Active ingredients: Dexamethasone
DECADRON 0.5 mg tablets
DECADRON 0.75 mg tablets
Decadron package inserts are available for pack sizes: - DECADRON 0.5 mg tablets, DECADRON 0.75 mg tablets
- Decadron 2 mg / ml oral drops, solution
- DECADRON 4mg / 1ml solution for injection, DECADRON 8mg / 2ml solution for injection
Why is Decadron used? What is it for?
PHARMACO-THERAPEUTIC CATEGORY
DECADRON is a corticosteroid (or glucocorticoid), a hormonal preparation.
INDICATIONS
- Allergic forms - Control of allergies or disabling allergic states that do not respond to adequate attempts with conventional therapy: seasonal or perennial allergic rhinitis; bronchial asthma (including asthmatic state); contact dermatitis; Atopic dermatitis; serum sickness; angioneurotic edema; urticaria.
- Rheumatic diseases - As adjunctive therapy for a short period of time during an acute episode or in the flare-up of the following forms: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (low-dose maintenance therapy may be required in special cases); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis.
- Dermatological diseases - Pemphigus; bullous herpetiform dermatitis; severe polymorphic erythema (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis.
- Ophthalmology - Serious acute and chronic allergic and inflammatory processes affecting the eye and its appendages, such as: allergic conjunctivitis; keratitis; allergic corneal marginal ulcer; ophthalmic herpes zoster; iritis and iridocyclitis; chorioretinitis; inflammation of the anterior segment; diffuse posterior uveitis and choroiditis ; ophthalmic neuritis; retrobulbar neuritis; sympathetic ophthalmia.
- Endocrine diseases - Primary or secondary adrenal insufficiency (the drugs of first choice are hydrocortisone or cortisone; similar synthetic drugs can be used, when possible, in association with mineralocorticoids; in pediatrics the supplementary intake of mineralocorticoids is particularly importance). Congenital adrenal hyperplasia. Non-suppurative thyroiditis.
- Diseases of the respiratory system - Sarcoidosis; Loeffler's syndrome not treatable by other means; berylliosis; fulminant or disseminated pulmonary tuberculosis, in association with appropriate antituberculous chemotherapy; pulmonary emphysema, in cases where bronchospasm or bronchial edema plays a significant role; diffuse interstitial pulmonary fibrosis (Hamman-Rich syndrome).
- Hematological diseases - Idiopathic and secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia; congenital hypoplastic anemia (erythroid).
- Neoplastic diseases - For the palliative treatment of leukemias and lymphomas in adults; acute leukemia in children.
- Edematous states - To cause diuresis or remission of proteinuria in nephrotic syndrome without uremia, of the idiopathic type or due to lupus erythematosus. In association with diuretics, to induce diuresis; cirrhosis of the liver with refractory ascites; refractory congestive heart failure.
- Cerebral edema - DECADRON (tablets) can be used in the treatment of patients with cerebral edema of various etiologies. In patients with cerebral edema due to primary or metastatic brain tumors, oral administration of DECADRON may be useful. The drug can also be used to prepare for surgery in patients with intracranial hypertension secondary to brain tumors; as a palliative in patients with inoperable or relapsed brain tumors; in the treatment of cerebral edema following neurosurgery. Certain patients with cerebral edema due to head injury or pseudotumors of the brain may also benefit from oral therapy with DECADRON. The use of the drug in cerebral edema does not exclude the need for a careful neurosurgical evaluation and radical treatments, such as neurosurgery, or other specific therapies.
- Gastrointestinal diseases - During critical periods as an adjuvant in: ulcerative colitis; regional enteritis; refractory sprue.
- Miscellaneous - Tuberculous meningitis with subarachnoid or obstructive block in association with appropriate antituberculous therapy. Inflammatory reactions following dental surgery. In exacerbation or for maintenance therapy in selected cases of systemic lupus erythematosus; acute rheumatic endocarditis.
- For the differential diagnosis of adrenocortical hyperfunction
Precautions for use What you need to know before taking Decadron
It is advisable to use the minimum posology necessary for the control of the disease, implementing a gradual dose reduction as soon as this is possible. Medium or high doses of hydrocortisone or cortisone can cause increased blood pressure, salt water retention, or excessive potassium depletion. Such effects are less likely to occur with synthetic derivatives, unless they are administered at high doses. A low salt diet and extra potassium intake may be needed. All corticosteroids increase the excretion of calcium. In patients under corticosteroid therapy exposed to considerable stress, an increase in the dosage of fast-acting corticosteroids is indicated, before, during and after the stressful situation. A secondary adrenocortical insufficiency induced by the drug may be reduced to a minimum by gradually reducing the dosage. However, this type of relative insufficiency may persist for a few months after the suspension of therapy: in any stressful situation that occurs during this period, it is therefore advisable to re-institute hormone therapy. If the patient is already on steroid treatment, an increase in dosage may be necessary. Since the secretion of mineralocorticoids may be inadequate, the simultaneous administration of salts and / or a mineralocorticoid is advisable. Patients should not be vaccinated against smallpox during corticosteroid therapy. Other immune procedures should not be implemented in patients treated with corticosteroids, especially at high doses, given the danger of neurological complications and a lack of antibody response. In the presence of hypoprothrombinemia, acetylsalicylic acid should be used with caution during corticosteroid therapy. In hypothyroid patients or patients with liver cirrhosis the response to corticosteroids may increase. The use of DECADRON tablets in current tuberculosis should be limited to cases of fulminant or disseminated tuberculosis in which corticosteroid is used to treat the disease in combination with an appropriate antituberculous regimen.Strict monitoring is required when corticosteroids are indicated in patients with latent tuberculosis or a positive response to tuberculin, as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should undergo chemoprophylaxis. Steroids should be used with caution in the presence of: non-specific ulcerative colitis with danger of perforation; abscesses or other pyogenic infections; diverticulitis; recent intestinal anastomoses; active or latent gastric ulcer; kidney failure; hypertension; osteoporosis; myasthenia gravis. Cases of embolism caused by adipose tissue emboli have been described as a possible complication of hypercortisonism. Corticosteroids should be used with caution in patients with ophthalmic herpes simplex, given the possible risk of corneal ulceration and perforation. In hypothyroid and cirrhotic patients the effects of corticosteroids are more marked. Corticosteroids can mask the symptoms of infection and overlapping infections may occur during their use. In the course of corticosteroid therapy, reduced resistance to infections and the tendency of infectious processes not to localize can be observed. Corticosteroids can manifest psychic alterations that can range from euphoria, insomnia, mood swings, personality changes, severe depression, to real psychotic manifestations. When present, psychic instability and psychotic tendencies can be aggravated by corticosteroids. "Prolonged use of corticosteroids can cause posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and can favor the onset of secondary ocular infections due to fungi or viruses. Children and young people undergoing prolonged corticosteroid therapy should be carefully monitored as far as possible. it's about growth and development. In some patients, steroids can increase or decrease mobility and sperm count. Diphenylhydantoin may induce an increase in the metabolism and clearance of corticosteroids; consequently it may be necessary to increase the dosage of the steroid.
Use in Pregnancy and Lactation
As there are still no adequate studies on corticosteroids in relation to human reproduction, the use of these drugs in pregnant women, in nursing mothers or in women of childbearing age requires that the possible risks and advantages deriving from the drug for the mother and for the embryo or fetus. Babies born to mothers who have been treated with substantial doses of corticosteroids during pregnancy should be subjected to careful checks to ascertain any signs of hypoadrenalism.
Interactions Which drugs or foods can modify the effect of Decadron
Diphenylhydantoin, phenobarbital, ephedrine and rifampicin may increase the clearance of corticosteroids with decreased blood levels and decreased physiological activity; this requires an adjustment of the corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests, which should be interpreted with caution when administering these drugs. Prothrombin time should be monitored frequently in patients receiving coumarin corticosteroids and coumarin anticoagulants at the same time, as corticosteroids have impaired response to these anticoagulants in some cases. Studies have shown that the The effect usually caused by the addition of corticosteroids is inhibition of the response to coumarin compounds, although there have been some conflicting reports indicating potentiation. When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be closely monitored for the development of hypokalaemia.
Warnings It is important to know that:
For those who play sports: the use of the drug without therapeutic necessity constitutes doping: it can cause doping effects and cause positive anti-doping tests even for therapeutic doses. The product can be taken without risk by patients suffering from celiac disease.
Effects on Ability to Drive and Use of Machines
The substance does not interfere with the ability to drive and use machines.
Dosage and method of use How to use Decadron: Dosage
Therapy should be conducted according to the following general principles: 1. The dosage should be adapted to individual cases, according to the severity of the disease and the individual response. The severity, prognosis, foreseeable duration of the disease and the patient's response to the drug are determining factors for the posology. (For children, the recommended doses must generally be reduced: the choice of dosage must however be dictated more by the severity of the case than by age or body weight.) 2. Hormonal therapy is a complement and not a substitute for therapy. which, when indicated, must be instituted. 3. When the drug has been administered for a period of time exceeding a few days, the reduction of the dosage or the suspension of the treatment must be implemented gradually. 4. The constant monitoring of the patient afterwards. the discontinuation of corticosteroid therapy is of essential importance, as the sudden reappearance of severe symptoms of the disease for which the patient had been treated can be observed.
