Quest for the right Drug
קומטן ® COMTAN ® (ENTACAPONE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
טבליות מצופות פילם : FILM COATED 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 Entacapone should only be used in combination with levodopa/benserazide or levodopa/carbidopa. The prescribing information for these levodopa preparations is applicable to their concomitant use with entacapone. Posology One 200 mg tablet is taken with each levodopa/dopa decarboxylase inhibitor dose. The maximum recommended dose is 200 mg ten times daily, i.e. 2,000 mg of entacapone. Entacapone enhances the effects of levodopa. Hence, to reduce levodopa-related dopaminergic adverse reactions, e.g. dyskinesias, nausea, vomiting and hallucinations, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment. The daily dose of levodopa should be reduced by about 10 to 30% by COM API FEB14 CL V8 COR CPO CL REF BPI 180613 extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient. Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations slightly more (5 to 10%) than from standard levodopa/carbidopa preparations. Hence, patients who are taking standard levodopa/benserazide preparations may need a larger reduction of their levodopa dose when entacapone is initiated. If entacapone treatment is discontinued, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms. Renal impairment does not affect the pharmacokinetics of entacapone and there is no need for dose adjustment. However, for patients who are receiving dialysis therapy, a longer dosing interval may be considered (see section 5.2 Pharmacokinetic properties). Hepatic impairment: see section 4.3 Contraindications. Elderly No dosage adjustment of entacapone is required for elderly patients. Children Comtan is not recommended for use in children below age 18 due to lack of data on safety and efficacy. Method of administration Entacapone is administered orally and simultaneously with each levodopa/carbidopa or levodopa/benserazide dose. Entacapone can be taken with or without food (see section 5.2 Pharmacokinetic properties).
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
01/01/2000
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