Dexamethasone Krka

Leaflet attached to the packaging: information for the user

Dexamethasone Krka, 4 mg/ml, solution for injection/infusion

Dexamethasone Krka, 8 mg/2 ml, solution for injection/infusion

dexamethasone phosphate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including any adverse reactions 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 Dexamethasone Krka and what is it used for
• 2. Important information before using Dexamethasone Krka
• 3. How to use Dexamethasone Krka
• 4. Possible side effects
• 5. How to store Dexamethasone Krka
• 6. Contents of the packaging and other information

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

Dexamethasone is a synthetic glucocorticosteroid(adrenal cortex hormone)
affecting metabolism, electrolyte balance, and tissue function.
Dexamethasone Krka is used inthe treatment of 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 abscesses, bacterial meningitis (e.g., tuberculosis, typhoid fever, brucellosis);
• shock after severe injuries, for the preventive treatment of shock lung;
• severe acute asthma attack;
• initial stage of treatment of widespread, severe skin diseases, such as erythroderma, bullous pemphigoid, 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;
• supportive treatment of malignant tumors;
• prevention and treatment of post-operative or chemotherapy-induced vomiting;
• Dexamethasone Krka is used 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.

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;
• infiltration (only if strictly indicated): non-bacterial tendon or bursa inflammation (bursa filled with fluid that forms under the skin, usually over the joints), periarticular disorders, tendon disorders;
• intraocular administration: subconjunctival injection in case of non-infectious inflammation of various parts of the eye (cornea and conjunctiva, scleritis, uveitis and ciliary body), inflammation of the middle part of the eye (chorioretinitis).

2. Important information before using Dexamethasone Krka

When not to use Dexamethasone Krka

• if the patient is allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has an infection, including those caused by fungi, unless anti-infective treatment is used.

In individual cases, during the use of Dexamethasone Krka, severe
hypersensitivity reactions (anaphylactic reactions) with circulatory collapse, cardiac arrest,
arrhythmia, shortness of breath (bronchospasm) and/or decreased or increased
blood pressure have been observed.
Intra-articular injection is contraindicated in:

• infections in or near the joint, requiring treatment,
• bacterial arthritis,
• joint instability requiring treatment,
• bleeding tendency (spontaneous or caused by anticoagulant medications),
• calcifications in the joint area,
• avascular necrosis of bone,
• tendon rupture,
• Charcot's joint.

It is not recommended to administer infiltration without additional causal treatment in case of infections at the injection site; similarly, the drug should not be administered subconjunctivally in case of bacterial, viral, or fungal eye diseases or corneal damage and ulcers.

Special caution is required when using Dexamethasone Krka in the following cases:

If during treatment with Dexamethasone Krka, special physical stress situations occur (accident, surgery, childbirth, etc.), it may be necessary to temporarily increase the dose.
Dexamethasone Krka may mask the symptoms of an existing or developing infection, making diagnosis difficult. Latent infections may recur.
In the circumstances listed below, treatment with Dexamethasone Krka 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),
• from about 8 weeks before and up to 2 weeks after vaccinations with live attenuated microorganisms (live vaccines),
• acute and chronic bacterial infections,
• fungal infections with internal organ involvement,
• certain parasitic diseases (amoeba or worm infestations). In case of infestation or suspected infestation with roundworms, Dexamethasone Krka may lead to activation and massive multiplication of these parasites,
• Guillain-Barré syndrome,
• lymph node disorders after BCG vaccination,
• if the patient has had tuberculosis in the past, the drug can only be used in combination with anti-tuberculosis agents.

During the use of Dexamethasone Krka, the course of the following diseases should be carefully monitored and appropriate treatment should be applied:

• gastric or duodenal ulcers,
• bone density loss (osteoporosis),
• difficult-to-treat hypertension,
• difficult-to-treat diabetes,
• mental disorders (also in the past), 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 ulcers; ophthalmological supervision and appropriate treatment are recommended.