In acute forms where an immediate effect is needed, high doses can be administered, which for a short period of time may be indispensable. In chronic forms that require long-term therapy, it is advisable to use the minimum dose sufficient to determine adequate but not necessarily complete relief. If it is considered essential to administer the drug at a high dose for prolonged periods of time, patients should be rigorously monitored to detect any symptoms that may require dose reduction or discontinuation of hormonal treatment. Chronic diseases are subject to periods of spontaneous remission. During such periods the administration of corticosteroids should be gradually discontinued. During prolonged therapy it is advisable to carry out the usual laboratory tests at regular intervals such as urinalysis, determination of blood glucose two hours after a meal, control of blood pressure and body weight and chest radiological examination. In addition, it is advisable to periodically check the serum potassium levels. Radiological examinations of the upper gastrointestinal tract should be performed during prolonged treatments in patients with a history of peptic ulcer or in the presence of gastric disorders. By adequately adjusting the dosage, it is possible to pass from the administration of any other glucocorticoid to the administration of DECADRON. The following equivalences (milligram for milligram) facilitate the transition from other glucocorticoids to DECADRON:
TABLE 1
DECADRON: 0.75 mg
Methylprednisolone and triamcinolone: 4 mg
Prednisolone and prednisone: 5 mg
Hydrocortisone: 20 mg
Cortisone: 25 mg
Milligram for milligram, dexamethasone is practically equivalent to betamethasone, four to six times more potent than methylprednisolone and triamcinolone, six to eight times more potent than prednisone and prednisolone, 25 to 30 times more potent than hydrocortisone, and about 35 times more potent than cortisone. At the same anti-inflammatory doses, dexamethasone is almost completely free from the sodium retention effects of hydrocortisone and is very similar, in this respect, to hydrocortisone derivatives.
RECOMMENDED DOSAGE - In chronic diseases that are normally non-lethal, including endocrine diseases and chronic rheumatic forms, edematous states, respiratory and gastrointestinal diseases, certain dermatological and haematological diseases, start with low doses (from 0.5 to 1 mg per day ), gradually increasing the dosage until the minimum effective dose is reached, sufficient to induce the desired degree of symptomatic relief. The dosage can be divided into two, three or four daily doses. Once adequate symptom control has been achieved, the maintenance dosage should involve the minimum dose necessary to allow sufficient relief without excessive hormonal effects. Once the optimal maintenance dosage has been established, regardless of the initial daily dosage, satisfactory results are often obtained with a twice-daily regimen. - In congenital adrenal hyperplasia, the daily dosage is generally 0.5-1.5 mg. - In acute non-lethal diseases, including allergic states, ophthalmic diseases, acute and subacute rheumatic diseases, the dosage varies from 2 to 3 mg per day; however, higher doses may be required in some patients. As these diseases have a well-defined course and resolve within a given period of time, prolonged maintenance therapy is not usually necessary. acute self-limiting allergies and in exacerbations of chronic allergic diseases (e.g. acute allergic rhinitis, acute attacks of seasonal allergic bronchial asthma, drug urticaria, angioneurotic edema and contact dermatitis), the following parenteral therapy combination dosage schedule is recommended and oral:
Day 1: A single IM injection of 1 ml (4 mg) of DECADRON 4 mg solution for injection (dexamethasone 21-disodium phosphate)
2nd day: 2 DECADR0N tablets (0.5 mg) twice a day
3rd day: 2 DECADRON tablets (0.5 mg) twice a day
4th day: 1 DECADRON tablet (0.5 mg) twice a day
5th day: 1 DECADRON tablet (0.5 mg) twice a day
6th day: 1 DECADRON tablet (0.5 mg) once a day
Day 7: 1 DECADRON tablet (0.5 mg) once a day
8th day: check-up visit
Dosage schedule (as an alternative to the previous one)
1st day: 1 or 2 ml (4 mg / ml) i.m. of DECADRON 4 mg solution for injection
2nd day: 2 DECADRON tablets (0.75 mg) twice a day
3rd day: 2 DECADRON tablets (0.75 mg) twice a day
4th day: 1 DECADRON tablet (0.75 mg) twice a day
5th day: 1 DECADRON tablet (0.75 mg) once a day
6th day: 1 DECADRON tablet (0.75 mg) once a day
7th day: no treatment
8th day: check-up visit
The aim of this scheme is to offer adequate therapy during acute episodes and at the same time to minimize the danger of overdosing in chronic cases. Additional treatment may be required in some patients, for example with topical steroids, antihistamines, bronchodilators, or other systemic steroids. In chronic life-threatening diseases such as systemic lupus erythematosus, pemphigus, symptomatic sarcoidosis, the recommended initial dosage is 2-4.5 mg per day; higher doses are required in some patients. As soon as adequate relief is achieved, the posology should be gradually reduced to the minimum dose sufficient to determine the desired therapeutic effect. In case of acute life-threatening illnesses (eg acute rheumatic endocarditis, acute attacks of lupus erythematosus systemic, severe allergic reactions, pemphigus, neoplasms), the initial dosage varies from 4 to 10 mg per day to be divided into at least four doses; to obtain constant control, in some patients it may be necessary to increase the dosage. , the dosage should be gradually reduced to the minimum dose sufficient to maintain constant relief. If an extremely rapid onset of action is required, the first two or three doses of DECADRON solution for injection can be administered intravenously. In severe allergic reactions, the drug of first choice is adrenaline. DECADRON (tablets) is useful as a combination drug or for support therapy. In cerebral edema, DECADRON solution for injection is generally administered at the beginning at a dose of 10 mg by the iv route and subsequently at a dose of 4 mg by the im route every six hours until the symptoms of cerebral edema disappear. A response is typically seen within 12-24 hours; the treatment can be reduced after 2-4 days and gradually eliminated over the course of 5-7 days. For the palliative treatment of patients with recurrent or inoperable tumors, the maintenance dosage should be adapted to individual cases using DECADRON solution for injection or DECADRON tablets. A dosage of 2 mg two or three times a day may be adequate. The minimum posology necessary to control cerebral edema should be used. The usual precautions associated with corticosteroid therapy should be followed. Consideration should be given to prescribing antacids, anticholinergics and dietary measures to prevent gastrointestinal ulcers. or haemorrhages. - In adrenogenital syndrome, daily doses of 0.5-1.5 mg may be sufficient to control the disease and to prevent the reappearance of an "abnormal secretion of 17-ketosteroids. - For the massive therapy of certain diseases such as acute leukemia, nephrotic syndrome and pemphigus, the recommended dosage ranges from 10 to 15 mg per day. Patients treated with such high doses must be subjected to strict controls, in order to promptly detect the appearance of serious reactions. suppression with dexamethasone 1. Test for the detection of Cushing's syndrome. One 0.5 mg tablet of DECADRON every six hours for 48 hours. Determine 17-hydroxy corticosteroids in a 24-hour urine sample. For greater accuracy administer DECADRON 1.0 mg orally at 11 pm. Collect blood for plasma cortisol determination at 8 am the next morning. 2. Diagnostic test to differentiate adrenal tumors from adrenal hyperplasia. 2 mg of DECADRON orally every 6 hours for 48 hours. Collect 24-hour urine to determine the excretion of 17-hydroxy corticosteroids.
Overdose What to do if you have taken too much Decadron
There are no data on overdose.
Side Effects What are the side effects of Decadron
Water and electrolyte disorders: sodium retention; water retention; congestive heart failure in predisposed individuals; potassium depletion; hypokalemic alkalosis; hypertension.
Musculoskeletal: muscle asthenia; steroid myopathy; reduction in muscle mass; osteoporosis; vertebral compression fractures; aseptic necrosis of the femoral head and humerus; spontaneous fractures of the long bones.
Gastrointestinal: peptic ulcer with possible perforation and haemorrhage; pancreatitis; abdominal distension; ulcerative esophagitis.
Dermatological: delayed wound healing; thin and fragile skin; petechiae and bruising; facial erythema; increased perspiration; can suppress responses to skin tests.
Neurological: convulsions; increased intracranial pressure with papilledema (pseudotumor of the brain), usually after treatment; dizziness; headache.
Endocrinological: menstrual abnormalities; onset of cushingoid state; stunting in children; secondary adrenocortical and pituitary insufficiency, especially during periods of stress due to trauma, surgery or serious illness; impaired tolerance to carbohydrates; manifestations of latent diabetes mellitus; increased need for insulin or oral hypoglycaemics in diabetic patients.
Ophthalmological: posterior subcapsular cataract; increased intraocular pressure; glaucoma; exophthalmos.
Metabolic: protein catabolism with negative nitrogen balance so that in prolonged treatments the protein reaction must be adequately increased.
Expiry and Retention
CAUTION: DO NOT USE THE MEDICINAL PRODUCT AFTER THE EXPIRY DATE INDICATED ON THE PACKAGE.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping: it can cause doping effects and cause positive anti-doping tests even for therapeutic doses.
Store at a temperature not exceeding 25 ° C
Keep out of the reach and sight of children.
COMPOSITION
Each DECADRON 0.5 mg tablet contains:
active ingredient: dexamethasone 0.5 mg;
excipients: corn starch, dibasic calcium phosphate dihydrate, lactose monohydrate, magnesium stearate.
Each DECADRON 0.75 mg tablet contains:
active ingredient: dexamethasone 0.75 mg;
excipients: corn starch, dibasic calcium phosphate dihydrate, lactose monohydrate, magnesium stearate, E142 bright acid green BS.
PHARMACEUTICAL FORM
DECADRON 0.5 mg tablets: 0.5 mg tablets (pack of 10 tablets);
DECADRON 0.75 mg tablets: 0.75 mg tablets (pack of 10 tablets).
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
DECADRON
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mg tablet contains: 0.5 mg dexamethasone.
Each 0.75 mg tablet contains: 0.75 mg dexamethasone.
