Generic drug of the therapeutic class: Anti-inflammatories
active ingredients: Dexamethasone
laboratory: Sanofi-Aventis France
Box of 30
AFFECTIONS OR DISEASES:
o Evolutionary outbursts of systemic diseases, including: systemic lupus erythematosus, vasculitis, polymyositis, visceral sarcoidosis.
o Severe autoimmune bullous dermatoses, in particular pemphigus and bullous pemphigoid,
o severe forms of infant angiomas,
o certain forms of lichen plan,
o certain acute urticaria,
o severe forms of neutrophilic dermatoses.
o progressive attacks of ulcerative colitis and Crohn's disease,
o chronic active autoimmune hepatitis (with or without cirrhosis),
o severe acute alcoholic hepatitis, histologically proven.
o Subdose severe De Quervain thyroiditis,
o certain hypercalcemia,
o congenital adrenal hyperplasia, in case of failure of hydrocortisone.
o severe immunologic thrombocytopenic purpura,
o autoimmune hemolytic anemias,
o in combination with various chemotherapies in the treatment of lymphoid malignant hemopathies,
o Acquired or congenital chronic erythroblastopenia.
o tuberculous pericarditis and severe forms of life-threatening tuberculosis,
o Pneumocystis carinii pneumonia with severe hypoxia.
o anti-emetic treatment during antineoplastic chemotherapy,
o edematous and inflammatory thrust associated with antineoplastic treatments (radio and chemotherapy).
o nephrotic syndrome with minimal glomerular lesions,
o nephrotic syndrome of primitive segmental and focal hyalinosis,
o Stage III and IV of lupus nephropathy,
o intrarenal granulomatous sarcoidosis,
o vasculitis with renal impairment,
o primitive extra-capillary glomerulonephritis
o cerebral edema of tumoral cause,
o chronic polyradiculoneuropathy, idiopathic, inflammatory,
o infantile spasm (West syndrome) / Lennox-Gastaut syndrome,
o Multiple sclerosis in relapse of intravenous corticosteroids.
severe anterior and posterior uveitis,
o oedematous exophthalmos,
o certain optic neuropathies, in reliance on intravenous corticosteroids (in this indication, the first-line oral route is not recommended).
o certain serous otitis,
o nasosinusic polyposis
o certain acute or chronic sinusitis,
o seasonal allergic rhinitis in short cure,
o Stridulous acute laryngitis (subglottic laryngitis) in children.
o persistent asthma, preferably in short course, in case of failure of inhaled treatment in high doses,
o exacerbations of asthma, in particular severe acute asthma,
o chronic obstructive pulmonary disease in assessing the reversibility of the obstructive syndrome,
o active sarcoidosis,
o Diffuse interstitial pulmonary fibrosis.
o rheumatoid arthritis and certain polyarthritis,
o pseudo rhizomelic arthritis and Horton's disease,
o acute rheumatic fever,
o Severe and rebellious cervico-brachial neuralgia.
· TRANSPLANTATION OF ORGAN AND ALLOGENIC HEMATOPOIETIC STEM CELLS
o prophylaxis or treatment of transplant rejection,
o prophylaxis or treatment of graft-versus-host disease.
Dosage DECTANCYL 0.5 mg Tablet Box of 30
Anti-inflammatory equivalence (equipotence) for 5 mg prednisone: 0.75 mg dexamethasone
The dosage varies according to the diagnosis, the severity of the condition, the prognosis, the patient's response and the tolerance to the treatment.
· Attack treatment: 0.05 mg / kg / day at 0.2 mg / kg / day (0.35 mg / kg / day at 1.2 mg / kg / day prednisone equivalent). As an indication: 6 to 24 tablets in an adult of 60 kg.
In severe inflammatory diseases, the dosage ranges from 0.1 to 0.2 mg / kg / day of dexamethasone (0.75 mg / kg / day to 1.2 mg / kg / day prednisone equivalent). As an indication: 12 to 24 tablets per day for an adult of 60 kg.
Very exceptional situations may require higher doses.
· Maintenance treatment: 0.5 to 1.5 mg / day, or 1 to 3 tablets daily.
The dosage should be appropriate to the condition and weight of the child.
In children who can not swallow, the tablets will be crushed and mixed with the diet.