Before taking Dexamethasone Krka, the patient should discuss with their doctor if they have or suspect a pheochromocytoma (adrenal gland tumor).
If the patient is being treated for COVID-19, they should not stop taking any other steroid medications unless their doctor advises them to do so.
Before starting to take Dexamethasone Krka, the patient should discuss it with their doctor, pharmacist, or nurse.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
Due to the risk of intestinal perforation, Dexamethasone Krka may only be used in emergencies 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 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, metabolism should be regularly monitored, and a greater need for diabetes medications (insulin, oral antidiabetic drugs) should be considered.
Due to the risk of worsening the disease, patients with very high blood pressure and/or severe heart failure should be under close observation.
During the use of high doses of the drug, 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 simultaneously with fluoroquinolones (a type of antibiotic) and Dexamethasone Krka.
During the treatment of a certain type of muscle paralysis (myasthenia), there may be an initial worsening of symptoms.
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, the immune response may be weakened, and thus the effectiveness of the vaccine.
Especially during long-term treatment with high doses of Dexamethasone Krka, attention should be paid to the intake of sufficient potassium (e.g., vegetables, bananas) and limitation of salt consumption. The doctor will monitor the potassium level in the blood.
In patients treated with Dexamethasone Krka, viral diseases (e.g., measles, chickenpox) may have a particularly severe course, especially in children with impaired immunity and individuals who have not had measles or chickenpox before. If these individuals come into contact with people with measles or chickenpox while taking Dexamethasone Krka, they should immediately consult a doctor, who may take preventive measures if necessary.
The patient should consult a doctor if they experience symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision disturbances, or loss of vision, and shortness of breath, if they have a hematological malignancy.
Due to the possibility of adverse reactions during too rapid administration of the drug, such as unpleasant tingling or paresthesia, intravenous injection should be performed slowly (over 2-3 minutes).
Dexamethasone Krka is intended for short-term use. In case of improper use of the drug for a long time, the patient should familiarize themselves with the additional warnings and precautions regarding long-term therapy with glucocorticosteroid-containing medications.
After local administration, the possibility of adverse reactions and interactions should be considered, as with systemic administration.
Intra-articular administration of Dexamethasone Krka increases the risk of joint infections. Prolonged and repeated use of glucocorticosteroids in stressed joints may lead to worsening of degenerative joint changes. One possible cause is overloading of the affected joint after pain or other symptoms have subsided.
When administering intra-articular injections, the doctor will exercise special caution to minimize the risk of bacterial infection. The patient should not overload the affected joints, even if they do not feel pain.
Taking this medication can cause a pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare adrenal gland tumor. The crisis may manifest with symptoms such as headaches, sweating, palpitations, and hypertension. If any of these symptoms occur, the patient should immediately contact their doctor.
Local administration in case of eye diseases:
The patient should consult a doctor if they experience swelling or accumulation of fatty tissue on the face and torso, as these are usually the first symptoms of a disease called Cushing's syndrome. After discontinuation of long-term and intensive treatment with Dexamethasone Krka, adrenal insufficiency may occur. The patient should consult a doctor before stopping the medication. The risk of Cushing's syndrome and/or adrenal insufficiency is particularly high in children and patients treated with ritonavir or cobicistat (HIV medications).

Elderly patients

Due to the increased risk of osteoporosis, the doctor will assess the benefit-risk ratio of using the drug in elderly patients.

Children and adolescents

Dexamethasone is not recommended for routine use in preterm infants with respiratory disorders.
If dexamethasone is administered to a preterm infant, it is necessary to monitor the heart's function and structure.
In children, this drug can only be used if necessary, due to the risk of growth retardation. During long-term treatment, the child's growth should be regularly monitored.

Effects of use for doping purposes

Taking Dexamethasone Krka may cause positive results in doping tests.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medication.

Pregnancy

Dexamethasone passes through the placenta. During pregnancy, especially in the first three months, the drug should only be used after careful assessment of the benefit-risk ratio. If the patient is pregnant or becomes pregnant, they should inform their doctor. In case of long-term use of glucocorticosteroids during pregnancy, it cannot be ruled out that fetal growth disorders may occur. In case of glucocorticosteroid use in late pregnancy, the newborn may experience adrenal insufficiency. This may require replacement therapy, which should be gradually discontinued.
In newborns of mothers who received dexamethasone at the end of pregnancy, low blood sugar levels may occur after birth.

