RIDAZIN 100 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

THIORIDAZINE HYDROCHLORIDE

متاح من:

TARO PHARMACEUTICAL INDUSTRIES LTD

ATC رمز:

N05AC02

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

THIORIDAZINE HYDROCHLORIDE 100 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

TARO PHARMACEUTICAL INDUSTRIES LTD

المجال العلاجي:

THIORIDAZINE

الخصائص العلاجية:

Ridazin is indicated only for schizophrenic patients who fail to show an acceptable response to adequate courses of treatment with other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects. Thioridazine has not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.

تاريخ الترخيص:

2014-10-07

نشرة المعلومات

PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
RIDAZIN 10 MG
FILM-COATED TABLETS
The active ingredient and its quantity: Each tablet contains:
Thioridazine HCl 10 mg
RIDAZIN 25 MG
FILM-COATED TABLETS
The active ingredient and its quantity: Each tablet contains:
Thioridazine HCl 25 mg
RIDAZIN 100 MG
FILM-COATED TABLETS
The active ingredient and its quantity: Each tablet contains:
Thioridazine HCl 100 mg
For the list of inactive ingredients, please see section 6.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for treatment of your ailment.
Do not pass it on to others. It may harm them even if it seems to
you that their ailment is similar.
This medicine is not usually recommended for children and infants
under 2 years of age.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For treatment of schizophrenic patients who fail to respond
adequately to other antipsychotic medicines.
THERAPEUTIC GROUP: The phenothiazines group
2. BEFORE USING THE MEDICINE: DO NOT USE THIS MEDICINE:
∙ if you are sensitive (allergic) to the active ingredient
(thioridazine)
or any of the other ingredients of the medicine (see section
6).
∙ in comatose states or in conditions of severe central nervous
system depression, including drug induced central nervous
system depression (see section “If you are taking, or have
recently taken, other medicines”).
∙ if you suffer from serious impairment of heart function.
∙ in combination with other medicines known to prolong the QT
interval (e.g., quinolone antibiotics, terfenadine, astemizole,
cisapride, droperidol, haloperidol, risperidone).
∙ in patients with congenital prolonged QT syndrome or in patients
with a history of cardiac arrhythmias.
∙ in patients with a genetic disorder that causes reduced
cytoc

خصائص المنتج

The format of this leaflet was determined by the Ministry of Health
and its content was
checked and approved by the MoH in 11/2014
.
PHYSICIAN’S PRESCRIBING INFORMATION
RIDAZIN 10 MG, 25MG, 100MG
FILM COATED TABLETS
ACTIVE INGREDIENT
THIORIDAZINE HYDROCHLORIDE
DESCRIPTION
Thioridazine hydrochloride is
2-methylmercapto-10-[2-(N-methyl-2-piperidyl) ethyl]
phenothiazine. Its structural formula, molecular weight and molecular
formula are:
C
21
H
26
N
2
S
2
• HCl
M.Wt.: 407.05
WARNING
THIORIDAZINE HAS BEEN SHOWN TO PROLONG THE QTC INTERVAL IN A DOSE
RELATED MANNER, AND
DRUGS WITH THIS POTENTIAL, INCLUDING THIORIDAZINE, HAVE BEEN
ASSOCIATED WITH TORSADES DE
POINTES TYPE ARRHYTHMIAS AND SUDDEN DEATH. DUE TO ITS POTENTIAL FOR
SIGNIFICANT, POSSIBLY
LIFE THREATENING, PROARRHYTHMIC EFFECTS, THIORIDAZINE SHOULD BE
RESERVED FOR USE IN THE
TREATMENT OF SCHIZOPHRENIC PATIENTS WHO FAIL TO SHOW AN ACCEPTABLE
RESPONSE TO ADEQUATE
COURSES OF TREATMENT WITH OTHER ANTIPSYCHOTIC DRUGS, EITHER BECAUSE OF
INSUFFICIENT
EFFECTIVENESS OR THE INABILITY TO ACHIEVE AN EFFECTIVE DOSE DUE TO
INTOLERABLE ADVERSE
EFFECTS FROM THOSE DRUGS (SEE WARNINGS, CONTRAINDICATIONS, AND
INDICATIONS).
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 CARDIOVASCULAR (E.G., HEART FAILURE, SUDDEN
DEATH) OR INFECTIOUS
(E.G., PNEUMONIA) IN NATURE. OBSERVATIONAL STUDIES SUGGEST THAT,
SIMILAR TO ATYPICAL
ANTIPSYCHOTIC DRUGS