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What Dexamethasone is and what it is used for
Dexamethasone is a synthetic glucocorticoid. Glucocorticoids are hormones released from the adrenal cortex. The drug has anti-inflammatory, analgesic and anti-allergic effects and suppresses the immune system.
Dexamethasone is recommended for the treatment of rheumatic and autoimmune diseases (eg systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, polyarteritis nodosa), respiratory tract diseases (e.g. bronchial asthma, croup), skin (eg erythroderma, pemphigus vulgaris) tuberculous meningitis - only in combination with anti-infectious therapy, blood disorders (eg idiopathic thrombocytopenic purpura in adults), cerebral edema, symptomatic multiple myeloma, acute lymphoblast and leukemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other drugs, palliative treatment of malignant diseases, the prevention and treatment of nausea and vomiting caused by chemotherapy and prevention and treatment of vomiting after surgery, in the anti-emetic therapy.
2. What you need to know before you take Dexamethasone
Do not take Dexamethasone
if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6)
if you have an infection that affects the whole body (unless you are treated),
if you have stomach ulcer or duodenal ulcer,
if you are going to be vaccinated with live vaccines.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dexamethasone
if you have ever had severe depression or manic depression (bipolar disorder). This also includes a history of depression before or during administration of steroid medications such as dexamethasone.
if any of your close relatives had these diseases.
During the intake of steroids such as Dexamethasone Krka, mental health problems may occur. These violations can be serious. They usually start within a few days or weeks of treatment. Their appearance is more likely at high doses. Most of these problems resolve if the dose is reduced or the treatment is discontinued. However, if you experience such problems, you may need treatment.
Talk to your doctor if you (or someone taking this medicine) have any signs of mental health problems. This is especially important if you are depressed or have thoughts of suicide. In a few cases, mental problems have occurred with decreasing or discontinuing doses.
Talk to your doctor before taking this medicine:
if you have kidney or liver problems (liver cirrhosis or chronic hepatic failure),
if you have a tumor of the adrenal gland (pheochromocytoma)
if you have high blood pressure, heart disease, or have recently had a heart attack (heart muscle rupture has been reported) if you have diabetes or a family history of diabetes,
if you have osteoporosis (thinning of the bones), especially if you are a woman who is in menopause,
if you have experienced muscle weakness with this or other steroids in the past,
if you have glaucoma (elevated intraocular pressure) or a family history of glaucoma, a curtain (lens haze in the eye leading to decreased vision),
if you have myasthenia gravis (a disease that causes muscle weakness),
if you have bowel disorders or a stomach (peptic) ulcer,
if you have mental problems or have had a mental illness that is getting worse with this kind of medication,
if you have epilepsy (a condition where you have recurring seizures or seizures) if you have a migraine,
if you have a decreased thyroid function, if you have a parasitic infection,
if you have tuberculosis, septicemia or fungal infection of the eye if you have cerebral malaria,
if you have herpes (labia) or genitalia (genital), or eye (ocular herpes simplex) due to a possible cornea breakdown), if you have asthma,
if you are being treated to block blood vessels from blood clots (thromboembolism),
if you have corneal lesions or injuries.
Treatment with corticosteroids may reduce the body's ability to fight the infection. This can sometimes cause infections caused by micro-organisms that rarely cause infection under normal circumstances (so-called opportunistic infections). If you get an infection of any kind during treatment with this medicine, contact your doctor immediately. This is especially important if you notice signs of pneumonia: cough, fever, shortness of breath and chest pain. You may also feel confused, especially if you are elderly. You should also tell your doctor if you have had tuberculosis or if you have stayed in areas where roundworm infections (common nematodes) are common.
While taking this medicine, it is important to avoid contact with patients with chickenpox
If you have a suppressive test (a test to test the amount of hormone in your body), a skin allergy test, or a bacterial infection test, you should tell the person who is taking the test that you are taking dexamethasone as this may affect the results.
Your doctor may reduce the amount of salt in the diet and prescribe potassium supplements while taking this medicine.
If you are elderly, some of the side effects of this medicine may be more serious, especially bone thinning (osteoporosis), high blood pressure, low potassium levels, diabetes, susceptibility to infections and skin thinning. Your doctor will monitor you more closely.
If this medicine is taken by a child, it is important that the doctor monitors its growth and development at frequent intervals. Dexamethasone should not be routinely used in premature neonates with respiratory problems.
