids, the immune response and thus vaccine efficacy may be reduced.
Particularly during long-term treatment with high doses of Dexamethasone Accord, attention should be paid to consuming sufficient potassium (e.g. vegetables, bananas). Salt intake should be limited and blood potassium levels monitored.
Viral diseases (e.g. measles, chickenpox) may have a particularly severe course in patients treated with Dexamethasone Accord. This is especially true for immunocompromised individuals who have not previously had measles or chickenpox. If such individuals come into contact with persons suffering from measles or chickenpox while receiving Dexamethasone Accord, they should immediately consult a doctor, who may apply preventive measures if necessary.
Contact a doctor if the patient experiences muscle cramps, muscle weakness, confusion, visual disturbances or loss of vision, or shallow breathing, especially if the patient has a haematological malignancy. These may be symptoms of tumour lysis syndrome.
For intravenous administration, the injection should be given slowly over 2–3 minutes. Too rapid administration may cause transient and essentially harmless adverse effects such as unpleasant tingling or paresthesia, lasting up to 3 minutes.
Dexamethasone Accord is intended for short-term use. In case of inappropriate long-term use, additional warnings and precautions regarding long-term therapy with glucocorticosteroid-containing medicines should be observed.
After local administration, adverse effects and interactions similar to those of systemic administration should be considered.
Intra-articular administration of glucocorticosteroids increases the risk of joint infections. Prolonged and repeated use of glucocorticosteroids in weight-bearing joints may lead to worsening of degenerative joint changes due to overuse of the affected joint after pain or other symptoms have subsided.

Children and adolescents
Dexamethasone should not be routinely used in premature infants with breathing difficulties.
Dexamethasone Accord should be used in children only when necessary, due to the risk of growth retardation or growth suppression. During long-term treatment, a child's growth should be monitored regularly.
If dexamethasone is administered to a prematurely born infant, cardiac function and structure must be monitored.

Elderly patients
Due to the increased risk of adverse effects, e.g. osteoporosis, the physician will evaluate the benefit-risk ratio of using the medicine in elderly patients.

Dexamethasone Accord and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is particularly important for the following medicines, as they may affect the action of Dexamethasone Accord.

Medicines that may affect the action of Dexamethasone Accord:

• Medicines that accelerate its metabolism in the liver, such as certain sleeping pills (barbiturates), anticonvulsants (phenytoin, carbamazepine, primidone), and certain anti-tuberculosis drugs (rifampicin), may reduce the effect of corticosteroids.
• Medicines that slow corticosteroid metabolism in the liver, such as certain antifungal drugs (ketoconazole, itraconazole), may enhance the effect of corticosteroids.
• Certain female sex hormones, e.g. contraceptive drugs (oral contraceptives): the effect of Dexamethasone Accord may be increased.
• Ephedrine (a component, e.g. of drugs used to treat low blood pressure, chronic bronchitis, asthma attacks, nasal decongestants in colds, and appetite suppressants): the effectiveness of Dexamethasone Accord may be reduced due to accelerated metabolism of glucocorticosteroids.
• Medicines used to treat HIV: ritonavir, cobicistat may enhance the effect of Dexamethasone Accord, so the doctor may wish to monitor the patient's condition.

Effect of Dexamethasone Accord on other medicines:

• Dexamethasone Accord may enhance the effects of cardiac-stimulating drugs (cardiac glycosides) by causing potassium deficiency.
• Dexamethasone Accord may enhance potassium loss caused by diuretics (saluretics) or laxatives.
• Dexamethasone Accord may reduce the effectiveness of oral antidiabetic drugs and insulin in lowering blood glucose.
• Medicines used to prevent blood clotting (oral anticoagulants, coumarins). Their effect may be weakened or enhanced by Dexamethasone Accord. The doctor will decide whether a dose adjustment of the anticoagulant is necessary.
• If Dexamethasone Accord is used concomitantly with anti-inflammatory and antirheumatic drugs (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs), there may be an increased risk of gastric ulcers and gastrointestinal bleeding.
• Dexamethasone Accord may prolong the muscle-relaxing effect of certain drugs (non-depolarizing muscle relaxants).
• Dexamethasone Accord may enhance the effect of drugs that increase intraocular pressure (atropine and other anticholinergics).
• Dexamethasone Accord may reduce the effectiveness of drugs used to treat worm infestations (praziquantel).
• When used concomitantly with drugs used to treat malaria or rheumatic diseases (chloroquine, hydroxychloroquine, mefloquine), Dexamethasone Accord may increase the risk of muscle or heart disease (myopathy, cardiomyopathy).
• Dexamethasone Accord may reduce the increase in thyroid-stimulating hormone (TSH) activity after administration of protirelin (TRH, a hormone produced by the hypothalamus).
• Concomitant use of Dexamethasone Accord with immunosuppressive drugs may increase susceptibility to infections and worsen the course of existing but not yet apparent infections.
• Cyclosporine (an immunosuppressive drug) – concomitant use with Dexamethasone Accord may increase cyclosporine blood levels and thus the risk of seizures.
• Fluoroquinolones, a group of antibiotics: may increase the risk of tendon rupture.

