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Dexametazona 4 mg. 20 tablets

Product Code: Dexametazona 4 mg. 20 tablets
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Product viewed: 401

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What Dexametazona is and what it is used for
Dexametazona Krka is a synthetic glucocorticoid. Glucocorticoids are hormones released from the bark of the kidney. The drug has anti-inflammatory, analgesic and anti-allergic effects and suppresses the immune system.
Dexamethasone Krka is recommended for the treatment of rheumatic and autoimmune diseases (for example, systemic lupus erythematosus, rheumatoid arthritis, juvenile idiopathic arthritis, polyarteritis nodosa), respiratory tract diseases (e.g. bronchial asthma, croup), skin (for example, erythroderma, vulgaris), tuberculous meningitis - only in combination with anti-infectious therapy, blood disorders (e.g., idiopathic thrombocytopenic purpura in adults), cerebral edema, symptomatic multiple myeloma, acute lymphocyte leukemia, acute lymphoblastic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other drugs, palliative treatment of malignancies, prophylaxis and treatment of nausea and vomiting caused by chemotherapy and prophylaxis and treatment of post-operative vomiting within anti-emetic treatment .
2. What you need to know before taking Dexamethasone Krka
Do not take Dexamethasone Krka:
- 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 being 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 Krka:
- if you have ever had severe depression or manic depression (bipolar disorder). This also includes a history of depression prior to 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 several 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 liver failure);
- if you have a tumor of the adrenal gland (pheochromocytoma);
- if you have high blood pressure, heart disease or have recently suffered a heart attack (there is a rupture of the heart muscle);
- 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 visual impairment);
- if you have myasthenia gravis (a disease that causes muscle weakness);
- if you have bowel disorders or a stomach (peptic) ulcer;
- if you have psychiatric problems or have had a mental illness that is aggravated by this type of medication;
- if you have epilepsy (a condition where you have recurring seizures or seizures);
- if you have migraine;
- if you have a decreased thyroid function;
- if you have a parasitic infection;
- if you have tuberculosis, septicemia or a fungal infection of the eye;
- if you have cerebral malaria;
- if you have herpes (labia) or genital (genital) or ocular (occipital herpes simplex) due to a possible cornea breakdown;
- if you have asthma;
- if you are being treated for blockage of the blood vessels from blood clots (thromboembolism);
- if you have corneal ulcers or injuries.
Treatment with corticosteroids may reduce the body's ability to fight the infection. This can sometimes result in infections caused by micro-organisms that rarely cause infection under normal circumstances. 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 chickenpox, herpes zoster or measles. If you think you may have been exposed to any of these conditions, talk to your doctor immediately. You should also tell your doctor if you have ever had an infectious disease, such as measles or chicken pox, and for all vaccinations.
Treatment with this medicine may cause central serous chorioretinopathy, an ocular disease that causes blurred or distorted vision. It usually appears in one eye. If you notice a blurred or distorted vision that lasts for several days, please contact your doctor.
Treatment with this medicine can cause inflammation of the tendon. In extremely rare cases, tendon rupture may occur. This risk increases with treatment with some antibiotics and with kidney problems. Contact your doctor if you notice painful, stiff or swollen joints or tendons.
Treatment with Dexamethasone Krka may result in a condition called adrenal insufficiency. It may result in a change in the efficacy of the drug after stress and trauma, surgery, birth or illness, and the body may not be able to respond in the usual way to severe stress, such as an accident, surgery, birth or illness. If you have an accident, suffer from illness or have other specific physical stresses, or require surgery (even dental) or vaccination (especially with live viral vaccines) while taking or after you have stopped taking Dexamethasone Krka, you should tell your doctor that you are taking or have taken steroids.
If you are going to have a suppressive test (hormone test), a skin allergy test, or a bacterial infection test, you should tell the test person that you are taking dexamethasone as this may affect the results.
Your doctor may reduce the amount of salt in the diet and prescribe a potassium supplement while you are 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.
Children
If this medicine is taken by a child, it is important that the doctor monitors its growth and development at frequent intervals.
