CLOZARIL clozapine tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

CLOZAPINE (UNII: J60AR2IKIC) (CLOZAPINE - UNII:J60AR2IKIC)

Διαθέσιμο από:

Cardinal Health

INN (Διεθνής Όνομα):

CLOZAPINE

Σύνθεση:

CLOZAPINE 100 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

CLOZARIL- CLOZAPINE TABLET
CARDINAL HEALTH
----------
CLOZARIL
CLOZARIL
(_CLOZAPINE_) TABLETS
RX ONLY
PRESCRIBING INFORMATION
Before prescribing CLOZARIL (clozapine), the physician should be
thoroughly familiar with the
details of this prescribing information.
®
®
BOXED WARNING
1. AGRANULOCYTOSIS
BECAUSE OF A SIGNIFICANT RISK OF AGRANULOCYTOSIS, A POTENTIALLY
LIFE-THREATENING ADVERSE EVENT, CLOZARIL (CLOZAPINE) SHOULD BE
RESERVED FOR USE IN (1) THE TREATMENT OF SEVERELY ILL PATIENTS
WITH SCHIZOPHRENIA WHO FAIL TO SHOW AN ACCEPTABLE RESPONSE TO
ADEQUATE COURSES OF STANDARD ANTIPSYCHOTIC DRUG TREATMENT, OR
(2) FOR REDUCING THE RISK OF RECURRENT SUICIDAL BEHAVIOR IN
PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER WHO ARE
JUDGED TO BE AT RISK OF REEXPERIENCING SUICIDAL BEHAVIOR.
PATIENTS BEING TREATED WITH CLOZAPINE MUST HAVE A BASELINE WHITE
BLOOD CELL (WBC) COUNT AND ABSOLUTE NEUTROPHIL COUNT (ANC)
BEFORE INITIATION OF TREATMENT AS WELL AS REGULAR WBC COUNTS
AND ANCS DURING TREATMENT AND FOR AT LEAST 4 WEEKS AFTER
DISCONTINUATION OF TREATMENT (SEE WARNINGS).
CLOZAPINE IS AVAILABLE ONLY THROUGH A DISTRIBUTION SYSTEM THAT
ENSURES MONITORING OF WBC COUNT AND ANC ACCORDING TO THE
SCHEDULE DESCRIBED BELOW PRIOR TO DELIVERY OF THE NEXT SUPPLY OF
MEDICATION (SEE WARNINGS).
2. SEIZURES
SEIZURES HAVE BEEN ASSOCIATED WITH THE USE OF CLOZAPINE. DOSE
APPEARS TO BE AN IMPORTANT PREDICTOR OF SEIZURE, WITH A GREATER
LIKELIHOOD AT HIGHER CLOZAPINE DOSES. CAUTION SHOULD BE USED
WHEN ADMINISTERING CLOZAPINE TO PATIENTS HAVING A HISTORY OF
SEIZURES OR OTHER PREDISPOSING FACTORS. PATIENTS SHOULD BE
ADVISED NOT TO ENGAGE IN ANY ACTIVITY WHERE SUDDEN LOSS OF
CONSCIOUSNESS COULD CAUSE SERIOUS RISK TO THEMSELVES OR OTHERS.
(SEE WARNINGS.)
3. MYOCARDITIS
ANALYSES OF POSTMARKETING SAFETY DATABASES SUGGEST THAT
CLOZAPINE IS ASSOCIATED WITH AN INCREASED RISK OF FATAL
MYOCARDITIS, ESPECIALLY DURING, BUT NOT LIMITED TO, THE FIRST
MONTH OF THERAPY. IN PATIENTS IN WHOM MYOCARDITIS IS SUSPECTED,
CLOZAPINE TREATMENT SHOULD BE PROMPTLY DIS