Breastfeeding

Glucocorticosteroids, including dexamethasone, pass into breast milk.
No harmful effects on the infant have been reported so far. However, the need for treatment during breastfeeding should be carefully considered. If high doses are necessary due to the disease, breastfeeding should be discontinued, and the patient should immediately consult a doctor.
Before taking/using any medication, the patient should consult a doctor or pharmacist.

Driving and using machines

So far, there is no evidence that Dexamethasone Krka affects the ability to drive and use machines or perform work that requires balance.

Dexamethasone Krka and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

The patient should inform their doctor if they are taking any of the following medications, as they may affect the action of Dexamethasone Krka:

• Medications that accelerate its breakdown in the liver, such as certain sleeping pills (barbiturates), antiepileptic drugs (phenytoin, carbamazepine, primidone), and some anti-tuberculosis drugs (rifampicin), may weaken the effect of corticosteroids.
• Medications that slow down the metabolism of corticosteroids in the liver, such as certain antifungal drugs (ketoconazole, itraconazole), may enhance the effect of corticosteroids.
• Certain female sex hormones, e.g., contraceptives (pills): the effect of Dexamethasone Krka may be increased.
• Ephedrine (a component of, e.g., medications used to treat low blood pressure, chronic bronchitis, asthma attacks, nasal decongestants, and appetite suppressants): the effectiveness of Dexamethasone Krka may be reduced due to accelerated metabolism of glucocorticosteroids.

The patient should inform their doctor if they are taking ritonavir or cobicistat (HIV medications), as this may increase the amount of dexamethasone in the blood.

Effect of Dexamethasone Krka on the action of other medications

• Concomitant use with certain blood pressure-lowering medications (ACE inhibitors) may increase the risk of changes in blood counts.
• Dexamethasone Krka may enhance the effects of heart-strengthening medications (cardiac glycosides) by causing potassium deficiency.
• Dexamethasone Krka may enhance potassium loss caused by diuretics (saluretics) or laxatives.
• Dexamethasone Krka may weaken the effect of oral antidiabetic medications and insulin.
• Dexamethasone Krka may weaken or enhance the effect of blood-thinning medications (oral anticoagulants, coumarins). The doctor will decide whether a change in the dose of the anticoagulant is necessary.
• If Dexamethasone Krka is used concomitantly with anti-inflammatory and anti-rheumatic medications (salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs), the risk of stomach ulcers and gastrointestinal bleeding may increase.
• Dexamethasone Krka may prolong the action of certain muscle relaxants (non-depolarizing muscle relaxants).
• Dexamethasone Krka may enhance the effect of medications that increase intraocular pressure (atropine and other anticholinergic medications).
• Dexamethasone Krka may reduce the effectiveness of medications used to treat worm infestations (praziquantel).
• Concomitant use with medications used to treat malaria and rheumatic diseases (chloroquine, hydroxychloroquine, and mefloquine) may increase the risk of muscle or heart disease (myopathy and cardiomyopathy).
• Dexamethasone Krka may weaken the increase in thyroid-stimulating hormone (TSH) activity after administration of protirelin (TRH, a hormone produced by the hypothalamus).
• Concomitant use with immunosuppressive medications may increase the susceptibility to infections and worsen the course of existing infections that have not yet manifested.
• Cyclosporine (an immunosuppressive medication): Dexamethasone Krka may increase the blood level of cyclosporine 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.

Dexamethasone Krka contains sodium

Dexamethasone Krka, 4 mg/ml, solution for injection/infusion
The drug contains 3 mg of sodium (the main component of table salt) per ampoule. This corresponds to 0.15% of the maximum recommended daily sodium intake in the diet for adults.
Dexamethasone Krka, 8 mg/2 ml, solution for injection/infusion
The drug contains 6 mg of sodium (the main component of table salt) per ampoule. This corresponds to 0.3% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Dexamethasone Krka

Dexamethasone Krka should always be used as directed by a doctor. The doctor will decide how long the patient should use dexamethasone. The doctor will determine the dose of the drug suitable for the patient. The patient should follow the instructions, as otherwise, the effect of Dexamethasone Krka may not be correct. In case of doubts, the patient should consult a doctor or pharmacist.

