Quest for the right Drug
בטנזול טבליות BETNESOL TABLETS (BETAMETHASONE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
טבליה : TABLETS
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Posology : מינונים
4.2 Posology and method of administration Glucocorticoids should only be administered at lowest therapeutic required doses and as long as it is absolutely necessary to achieve and maintain the desired therapeutic effect. The dosage must be adjusted to the specific situation of the patient, considering severity of disease of the occurred effect and glucocorticoid tolerance. Posology Adults and adolescents over 12 years of age The daily dose is administered usually in the morning and at once as this will less affect the rhythm of adrenal cortex-secretion. Short-term treatment Acute asthma attacks, pollinosis or other allergic diseases of the respiratory tract, generalised eczema, urticaria, dermatitis medicamentosa, and various inflammatory skin diseases. 6 tablets in the morning for 2 days, followed by 1 tablet in the morning for 2 days, followed by ½ tablet in the morning for 2 days. Arthritis rheumatica: 1-4 tablets (0,5 mg to 2 mg) daily in the morning for 1-2 weeks, then a gradual withdrawal of treatment, starting with one tablet less a day, later half a tablet less, by keeping each dosage for one week. Thus it is possible to evaluate the minimum effective dose. Other diseases: Betnesol effervescent tablets is indicated particularly for patients with nephrosis since it shows nearly no sodium chloride and water retention effect. In this disease the usual dose is 1-8 tablets (0,5 mg to 4 mg) daily in the morning for 1 to 3 weeks, maybe also longer. Then the medication is withdrawn step by step. To reach the therapeutic effect in pemphigus, erythematosus or collagenosis of the skin often higher doses are required. Dosage in children over 6 years of age The effects of glucocorticoids on the pathophysiology and history of the disease are considered similar in adults and children. In children in general lower doses than indicated above are sufficient, but dosage should be adjusted more to the severity of the disease than to age, body weight, or body size. After sufficient response Betnesol should be withdrawn step by step as quickly as possible. Long- term treatment is not recommended. Exact dosages have not been established in clinical trials. From clinical experience following guidelines for short-time treatment were shown: Recommended initial dose: 7 to 12 years: up to 8 tablets/day (= 4 mg). Elderly Caution is advised on higher frequency of adverse events in older patients during administration of betamethasone particularly in long-term therapy including osteoporosis, worsening diabetes, hypertension, susceptibility to infections and thinning of the skin. Patients with impaired liver function and thyroid disease Betamethasone is basically metabolized in the liver. In patients with hepatic insufficiency or hypothyroidism relatively low doses may be sufficient or dose reduction may be required. Method of administration Betnesol tablets should be solved in water and then the solution should be drunk, or the tablets could be swallowed whole with some water. Only for short-term treatment The dosage to continue therapy has to be adjusted to the disease and the response of the patient. The patient must therefore be monitored and the dosage checked frequently or adjusted, respectively. Maintenance doses of more than 7.5 mg prednisolone equivalent/day (= Cushing threshold dose; corresponding approximately to 1 mg betamethasone) have to be avoided, because they suppress the endogenous cortisol production by hypothalamic inhibition without reaching the intended pharmacologic effects. To lower the undesired effects the following therapy instructions have to be followed: •lowest therapeutic required dose and shortest duration of therapy. Although short-term high-dosage glucocorticoid administration (up to 10 days) is not critical, an initial high dose should be lowered to a maintenance dose below twice the Cushing threshold dose within short time. The entire dose should be administered in the morning before 8 o’clock, since the rhythm of adrenal secretion. In children and adolescents up to 14 years a 4 days-therapy-free interval (intermittent therapy) should be kept following 3-days therapy because of the risk of growth retardation. Withdrawal has to be done solely with treatment pauses.
שימוש לפי פנקס קופ''ח כללית 1994
Endocrine disorders, hypercalcemia associated with cancer, rheumatic disorders, collagen diseases, acute rheumatic carditis, dermatological diseases, severe allergic conditions, ophthalmic diseases, respiratory diseases, hematological disorders, neoplastic diseases, gastrointestinal diseases, nephrotic syndrome, tuberculous meningitis, trichinosis, multiple sclerosis
תאריך הכללה מקורי בסל
01/01/1995
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