产品特点
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quetiapine Pfizer 25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of quetiapine (as quetiapine fumarate).
Excipient: 5.167 mg lactose monohydrate per tablet.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Peach, round, with diameter 5.7mm, biconvex, film coated tablet debossed with ‘E 52’ on one side and plain on the
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Quetiapine Pfizer is indicated for the treatment of:
Schizophrenia.
Quetiapine Pfizer is indicated for the treatment of bipolar disorder:
For the treatment of moderate to severe manic episodes in bipolar disorder.
For the treatment of major depressive episodes in bipolar disorder.
For the prevention of recurrence in patients with bipolar disorder, in patients whose manic or depressive episode has
responded to quetiapine treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Quetiapine Pfizer can be administered with or without food.
_Adults:_
FOR THE TREATMENT OF SCHIZOPHRENIA
For the treatment of schizophrenia, Quetiapine Pfizer should be administered twice a day. The total daily dose for the
first 4 days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4).
From Day 4 onwards, the dose should be titrated to the usual effective dose of 300 to 450 mg/day. Depending on the
clinical response and tolerability of the individual patient, the dose may be adjusted within the range 150 to 750
mg/day.
FOR THE TREATMENT OF MODERATE TO SEVERE MANIC EPISODES IN BIPOLAR DISORDER
For the treatment of manic episodes associated with bipolar disorder, Quetiapine Pfizer should be administered twice a
day. The total daily dose for
阅读完整的文件
产品特点 