Method of administration

This medication will be administered by medical personnel.

The medication will be administered intravenously, but it can also be administered intramuscularly, intra-articularly (directly into the joint), or as a soft tissue injection.

Dexamethasone Krka should be administered slowly (over 2-3 minutes) intravenously (into a vein). The drug can be administered intramuscularly (into a muscle) if there are difficulties with venous access, but blood circulation is normal.

Suitability for use

Only a clear solution should be used. The contents of the ampoule are intended for single use only. Any remaining solution after injection should be discarded.

If the doctor does not prescribe 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 to 10 mg (up to 80 mg) intravenously, then 16 to 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. Severe infectious diseases with symptoms similar to sepsis: 4 to 20 mg/day intravenously, for several days, only in combination with appropriate anti-infective therapy; in individual cases (e.g., typhoid fever) initially up to 200 mg intravenously, then gradually decreasing doses.
• Shock after severe injury: initial dose 40 to 100 mg (in children 40 mg) intravenously, repeated after 12 hours or 16 to 40 mg every 6 hours for 2-3 days.
• Severe acute asthma attack: Adults: 8 to 20 mg intravenously, administered as soon as possible, if necessary, the dose may be repeated depending on the individual patient's response and clinical needs. Children: 0.15 to 0.3 mg/kg body weight. If necessary, the dose may be repeated depending on the individual patient's response and clinical needs.
• Acute skin diseases: depending on the type and extent of the disease, daily doses of 8 to 40 mg intravenously, and in individual cases up to 100 mg. Then, treatment with tablets in gradually decreasing doses can be used.
• Systemic lupus erythematosus: 6 to 16 mg/day.
• Rheumatoid arthritis with severe, progressive course, e.g., rapidly progressive forms of the disease leading to joint damage and/or extra-articular tissue damage: 12 to 16 mg/day; in case of extra-articular tissue damage: 6 to 12 mg/day.
• Supportive treatment of malignant tumors: initially 8 to 16 mg/day; 4 to 12 mg/day in case of long-term therapy.
• Prevention and treatment of chemotherapy-induced vomiting: 8 to 20 mg intravenously before starting chemotherapy, and then, if necessary, 4 to 8 mg up to 1-2 times a day for 2-3 days (moderately emetogenic chemotherapy) or for 3-4 days (highly emetogenic chemotherapy).
• Prevention and treatment of post-operative vomiting: single dose 4 to 8 mg intravenously before surgery; children over 2 years: 0.15 mg/kg body weight (up to 8 mg).
• Treatment of COVID-19: the recommended dose for adult patients is 6 mg intravenously once a day, for a maximum of 10 days. Use in adolescents: in adolescents (aged 12 and older), the recommended dose is 6 mg intravenously once a day, for a maximum of 10 days.

Local administration:

Treatment by infiltration and local injection usually requires a dose of 4 to 8 mg; in case of injection into small joints or subconjunctival injection, a dose of 2 mg of dexamethasone sodium phosphate is sufficient.

Method of administration

If possible, the entire daily dose should be administered in the morning as a single dose.
However, in case of diseases that require treatment with high doses, dividing the daily dose into several doses may provide a better therapeutic effect.
If it is necessary to administer high doses of the drug at once, the use of a more potent/higher volume dexamethasone-containing drug should be considered.
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 the treatment will be discontinued.
Sudden discontinuation of treatment after about 10 days may cause acute adrenal insufficiency; therefore, if treatment is to be discontinued, the dose should be gradually reduced.
In case of hypothyroidism or liver cirrhosis, relatively small doses may be sufficient, or the dose may need to be reduced.

Use of a higher than recommended dose of Dexamethasone Krka

This medication will be administered by a doctor or nurse, so it is unlikely that the patient will receive too much or too little of the drug. In case of doubts, the patient should consult a doctor or nurse.

