Dexamethasone of the tab. of 0.5 mg No. 10

"Dexamethasone" of a tablet of 0.5 mg: the instruction for use

"Dexamethasone" — hormonal tablets of synthetic origin, are applied at development of symptoms of pathology of bark of adrenal glands, to treatment of autoimmune and allergic diseases, at shock conditions, acute and chronic inflammations of joints and connective tissue. Has the expressed anti-inflammatory effect, has immunosuppressive properties.

Dosage form

Tablet of 0.5 mg — flat, round, white color, with a facet.

Structure

Active ingredient — dexamethasone. 1 tablet contains 0.5 mg of dexamethasone.

Excipients: lactose, starch prezhelatinizirovanny, magnesium stearate, silicon dioxide colloidal.

Pharmacological properties

"Dexamethasone" — derivative the ftorprednizolona, a synthetic glucocorticosteroid, belongs to the pharmacotherapeutic Glucocorticosteroids group.

Pharmacodynamics

Anti-inflammatory effect is reached by

due to oppression of release of mediators of inflammation, decrease in quantity of mast cells which synthesize hyaluronic acid. Active antiallergic action is caused by ability to suppress synthesis of mediators of an allergy and to slow down release of mast cells and a histamine. "Dexamethasone" reduces concentration of T - and V-lymphocytes, suppresses the immune response of an organism, influences proteinaceous, carbohydrate and fat exchanges.

At HOBL medicine slows down inflammatory processes, interferes with hypostasis of mucous membranes of lungs and bronchial tubes, stimulates a secret exit due to decrease in its viscosity.

Pharmacokinetics

Dexamethasone is quickly and completely absorbed by

. Concentration of active ingredient reaches the maximum in 1–2 hours after reception. Biotransformation of medicine happens in a liver to formation of inactive metabolites. Out of an organism it is brought through kidneys.

"Dexamethasone" of a tablet are applied by

Indication

to reception at the following indications:

• endocrine violations;
• rheumatic diseases;
• general diseases of connective tissue, vasculitis and amyloidosis;
• a disease of skin;
• allergic diseases;
• a disease of organs of sight;
• gastrointestinal diseases;
• a respiratory disease;
• hematologic diseases;
• renal diseases;
• wet brain.

Contraindication

Hypersensitivity to dexamethasone or any other ingredient of medicine, sharp viral, bacterial or system fungal infections (if appropriate therapy), Cushing's syndrome, vaccination by live vaccine and also feeding by a breast (except for urgent cases is not performed).

"Dexamethasone" in the form of tablets is contraindicated to

at a hereditary lactose intolerance, glyukozo-galaktozny malabsorption and deficiency of lactase. Similar restriction is caused by existence in composition of medicine of lactose.

is Appointed with care in such cases:

• infectious and parasitic diseases, except for crushing infectious defeats. In such cases the use of medicine along with specific antibacterial therapy is allowed;
• period to or after vaccination;
• cankers and other functional disorders of a GIT;
• endocrine diseases (hypothyroidism, diabetes and thyrotoxicosis, Itsenko-Cushing's disease);
• a chronic liver failure in a severe chronic form;
• poliomyelitis;
• system osteoporosis;
• glaucoma;
• mental disorders;
• obesity 3-4 degrees;
• advanced age;
• gerpesny infections of eyes;
• pregnancy.

to children glucocorticosteroids appoint

during active growth only according to vital indications. The entire period of treatment they have to be under control of the doctor.

Route of administration

Dose for adults and children should be determined by

individually according to a disease of the specific patient, taking into account the provided period of treatment, shipping of corticosteroids and reaction of an organism.

Dose

Recommended daily dose — 0.75-9 mg. Application of a bigger dose in hard cases is allowed, at the same time reception needs to be divided into 3-4 times. In day the use no more than 15 mg is allowed.

After achievement of medical effect a dosage is gradually reduced to supporting — 2-4.5 mg a day.

Children's dose is calculated on age and the child's weight. The received dosage should be divided into 3-4 parts and to accept with equal intervals within a day.

Mode of dosing of the tablets "Dexamethasone" of 0.5 mg:

• bronchial asthma, nonspecific ulcer colitis, pseudorheumatism: 1.5 mg a day;
• oncohematological diseases: 7.5-10 mg/days;
• system lupus erythematosus: 2-4.5 mg a day;
• allergic reactions: 4–8 mg a day.

Pregnant

"Dexamethasone" pregnant women can appoint

Feature of application

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only in exceptional urgent cases when the expected advantage for mother exceeds potential risk for a fruit.