Effect on diagnostic tests
Glucocorticosteroids may suppress skin reactions in allergy tests.
Due to interactions with these medicines, the doctor may need to adjust the dose of the medicine being administered to the patient.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a 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 during the first three months, the medicine should be used only after careful assessment of benefit versus risk.
With prolonged or repeated use of dexamethasone during pregnancy, growth disturbances in the unborn child cannot be excluded. In case of glucocorticosteroid use in late pregnancy, neonatal adrenal insufficiency may occur, which may require replacement therapy in the newborn. Newborns of mothers who received Dexamethasone Accord near the end of pregnancy may have low blood sugar levels after birth.
Glucocorticosteroids, including dexamethasone, pass into breast milk.
No harmful effects on the infant have been reported, but if high doses are required, breastfeeding should be discontinued.

Driving and operating machinery
There is currently no evidence that Dexamethasone Accord affects the ability to drive or operate machinery or perform work under hazardous conditions.

Dexamethasone Accord contains sodium
This medicine contains 1.4 mg of sodium (main component of table salt) in each mL of solution.
This corresponds to 0.07% of the maximum recommended daily sodium intake in the diet of adults.

3. How to use Dexamethasone Accord

This medicine will be administered by a nurse or doctor.
The dose appropriate for the individual patient, as well as the route and duration of administration, will be determined by the physician.
This medicine is an injection solution administered intravenously (i.v.), intramuscularly (i.m.), subcutaneously (s.c.) or into tissues.
The dosage depends on the indication, severity of symptoms, individual patient response, and, in the case of intra-articular injection, on the size of the joint.
Dexamethasone Accord should be administered slowly (over 2–3 minutes) by intravenous injection. Dexamethasone Accord may be administered intramuscularly if intravenous administration is not possible and if circulatory function is not impaired. Dexamethasone Accord may also be administered by subcutaneous injection or continuous subcutaneous infusion.
Dexamethasone Accord may also be administered intrathecally or injected directly into a joint.
The duration of treatment is determined based on the underlying disease and its course. The physician will establish a treatment schedule which must be strictly followed. After achieving a satisfactory treatment response, the dose should be reduced to a maintenance dose or treatment should be discontinued. Abrupt discontinuation of treatment after approximately 10 days may result in acute adrenal insufficiency; therefore, if treatment needs to be stopped, the dose should be tapered gradually. In cases of adrenal insufficiency or liver cirrhosis, relatively low doses may be sufficient, or dose reduction may be necessary.

Treatment of COVID-19:
Adult patients are recommended to receive 6 mg intravenously once daily for up to 10 days.

Use of a higher than recommended dose of Dexamethasone Accord or missing a dose of the medicine
Since this medicine will be administered by a doctor or nurse, it is unlikely that the patient will receive too high or too low a dose. In case of any doubts, consult your doctor or nurse.
Generally, Dexamethasone Accord is well tolerated even at high doses, especially during short-term use, without complications. No special precautions are required. If you experience more severe or unusual adverse effects, consult your doctor.
A missed dose may be administered later the same day, and the next prescribed dose should be taken the following day as usual. If more than one dose is missed, recurrence or worsening of disease symptoms may occur. In such a case, contact your doctor, who will assess the situation and, if necessary, adjust the treatment.

Stopping treatment with Dexamethasone Accord
You must strictly follow your doctor's instructions regarding dosage. Never discontinue treatment with Dexamethasone Accord on your own, especially since prolonged use of the medicine may lead to suppression of the body's own production of glucocorticosteroids (adrenal insufficiency). In such a case, significant physiological stress without sufficient glucocorticosteroid levels could pose a life-threatening risk. If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The risk of adverse reactions with short-term treatment with dexamethasone is low.
The following adverse reactions may occur:

• gastric or duodenal ulcers;
• reduced resistance to infections;
• increased blood glucose concentration (reduced glucose tolerance).

