Dexamethasone 20 mg. 20 tablets

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 Krka is recommended for the treatment of rheumatic and autoimmune diseases (eg myositis), skin (eg pemphigus vulgaris), blood disorders (eg idiopathic thrombocytopenic purpura in adults), symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other drugs, metastatic compression of the spinal cord (pressure on the nerves of the spinal cord caused by a tumor), prophylaxis and treatment of nausea and vomiting caused by chemotherapy, in amkite of antiemetic treatment.

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 have been 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 prior to or during administration of steroid medications such as dexamethasone;
if any of your close relatives had these ailments.
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 (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 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 than this kind 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 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 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, 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 chickenpox and for all

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 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 , you should tell your doctor that you are taking or have taken steroids.
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.

Children
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 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 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 (for nose detachment);
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 movements 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, in multiple myeloma;
Praziquantel prescribed for certain worm infections;
Vaccination with live vaccines;
Chloroquine, Hydroxychloroquine and Mefloquine (for malaria);
Somatotropin;
Protirelin.
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, cystitis);
Acetylsalicylic acid or other similar drugs (non-steroidal anti-inflammatory agents), 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);
Medicines used to treat high blood pressure;
Thalidomide, used, for example, in multiple myeloma;
Vaccination with live vaccines;
Medicines that support muscle movements 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 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. Risk can not 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 engage in any high-risk activities if side effects such as confusion, hallucinations, dizziness, fatigue, drowsiness, loss of consciousness, or blurred vision occur.

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 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.

Please note that this is a viscous pharmaceutical form. It is recommended that Dexamethasone Krka be used at the lowest effective dose.

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 specified, the following dosing recommendations are applicable:
The following dosage recommendations are given for guidance only. Initial daily doses should always be determined based on the patient's individual response and the severity of the disease.

Pemphigus: Initial dose of 300 mg daily for three days, followed by titration of dose titration according to clinical needs;
Myositis: 40 mg daily for 4 days in cycles;
Idiopathic thrombocytopenic purpura: 40 mg daily for 4 days in cycles;
Metastatic Spinal Cord Compression: Initial dose and duration of treatment, depending on cause and severity. Very high doses up to 96 mg can be used for palliative care. For optimal dosing and decreasing 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;
Prophylaxis and treatment of cytostatic-induced vomiting, emetogenic chemotherapy, within the antiemetic treatment: 8-20 mg (one 20 mg tablet or half a 40 mg dexamethasone tablet) before chemotherapy, then 4-16 mg daily in Day 2 and Day 3
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 people or me should be respected
Increased weight, loss of protein and calcium balance, increased appetite, impaired balance of salts, retention of water in the body, loss of potassium, which may cause heart rhythm disturbances, increased need for diabetes medications, manifestation of hidden diabetes , high levels of cholesterol and triglycerides in the blood (hypercholesterolemia and hypertriglyceridemia);
Severe mood swings, worsening of schizophrenia (mental disorder, depression, insomnia);
Severely unusual headache with visual disturbances associated with cessation of treatment, seizures and worsening of epilepsy, dizziness;
Increased eye pressure, eye swelling, thinning of the ophthalmic 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: the 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 swelling, inflammation and ulcer of the esophagus, peptic ulcers that can open and bleed, inflammation of the pancreas (which can be seen as back and abdominal pain), flatulence, oesophageal candidiasis ;
Tired skin, abnormal skin scarring, bruising, flushing 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 water in the body, pigmentary disorders, weakened capillaries that can easily burst, manifesting as bleeding under the skin (increased capillary fragility), skin irritation 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 (premature pineal closure);
Changes in the number and movement of sperm, impotence;
Impaired response to vaccinations and skin tests, slow wound healing, 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 Krka 20 mg tablets
Each tablet contains 20 mg of dexamethasone.

Dexamethasone Krka 40 mg tablets
Each tablet contains 40 mg of dexamethasone.

The other ingredients are: lactose monohydrate, pregelatinized maize 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

20 mg tablets: white or almost white, circular tablets with bevelled edges and scored line and with 20 markings on one side (thickness: 4.0-6.0 mm, diameter: 10.7-11.3 mm). The tablet can be divided into two equal doses.

 

 

 

 

 

 

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