For excipients, see 6.1
03.0 PHARMACEUTICAL FORM
Tablets
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Allergic forms - Control of allergies or disabling allergic states that do not respond to adequate attempts with conventional therapy: seasonal or perennial allergic rhinitis; bronchial asthma (including asthmatic state); contact dermatitis; Atopic dermatitis; serum sickness; angioneurotic edema; urticaria.
Rheumatic diseases- As a supplementary therapy for a short period of time during an acute episode or in the flare-up of the following forms: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (low-dose maintenance therapy may be required in special cases); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis.
Dermatological diseases- Pemphigus; bullous herpetiform dermatitis; severe polymorphic erythema (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis.
Ophthalmology - Severe allergic and acute and chronic inflammatory processes affecting the eye and its appendages, such as: allergic conjunctivitis; keratitis; allergic corneal marginal ulcer; ophthalmic herpes zoster; iritis and iridocyclitis; chorioretinitis; inflammation of the anterior segment; diffuse posterior uveitis and choroiditis; ophthalmic neuritis; retrobulbar neuritis; sympathetic ophthalmia.
Endocrine diseases - Primary or secondary adrenal insufficiency (the drugs of first choice are hydrocortisone or cortisone; similar synthetic drugs can be used, when possible, in combination with mineralocorticoids; in pediatrics the supplementary supply of mineralocorticoids is of particular importance) . Congenital adrenal hyperplasia. Non-suppurative thyroiditis.
Diseases of the respiratory system- Sarcoidosis; Loeffler's syndrome not treatable by other means; berylliosis; fulminant or disseminated pulmonary tuberculosis, in association with appropriate antituberculous chemotherapy; pulmonary emphysema, in cases where bronchospasm or bronchial edema play a significant role; diffuse interstitial pulmonary fibrosis (Hamman-Rich syndrome).
Hematological diseases- Idiopathic and secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia; congenital hypoplastic anemia (erythroid).
Neoplastic diseases- For the palliative treatment of leukemias and lymphomas in adults; acute leukemia in children.
Edematous states - To cause diuresis or remission of proteinuria in nephrotic syndrome without uremia, of the idiopathic type or due to lupus erythematosus. In association with diuretics, to induce diuresis; cirrhosis of the liver with refractory ascites; refractory congestive heart failure.
Cerebral edema - DECADRON (tablets) can be used in the treatment of patients with cerebral edema of various etiologies. In patients with cerebral edema due to primary or metastatic brain tumors, oral administration of DECADRON may be useful. The drug can also be used to prepare for surgery in patients with intracranial hypertension secondary to brain tumors; as a palliative in patients with inoperable or relapsed brain tumors; in the treatment of cerebral edema following neurosurgery. Certain patients with cerebral edema due to head injury or pseudotumors of the brain may also benefit from oral therapy with DECADRON. The use of the drug in cerebral edema does not exclude the need for a careful neurosurgical evaluation and radical treatments, such as neurosurgery, or other specific therapies.
Gastrointestinal diseases - During critical periods as an adjuvant in: ulcerative colitis; regional enteritis; refractory sprue.
Various- Tuberculous meningitis with subarachnoid or obstructive block in association with appropriate antituberculous therapy. Inflammatory reactions following dental surgery. In exacerbation or for maintenance therapy in selected cases of systemic lupus erythematosus; acute rheumatic endocarditis.
For the differential diagnosis of adrenocortical hyperfunction.
04.2 Posology and method of administration
Therapy must be conducted according to the following general principles:
The posology should be adapted to individual cases, depending on the severity of the disease and the individual response. The severity, prognosis, foreseeable duration of the disease and the patient's response to the drug are determining factors for the posology. (For children, the recommended doses must generally be reduced: the choice of dosage must however be dictated more by the severity of the case than by age or body weight).
Hormone therapy is a complement and not a replacement of conventional therapy which, when indicated, must be instituted.
When the drug has been administered for more than a few days, dose reduction or discontinuation of treatment should be implemented gradually.
Constant monitoring of the patient after discontinuation of corticosteroid therapy is of essential importance, as the sudden reappearance of severe symptoms of the disease for which the patient was treated can be observed.
In acute forms where an immediate effect is needed, high doses can be administered, which for a short period of time may be indispensable.
In chronic forms that require long-term therapy, it is advisable to use the minimum dose sufficient to determine adequate but not necessarily complete relief. If it is considered essential to administer the drug at a high dose for prolonged periods of time, patients should be rigorously monitored to detect any symptoms that may require dose reduction or discontinuation of hormonal treatment.
Chronic diseases are subject to periods of spontaneous remission. During such periods the administration of corticosteroids should be gradually discontinued.
During prolonged therapy it is advisable to carry out the usual laboratory tests at regular intervals such as urinalysis, determination of blood glucose two hours after a meal, control of blood pressure and body weight and chest radiological examination. In addition, it is advisable to periodically check the serum potassium levels. Radiological examinations of the upper gastrointestinal tract should be performed during prolonged treatments in patients with a history of peptic ulcer or in the presence of gastric disorders.