The following adverse reactions may occur, which largely depend on the dose and duration of treatment, and therefore their frequency is unknown (frequency cannot be estimated from the available data):
Infections and parasitic infections:
Masking of signs of infection, occurrence or worsening of viral, fungal, bacterial, parasitic or opportunistic infections, activation of tapeworm infection.
Blood and lymphatic system disorders:
Changes in blood cell count (increased white blood cell count or increased count of all types of blood cells, decreased count of certain white blood cells).
Immune system disorders:
Hypersensitivity reactions (e.g. drug rash), severe anaphylactic reactions such as cardiac arrhythmia, bronchospasm (spasm of smooth muscles of the bronchi), excessively 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 of the adrenal cortex.
Metabolism and nutrition disorders:
Weight gain, increased blood glucose concentration, diabetes, increased blood lipid concentration (cholesterol and triglycerides), increased sodium concentration with tissue swelling (oedema), potassium deficiency caused by increased potassium excretion (this may lead to cardiac arrhythmia), 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, occurrence of symptoms of previously unrecognized epilepsy, increased frequency of seizures in diagnosed epilepsy.
Eye disorders:
Increased intraocular pressure (glaucoma), lens opacity (cataract), worsening of corneal ulcers, increased frequency or severity of infections caused by viruses, bacteria or fungi; worsening of bacterial keratitis, ptosis (drooping eyelid), pupil dilation, conjunctival oedema, scleral perforation (of the white part of the eyeball), visual disturbances, loss of vision.
In rare cases, transient exophthalmos (protrusion of the eyes) has occurred.
Cardiac disorders:
Thickening of the heart muscle (hypertrophic cardiomyopathy) in premature infants, which usually resolves after discontinuation of treatment.
Vascular disorders:
High blood pressure, increased risk of atherosclerosis and thrombosis, vasculitis (also as withdrawal syndrome after long-term treatment), increased capillary fragility.
Gastrointestinal disorders:
Gastrointestinal ulcers, gastrointestinal bleeding, pancreatitis, gastric discomfort.
Skin and subcutaneous tissue disorders:
Skin striae, decreased skin thickness ("parchment skin"), skin telangiectasia, tendency to bruising, petechial or extensive skin haemorrhages, excessive body hair growth, acne, inflammatory skin changes on the face, particularly around the mouth, nose and eyes, skin pigmentation changes.
Musculoskeletal and connective tissue disorders:
Muscle disorders, muscle weakness and atrophy, loss of bone mass (osteoporosis) dose-dependent and possible even after short-term therapy, other forms of bone tissue necrosis (avascular necrosis), tendon-related symptoms, tendonitis, tendon rupture, deposition of fat deposits in the spine (epidural lipomatosis), growth suppression 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 (manifesting as irregular menstruation or absence of menstruation (amenorrhoea), male-pattern hair growth in women (hirsutism), impotence).
General disorders and administration site conditions:
Slower wound healing.
Local administration:
Possible occurrence of irritant and hypersensitivity reactions (burning sensation, persistent pain). In case of improper intra-articular administration (outside the joint cavity), atrophy (wasting) of the skin and subcutaneous tissue at the injection site cannot be excluded.
If any of the following situations occur in a patient, seek immediate medical advice:

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

It is very important to remember not to abruptly stop using this medicine (even if adverse reactions occur), unless otherwise advised by a doctor (see section 2 and 3).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Dexamethasone Accord

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Keep the vial in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the vial and carton after:
EXP. The expiry date refers to the last day of the stated month.
For single use only. Any unused portion of the solution must 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Deksametazon Accord contains
The active substance is dexamethasone phosphate.
Each 1 mL of injection/infusion solution contains 4.0 mg of dexamethasone phosphate
(in the form of dexamethasone sodium phosphate).
Each 2 mL of injection/infusion solution contains 8.0 mg of dexamethasone phosphate
(in the form of dexamethasone sodium phosphate).
Each 5 mL of injection/infusion solution contains 20.0 mg of dexamethasone phosphate
(in the form of dexamethasone sodium phosphate).
The 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
A clear, colourless, sterile solution in a vial made of colourless glass.
1 mL: A 2 mL vial made of colourless type I glass, with a chlorobutyl rubber stopper and an aluminium blue flip-off seal.
2 mL: A 2 mL vial made of colourless type I glass, with a chlorobutyl rubber stopper and an aluminium light blue flip-off seal.
5 mL: A 6 mL vial made of colourless type I glass, with a chlorobutyl rubber stopper and an aluminium light blue 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 Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 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 medicinal product is authorised in the European Economic Area countries under the following names: