Quest for the right Drug
בקלופן ביואינדוסטריה אל.אי.אמ. 10 מ"ג/5 מ"ל BACLOFENE BIOINDUSTRIA L.I.M 10 MG/5 ML (BACLOFEN)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תוך-שדרתי : INTRATHECAL
צורת מינון:
תמיסה להזרקה : SOLUTION 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
Interactions : אינטראקציות
4.5 Interaction with other medicinal products and other forms of interaction The co-administration of other intrathecal agents with Baclofene Bioindustria L.I.M. 10 mg/5 ml is not recommended. An attempt should be made to reduce or discontinue concomitant oral antispastic medications, preferably before initiating baclofen infusion. However, abrupt reduction or discontinuation during chronic intrathecal baclofen therapy should be avoided. There is little experience with the use of Baclofene Bioindustria L.I.M. 10 mg/5 ml in combination with systemic medications to be able to predict specific drug-drug interactions, although it is suggested that the low baclofen systemic exposure after intrathecal administration could reduce the potential for pharmacokinetic interactions (see section 5.2). Experience with oral baclofen would suggest that: • Alcohol and other compounds affecting the CNS: There may be increased sedation where baclofen is taken concomitantly with other drugs acting on the CNS (e.g. analgesics, neuroleptics, barbiturates, benzodiazepines, anxiolytics) or with alcohol. • Tricyclic antidepressants: During concurrent treatment with tricyclic antidepressants, the effect of baclofen may be potentiated, resulting in muscular hypotonia. • Antihypertensives: Since concomitant treatment with baclofen and anti-hypertensives is likely to increase the fall in blood pressure, it may be necessary to reduce the dosage of antihypertensive medication. • Levodopa: Concomitant use of oral baclofen and levodopa/dopa-decarboxylase (DDC) inhibitor resulted in increased risk of adverse events like visual hallucinations, confusional state, headache and nausea. Worsening of the symptoms of Parkinsonism has also been reported. Thus, caution should be exercised when intrathecal baclofen is administered to patients receiving levodopa/DDC inhibitor therapy. Morphine The combined use of morphine and intrathecal baclofen has been responsible for hypotension in one patient; the potential for this combination to cause dyspnoea or other CNS symptoms cannot be excluded. Anaesthetics Concomitant use of intrathecal baclofen and general anaesthetics (e.g. fentanyl, propofol) may increase the risk of cardiac disturbances and seizures. Thus, caution should be exercised when anaesthetics are administered to patients receiving intrathecal baclofen.
שימוש לפי פנקס קופ''ח כללית 1994
Spasticity associated with multiple sclerosis, spinal cord injuries and spinal cord diseases
תאריך הכללה מקורי בסל
01/01/1995
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