Medicinal Products

BETNESOL 0.5 mg

Generic drug of the therapeutic class: Anti-inflammatories
active ingredients: Betamethasone
laboratory: Sigma Tau (Italy)

Effervescent tablet
Box of 30
All forms

Indication

AFFECTIONS OR DISEASES :
I - COLLAGENOSES-CONNECTIVITES :
a - Evolutionary thrusts of systemic diseases, in particular: systemic lupus erythematosus, vasculitis, polymyositis, visceral sarcoidosis.
II - DERMATOLOGICAL
a - Severe autoimmune bullous dermatoses, especially pemphigus and bullous pemphigoid.
b - severe forms of the angiomas of the infant.
c - certain forms of lichen plan.
d - certain acute urticaria.
e - severe forms of neutrophilic dermatoses.
III - DIGESTIVE :
a - progressive attacks of ulcerative colitis and Crohn's disease.
b - active autoimmune chronic hepatitis (with or without cirrhosis).
c - severe acute alcoholic hepatitis, histologically proven.
IV - ENDOCRINE :
a - Subacute severe De Quervain thyroiditis.
b - certain hypercalcemias.
V - HEMATOLOGICAL :
a - severe immunologic thrombocytopenic purpura.
b - autoimmune hemolytic anemias.
c - in combination with various chemotherapies in the treatment of lymphoid malignant hemopathies.
d - Acquired or congenital chronic erythroblastopenia.
VI - INFECTIOUS :
a - tuberculous pericarditis and severe forms of life-threatening tuberculosis.
b - Pneumocystis carinii pneumonia with severe hypoxia.
VII - NEOPLASICS :
a - anti-emetic treatment during antineoplastic chemotherapy.
b - oedematous and inflammatory thrust associated with antineoplastic treatments (radio and chemotherapy).
VIII - NEPHROLOGIC :
a - Nephrotic syndrome with minimal glomerular lesions.
b - Nephrotic syndrome of primitive segmental and focal hyalinosis.
c - stage III and IV of lupus nephropathy.
d - intrarenal granulomatous sarcoidosis.
e - vasculitis with renal involvement.
primitive extracapillary glomerulonephritis.
IX - NEUROLOGICAL :
a - myasthenia.
b - cerebral edema of tumoral cause.
c - chronic polyradiculoneuropathy, idiopathic, inflammatory.
d - infantile spasm (West syndrome) / Lennox-Gastaut syndrome.
e - Multiple sclerosis in relapse of intravenous corticosteroid therapy.
X - OPHTHALMOLOGIC :
severe anterior and posterior uveitis.
b - edematous exophthalmos.
c - certain optic neuropathies, in rela- tion with intravenous corticosteroids (in this indication, the first-line oral route is not recommended).
XI - ENT :
a - certain serous otitis.
b - nasosinus polyposis
c - some acute or chronic sinusitis.
d - seasonal allergic rhinitis in short cure.
Stridulous acute laryngitis (subglottic laryngitis) in children.
XII - RESPIRATORY :
a - persistent asthma, preferably in short course, in case of failure of inhaled treatment at high doses.
b - exacerbations of asthma, in particular severe acute asthma.
c - chronic obstructive bronchopneumopathy in evaluation of the reversibility of the obstructive syndrome.
d - progressive sarcoidosis.
e - diffuse pulmonary interstitial fibrosis.
XIII - RHEUMATOLOGICAL :
a - rheumatoid arthritis and some polyarthritis.
b - rhizomelic pseudopolyarthritis and Horton's disease.
c - rheumatic fever.
d - severe and rebellious cervicobrachial neuralgia.
XIV - TRANSPLANTATION OF ORGAN AND ALLOGENIC HEMATOPOIETIC STEM CELLS :
a - prophylaxis or treatment of transplant rejection.
b - prophylaxis or treatment of the graft versus host reaction.

Dosage BETNESOL 0.5 mg Effervescent tablet Box of 30

Oral way.
Anti-inflammatory equivalence (equipotence) for 5 mg prednisone: 0.75 mg betamethasone.
The tablets can be swallowed with a glass of water but will preferably be dissolved in a little water. They are effervescent and color the dilution water.
ADULTS:
- 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 to 0.2 mg / kg / day (0.35 mg / kg / day to 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 varies from 0.1 to 0.2 mg / kg / day of betamethasone (0.75 mg / kg / day to 1.2 mg / kg / day equivalent prednisone). As an indication: 12 to 24 tablets per day for an adult of 60 kg.
- Very exceptional situations may require higher doses.
- Maintenance treatment: from 0.5 to 1.5 mg / day, ie from 1 to 3 tablets per day.
CHILDREN:
- The dosage should be appropriate to the condition and weight of the child.
- Attack treatment: 0.075 mg / kg / day to 0.3 mg / kg / day of betamethasone (0.5 to 2 mg / kg / day equivalent prednisone). 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.
- The prescription of corticosteroid alternating day (one day without corticosteroid and the second day with a double dosage of the daily dosage that would have been required) is used in children to try to limit stunting. This alternate day schedule can be considered only after control of inflammatory disease by high doses of corticosteroids, and when during decay no rebound is observed.
IN GENERAL :
- "At the attack dose" treatment should be continued until the disease is permanently controlled. In the case of long-term treatment, the decrease 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.
- Stop treatment:
. 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, the stop must 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, alone, the possibility of occurrence 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.

Against indications

CONTRAINDICATED:
This drug is generally contraindicated in the following situations (there is, however, no absolute contraindication for life-threatening corticosteroid therapy):
- Hyper-sensitivity to one of the compounds.
- Any infectious condition excluding specified indications (see indications section).
- Some viruses in evolution (in particular hepatitis, herpes, chickenpox, shingles).
Psychotic states not yet controlled by treatment.
- Live vaccines.
NOT RECOMMENDED: This drug is not recommended in combination with sultopride or live attenuated vaccine (see section interactions).

Betnesol side effects

They are especially to be feared in important doses or during a prolonged treatment over several months.
- Hydro-electrolytic disorders: hypokalemia, metabolic alkalosis, water-soluble retention, arterial hypertension, congestive heart failure.
- Endocrine and metabolic disorders: iatrogenic Cushing's syndrome, inertia of ACTH secretion, sometimes permanent adrenocortical atrophy, decrease in glucose tolerance, revelation of latent diabetes, stunting of growth in children, menstrual irregularities.
- Musculoskeletal disorders: Muscular atrophy preceded by muscle weakness (increased protein catabolism), osteoporosis, pathological fractures, particularly 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 gastrointestinal bleeding, acute pancreatitis have been reported, especially in children.
- Skin disorders: acne; purpura; bruising, hypertrichosis, delayed healing.
- Neuropsychic disorders:
. frequently: euphoria, insomnia, excitement;
. rarely: manic pace, confusional or confuso-oniric conditions, convulsions (general or intrathecal);
. depressive state upon discontinuation of treatment.
- Eye disorders: some forms of glaucoma and cataracts.

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