Dexamethasone phosphate Sf

Leaflet attached to the packaging: patient information

Dexamethasone phosphate SF, 4 mg/ml, solution for injection

Dexamethasone phosphate

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 or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Dexamethasone phosphate SF is and what it is used for

Dexamethasone phosphate SF solution for injection contains dexamethasone phosphate. Dexamethasone is a synthetic glucocorticosteroid (a type of adrenal cortex hormone) that affects metabolism, electrolyte balance, and tissue function. Dexamethasone phosphate SF is used in clinical situations 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 abscesses, bacterial meningitis;
• Shock after severe injuries, for preventive treatment of shock lung;
• Severe acute asthma attack;
• Initial treatment of widespread, acute skin diseases with a severe course, such as erythroderma, pemphigus vulgaris, 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 tissue damage outside the joint;
• Severe infectious diseases with symptoms of intoxication (e.g., tuberculosis, typhoid, brucellosis) exclusively in combination with anti-infective treatment;
• Palliative treatment of malignant tumors;
• Prevention and treatment of vomiting after surgery or caused by the use of cytostatics;
• Dexamethasone phosphate SF is indicated for 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.

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 painful shoulder syndrome;
• Soft tissue injection (only if strictly indicated): non-bacterial tendonitis or bursitis (a fluid-filled sac that forms under the skin, usually over the joints), peritendinitis, tendon disorders.

2. Important information before using Dexamethasone phosphate SF

When not to use Dexamethasone phosphate SF:

• 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 SF, severe hypersensitivity reactions (anaphylactic reactions) with circulatory collapse, cardiac arrest, arrhythmia, dyspnea (bronchospasm), and/or decreased or increased blood pressure have been observed.Intra-articular injection is contraindicated in cases of infections in or near the joint, requiring treatment, septic arthritis, joint instability requiring treatment, tendency to bleed (spontaneous or caused by anticoagulant medications), calcifications in the joint area, avascular necrosis of bone, tendon rupture, Charcot's joint.

Do not administer soft tissue injections without additional causal treatment in case of infections at the injection site.

Warnings and precautions

Before starting treatment with Dexamethasone phosphate SF, discuss it with your doctor, pharmacist, or nurse. Do not stop taking any other steroid medications unless your doctor advises you to do so. General precautions for the use of steroid medications in certain diseases, masking of infections, concomitant medications, etc., in accordance with current recommendations. Dexamethasone should not be administered in COVID-19 patients who do not require oxygen or mechanical ventilation, due to the lack of therapeutic benefits and the risk of worsening the condition in this patient group. If special physical stress situations occur during treatment with Dexamethasone phosphate SF (accident, surgery, childbirth, etc.), it may be necessary to temporarily increase the dose. Dexamethasone phosphate SF may mask the symptoms of existing or developing infections, making diagnosis difficult. Latent infections may recur. In the circumstances listed below, treatment with Dexamethasone phosphate SF can only be initiated if the attending physician considers it necessary. If necessary, other medications with anti-microbial effects should also be taken:

• Acute viral infections (chickenpox, shingles, herpes virus infections, corneal herpes),
• Chronic active hepatitis with a positive HBsAg test result (infectious hepatitis),
• About 8 weeks before and up to 2 weeks after vaccinations with live vaccines,
• Acute and chronic bacterial infections,
• Fungal infections with internal organ involvement,
• Certain parasitic diseases (amoebic or worm infestations). In the case of infestation or suspected infestation with roundworms, Dexamethasone phosphate SF may lead to activation and massive multiplication of these parasites,
• Heine-Medin disease,
• Lymph node disorders after BCG vaccination,
• If the patient has had tuberculosis in the past, the medicine can only be used in combination with anti-tuberculosis medications.

