QUETIAPINE-ZP XR quetiapine (as fumarate) 200mg modified release tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

quetiapine fumarate, Quantity: 230.3 mg (Equivalent: quetiapine, Qty 200 mg)

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Quetiapine fumarate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: purified talc; lactose monohydrate; magnesium stearate; sodium chloride; hypromellose; povidone; titanium dioxide; iron oxide yellow; macrogol 400

Administration route:

Oral

Units in package:

10, 30, 60, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Bipolar disorder,? Maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? Treatment of depressive episodes associated with bipolar disorder (see DOSAGE AND ADMINISTRATION) ? Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate,Efficacy of quetiapine modified release tablets in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets.,Schizophrenia Treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy.,Major depressive disorder Treatment of recurrent major depressive disorder (MDD) in patients who are intolerant of, or who have an inadequate response to alternative therapies.,Generalised anxiety disorder Treatment of generalised anxiety disorder (GAD).

Product summary:

Visual Identification: Yellow coloured, round shaped, biconvex film coated tablets, debossed with 'I2' on one side and plain on other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-03-21