国: イスラエル
言語: 英語
ソース: Ministry of Health
PERPHENAZINE
TARO PHARMACEUTICAL INDUSTRIES LTD
N05AB03
FILM COATED TABLETS
PERPHENAZINE 8 MG
PER OS
Required
TARO PHARMACEUTICAL INDUSTRIES LTD
PERPHENAZINE
PERPHENAZINE
Tranquilizer, antiemetic.
2021-03-31
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Page 1 of 10 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. Page 2 of 10 Perphenan 完全なドキュメントを読む