Missing a dose of Dexamethasone Krka

A missed dose can be taken on the same day. The next day, the dose is taken as usual. If the patient misses several doses, the disease may recur or worsen. In such cases, the patient should consult a 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 Krka

The patient should carefully follow the doctor's instructions regarding dosing. The patient should not suddenly stop taking the medication, as this can be dangerous. The doctor will inform the patient how the dose will be gradually reduced. The patient should never discontinue Dexamethasone Krka on their own, especially since long-term use of the drug can lead to suppression of the body's own glucocorticosteroid production. Increased stress on the body could be life-threatening. In case of any further doubts related to the use of this medication, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Dexamethasone Krka can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects during the use of Dexamethasone Krka, they should inform their doctor or pharmacist. The patient should never stop the treatment on their own.

Possible side effects

During short-term treatment with dexamethasone, the risk of side effects is low. The only exception is parenteral treatment with high doses, which may lead to changes in electrolytes, edema, possible increased blood pressure, cardiac arrest, arrhythmia, or seizures; clinical symptoms of infections can also be observed, even during short-term use.
Attention should be paid to the possibility of stomach and duodenal ulcers (often associated with stress), as corticosteroid treatment may mask their symptoms, as well as to the decrease in glucose tolerance.

If the patient experiences any of the following situations, they should immediately consult a doctor:

• Severe allergic reaction (rare side effect) - may cause sudden itchy rash (hives), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing) and a feeling of impending fainting.
• Discomfort in the stomach or intestines, back pain, pain in the shoulder and hip area, mental problems, significant changes in blood sugar levels (in diabetic patients).

During long-term treatment with this medication, side effects of varying severity can be expected to occur regularly (frequency cannot be determined based on available data).

Infections and infestations:

Masking of infection symptoms, occurrence or worsening of viral, fungal, bacterial, parasitic, or opportunistic infections, activation of worm infestations.

Blood and lymphatic system disorders:

Change in blood cell count (increase in white blood cell count or all types of blood cells, decrease in certain white blood cells).

Immune system disorders:

Hypersensitivity reactions (e.g., drug rash), severe anaphylactic reactions, such as arrhythmia, bronchospasm (smooth muscle contraction in the bronchi), too high or too low blood pressure, circulatory collapse, cardiac arrest, immune system weakness.

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 levels of fats in the blood (cholesterol and triglycerides), increased sodium levels with tissue edema (swelling), potassium deficiency due to increased 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, occurrence of symptoms of previously undiagnosed epilepsy, increased frequency of seizures in diagnosed epilepsy.

Eye disorders:

Increased intraocular pressure (glaucoma), cataract (lens clouding), worsening of corneal ulcers, increased frequency or worsening of infections caused by viruses, bacteria, or fungi; worsening of bacterial corneal inflammation, ptosis (drooping eyelid), mydriasis (pupil dilation), conjunctival edema, corneal perforation (perforation of the white part of the eye), vision disturbances, loss of vision. Rarely, transient exophthalmos (bulging eye), and after subconjunctival administration, also herpetic keratitis, corneal perforation in case of existing corneal inflammation, blurred vision.

Cardiac disorders:

Hypertrophic cardiomyopathy (thickening of the heart muscle) in preterm infants, which usually returns to normal after discontinuation of treatment.

Vascular disorders:

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

Gastrointestinal disorders:

Gastrointestinal ulcers, gastrointestinal bleeding, pancreatitis, discomfort in the stomach, hiccups.

Skin and subcutaneous tissue disorders:

Stretch marks on the skin, thinning of the skin ("parchment-like" skin), dilation of skin blood vessels, tendency to bruise, pinpoint or widespread bleeding of the skin, increased hair growth, acne, facial skin inflammation, especially around the mouth, nose, and eyes, changes in skin pigmentation.

Musculoskeletal and connective tissue disorders:

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

Reproductive system and breast disorders:

Disorders of sex hormone secretion (manifested as irregular or absent menstrual periods (amenorrhea), male-type hair growth in women (hirsutism), impotence).

General disorders and administration site conditions:

Slower wound healing.