Other medicines and Dexamethasone Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
- Anti-coagulant drugs that dilute blood (eg warfarin);
- Acetylsalicylic acid or other similar drugs (non-steroidal anti-inflammatory drugs), 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 tuberculosis);
- Antacids - especially those containing magnesium trisilicate;
- Barbiturates (medicines used to help sleep and reduce anxiety);
- Aminoglutethimide (anticancer treatment);
- Carbenoxolone (used to treat stomach ulcers);
- Ephedrine (to nose);
- Acetazolamide (used for glaucoma and epilepsy);
- Hydrocortisone, cortisone and other corticosteroids;
- Ketoconazole, itraconazole (for fungal infections);
- Ritonavir (for HIV)
- 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 the study of adrenal function;
- Sulpride used to soothe emotions;
- Ciclosporin used to prevent rejection after transplantation;
- Thalidomide, used, for example, for multiple myeloma;
- Praziquantel prescribed for certain worm infections;
- Vaccination with live vaccines;
You may be at an increased risk of serious side effects if you are taking dexamethasone with these medicines:
- Acetylsalicylic acid or other similar drugs (non-steroidal anti-inflammatory drugs), for example indomethacin;
- Medicines used to treat diabetes;
- Medicines used to treat heart disease;
- Diuretics (drainage tablets);
- amphotericin B for injections;
- Acetazolamide (used for glaucoma and epilepsy);
- Tetracosactide used in the adrenal function test;
- Carbenoxolone (used to treat stomach ulcers);
- Chlorocin, Hydroxychloroquine and Mefloquine (for malaria);
- Medicines used to treat high blood 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 medicinal products 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 care is required for pregnancy testing and prevention.
Dexamethasone Krka 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 are breast-feeding, think you may be pregnant or plan 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 for the mother and the child. If you become pregnant while taking the medicine, do not stop taking dexamethasone but talk to your doctor immediately that you are pregnant.
Corticosteroids may pass into breast milk. No risk can be excluded for newborns / infants. A decision should be made whether to continue / discontinue breast-feeding or to continue / discontinue dexamethasone therapy, taking into account the benefit of breast-feeding to the child and the benefit of dexamethasone therapy to the woman.
Driving and using machines
Do not drive, use tools or machines, and do not perform any high-risk activities if side effects such as confusion, hallucinations, dizziness, fatigue, drowsiness, loss of consciousness or blurred vision occur.
Dexamethasone Krka contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Dexamethasone Krka
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Dexamethasone Krka 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 being 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.
Acute 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 a single dose.
Acute skin diseases: Depending on the nature and severity of the disease, daily doses of 8-40 mg, in some cases up to 100 mg, which should be subsequently reduced as clinically necessary.
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.
Tuberculous 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 kilogram per day in Week 3 and 0.1 mg per kilogram per day in Week 4) and then orally for four weeks starting at 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 may 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.
Prevention and treatment of postoperative vomiting, within anti-emetic treatment: single dose of 8 mg prior to surgery.
Treatment of symptomatic multiple myeloma, acute lymphocytic leukemia, 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 the 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 treatment protocols and guidelines should be followed. Prescribing doctors should carefully assess the dose of dexamethasone taking into account the condition and status of the patient's disease.
Continuous treatment
In the long-term treatment of a number of conditions, after initial therapy, glucocorticoid therapy should be switched from dexamethasone to prednisone / prednisolone to reduce 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.
If you forget to take Dexamethasone Krka
If you forget to take a dose, take it as soon as you remember unless it is almost time for the next dose. Do not take a double dose to make up for the missed tablet.
If you stop taking Dexamethasone Krka
If treatment should be discontinued, follow the advice of your doctor. He can tell you to gradually reduce the amount of medicine you take until you stop it completely. Symptoms reported with too rapid discontinuation of treatment included low blood pressure and, in some cases, recurrence of the disease for which treatment was prescribed.
