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עמוד הבית / בריקלין טורבוהלר / מידע מעלון לרופא

בריקלין טורבוהלר BRICALIN TURBUHALER (TERBUTALINE SULFATE)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

שאיפה : INHALATION

צורת מינון:

אבקה לשאיפה : POWDER FOR INHALATION

Pregnancy & Lactation : הריון/הנקה

4.6        Pregnancy and lactation
There are, no adequate and well-controlled studies of terbutaline sulfate in pregnant women.
Published animal studies show that rat offspring exhibit alterations in behavior and brain development, including decreased cellular proliferation and differentiation when dams were treated subcutaneously with terbutaline during the late stage of pregnancy and lactation period. Terbutaline exposures in rat dams were approximately 6.5 times the common human dose in adults of 15 mg/day, on a mg/m2 basis.

Oral terbutaline sulfate has not been approved for and should not be used for acute or maintenance tocolysis. In particular, terbutaline sulfate should not be used for tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration. [See Boxed Warning: Tocolysis and Contraindications, Tocolysis.]

In animal embryofetal developmental studies, no teratogenic effects were observed in offspring when pregnant rats and rabbits received terbutaline sulfate at oral doses up to 50 mg/kg/day, approximately 32 and 65 times, respectively, the maximum recommended daily oral dose for adults, on a mg/m2 basis.
Terbutaline sulfate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Terbutaline is secreted via breast milk but any effect on the infant is unlikely at therapeutic doses.
Transient hypoglycemia has been reported in newborn preterm infants after maternal beta2- agonist treatment.

שימוש לפי פנקס קופ''ח כללית 1994 Bronchial asthma, bronchospasm
תאריך הכללה מקורי בסל 01/01/1995
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