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

• Stomach or intestinal ulcers,
• Bone density loss (osteoporosis),
• Difficult-to-treat high blood pressure,
• Difficult-to-treat diabetes,
• Mental 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 the onset of a crisis in the course of a pheochromocytoma (a rare adrenal gland tumor), which can lead to death. 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 Dexamethasone phosphate SF, 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, Dexamethasone phosphate SF may only be used if there are valid reasons and under appropriate control:

• In severe colitis (ulcerative colitis) with a risk of perforation, with ulcerative or abscessing inflammation, which may occur without peritoneal irritation,
• In diverticulitis (inflammation of the intestinal wall pouches),
• After certain intestinal surgeries (intestinal anastomosis), immediately after surgery.

Signs of peritoneal irritation after gastrointestinal perforation may not occur in patients receiving large doses of glucocorticosteroids. In diabetic patients, it is necessary to regularly monitor metabolism and consider the increased need for diabetes medications (insulin, oral anti-diabetic medications). Due to the risk of worsening the condition, patients with very high blood pressure and/or severe heart failure should be under close observation. During the use of large doses of the medicine, the pulse may be lower than usual. If dexamethasone is administered prematurely to a newborn, it is necessary to monitor the function and structure of the heart. There may be severe anaphylactic reactions (hypersensitivity of the immune system). The risk of tendon diseases, tendonitis, and tendon rupture increases in patients treated simultaneously with fluoroquinolones (a type of antibiotic) and Dexamethasone phosphate SF. During the treatment of a certain type of muscle paralysis (myasthenia), symptoms may initially worsen. Vaccination with vaccines containing killed microorganisms (inactivated vaccines) is generally possible. However, it should be noted that after the administration of large doses of corticosteroids, there may be a weakening of the immune response, and thus the effectiveness of the vaccine. Fluoroquinolones (a type of antibiotic) may increase the risk of tendon rupture. During long-term treatment with high doses of Dexamethasone phosphate SF, attention should be paid to the intake of sufficient potassium and the restriction of salt consumption. The doctor will monitor the potassium level in the blood. Patients with liver or kidney function disorders should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.

3. How to use Dexamethasone phosphate SF

This medicine should always be used as directed by your doctor. The doctor will decide how long you should take dexamethasone. The doctor will determine the dose of the medicine suitable for the individual patient. You should follow the instructions, as otherwise, the effect of Dexamethasone phosphate SF may not be correct. If you have any doubts, consult your doctor or pharmacist.

Method of administration

The medicine will be administered by intravenous injection, but it can also be administered by intramuscular injection, soft tissue injection, or intra-articular injection. Dexamethasone phosphate SF should be administered slowly (over 2-3 minutes) by intravenous injection (into a vein). The medicine can be administered intramuscularly (into a muscle) if there are difficulties with accessing a vein, but blood circulation is normal. Intra-articular injections are treated as open joint procedures and can only be performed under sterile conditions. A single intra-articular injection is usually sufficient to effectively alleviate symptoms. If another injection is necessary, it should not be administered for at least 3-4 weeks. The number of injections into one joint should be limited to 3-4 times. It is recommended to perform a medical examination of the joints, especially after repeated injections. Dexamethasone phosphate SF is administered by soft tissue injection in the areas with the most intense pain or areas of tendon attachments. Note: do not inject into the tendon! It is necessary to avoid injections at short intervals. Strict adherence to sterile conditions is required.

Suitability for use

Only a clear solution can be used. The contents of the ampoule are intended for single use only. Any remaining solution for injection should be discarded. Immediately before administration in an infusion, the contents of the ampoule are diluted in an isotonic sodium chloride solution or 5% glucose solution.