Other medicines and Dexamethasone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
Anti-coagulant drugs that dilute the blood (eg warfarin)
Acetylsalicylic acid or other similar drugs (non-steroidal
anti-inflammatory agents), for example, indomethacin
Medicines used to treat diabetes
Medicines used to treat high blood pressure
Medicines used to treat heart disease
Diuretics (drainage tablets)
Amphotericin B for injections
Phenytoin, carbamazepine, primidone (medicines for epilepsy)
Rifabutin, rifampicin, isoniazid (antibiotics used to treat CYP3A4)
Antacids - especially those containing magnesium trisilicate Barbiturates (medicines used to help sleep and reduce anxiety)
(Used for glaucoma and epilepsy) Hydrocortisone, cortisone and other corticosteroids Ketoconazole, narraconazole (for fungal infections) Ritonavir (for H1V) Aminoglutethimide (anticancer treatment) Carbenoxolone (used to treat stomach ulcers)
Antibiotics, including erythromycin, fluoroquinolones
Medicines that support muscle movement in myasthenia gravis (eg neostigmine)
Cholestyramine (for high cholesterol levels) Estrogenic hormones including birth control pills Tetracosactide used in adrenal function study Sultipride used to relieve emotions
Ciclosporin used to prevent post-transplant rejection Thalidomide used for, for example, multiple myeloma Praziquantel prescribed for certain worm infections Vaccination with live vaccines
Chloroquine, Hydroxychloroquine and Mefloquine (for malaria)
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You may be at an increased risk of serious side effects if you are taking dexamethasone with these medicines:
Some medicines may increase the effect of Dexamethasone and your doctor may want to monitor you closely if you are taking such medicines (including some medicines for HIV: ritonavir, cubiclistat).
Acetylsalicylic acid or other similar drugs (non-steroidal anti-inflammatory drugs), for example, indomethacin Medicines used to treat diabetes Drugs used to treat heart disease Diuretics (drainable tablets) Amphotericin B for injection Acetazolamide (used for glaucoma and epilepsy) Tetracosactide used in adrenal function test Carbenoxolone (used to treat stomach ulcers) Chloroquine, Hydroxychloroquine and Mefloquine (for malaria) Medicines used to treat high blood pressure pressure Thalidomide used for example in multiple myeloma Vaccination with live vaccines
Medicines that support muscle movement in myasthenia gravis (eg neostigmine)
Antibiotics, including fluoroquinolones
You should read the leaflets of all medicines that should be taken in combination with Dexamethasone Krka for information on these medicines before starting treatment with Dexamethasone Krka. When using thalidomide, lenalidomide or pamalidomide, special caution is required for pregnancy testing and prevention.
Dexamethasone with food, beverages and alcohol
Dexamethasone should be taken during or after a meal to minimize irritation of the gastrointestinal tract. Beverages containing alcohol or caffeine should be avoided. It is often recommended to eat small portions and possibly take anti-acid medicines at the discretion of your doctor.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Dexamethasone Krka should be prescribed during pregnancy and especially during the first trimester of pregnancy only if the benefit outweighs the risk
Dexamethasone contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Dexamethasone
tor has told you. If you are not sure, ask your doctor or pharmacist.
Dexamethasone is in the form of tablets of 4 mg, 8 mg, 20 mg and 40 mg. The tablet can be divided into two equal halves in order to provide additional concentrations of 2 mg and 10 mg and to facilitate swallowing.
Dexamethasone is administered in usual doses of 0.5 mg to 10 mg daily, depending on the disease to be treated. In more severe disease states, doses above 10 mg per day may be required. The dose should be based on the individual response of the patient and the severity of the disease. To minimize side effects, the lowest effective dose should be used.
Unless otherwise stated, the following dosing recommendations are applied: The following dosage recommendations are given for guidance only. Initial and daily doses should always be determined based on the patient's individual response and the severity of the disease.
- Brain edema: Initial dose and duration of treatment, depending on cause and severity - 6-16 mg (up to 24 mg) daily, orally divided into 3-4 divided doses.
- Asthma: Adults: 16 mg daily for two days. Children: 0.6 mg / kg body weight for one or two days.
- Krupp: Children: 0.15 mg / kg - 0.6 mg / kg in single dose.
- Acute skin diseases: Depending on the nature and extent of the disease, daily doses of 8-40 mg, in some cases up to 100 mg, which should be subsequently reduced according to the clinical need.
- Active phase of rheumatic systemic diseases: systemic lupus erythematosus - 6 - 16 mg daily.
- Active rheumatoid arthritis with severe progressive stroke: fast-acting destructive forms - 12-16 mg daily; with extraordinary events - 6-12 mg daily.
- Idiopathic thrombocytopenic purpura: 40 mg daily for 4 days in cycles.
- Tuberculosis meningitis: Patients with grade II or III disease are treated intravenously for four weeks (0.4 mg per kilogram per day in Week 1, 0.3 mg per kilogram per day in Week 2, 0.2 mg per kg per day in Week 3 and 0.1 mg per kilogram per day in Week 4) and then orally for four weeks beginning with a total dose of 4 mg per day reduced by 1 mg per week . Patients with grade I of the disease were treated intravenously for two weeks (0.3 mg per kilogram per day in Week 1 and 0.2 mg per kilogram per day in Week 2) and then orally for four weeks (0.1 mg per kilogram per day in Week 3, then with a total dose of 3 mg per day that is reduced by 1 mg every week).
- Palliative treatment of malignancies: Starting dose and duration of treatment, depending on cause and severity - 3-20 mg daily. Very high doses up to 96 mg can also be used for palliative care. For optimal dosing and reducing the number of tablets, a combination of lower dose (4 and 8 mg) and higher dose (20 mg or 40 mg) concentrations can be used.