By adequately adjusting the dosage, it is possible to switch from the administration of any other glucocorticoid to the administration of DECADRON.
The following equivalences (milligram for milligram) facilitate the transition from other glucocorticoids to DECADRON:
DECADRON 0.75 mg
Methylprednisolone and triamcinolone 4 mg
Prednisolone and prednisone 5 mg
Hydrocortisone 20 mg
Cortisone 25 mg
Milligram for milligram, dexamethasone is practically equivalent to betamethasone, four to six times more potent than methylprednisolone and triamcinolone, six to eight times more potent than prednisone and prednisolone, 25 to 30 times more potent than hydrocortisone, and about 35 times more potent than cortisone. At the same anti-inflammatory doses, dexamethasone is almost completely free from the sodium retention effects of hydrocortisone and is very similar, in this respect, to hydrocortisone derivatives.
Recommended dosage
In chronic diseases that are normally non-lethal, including endocrine diseases and chronic rheumatic forms, edematous states, respiratory and gastrointestinal diseases, certain dermatological and haematological diseases, start with low doses (from 0.5 to 1 mg per day), gradually increasing the dosage until reaching the minimum effective dose sufficient to induce the desired degree of symptom relief. The dosage can be divided into two, three or four daily doses. Once adequate symptom control has been achieved, the maintenance dosage should involve the minimum dose necessary to allow sufficient relief without excessive hormonal effects. Once the optimal maintenance dosage has been established, regardless of the initial daily dosage, satisfactory results are often obtained with a twice-daily regimen.
In congenital adrenal hyperplasia the daily dosage is generally 0.5-1.5 mg.
In acute non-lethal diseases, including allergic states, ophthalmic diseases, acute and subacute rheumatic diseases, the dosage varies from 2 to 3 mg per day; however, higher doses may be required in some patients. Since these diseases have a well-defined course and resolve within a given period of time, prolonged maintenance therapy is not usually necessary.
Associated therapy
In acute self-limiting allergies and exacerbations of chronic allergic diseases (for example acute allergic rhinitis, acute attacks of seasonal allergic bronchial asthma, drug urticaria, angioneurotic edema and contact dermatitis), the following combination dosage scheme of parenteral and oral therapy is recommended:
---------------------------------------------------------------------------------------
Day 1: A single IM injection 1 ml (4 mg) of DECADRON phosphate for injection (dexamethasone sodium phosphate, MSD)
2nd day: 2 DECADRON tablets (0.5 mg) twice a day
3rd day: 2 DECADRON tablets (0.5 mg) twice a day
4th day: 1 DECADRON tablet (0.5 mg) twice a day
5th day: 1 DECADRON tablet (0.5 mg) twice a day
6th day: 1 DECADRON tablet (0.5 mg) once a day
Day 7: 1 DECADRON tablet (0.5 mg) once a day
8th day: check-up visit
---------------------------------------------------------------------------------------
Dosage schedule (as an alternative to the previous one)
1st day: 1 ml (4 mg / ml) i.m. of DECADRON phosphate for injection
2nd day: 2 DECADRON tablets (0.75 mg) twice a day
3rd day: 2 DECADRON tablets (0.75 mg) twice a day
4th day: 1 DECADRON tablet (0.75 mg) twice a day
5th day: 1 DECADRON tablet (0.75 mg) once a day
6th day: 1 DECADRON tablet (0.75 mg) once a day
7th day: no treatment
8th day: check-up visit
---------------------------------------------------------------------------------------
The aim of this scheme is to offer adequate therapy during acute episodes and at the same time to minimize the danger of overdosing in chronic cases. Additional treatment may be required in some patients, for example with topical steroids, antihistamines, bronchodilators, or other systemic steroids.
In chronic life-threatening diseasessuch as systemic lupus erythematosus, pemphigus, symptomatic sarcoidosis, the initial recommended dosage is 2-4.5 mg per day; higher doses are required in some patients. As soon as adequate relief is achieved, the posology should be gradually reduced to the lowest dose sufficient to determine the desired therapeutic effect.
In case of acute illnesses that endanger the patient's life(for example acute rheumatic endocarditis, acute attacks of systemic lupus erythematosus, severe allergic reactions, pemphigus, neoplasms), the initial dosage varies from 4 to 10 mg per day to be divided into at least four doses; in some patients it may be necessary to increase the dosage to achieve constant control. As soon as control is achieved, the dosage should be gradually reduced to the lowest dose sufficient to maintain constant relief.
If an extremely rapid onset of action is required, the first two or three doses of DECADRON phosphate for injection can be administered intravenously.
In severe allergic reactions the drug of first choice is adrenaline. DECADRON (tablets) is useful as a combination drug or for support therapy.