Local administration:

Possible occurrence of irritation and hypersensitivity reactions (burning sensation, persistent pain), especially after intraocular administration. In case of improper intra-articular administration (outside the joint cavity), it cannot be ruled out that atrophy (wasting) of the skin and subcutaneous tissue at the injection site may occur.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the
Department of Drug Safety Monitoring
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, more information can be collected on the safety of the medication.

5. How to store Dexamethasone Krka

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Store in the original packaging to protect from light.
After dilution:
Physical and chemical stability of the drug has been demonstrated for 48 hours when stored at 15-25°C.
From a microbiological point of view, unless the dilution method excludes the risk of microbial contamination, the drug should be used immediately.
Otherwise, the user is responsible for the conditions and storage time of the drug.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Dexamethasone Krka contains

• The active substance of the drug is dexamethasone phosphate.
• 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).
• Other ingredients are: disodium edetate, creatinine, sodium citrate, anhydrous, sodium hydroxide (to adjust pH), water for injections. See section 2 "Dexamethasone Krka contains sodium".

What Dexamethasone Krka looks like and what the pack contains

The solution for injection/infusion is a clear, colorless to light yellow solution, practically free of particles.
Dexamethasone Krka is available in cardboard boxes containing 10 ampoules.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information about this medication, the patient should contact the local representative of the marketing authorization holder:
Krka Polska Sp. z o.o.
Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00
Date of last revision of the leaflet: 13.05.2022

Dexamethasone Krka, 8 mg/2 ml, solution for injection/infusion

dexamethasone phosphate
Each 1 ml ampoule contains 4 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
Each 2 ml ampoule contains 8 mg of dexamethasone phosphate (as dexamethasone sodium phosphate).
The solution for injection/infusion is a clear, colorless to light yellow solution, practically free from particulate matter.
The medicinal product Dexamethasone Krka, solution for injection/infusion is intended for intravenous, intramuscular, intra-articular, intralesional, and subconjunctival administration.
Administration method
The medicinal product Dexamethasone Krka should be administered in a slow (lasting 2-3 minutes) intravenous injection or infusion, but it can also be administered intramuscularly, in case of difficulties with venous access, but with normal blood circulation. The medicinal product Dexamethasone Krka can also be administered locally, as an intra-articular or subconjunctival injection. The duration of treatment depends on the indications.
If it is necessary to administer large doses at once, consideration should be given to using a medicinal product containing dexamethasone with a higher potency per unit volume.
In cases of hypothyroidism or liver cirrhosis, small doses may be sufficient or it may be necessary to reduce the dose.
Intra-articular injection should be treated as an open-joint procedure and performed only under aseptic conditions. A single intra-articular injection is usually sufficient to effectively alleviate symptoms. If a subsequent injection is necessary, it should not be administered earlier than 3-4 weeks later. The number of injections into one joint should be limited to 3-4 times. It is recommended to examine the joints medically, especially after repeated injections.
Local administration: the medicinal product Dexamethasone Krka is administered locally in the most painful areas or areas of tendon attachments. Note: do not inject into the tendon! It is necessary to avoid performing injections at short intervals. It is essential to maintain aseptic conditions.
Suitability for use
Only a clear solution can be used. The contents of the ampoule are intended for single use. The remaining solution after injection should be discarded.
Instructions for use and preparation of the medicinal product for use
The medicinal product Dexamethasone Krka, 4 mg/ml, solution for injection/infusion and Dexamethasone Krka, 8 mg/2 ml, solution for injection/infusion are best administered as a direct intravenous injection or injection into an infusion tube. The solution for injection/infusion is compatible with the following infusion solutions (each 250 ml and 500 ml) and is intended for use within 48 hours:

• isotonic sodium chloride solution
• Ringer's solution
• 5% glucose solution
• 10% glucose solution

Pharmaceutical incompatibilities
When used with other infusion solutions, the information provided by the supplier regarding the specific infusion solution, including compatibility, contraindications, adverse reactions, and interactions, should be taken into account.
Precautions during storage
Physical and chemical stability of the medicinal product has been demonstrated for 48 hours during storage at a temperature of 15-25°C.
From a microbiological point of view, the product should be used immediately, unless the dilution method excludes the risk of microbiological contamination.
Otherwise, the user is responsible for the conditions and storage time of the product.