· Attack treatment: from 0.075 mg / kg / day to 0.3 mg / kg / day of dexamethasone (0.5 to 2 mg / kg / day prednisone equivalent). As an indication: 4 to 15 tablets for a child of 25 kg.
· Maintenance treatment: 0.03 mg / kg / day. As an indication 1 to 2 tablets for a child of 25 kg.
In the case of congenital adrenal hyperplasia, in case of failure of hydrocortisone, the dosage varies from 0.25 to 0.5 mg at bedtime (0.5 to 1 tablet per day).
The prescription of alternating day corticosteroid therapy (one day without corticosteroid and the second day with a daily double dose that would have been required) is used in children to try to limit stunting. This alternating day schedule can be considered only after the control of inflammatory disease by the high doses of corticosteroids, and when during the decay no rebound is observed.
Treatment at the "attack dose" should be continued until the disease is well controlled. Decay must be slow. Obtaining a weaning is the goal. Maintaining a maintenance dose (minimum effective dose) is a compromise that is sometimes necessary.
For prolonged treatment at high doses, the first doses can be divided into two daily doses. Thereafter, the daily dose may be administered as a single dose preferably in the morning during a meal.
The rate of withdrawal depends mainly on the duration of treatment, the starting dose and the disease.
The treatment causes resting secretions of ACTH and cortisol with sometimes lasting adrenal insufficiency. When weaning, stopping should be done gradually, in stages because of the risk of relapse: reduction of 10% every 8 to 15 days on average.
For short courses of less than 10 days, stopping treatment does not require decay.
When decreasing doses (prolonged cure): at the dosage of 5 to 7 mg of prednisone equivalent, when the causal disease no longer requires corticosteroid treatment, it is desirable to replace the synthetic corticoid with 20 mg / day of hydrocortisone until recovery of corticotropic function. If corticosteroid therapy is to be maintained at less than 5 mg prednisone equivalent per day, a small dose of hydrocortisone can be added to achieve a hydrocortisone equivalent of 20 to 30 mg per day. When the patient is only under hydrocortisone, it is possible to test the corticotropic axis by endocrine tests. These tests do not eliminate the possibility of adrenal insufficiency during a stress.
Under hydrocortisone or even at a distance from arrest, the patient should be advised of the need to increase the usual dosage or to resume replacement therapy (eg 100 mg hydrocortisone intramuscularly every 6 to 8 hours) in case stress: surgery, trauma, infection.
This drug is generally contraindicated in the following situations (there is, however, no absolute contraindication for life-threatening corticosteroid therapy):
· Any infectious condition, with the exception of the indications specified (see section Therapeutic indications ),
· Some developing viruses (including hepatitis, herpes, chickenpox, shingles),
· Psychotic states not yet controlled by a treatment,
· Live vaccines,
Hypersensitivity to dexamethasone or any of the excipients.
Dectancyl side effects
They are especially to be feared in important doses or during a prolonged treatment over several months.
· Hydroelectrolytic disorders: hypokalaemia, metabolic alkalosis, water-soluble retention, arterial hypertension, congestive heart failure.
· Endocrine and metabolic disorders: iatrogenic Cushing's syndrome, inertness of ACTH secretion, sometimes permanent adrenocortical atrophy, decreased glucose tolerance, revelation of latent diabetes, retarded growth in children, menstrual irregularities.
· Musculoskeletal disorders: Muscular atrophy preceded by muscle weakness (increased protein catabolism), osteoporosis, pathological fractures, especially vertebral compression, aseptic osteonecrosis of the femoral heads.
Some cases of tendon ruptures have been described in an exceptional way, in particular in co-prescription with fluoroquinolones.
· Digestive disorders: peptic ulcers, ulceration of the small bowel, perforations and digestive haemorrhages; acute pancreatitis has been reported, especially in children.
· Skin disorders: skin atrophy, acne, purpura, bruising, hypertrichosis, delayed healing.
· Neuropsychic disorders:
o frequently: euphoria, insomnia, excitement;
o rarely: manic pace, confusional or confuso-oniric states, convulsions (general or intrathecal);
o Depressive state when the treatment is stopped.
· Eye disorders: some forms of glaucoma and cataracts.