In the "cerebral edema DECADRON phosphate for injection is generally administered at the beginning at a dose of 10 mg i.v. and subsequently at a dose of 4 mg by the i.m. route every six hours until the symptoms of cerebral edema disappear. A response is typically seen within 12-24 hours; the treatment can be reduced after 2-4 days and gradually eliminated over the course of 5-7 days. For the palliative treatment of patients with recurrent or inoperable tumors, the maintenance dosage should be adapted to individual cases using DECADRON phosphate for injection or DECADRON tablets. A dosage of 2 mg two or three times a day may be adequate. The minimum posology necessary to control cerebral edema should be used. The usual precautions associated with corticosteroid therapy should be followed. Consideration should be given to prescribing antacids, anticholinergics and dietary measures to prevent gastrointestinal ulcers. or bleeding.
In adrenogenital syndrome daily doses of 0.5-1.5 mg may be sufficient to control the disease and to prevent the return of an "abnormal secretion of 17-ketosteroids.
For massive therapy for certain diseases such as acute leukemia, nephrotic syndrome and pemphigus, the recommended dosage ranges from 10 to 15 mg per day. Patients treated with such high dosages must be subjected to strict controls, in order to promptly detect the appearance of serious reactions.
Dexamethasone suppression test
Test for the detection of Cushing's syndrome. For greater accuracy administer one 0.5 mg tablet of DECADRON every six hours for 48 hours. Determine 17-hydroxycorticosteroids in a 24-hour urine sample. Administer 1.0 mg. of DECADRON orally at 11 pm Collect blood for plasma cortisol determination at 8 am the following morning.
Diagnostic test to differentiate adrenal tumors from adrenal hyperpiasia. 2 mg of DECADRON orally every 6 hours for 48 hours. Collect 24-hour urine to determine the excretion of 17-hydroxy corticosteroids.
04.3 Contraindications
Systemic fungal infections
Hypersensitivity to this drug.
04.4 Special warnings and appropriate precautions for use
It is advisable to use the minimum posology necessary for the control of the disease, implementing a gradual dose reduction as soon as this is possible. Medium or high doses of hydrocortisone or cortisone can cause increased blood pressure, water and salt retention, or excessive potassium depletion. Such effects are less likely to occur with synthetic derivatives, unless they are administered at high doses. A low salt diet and extra potassium intake may be needed.
All corticosteroids increase calcium excretion.
When high dosages are given, it is recommended that corticosteroids be taken with meals and antacids are taken between meals to help prevent peptic ulcer.
In patients under corticosteroid therapy exposed to considerable stress, an increase in the dosage of fast-acting corticosteroids is indicated, before, during and after the stressful situation.
A "secondary adrenocortical insufficiency induced by the drug can be minimized by gradually reducing the posology. This type of relative insufficiency may however persist for a few months after the suspension of therapy: in any stressful situation that occurs during this period, it is therefore advisable re-institute hormone therapy If the patient is already on steroid treatment, an increase in dosage may be necessary.
Since the secretion of mineralocorticoids may be inadequate, the simultaneous administration of salts and / or a mineralocorticoid is advisable.
Patients should not be vaccinated against smallpox during corticosteroid therapy. Administration of live viral vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not occur.However, immunization of patients who are taking corticosteroids as replacement therapy, for example in Addison's disease, can be done.
In the presence of hypoprothrombinemia, acetylsalicylic acid should be used with caution during corticosteroid therapy.
The use of DECADRON tablets in existing tuberculosis should be limited to cases of fulminant or disseminated tuberculosis in which the corticosteroid is used to treat the disease in combination with an appropriate antituberculous regimen. When corticosteroids are indicated in patients with latent or tuberculosis. with a positive response to tuberculin, rigorous monitoring is required, as reactivation of the disease may occur During prolonged corticosteroid therapy, these patients should undergo chemoprophylaxis.
Steroids should be used with caution in the presence of: non-specific ulcerative colitis with danger of perforation; abscesses or other pyogenic infections; diverticulitis; recent intestinal anastomoses; active or latent peptic ulcer; kidney failure; hypertension; osteoporosis; myasthenia gravis. Signs of peritoneal irritation after intestinal perforation in patients receiving high doses of corticosteroids may be minimal or absent.
Cases of embolism caused by adipose tissue emboli have been described as a possible complication of hypercortisonism.
Corticosteroids should be used with caution in patients with ophthalmic herpes simplex, given the possible risk of corneal perforation.
In hypothyroid and cirrhotic patients the effects of corticosteroids are more marked.
Corticosteroids can mask the symptoms of infection and overlapping infections may occur during their use. In the course of corticosteroid therapy, reduced resistance to infections and the tendency of infectious processes not to localize can be observed. In addition, corticosteroids can affect the nitroblutetrazolium test for bacterial infections and produce false negative results.
Corticosteroids can activate latent amoebiasis. Therefore, it is recommended to rule out latent or active amoebiasis before initiating corticosteroid therapy in any patient who has been in the tropics or in any patient with unexplained diarrhea.