- Prevention and treatment of cytostatic-induced emesis, emetogenic chemotherapy, within anti-emetic treatment: 8-20 mg dexamethasone prior to chemotherapy, then 4-16 mg daily on Day 2 and Day 3. Prophylaxis and treatment of post-operative vomiting , within the framework of anti-emetic treatment: a single dose of 8 mg prior to surgery.
- Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma, in combination with other medicinal products: the usual dose is 40 mg or 20 mg once a day.
The dose and frequency of administration vary depending on the treatment protocol and concomitant treatment (s). The use of dexamethasone should follow the directions for use of dexamethasone when described in the Summary of Product Characteristics of the concomitant treatment (s). Otherwise, local or international medical protocols and guidelines should be followed. Prescribers should carefully assess the dose of dexamethasone to take into account the condition and the status of the patient's disease.
In the long-term treatment of a number of conditions, after initial therapy, glucocorticoid therapy should be switched from dexamethasone to prednisone / prednisolone after reduction in the suppression of adrenal cortex function.
Use in children
If this medicine is taken by a child, it is important that the doctor monitors its growth and development at frequent intervals.
If you take more Dexamethasone Krka than you should
If you take too much of the medicine, contact a doctor or hospital immediately.
Weight gain, loss of the balance between protein and calcium, increased appetite, imbalance of salts, water retention in the body, potassium loss, which can cause heart rhythm disturbances, increased need for drugs for diabetes, display of hidden diabetes , high levels of cholesterol and triglycerides in the blood (hypercholesterolemia and hypertriglyceridemia).
Severe mood changes, worsening of schizophrenia (mental disorder), depression, insomnia.
Severely unusual headache with visual disturbances associated with discontinuation
treatment, seizures and worsening of epilepsy, dizziness.
Increased eye pressure, swelling of the eye, thinning of the eye membranes,
increased viral, fungal and bacterial eye infections, worsening symptoms associated with corneal ulceration, worsening of existing eye infections, protrusion of the eyes, cataracts, visual disturbances, loss of vision, blurred vision.
Congestive heart failure in predisposed people, rupture of the heart muscle after a recent heart attack, cardiac decompensation.
High blood pressure, blood clots: the formation of blood clots that can block the blood vessels, for example in the legs or lungs (thromboembolic complications).
Nausea, vomiting, abdominal discomfort and abdominal swelling, inflammation and ulcers in the esophagus, peptic ulcers, which can be opened and bleeding, inflammation of the pancreas (which may manifest as back pain and abdomen), flatulence, oesophageal candidiasis .
Tapered delicate skin, abnormal scars in the skin, bruising, redness and inflammation of the skin, stretch marks, visible dilated capillaries, acne, increased sweating, skin rash, swelling, thinning hair, abnormal fat deposits, excessive hair growth, inhibition of water in the body, pigmentary disorders, weakened capillaries that can easily burst, manifesting as bleeding under the skin (increased capillary fragility), irritation of the skin around the mouth (perioral dermatitis).
Thinning of the bones with a higher risk of fractures (osteoporosis), bone necrosis, tendinitis, torn tendons, muscle loss, myopathy, muscle weakness, early cessation of bone growth (premature closure of the epiphysis). Changes in the number and movement of sperm, impotence. Impaired response to vaccinations and skin tests, slow healing of the wounds, discomfort, malaise.
Possible withdrawal symptoms include fever, muscle and joint pain, inflammation of the lining of the nose (rhinitis), weight loss, pruritus and painful nodes on the skin and eye inflammation (conjunctivitis).
How to Store Dexamethasone
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions. Store in the original package in order to protect from light and moisture.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Dexamethasone contains
The active substance is dexamethasone.
Dexamethasone 4 mg tablets
Each tablet contains 4 mg of dexamethasone.
Dexamethasone 8 mg tablets
Each tablet contains 8 mg of dexamethasone.
The other ingredients are lactose monohydrate, pregelatinized maize starch, colloidal anhydrous silica and magnesium stearate (E470b). See point 2 "Dexamethasone Krka contains lactose".
What Dexamethasone looks like and what the package contains
4 mg tablets: white or almost white, circular tablets with bevelled edges and scored on one side (thickness: 2.5-3.5 mm, diameter: 5.6-6.3 mm). The tablet can be divided into two equal doses.
8 mg tablets: White or almost white oval tablets, with a line on one side (thickness: 3.5-5.5 mm, length: 8.7-9.3 mm). The tablet can be divided into two equal doses.
Dexamethasone Krka 4 mg tablets are available in cartons containing 10, 20, 28, 30, 50, 56, 60, 100, 10 x 1.20 x 1.28 x 1.30 x 1, 50 x 1.56 x 1.60 x 1 and 100 x 1 tablets in blisters. Dexamethasone Krka 8 mg tablets are available in cartons containing 10,20,30,50,60,100
10 x 1.20x 1.30 x 1, 50 x 1, 60 x 1, and 100 x 1 tablets in blisters. Not all pack sizes may be marketed.
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