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עמוד הבית / פרוטין 20 / מידע מעלון לרופא

פרוטין 20 PAROTIN 20 (PAROXETINE AS HYDROCHLORIDE)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : PER OS

צורת מינון:

טבליות מצופות : COATED TABLETS

Posology : מינונים

4.2      Posology and method of administration
It is recommended that Parotin is administered once daily in the morning with food. The tablet should be swallowed whole or crushed and swallowed immediately.

Depressive disorder:
Adults
The recommended dose is 20 mg daily. Some patients not responding to a 20 mg dose may benefit from dose increases in 10mg/day increments, up to a maximum dosage of 50mg/day according to the patient's response.
As with all antidepressant drugs, dosage should be reviewed and adjusted if necessary within 2 to 3 weeks of initiation of therapy and thereafter as judged clinically appropriate.
Patients with depression should be treated for a sufficient period to ensure that they are free from symptoms.
This period may be several months.

Obsessive compulsive disorder:
Adults
The recommended dose is 40 mg daily. Patients should start on 20 mg and can be increased weekly in 10 mg increments. Some patients will benefit from having their dose increased up to a maximum of 60 mg/day.
Patients with OCD should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months or even longer.
Panic disorder:
Adults
The recommended dose is 40 mg daily. Patients should be started on 10mg/day and the dose increased weekly in 10mg increments according to patient's response. Some patients may benefit from having their dose increased up to a maximum of 60mg/day.
A low initial starting dose is recommended to minimize the risk of a potential worsening of panic symptomatology, which is generally recognized to occur early in the treatment of this disorder.
Patients with Panic disorder should be treated for a sufficient period to ensure that they are free from symptoms.
This period may be several months or even longer.
Social Phobia
Adults
The recommended dose is 20 mg daily. Some patients not responding to a 20 mg dose may benefit from having dose increases in 10 mg increments as required, up to a maximum of 50 mg/day according to the patient's response.
Generalised Anxiety Disorder
Adults
The recommended dose is 20 mg daily. Some patients not responding to a 20 mg dose may benefit from having dose increases in 10 mg increments as required, up to a maximum of 50 mg/day to the patient's response.
Post-traumatic stress disorder
Adults
The recommended dose is 20mg daily. Some patients not responding to a 20mg dose may benefit from having dose increases in 10mg increments as required, up to a maximum of 50 mg/day according to the patient's response.

General Information
DISCONTINUATION OF PAROXETINE
As with other psychoactive medications, abrupt discontinuation should generally be avoided (see sections 4.4 Special warnings and precautions for use & 4.8 Undesirable effects). The taper phase regimen used in recent clinical trials involved a decrease in the daily dose by 10 mg/day at weekly intervals.
When a daily dose of 20 mg/day was reached, patients were continued on this dose for one week before treatment was stopped. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Populations
• Elderly
Increased plasma concentrations of paroxetine occur in elderly subjects, but the range of concentrations overlaps with that observed in younger subjects.
Dosing should commence at the adult starting dose and may be increased up to 40 mg daily.
• Children and adolescents (<18 years) Paroxetine is not indicated for use in children or adolescents aged <18 years (see 4.1 Therapeutic Indications and 4.4 Special warnings and precautions for use).
• Renal/hepatic impairment Increased plasma concentrations of paroxetine occur in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or in those with hepatic impairment. Therefore, dosage should be restricted to the lower end of the dosage range.

פרטי מסגרת הכללה בסל

א.  התרופה תינתן לטיפול בכל אחד מאלה: 1. טיפול בהתקפי אימה  2. טיפול בהפרעה אובססיבית כפייתית.  3. טיפול בדיכאון ב.  מתן התרופה ייעשה לפי מרשם של רופא מומחה בפסיכיאטריה או בפסיכיאטריה של הילד המתבגר.

מסגרת הכללה בסל

התוויות הכלולות במסגרת הסל

התוויה תאריך הכללה תחום קליני Class Effect מצב מחלה
טיפול בדיכאון 09/03/1999
טיפול בהפרעה אובססיבית כפייתית. (Obssesive compulsive disorder) 09/03/1999
טיפול בהתקפי אימה (Panic disorder) 09/03/1999
שימוש לפי פנקס קופ''ח כללית 1994 לא צוין
תאריך הכללה מקורי בסל 09/03/1999
הגבלות תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת

רישום

133 48 31068 00

מחיר

0 ₪

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פרוטין 20

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