Psychic alterations may occur during treatment with corticosteroids, ranging from euphoria, insomnia, mood changes, personality alterations, severe depression, to real psychotic manifestations. When present, psychic instability and psychotic tendencies can be aggravated by corticosteroids.
Prolonged use of corticosteroids can cause posterior subcapsular cataract, glaucoma with possible damage to the optic nerves, and can favor the onset of secondary ocular infections due to fungi or viruses.
Children and adolescents undergoing prolonged corticosteroid therapy should be closely monitored for growth and development.
In some patients, steroids can increase or decrease mobility and sperm count.
04.5 Interactions with other medicinal products and other forms of interaction
Diphenyldantoin, phenobarbital, ephedrine and rifampicin may increase the clearance of corticosteroids with decreased blood levels and decreased physiological activity; this requires an adjustment of the corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests, which should be interpreted with caution when administering these drugs.
Prothrombin time should be monitored frequently in patients receiving coumarin corticosteroids and coumarin anticoagulants at the same time, as corticosteroids have impaired response to these anticoagulants in some cases. Some studies have shown that the effect usually caused by the addition of corticosteroids is inhibition of the response to coumarin compounds, although there have been some conflicting reports indicating potentiation.
When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be closely monitored for the development of hypokalaemia.
04.6 Pregnancy and lactation
Pregnancy
As there are still no adequate studies on corticosteroids in relation to human reproduction, the use of these drugs in pregnant women, in nursing mothers or in women of childbearing age requires that the possible risks and advantages deriving from the drug for the mother and for the embryo or fetus. Babies born to mothers who have been treated with substantial doses of corticosteroids during pregnancy should be subjected to careful checks to ascertain any signs of hypoadrenalism.
Feeding time
Corticosteroids have been found in breast milk and can stop growth, interfere with the production of endogenous corticosteroids, or cause other side effects. Mothers on corticosteroid therapy should be advised not to breastfeed.
04.7 Effects on ability to drive and use machines
The substance does not affect the ability to drive and use machines.
04.8 Undesirable effects
Water and electrolyte disturbances: sodium retention; water retention; congestive heart failure in predisposed individuals; potassium depletion; hypokalemic alkalosis; hypertension.
Musculoskeletal: muscle asthenia; steroid myopathy; reduction in muscle mass; osteoporosis; vertebral compression fractures; aseptic necrosis of the femoral head and humerus; spontaneous long bone fractures; tendon ruptures.
Gastrointestinal: peptic ulcer with possible perforation and haemorrhage; perforation of the small and large intestine, particularly in patients with inflammatory bowel disease; pancreatitis; abdominal distension; ulcerative esophagitis.
Dermatological: delayed wound healing; thin and delicate skin; petechiae and bruising; erythema; increased perspiration; can suppress responses to skin tests. Other skin disorders such as allergic dermatitis, urticaria, angioneurotic edema.
Neurological: convulsions; increased intracranial pressure with papilledema (pseudotumor of the brain), usually after treatment; dizziness; headache.
Endocrinological: menstrual abnormalities; onset of cushingoid state; stunting in children; secondary adrenocortical and pituitary insufficiency, particularly during periods of stress due to trauma, surgery or disease; impaired tolerance to carbohydrates; manifestations of latent diabetes mellitus; increased need for insulin or oral hypoglycemic agents in diabetic patients.
Ophthalmologists: posterior subcapsular cataract; increased intraocular pressure; glaucoma; exophthalmos.
Metabolic: protein catabolism with negative nitrogen balance.
Others: hypersensitivity; Thromboembolism; weight gain; increased appetite; Nausea; malaise.
04.9 Overdose
There are no data on overdose.
05.0 PHARMACOLOGICAL PROPERTIES
DECADRON (dexamethasone, MSD) is a synthetic glucocorticoid mainly used for its powerful anti-inflammatory effect. While its anti-inflammatory activity is marked, even at low doses, its effect on electrolyte metabolism is limited. Glucocorticoids cause profound and various metabolic effects. They also modify the body's immune response to various stimuli.
05.1 Pharmacodynamic properties
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05.2 Pharmacokinetic properties
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05.3 Preclinical safety data
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06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Cornstarch; Calcium dibasic phosphate dihydrate; Lactose monohydrate; Magnesium stearate; E142 bright acid green BS.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
Validity: 36 months
06.4 Special precautions for storage
There are no special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
PVC and aluminum blisters
10 tablets of 0.5 mg
10 tablets of 0.75 mg
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Visufarma S.r.l
Via Canino, 21 - 00191 - Rome
08.0 MARKETING AUTHORIZATION NUMBER
10 tablets of 0.5 mg 014729014
10 tablets of 0.75 mg 014729038
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
June 2000
10.0 DATE OF REVISION OF THE TEXT
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