Quest for the right Drug
דפו מדרול 40 מ"ג/מ"ל DEPO MEDROL 40 MG/ML (METHYLPREDNISOLONE ACETATE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
זריקה ליד המפרק, תוך-שרירי, תוך מפרקי, לתוך פצע, לתוך נוזל העצם, להחדרה רקטלית, לרקמות רכות : PERIARTICULAR, I.M, INTRA-ARTICULAR, INTRA-LESIONAL, INTRABURSAL, INTRARECTAL INSTILLATION, SOFT TISSUES
צורת מינון:
תרחיף להזרקה : SUSPENSION FOR INJECTION
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
Pregnancy & Lactation : הריון/הנקה
4.6 Fertility, pregnancy and lactation
Fertility
2023-0085608 Page 14 of 21
Corticosteroids have been shown to impair fertility in animal studies (see section 5.3).
Pregnancy
The ability of corticosteroids to cross the placenta varies between individual drugs, however, methylprednisolone does cross the placenta. One retrospective study found an increased incidence of low birth weights in infants born of mothers receiving corticosteroids. In humans, the risk of low birth weight appears to be dose related and may be minimized by administering lower corticosteroid doses.
.Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate in man, however, when administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. Although neonatal adrenal insufficiency appears to be rare in infants who were exposed in utero to corticosteroids, those exposed to substantial doses of corticosteroids must be carefully observed and evaluated for signs of adrenal insufficiency. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with normal pregnancies may be treated as though they were in the non- gravid state. However, corticosteroids do not appear to cause congenital anomalies when given to pregnant women.
Since adequate human reproductive studies have not been done with methylprednisolone acetate, this medicinal product should be used during pregnancy only after a careful assessment of the benefit-risk ratio to the mother and fetus.
Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy.
Breast-feeding
Corticosteroids are excreted in small amounts in breast milk, however, doses of up to 40 mg daily of methylprednisolone are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression, but the benefits of breast-feeding are likely to outweigh any theoretical risk.
Corticosteroids distributed into breast milk may interfere with endogenous glucocorticoid production in nursing infants. This medicinal product should be used during breast feeding only after a careful assessment of the benefit-risk ratio to the mother and infant.
שימוש לפי פנקס קופ''ח כללית 1994
Rheumatoid arthritis, osteoarthritis, other arthritic conditions by intra-articular injection, inflammatory, allergic & rheumatic conditions requiring a glucocorticoid effect, in patients for whom treatment with oral corticosteroid is not feasible
תאריך הכללה מקורי בסל
01/01/1995
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דפו מדרול 40 מ"ג/מ"ל