If the doctor does not recommend otherwise, the following doses should be used:

Systemic administration:

• Brain edema: initially, in acute conditions, depending on the cause and severity of the disease, the initial dose is 8-10 mg (up to 80 mg) intravenously, then 16-24 mg (up to 48 mg) per day, divided into 3-4 (up to 6) single doses for 4-8 days.
• Brain edema caused by bacterial meningitis: 0.15 mg/kg body weight every 6 hours, for 4 days. Children: 0.4 mg/kg body weight every 12 hours, for 2 days, starting before the administration of the first dose of antibiotics.
• Shock after severe injury: initial dose of 40-100 mg (in children 40 mg) intravenously, repeated after 12 hours or 16-40 mg every 6 hours for 2-3 days.
• Severe acute asthma attack: Adults: 8-20 mg intravenously, administered as quickly as possible. If necessary, repeat injections with a dose of 8 mg every 4 hours. Children: 0.15-0.3 mg/kg body weight or dexamethasone orally or initially 1.2 mg/kg body weight as a bolus, then 0.3 mg/kg body weight every 4-6 hours. Additionally, aminophylline and secretolytic medications can be administered.
• Acute skin diseases: depending on the type and extent of the disease, daily doses of 8-40 mg intravenously, and in severe cases up to 100 mg. Then, treatment with tablets in gradually decreasing doses can be used.
• Systemic lupus erythematosus: 6-16 mg.
• Rheumatoid arthritis with a severe, progressive course, e.g., rapidly progressive forms of the disease leading to joint damage: 12-16 mg; in cases of tissue damage outside the joint: 6-12 mg.
• Severe infectious diseases with symptoms of intoxication: 4-20 mg/day intravenously, for several days, exclusively in combination with appropriate anti-infective therapy; in individual cases (e.g., typhoid), initially up to 200 mg intravenously, then gradually decreasing doses.
• Palliative treatment of malignant tumors: initially 8-16 mg/day; 4-12 mg/day in the case of long-term therapy.
• Prevention and treatment of vomiting caused by the use of cytostatics as part of anti-emetic therapy: 10-20 mg intravenously before the start of chemotherapy, and then, if necessary, 4-8 mg 2-3 times a day for 1-3 days (moderately emetogenic chemotherapy) or for 6 days (highly emetogenic chemotherapy).
• Prevention and treatment of postoperative vomiting: single dose of 4-8 mg intravenously before surgery; children over 2 years: 0.15-0.5 mg/kg body weight (up to 16 mg).
• Treatment of COVID-19: adults are recommended to receive 6 mg intravenously once a day for up to 10 days. Use in adolescentsChildren and adolescents (aged 12 and older) are recommended to receive 6 mg intravenously once a day for up to 10 days.

Local administration:

Treatment with soft tissue injection and local injection usually requires a dose of 4-8 mg; in the case of injection into small joints, a dose of 2 mg of dexamethasone phosphate is sufficient.

Method of administration

The duration of treatment depends on the type of disease and its course. The doctor will determine the treatment plan, which should be strictly followed. As soon as a satisfactory treatment result is achieved, the dose will be reduced to a maintenance dose or treatment will be discontinued. Abrupt discontinuation of treatment after about 10 days may cause acute adrenal insufficiency, so if treatment is to be discontinued, the dose should be gradually reduced. In cases of hypothyroidism or liver cirrhosis, smaller doses may be sufficient or the dose may need to be reduced.

Use of a higher than recommended dose of Dexamethasone phosphate SF

Dexamethasone phosphate SF is generally well-tolerated even when used in large quantities for a short period. No special precautions are required. If the patient notices the occurrence of intensified or atypical side effects, they should consult their doctor.

Missing a dose of Dexamethasone phosphate SF

A missed dose can be taken on the same day. The next day, the dose is taken as usual. If several doses are missed, the disease symptoms may recur or worsen. In such cases, the patient should consult their doctor, who will check and possibly correct the treatment. A double dose should not be taken to make up for a missed dose.