It is also possible to experience "withdrawal syndrome", which includes fever, muscle and joint pain, inflammation of the nose (rhinitis), weight loss, itchy skin and eye inflammation (conjunctivitis). If you stop treatment prematurely and some of these symptoms occur, you should talk to your doctor as soon as possible.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Tell your doctor immediately if you have serious mental health problems. They can affect about 5 out of every 100 people taking medicines like dexamethasone. These issues include:
- feeling depressed, including suicidal thoughts;
- feeling dizzy (mania) or sudden mood swings;
- feeling of anxiety, sleeping problems, difficulty in thinking or confusion and loss of memory;
- feeling, seeing or hearing things that do not exist; strange and frightening thoughts, changing the way you act or feeling alone
Tell your doctor immediately if you have:
- severe abdominal pain, nausea, vomiting, diarrhea, deep muscle weakness and fatigue, extremely low blood pressure, weight loss and fever, as these may be signs of adrenal insufficiency;
- Sudden abdominal pain, tingling, nausea, vomiting, fever and blood in the stool, as these may be signs of intestinal tract discomfort, especially if you have or have had bowel disease.
This medicine can aggravate an existing heart problem. If you have shortness of breath or swollen ankles, talk to your doctor.
Other side effects (not known):
- More likely infections, including viral and fungal infections, such as thrush; recurrence of tuberculosis or other infections, such as eye infections if you already have them.
- Reduced white blood cell counts or increased white blood cell counts - Coagulation disorders.
- Allergic reaction to the medicine, including a serious, potentially life-threatening allergic reaction (which may be as rash and swelling of the throat or tongue, and in severe cases with difficulty breathing or dizziness.
- Decreased regulation of hormones in the body, swelling and weight gain of the body and face (Cushingoid condition), change in the effectiveness of endocrine hormones after stress and trauma, surgery, birth or illness, your body may not be able to respond to the usual way of severe stress such as accident, surgery, birth or illness, slow growth in children and adolescents, irregular and absent menstrual cycle, development of excessive body hair (especially in women).
- Increase in weight, loss of protein and calcium balance, increased appetite, impaired salt balance, retention of water in the body, loss of potassium that may cause heart rhythm disturbance), increased need for diabetes medications, hidden diabetes, high blood cholesterol and triglycerides (hypercholesterolemia and hypertriglyceridemia).
- Mood swings, worsening of schizophrenia (mental disorder), depression, insomnia.
- Severely abnormal headache with visual disturbances associated with cessation of treatment, seizures and worsening of epilepsy, dizziness.
- Increased eye pressure, eye swelling, thinning of the eye membranes, increased viral, fungal and bacterial eye infections, worsening of symptoms associated with corneal ulcers, worsening of existing eye infections, ocular protrusion, cataracts.
- Congestive heart failure in predisposed people, rupture of the heart muscle after a recent heart attack, cardiac decompensation.
- High blood pressure, blood clots: formation of blood clots that can block blood vessels, for example in the legs or lungs (thromboembolic complications).
- Hiccup.
- Nausea, vomiting, stomach discomfort and abdominal distension, inflammation and ulcer of the esophagus, peptic ulcers that can open and bleed, inflammation of the pancreas (which may be as back and abdominal pain), flatulence, oesophageal candidosis.
- Thinning of delicate skin, abnormal skin scarring, bruising, redness and inflammation of the skin, stretch marks, visibly enlarged capillaries, acne, increased sweating, skin rashes, swelling, hair thinning, abnormal fat accumulation, excessive hair growth, retention of the 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 bones with increased risk of fractures (osteoporosis), bone necrosis, tendinitis, torn tendons, muscle loss, myopathy, muscle weakness, early bone growth (early pineal closure).
- Changes in sperm count and movement, impotence.
- Disturbed response to vaccinations and skin tests, slow wound healing, discomfort, malaise.
- Possible withdrawal symptoms include fever, muscle and joint pain, inflammation of the nose (rhinitis), weight loss, pruritus and painful nodes on the skin and eye inflammation (conjunctivitis).
How to store Dexamethasone Krka
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 sewage system 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 Krka contains
- The active substance is dexamethasone.
Dexamethasone Krka 4 mg tablets
Each tablet contains 4 mg of dexamethasone.
Dexamethasone Krka 8 mg tablets
Each tablet contains 8 mg of dexamethasone.
The other ingredients are: lactose monohydrate, pregelatinized corn starch, colloidal anhydrous silica and magnesium stearate (E572). See point 2 "Dexamethasone Krka contains lactose".
What Dexamethasone Krka looks like and contents of the pack
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, scored 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 per carton.
Dexamethasone Krka 8 mg tablets are available in cartons containing 10, 20, 30, 50, 60, 100, 10 x 1, 20 x 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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