Quest for the right Drug
ספסמלגין SPASMALGIN (ATROPINE SULFATE, CODEINE PHOSPHATE, PAPAVERINE HYDROCHLORIDE, PARACETAMOL)
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
Pregnancy & Lactation : הריון/הנקה
4.6 Fertility, pregnancy and lactation The medicine is forbidden to use during pregnancy and breastfeeding Paracetamol & Codeine: The safety of paracetamol and codeine tablets during pregnancy has not been established and in view of the possible association of codeine with respiratory depression and heart malformations, use during this period should be avoided. Codeine should not be used during breastfeeding. At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses. If the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. Atropine: Atropine crosses the placenta and traces are found in breast milk. It should therefore only be used with caution. Papaverine: Pregnancy Risk cannot be ruled out. There are no satisfactory studies in pregnant women, but animal studies demonstrated a risk to the fetus; potential benefits of the drug may outweigh the risks Lactation Not known whether papaverine distributes into human milk. Use with caution in nursing women.
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
01/03/2002
הגבלות
תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת
מידע נוסף