Discontinuation of Dexamethasone phosphate SF

It is necessary to strictly follow the doctor's instructions regarding dosing. Under no circumstances should the patient stop taking Dexamethasone phosphate SF on their own, especially since long-term use of the medicine can lead to suppression of the body's own glucocorticosteroid production. Severe stress for the body could be life-threatening. In case of any further doubts related to the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dexamethasone phosphate SF can cause side effects, although not everybody gets them. During short-term treatment with dexamethasone, the risk of side effects is low. However, short-term treatment with high doses requires monitoring of electrolyte changes, edema, possible increased blood pressure, heart failure, arrhythmias, or seizures, as well as expected clinical symptoms of infection. Monitoring for decreased glucose tolerance is also required, as well as the occurrence of stomach and intestinal ulcers (often associated with stress), which may be less pronounced due to corticosteroid treatment. In very rare cases, Dexamethasone phosphate SF may cause allergic reactions, including anaphylactic shock. However, during long-term use, especially with high doses, side effects of varying severity can be expected. Infections and infestationsMasking of infections, occurrence or worsening of viral, fungal, and bacterial infections, as well as parasitic infections and those caused by opportunistic pathogens, stimulation of intestinal roundworm infection. Blood and lymphatic system disordersChanges in blood morphology (increased white blood cell count or all blood cells, decreased count of certain white blood cells). Immune system disordersHypersensitivity reactions (e.g., drug rash), severe anaphylactic reactions, such as arrhythmias, bronchospasm, excessively high or low blood pressure, circulatory collapse, cardiac arrest, weakening of the immune system. Endocrine disordersDevelopment of Cushing's syndrome (typical symptoms include moon face, central obesity, and facial flushing), decreased adrenal cortex function. Metabolic and nutritional disordersWeight gain, increased blood glucose levels, diabetes, increased blood lipid levels (cholesterol and triglycerides), increased sodium levels with tissue edema, potassium deficiency due to increased potassium excretion (may lead to arrhythmias), increased appetite. Psychiatric disordersDepression, irritability, euphoria, increased drive, psychosis, mania, hallucinations, mood changes, feeling of anxiety (anxiety), sleep disturbances, suicidal thoughts (suicide risk). Nervous system disordersIncreased intracranial pressure, occurrence of previously unrecognized epilepsy symptoms, increased frequency of seizures in patients with recognized epilepsy. Eye disordersIncreased intraocular pressure (glaucoma), cataracts, worsening of corneal ulcers, occurrence or worsening of viral, fungal, and bacterial eye infections, worsening of bacterial corneal ulcers, ptosis, mydriasis, conjunctival edema, corneal perforation, vision disturbances, loss of vision; in rare cases, reversible exophthalmos (bulging of the eyeball), blurred vision. Cardiac disordersHypertrophic cardiomyopathy in premature infants, which usually returns to normal after discontinuation of treatment (frequency unknown). Vascular disordersHypertension, increased risk of atherosclerosis and thrombosis, vasculitis (also as a withdrawal syndrome after long-term treatment), increased capillary fragility. Respiratory, thoracic, and mediastinal disordersHiccup. Gastrointestinal disordersStomach and intestinal ulcers, gastrointestinal bleeding, pancreatitis, abdominal discomfort. Skin and subcutaneous tissue disordersStretch marks, skin thinning ("parchment-like skin"), telangiectasia, tendency to bruise, very small or superficial bleeding, hirsutism, acne, facial skin inflammation, especially around the mouth, nose, and eyes, skin pigmentation changes. Musculoskeletal and connective tissue disordersMuscle disorders, muscle weakness, muscle atrophy, and osteoporosis, which depend on the dose and are also possible during short-term use; other forms of bone degeneration (bone necrosis), tendon disorders, tendonitis, tendon rupture, fat accumulation in the spine (epidural lipomatosis), growth retardation in children. Note: Disorders such as withdrawal syndrome, manifested by muscle pain and joint pain, may occur if the dose is reduced too quickly after long-term treatment. Reproductive system and breast disordersHormonal disorders leading to irregular menstrual bleeding or amenorrhea, hirsutism in women, impotence. General disorders and administration site conditionsDelayed wound healing. Local administration: Local irritation and intolerance symptoms (feeling of heat, prolonged pain) may occur. It is not possible to exclude the occurrence of skin and subcutaneous tissue atrophy at the injection site if corticosteroids are not injected precisely into the joint cavity.

