Medicinal Products

BETAMETHASONE ZENTIVA 2 mg

Celestene Generic Drug
Therapeutic class: Anti-inflammatories
active ingredients: Betamethasone
laboratory: Sanofi-Aventis France

Breakable dispersible tablet
Box of 20
All forms

Indication

AFFECTIONS OR DISEASES:

I-collagen-connective

Evolutionary thrusts of systemic diseases, including: systemic lupus erythematosus, vasculitis, polymyositis, visceral sarcoidosis.

II-DERMATOLOGICALS

a-severe autoimmune bullous dermatoses, especially pemphigus and bullous pemphigoid

severe b-forms of infant angiomas

c-some forms of lichen plan

d-certain acute urticaria

severe e-forms of neutrophilic dermatoses

III- DIGESTIVE

a-progressive flares of ulcerative colitis and Crohn's disease

b-chronic active autoimmune hepatitis (with or without cirrhosis).

c-severe acute alcoholic hepatitis, histologically proven

IV-ENDOCRINE

Subacute a-thyroiditis of severe De Quervain

b-certain hypercalcemia

V- HEMATOLOGICAL

Severe immunological thrombocytopenic purpura

autoimmune haemolytic anemias

c-in combination with various chemotherapies in the treatment of lymphoid malignant hemopathies

Acquired or congenital chronic erythroblastopenia

VI-INFECTIOUS

a-pericarditis tuberculosis and severe forms of life-threatening tuberculosis

b- Pneumocystis carinii pneumopathy with severe hypoxia

VII-NEOPLASTIC

a-anti-emetic treatment during antineoplastic chemotherapy

oedematous and inflammatory b-flush associated with antineoplastic treatments (radio and chemotherapy)

VIII-nephrological

a-nephrotic syndrome with minimal glomerular lesions

Nephrotic b-syndrome of primitive segmental and focal hyalinosis

c-stage III and IV of lupus nephropathy

d-sarcoidosis granulomatous intrarenal

e-vasculitis with renal impairment

primitive extra-capillary f-glomerulonephritis

IX-NEUROLOGICAL

Has gravis

b-cerebral edema of tumoral cause

chronic, idiopathic, inflammatory c-polyradiculoneuropathy

d-infantile spasm (West syndrome) / Lennox-Gastaut syndrome

e-multiple sclerosis in relapse of intravenous corticosteroid therapy

X-OPHTHALMOLOGIC

severe anterior and posterior uveitis

edematous b-exophthalmos

c-certain optic neuropathies, in reliance on intravenous corticosteroids (in this indication, the first-line oral route is not recommended)

XI-ENT

a-certain serous otitis

b-nasosinusic polyposis

c- some acute or chronic sinusitis

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 high doses

b-exacerbations of asthma, especially severe acute asthma

c-chronic obstructive pulmonary disease in assessing the reversibility of obstructive syndrome

d-progressive sarcoidosis

Diffuse interstitial pulmonary e-fibrosis

XIII-rheumatological

a-rheumatoid arthritis and some polyarthritis

b-rhizomelic pseudopolyarthritis and Horton's disease

c-rheumatic fever

severe and rebellious cervico-brachial neuralgia

XIV-TRANSPLANTATION OF ORGAN AND ALLOGENIC HEMATOPOIETIC STEM CELLS

a-prophylaxis or treatment of transplant rejection

b-prophylaxis or treatment of graft-versus-host disease

Dosage BETAMETHASONE ZENTIVA 2 mg Breakable dispersible tablet Box of 20

RESERVED FOR ADULTS

Oral way.

Anti-inflammatory equivalence (equipotence) for 5 mg prednisone: 0.75 mg betamethasone.

The tablets can be swallowed as is with a little water or dissolved in a little water, preferably during meals.

This drug is particularly suitable for the treatment of attack or short-term treatments requiring medium or high doses in adults.

In maintenance treatment, there are more appropriate dosages.

In children, there are more appropriate dosages and pharmaceutical forms.

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 to 0.2 mg / kg / day (0.35 mg to 1.2 mg / kg / day prednisone equivalent). As an indication: 1.5 to 6 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: 3 to 6 tablets per day for an adult of 60 kg.

Very exceptional situations may require higher doses.

IN GENERAL

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 the 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, 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.

Administration mode :

They can be swallowed as is with a little water or dissolved in a little water, preferably during the meal.

Against indications

This medication is usually contraindicated in the following situations:

(However, there is no absolute contraindication for a corticosteroid indication of vital indication):

· Any infectious condition excluding specified indications (see Indications),

· Some developing viruses (including hepatitis, herpes, chickenpox, shingles),

· Psychotic states not yet controlled by a treatment,

· Live vaccines,

· Hyper-sensitivity to one of the compounds,

· Phenylketonuria (related to the presence of aspartame).

This drug is generally not recommended in combination

with non-antiarrhythmic drugs, giving torsades de pointes (see Drug Interactions).

Adverse effects Betamethasone Zentiva

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, ACTH secretion inertia, sometimes permanent adrenocortical atrophy, decreased glucose tolerance, development of latent diabetes, stunting 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.

· Digestive disorders: hiccups, 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:

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.

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