PERPHENAN 8 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

PERPHENAZINE

Dostupné z:

TARO PHARMACEUTICAL INDUSTRIES LTD

ATC kód:

N05AB03

Forma lieku:

FILM COATED TABLETS

Zloženie:

PERPHENAZINE 8 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

TARO PHARMACEUTICAL INDUSTRIES LTD

Terapeutické skupiny:

PERPHENAZINE

Terapeutické oblasti:

PERPHENAZINE

Terapeutické indikácie:

Tranquilizer, antiemetic.

Dátum Autorizácia:

2021-03-31

Príbalový leták

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Súhrn charakteristických

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Perphenan 4 and 8 mg –SPC-Clean-02.2021
PERPHENAN FILM COATED TABLETS
NAME OF THE MEDICINAL PRODUCT
Perphenan 4mg
Perphenan 8mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perphenan 4mg - Each tablet contains 4mg Perphenazine
Perphenan 8mg - Each tablet contains 8mg Perphenazine
PHARMACEUTICAL FORM
Film coated tablet
Perphenan 4 mg - White, round, bi-convex, coated tablets.
Both sides plain.
Perphenan 8 mg - Gray, round, bi-convex, coated tablets. Both sides
plain.
THERAPEUTIC INDICATIONS
Tranquilizer, antiemetic
WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT
AN INCREASED RISK OF DEATH. ANALYSES OF SEVENTEEN PLACEBO-CONTROLLED
TRIALS (MODAL
DURATION OF 10 WEEKS), LARGELY IN PATIENTS TAKING ATYPICAL
ANTIPSYCHOTIC DRUGS, REVEALED A
RISK OF DEATH IN DRUG-TREATED PATIENTS OF BETWEEN 1.6 TO 1.7 TIMES THE
RISK OF DEATH IN
PLACEBO-TREATED PATIENTS. OVER THE COURSE OF A TYPICAL 10-WEEK
CONTROLLED TRIAL, THE RATE
OF DEATH IN DRUG TREATED PATIENTS WAS ABOUT 4.5%, COMPARED TO A RATE
OF ABOUT 2.6% IN
THE PLACEBO GROUP.
ALTHOUGH THE CAUSES OF DEATH WERE VARIED, MOST OF THE DEATHS APPEARED
TO BE EITHER
CARDIO VASCULAR (E.G., HEART FAILURE, SUDDEN DEATH) OR INFECTIOUS
(E.G., PNEUMONIA) IN
NATURE.
OBSERVATIONAL STUDIES SUGGEST THAT, SIMILAR TO ATYPICAL ANTIPSYCHOTIC
DRUGS, TREATMENT
WITH CONVENTIONAL ANTIPSYCHOTIC DRUGS MAY INCREASE MORTALITY. THE
EXTENT TO WHICH THE
FINDINGS OF INCREASED MORTALITY IN OBSERVATIONAL STUDIES MAY BE
ATTRIBUTED TO THE
ANTIPSYCHOTIC DRUG AS OPPOSED TO SOME CHARACTERISTIC(S) OF THE
PATIENTS IS NOT CLEAR.
PERPHENAZINE IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH
DEMENTIA-RELATED
PSYCHOS IS (SEE WARNINGS).
DESCRIPTION
Perphenazine
(4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a
piperazinyl
phenothiazine, having the chemical formula, C
21
H
26
CIN
3
OS. It is available as oral tablets
containing 4 mg and 8 mg of perphenazine.
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Perphenan