Procedure

If any of the side effects listed or not listed in the leaflet occur, consult your doctor or pharmacist. Do not stop treatment without consulting your doctor. If gastrointestinal or joint disorders, back or shoulder pain, or psychiatric disorders occur, or if there are noticeable changes in blood glucose levels (in diabetic patients) or any other disorders, immediately contact your doctor.

Reporting side effects

If you experience any side effects, 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 Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +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 Dexamethasone phosphate SF

Keep the medicine out of the sight and reach of children. Do not store above 25°C. Do not store in the refrigerator or freeze. Store in the outer packaging to protect from light. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. 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. Contents of the packaging and other information

What Dexamethasone phosphate SF contains

• The active substance of the medicine is dexamethasone phosphate (in the form of dexamethasone sodium phosphate). 1 ml of the solution contains 4 mg of dexamethasone phosphate.
• The other ingredients are disodium edetate, propylene glycol, sodium chloride, sodium hydroxide, water for injections.

What Dexamethasone phosphate SF looks like and contents of the packaging

Dexamethasone phosphate SF is available in colorless ampoules containing 1 ml or 2 ml of a clear, colorless or almost colorless solution for injection in a cardboard box. Packaging sizes: 1, 5, or 10 ampoules of 1 ml solution. 1 or 10 ampoules of 2 ml solution. Not all packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o. ul. Dolna 21 05-092 Łomianki tel. +48 22 350 66 69

Manufacturer

mibe GmbH Arzneimittel Münchener Straße 15 06796 Brehna Germany SUN-FARM Sp. z o.o. ul. Dolna 21 05-092 Łomianki

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Each 1 ml ampoule contains 4 mg of dexamethasone phosphate (in the form of dexamethasone sodium phosphate). Each 2 ml ampoule contains 8 mg of dexamethasone phosphate (in the form of dexamethasone sodium phosphate).

Method of administration:

Dexamethasone phosphate SF should be administered in a slow (lasting 2-3 minutes) intravenous injection or infusion, but it can also be administered intramuscularly if there are difficulties with accessing a vein, but blood circulation is normal. Dexamethasone phosphate SF can also be administered by soft tissue injection or intra-articular injection. The duration of treatment depends on the indications. In cases of hypothyroidism or liver cirrhosis, smaller doses may be sufficient or the dose may need to be reduced. Intra-articular injection should be treated as an open joint procedure and performed under sterile conditions. A single intra-articular injection is usually sufficient to effectively alleviate symptoms. If another injection is necessary, it should not be administered for at least 3-4 weeks. The number of injections into one joint should be limited to 3-4 times. It is recommended to perform a medical examination of the joints, especially after repeated injections. Soft tissue injection: Dexamethasone phosphate SF is administered by soft tissue injection in the areas with the most intense pain or areas of tendon attachments. Note: do not inject into the tendon! It is necessary to avoid injections at short intervals. Strict adherence to sterile conditions is required.

Instructions for use

Only a clear solution can be used. The contents of the ampoule are intended for single use only. Any remaining solution for injection should be discarded. Immediately before administration in an infusion, the contents of the ampoule are diluted in an isotonic sodium chloride solution or 5% glucose solution.

Storage conditions:

See section 5 "How to store Dexamethasone phosphate SF". After opening: use immediately. After dilution in infusion fluids, chemical and physical stability has been demonstrated for 24 hours at 25°C. Do not store in the refrigerator. For microbiological reasons, the product should be used immediately, unless the opening/dilution method prevents the possibility of microbial contamination. If the product is not used immediately, the user is responsible for the storage time and conditions.