LEPONEX 100 mg TABLET

Ülke: Güney Afrika

Dil: İngilizce

Kaynak: South African Health Products Regulatory Authority (SAHPRA)

Mevcut itibaren:

Mylan Pharmaceuticals (Pty) Ltd

Doz:

See ingredients

Farmasötik formu:

TABLET

Kompozisyon:

EACH TABLET CONTAINS CLOZAPINE 100 mg

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

1975-06-11

Ürün özellikleri

SCHEDULING STATUS S5
PROPRIETARY NAMES (AND DOSAGE FORM)
LEPONEX
®
25 mg Tablet
LEPONEX
®
100 mg Tablet
WARNING
BECAUSE OF THE SIGNIFICANT RISK THAT LEPONEX CAN CAUSE
AGRANULOCYTOSIS. ITS
USE SHOULD BE LIMITED TO PATIENTS:

WITH SCHIZOPHRENIA WHO IS NON-RESPONSIVE TO OR INTOLERANT OF CLASSICAL
ANTIPSYCHOTIC AGENTS, OR WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE
DISORDER
WHO ARE AT RISK OF RECURRENT SUICIDAL BEHAVIOUR.

AND WHO HAVE INITIALLY NORMAL LEUKOCYTE FINDINGS (WHITE BLOOD CELL
COUNT
(WBC) ≥ 3500/MM
3 (3,5 X 10
9
/L), AND ABSOLUTE NEUTROPHIL COUNTS (ANC) ≥
2000/MM
3 (2,0 X 10
9
/L).

AND IN WHOM REGULAR WHITE BLOOD CELL COUNTS AND, ABSOLUTE NEUTROPHIL
COUNTS CAN BE PERFORMED AS FOLLOWS: WEEKLY DURING THE FIRST 18 WEEKS
OF
THERAPY, AND AT LEAST EVERY 2 WEEKS THEREAFTER UP TILL 52 WEEKS AND AT
LEAST
EVERY 4 WEEKS THROUGHOUT TREATMENT. MONITORING MUST CONTINUE
THROUGHOUT TREATMENT AND FOR 4 WEEKS AFTER COMPLETE DISCONTINUATION OF
LEPONEX.

ORTHOSTATIC HYPOTENSION, WITH OR WITHOUT SYNCOPE, CAN OCCUR WITH
LEPONEX
TREATMENT. COLLAPSE CAN BE PROFOUND AND MAY BE ACCOMPANIED BY CARDIAC
AND/OR RESPIRATORY ARREST. SUCH EVENTS ARE MORE LIKELY TO OCCUR DURING
INITIAL
TITRATION IN ASSOCIATION WITH RAPID DOSE ESCALATION; BUT THEY MAY
OCCUR EVEN
AFTER THE FIRST DOSE. THEREFORE, PATIENTS COMMENCING LEPONEX TREATMENT
REQUIRE CLOSE MEDICAL SUPERVISION.
PRESCRIBING PHYSICIANS SHOULD COMPLY FULLY WITH THE REQUIRED SAFETY
MEASURES.
AT EACH CONSULTATION, A PATIENT RECEIVING LEPONEX SHOULD BE REMINDED
TO
CONTACT THE TREATING PHYSICIAN IMMEDIATELY IF ANY KIND OF INFECTION
BEGINS TO
DEVELOP. PARTICULAR ATTENTION SHOULD BE PAID TO FLU-LIKE COMPLAINTS
SUCH AS FEVER
OR SORE THROAT AND TO OTHER EVIDENCE OF INFECTION, WHICH MAY BE
INDICATIVE OF
NEUTROPENIA.
LEPONEX MUST BE DISPENSED UNDER STRICT MEDICAL SUPERVISION IN
ACCORDANCE
WITH OFFICIAL RECOMMENDATIONS.
COMPOSITION
Tablet 25 mg:
Each tablet contains 25 mg clozapine.
Tablet 100 mg:
Each tablet contains 100 mg clozapine.
LIST OF EXCIPIENTS:
Magnesium stearate; silica, co