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עמוד הבית / קומטן ® / מידע מעלון לרופא

קומטן ® COMTAN ® (ENTACAPONE)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : PER OS

צורת מינון:

טבליות מצופות פילם : FILM COATED TABLETS

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
הגבלות תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת

בעל רישום

NOVARTIS ISRAEL LTD

רישום

114 07 29631 01

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0 ₪

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