PHARMACOR OLANZAPINE 15 olanzapine 15 mg film-coated tablet in bottle pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
04-06-2021
Public Assessment Report
(PAR)
29-11-2017
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Active ingredient:
olanzapine, Quantity: 15 mg
Available from:
Pharmacor Pty Ltd
INN (International Name):
Olanzapine
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: magnesium stearate; hyprolose; lactose monohydrate; microcrystalline cellulose; hypromellose; crospovidone; titanium dioxide; polysorbate 80; macrogol 400; indigo carmine aluminium lake
Administration route:
Oral
Units in package:
100 Tablets in bottle pack
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Olanzapine tablets are indicated for the treatment of schizophrenia and related psychoses.,Olanzapine tablets alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.,Olanzapine tablets are also indicated for preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.
Product summary:
Visual Identification: Light blue,elliptical, biconvex, film-coated tablets debossed with "O4" on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2012-03-23
Summary of Product characteristics
Pharmacor Olanzapine (V – 02)
1
AUSTRALIAN PRODUCT INFORMATION – PHARMACOR OLANZAPINE
(OLANZAPINE) TABLETS
1
NAME OF THE MEDICINE
Olanzapine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in Pharmacor Olanzapine is olanzapine.
Excipients with known effect: Contains sugars as lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pharmacor Olanzapine 15 is presented as light blue, elliptical,
biconvex, film-coated tablets debossed
with “O4” on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Pharmacor Olanzapine is indicated for the treatment of schizophrenia
and related psychoses.
Pharmacor Olanzapine alone or in combination with lithium or valproate
is indicated for the short-
term treatment of acute manic episodes associated with Bipolar I
Disorder.
Pharmacor Olanzapine is indicated for preventing recurrence of manic,
mixed or depressive episodes
in Bipolar I Disorder.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Olanzapine 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets are unavailable in
this brand, however these
dosages in tablet form are available in other brands.
Schizophrenia and Related Disorders
The recommended starting dose for olanzapine is 5-10 mg/day,
administered as a single daily dose
without regard to meals. Daily dosage may subsequently be adjusted on
the basis of individual clinical
status within the range of 5-20 mg daily. An increase to a dose
greater than the routine therapeutic
dose of 10 mg/day is recommended only after appropriate clinical
reassessment.
Acute Mania Associated with Bipolar Disorder
The
recommended
starting
dose
for
olanzapine
is
10
or
15
mg
administered
once
a
day
as
monotherapy or 10 mg administered once daily in combination therapy
with lithium or valproate. It
may be given without regard to meals. Dosage adjustments, if
indicated, should generally occur at
intervals
of
not
less
than
24
hours.
When
dosage
adjustments
are
necessary,
dose
Pharmacor Olanzapine (V
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