Dexamethasone passes

through a placenta, it is found in breast milk. it is important to p to consider

that prolonged use of medicine can cause violations of pre-natal fetation. The use in the last trimester of pregnancy considerably increases risk of an atrophy of bark of adrenal glands at a fruit. Such state demands the corresponding therapy of the newborn.

in the period of a lactation in need of intake of "Dexamethasone" breastfeeding is stopped.

Children

is allowed to be Applied to children since the birth only in urgent cases.

Drivers

"Dexamethasone" does not affect ability to drive the car and other mechanisms.

Overdose is Very seldom reported to

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about cases of sharp overdose or a lethal outcome owing to the last.

Single reception of excessive quantity of tablets usually does not lead

to clinically essential intoxication.

Overdose most often only after several weeks of application of overdoses is shown by symptoms of strengthening of the described side effects: Cushing's syndrome, acne, ecchymomas, hirsutism, nausea, anorexia, round ulcer of a digestive tract, arthralgia, myopathy, myalgia, asthma, dizziness, loss of consciousness, fever, increase in arterial blood pressure, lipidemia, osteoporosis, orthostatic hypotension, development of infections, steroid diabetes, "crescent-shaped" face, sexual dysfunction.

Treatment. The medicament dose should be reduced or cancelled, further treatment has symptomatic character. There is no specific antidote. The hemodialysis is not an effective method of the accelerated removal of dexamethasone from an organism.

Side effects

Most widespread side reactions of short-term treatment are temporary insufficiency of adrenal glands, intolerance of glucose, the increased appetite and increase in weight, mental violations. More rare side effects — allergic reactions, a gipertriglitseridemiya, a peptic ulcer of a stomach and duodenum and sharp pancreatitis.

Frequency and degree of manifestation of side reactions depend on how long and in what dose the medicament was taken. In most cases "Dexamethasone" is transferred well.

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Nevertheless also other side effects can be observed:

• blood and lymphatic system: increase in development of blood cells, lymphopenia, moderate leukocytosis, eosinopenia, leukocyturia;
• immune system: an acute anaphylaxis, dermatitis, rash and an itch on skin;
• mental violations: depression, concern, differences of mood, disorientation, hallucinations;
• organs of sight: glaucoma, atrophy of an optic nerve, turbidity of sight, subkapsulyarny cataract, secondary infection of eyes, protrusion of eyeballs, perforation of a cornea, damage of the central retina of an eye;
• central nervous system: increase in arterial and intracranial pressure, headache, spasms, cerebellum pseudoneoplasm;
• heart and vessels: arrhythmia, decrease in a warm rhythm to less than 60 beats per minute, progressing of chronic heart failure with such predisposition, a thrombembolia, thromboses, the increased trombotichesky readiness, a vasculitis, delay of scarring of fabric at recently postponed myocardial infarction;
• musculoskeletal system: delay of ossification at children, osteoporosis, an atrophy of muscle bulk;
• skin: thinning and atrophy, skin candidiasis, pyoderma, violation of pigmentation, petechias, "steroid" eels, "vascular asterisks";
• organs of hearing: vertigo.

Interaction

Simultaneous application with "Dexamethasone" of non-steroidal anti-inflammatory medicaments or ethanol increases risk of gastrointestinal bleeding and formation of ulcers.

Efficiency of medicine decreases if at the same time to accept "Rifampicin", "Carbamazepine", "Phenobarbital", "Phenytoinum", "Primidonum", "Ephedrine" or Aminoglutetimid therefore the dose in such combinations should be increased. Interaction between "Dexamethasone" and all above-mentioned medicines can distort the test of suppression of dexamethasone. It needs to be considered at assessment of results.

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registered also other clinically significant medicinal interactions of dexamethasone with other medicines and medical substances:

• with antacids the absorbability of glucocorticosteroids decreases;
• is raised by the content of folic acid, especially at long reception;
• with cardiac glycosides their toxic action amplifies;
• is reduced by effect of acetylsalicylic acid;
• is strengthened by toxic influence of paracetamol on a liver;
• is reduced by medical effect of Somatotropinum;
• is reduced by efficiency of hypoglycemic means;
• thiazide diuretics can cause a hypopotassemia;
with medicines of sodium the development of hypostases and arterial hypertension is possible
• ;
• with non-steroidal anti-inflammatory medicaments the danger of gastrointestinal bleedings increases;
• Phenytoinum, ephedrine, rifampicin, barbiturates, theophylline reduce medical effect of dexamethasone;
• combination to Amphotericinum B and inhibitors of a karboangidraza contributes to the development of osteoporosis;
• estrogen enhances therapeutic effect of active ingredient of medicine;
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• with tricyclic antidepressants strengthening of clinical manifestations of a depression can be observed;
• concomitant use of other GKS increases risk of developing a cataract, promotes appearance of eels, excess pilosis on men's type at women;
• M-holinoblokatory are capable to provoke increase in intraocular pressure;
• with ftorkhinolony the inflammation of sinews at elderly patients and people with already available diseases of sinews can develop;
• with medicaments against malaria promotes emergence of a myopathy and cardiomyopathy;
• cyclosporine is capable to oppress dexamethasone metabolism;
• concomitant use with APF inhibitors can cause change of composition of peripheral blood;
• ketokonazol is strengthened by toxicity of dexamethasone;
• with inhibitors of an isoenzyme CYP3a the probability of emergence of system side effects of dexamethasone increases.

for the period of treatment should exclude intake of alcoholic drinks as ethanol increases risk of ulcerations mucous a GIT and bleedings.

Special instructions

After regular prolonged use within 5 months (every day) the atrophy of bark of adrenal glands occurs.

during intake of "Dexamethasone" the immunization by means of vaccination is inefficient

.

to

Needs specific antibacterial therapy at medicament treatment of tuberculosis, sepsis, infectious complications of a basic disease. Same recommendations concerns patients with a peptic ulcer of a GIT, osteoporosis.

Against the background of treatment by "Dexamethasone" some symptoms of an infection can proceed in the latent form.

Cannot finish administration of medicament suddenly: the withdrawal can develop, including at normal function of bark of adrenal glands which is shown by a loss of appetite, block, body and bones pain, nausea, weakness. Signs of an easy form of a withdrawal are that. At heavy the expressed lowering of arterial pressure, weakness, vomiting, violation of frequency of heartbeat, the increased sweating, the expressed weakness, reduction of a mocheotdeleniye, a diarrhea, a faint, hallucinations, a coma is observed.

Within 3–4 months after cancellation of "Dexamethasone" the relative insufficiency of bark of adrenal glands can remain. At emergence of stressful situations during this period to the patient temporarily appoint GKS.

If the child according to vital indications needs long administration of drug, it is important to provide stringent medical control of its state. If during treatment the child had a contact with the patient with measles or chicken pox, carrying out a preventive immunoglobulinoterapiya is required.

All patients, it is long accepting "Dexamethasone", need regular control of arterial blood pressure, assessment of a picture of peripheral blood, check of level of sugar in blood and water and electrolytic balance, in survey by the oculist. To lower a likelihood of development and severity of side effects, use anabolic steroids and antacids. It is also important to increase intake of potassium in an organism. For this purpose it is necessary to reconsider a diet and to enrich it with the products containing this macrocell.

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At intake of "Dexamethasone" does not exclude risk of development of various heavy anaphylactic reactions. Patients with chronic heart failure, glaucoma, ulcer and erosive damages of a GIT, uncontrollable arterial hypertension need careful medical control. At patients with a myasthenia the deterioration in a course of the disease can be observed. Masking of symptoms of perforation of a wall of a stomach or intestines manifestations of "irritation of a peritoneum" is possible.

Men should warn that "Dexamethasone" is capable to change a spermogram picture: the mobility of spermatozoa can change.

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In some endocrine diseases breaks clearance of dexamethasone: at a hypothyroidism decreases, at a thyrotoxicosis raises.

Patients having diabetes can need correction of a dose of hypoglycemic medicines, it is important to them to control the entire period of administration of medicament sugar level in blood.

System application of glucocorticosteroids is capable to lead

to a disorder of vision. If it became muddy and indistinct and also other symptoms are observed, consultation of the ophthalmologist is necessary for an exception of glaucoma, a cataract and other rare diseases of eyes which development is connected with application of glucocorticosteroids.

Storage conditions

needs to be Stored in original packing for protection against effect of light and moisture.

special temperature storage conditions are not required for

For medicine.

should be Stored out of children's reach.

Expiration date — 2 years.

Packing

"Dexamethasone" in tablets (0.5 mg 10 pieces) is packed in blisters from a polyvinylchloride film and aluminum foil. From cardboard put 1 blister together with the medical instruction for use in a pack.

Prescription status

Glucocorticosteroids belong to the category of prescription medicaments therefore tablets in drugstore release on the prescription.

Producer

JSC KRKA, d. d., Novo mesto (Slovenia).