QUETIAZIC XR (sustain release quetiapine oral tablets) is a second-generation antipsychotic approved for treatment of schizophrenia and bipolar disorder and as supplementary treatment for depression.

NAME OF THE MEDICINAL PRODUCT: Quetiazic 50 mg, 150 mg, 300 mg, 400 mg Extended release film coated tablet.

• Each 50 mg tablet contains 50 mg quetiapine (as quetiapine fumarate).
• Each 150 mg tablet contains 150 mg quetiapine (as quetiapine fumarate).
• Each 300 mg tablet contains 300 mg quetiapine (as quetiapine fumarate).
• Each 400 mg tablet contains 400 mg quetiapine (as quetiapine fumarate).

Therapeutic indications

Quetiazic XR is indicated for:

• 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.
• Bipolar disorder – Treatment of depressive episodes associated with bipolar disorder.
• Bipolar disorder – Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate.
• 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).

Posology

• Chronic antipsychotic treatment should generally be reserved for patients who appear to suffer from a chronic illness that (1) is known to respond to antipsychotic drugs, and (2) for whom alternative equally effective but potentially less harmful treatments are not available or appropriate.
• In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory response should be sought. The need for continued treatment should be reassessed periodically.
• Quetiazic XR should be administered once daily, without food.
• The tablets should be swallowed whole and not split, chewed or crushed.

Bipolar Disorder Maintenance

treatment Patients who have responded to Quetiazic XR for acute treatment of bipolar disorder should continue therapy at the same dose. It is generally recommended that responding patients be continued beyond the acute response, but at the lowest possible dose needed to maintain remission. For prevention of relapse/ recurrence of manic, depressive and mixed episodes in bipolar disorder, the usual effective dose is within the range of 300 to 800 mg/day. The dose of Quetiazic XR can be re-adjusted depending on the clinical response and tolerability of the individual patient. Patients should be periodically reassessed to determine the need for maintenance treatment.

Bipolar Depression

When treating depressive episodes in bipolar disorder, treatment should be initiated either by the treating psychiatrist or by the general practitioner after consultation with the psychiatrist. Quetiazic XR should be titrated as follows: 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiazic XR can be titrated to 400 mg on Day 5 and up to 600 mg by Day 8.

Acute mania

Quetiazic XR should be titrated as follows: 300 mg on (Day 1), 600 mg on Day 2 and up to 800 mg after Day 2, alone or in combination with a mood stabiliser. The dose should be adjusted within the usual effective dose range of 400 to 800 mg/day, depending on the clinical response and tolerability of the individual patient.

Schizophrenia

The daily dose at the start of therapy is 300 mg on (Day 1), 600 mg on Day 2 and up to 800 mg after Day 2. The dose should be adjusted within the usual effective dose range of 400 to 800 mg/ day, depending on the clinical response and tolerability of the individual patient. For maintenance therapy in schizophrenia no dosage adjustment is necessary. The safety of doses above 800 mg/ day has not been evaluated.

Recurrent major depressive disorder

When treating recurrent MDD in patients who are intolerant of, or who have an inadequate response to alternative therapies, treatment should be initiated either by the treating psychiatrist or by the general practitioner after consultation with the psychiatrist. Quetiazic XR should be administered once daily in the evening.

Initial dosing should begin at 50 mg on Day 1 and 2, increased to 150 mg on Day 3 and 4. The usual effective dose in MDD is 150 mg. Further adjustments can be made upwards or downwards within the recommended dose range of 50 mg to 300 mg depending upon the clinical response and tolerability of the patient. Patients who have not responded to Quetiazic XR after 6 weeks treatment for MDD should have treatment re-evaluated.

For maintenance therapy in MDD in patients who have responded to acute treatment, the effective dose during initial treatment should be continued. It is generally recommended that responding patients be continued beyond the acute response, but at the lowest possible dose needed to maintain remission. The dose can be adjusted within the recommended dose range depending upon the clinical response and tolerability of the patient. Patients should be periodically reassessed to determine the need for maintenance treatment.

Generalised anxiety disorder

Initial dosing should begin at 50 mg on Day 1 and 2, increased to 150 mg on Day 3 and 4. Further adjustments can be made within the recommended dose range of 50 mg to 150 mg depending upon the clinical response and tolerability of the patient. Efficacy was demonstrated with Quetiazic XR at doses ranging from 50 to 300 mg/day, however no additional benefit was seen with the 300 mg group compared to the 150 mg group. Doses above 150 mg/day are not recommended.

For maintenance therapy in GAD the effective dose during initial treatment should be continued. The dose can be adjusted within the recommended dose range depending upon the clinical response and tolerability of the individual patient.

Switching from Quetiapine immediate release tablets

For more convenient dosing, patients who are currently being treated with divided doses of Quetiapine immediate release tablets may be switched to Quetiazic XR at the equivalent total daily dose taken once daily. For example – patients administered Quetiapine immediate release 300 mg twice daily (total daily dose of 600 mg) would be switched to a dose of Quetiazic XR 600 mg once daily on the next calendar day. Individual dosage adjustments may be necessary.

Elderly

As with other antipsychotics, Quetiazic XR should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients. The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients. Elderly patients should be started on 50 mg/day. The dose can be increased in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerability of the individual patient.

In elderly patients with MDD, initial dosing should begin at 50 mg on Days 1-3, the dose can be increased to 100 mg on Day 4, 150 mg on Day 8 and then up to 300 mg depending on clinical response and tolerability.

In elderly patients with GAD, initial dosing should begin at 50 mg on Days 1-3, the dose can be increased to 100 mg on Day 4, 150 mg on Day 8. Further adjustments can be made within the recommended dose range of 50 mg to 150 mg depending on clinical response and tolerability.

Children and adolescents (<18 years of age)

The safety and efficacy of Quetiapine XR was evaluated in an 8-week study of children and adolescent patients (10-17 years of age) with bipolar depression. Efficacy in this study was not established. However, clinical trials have been conducted with Quetiapine in children and adolescents 10 to 17 years of age with bipolar mania (as monotherapy), and 13 to 17 years of age with schizophrenia.

Renal Impairment

Dosage adjustment is not necessary.

Hepatic impairment

Quetiapine is extensively metabolised by the liver. Therefore, Quetiazic XR should be used with caution in patients with known hepatic impairment, especially during the initial dosing period. Patients with hepatic impairment should be started on 50 mg/day. The dose can be increased in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerability of the individual patient.

Can Quetiazic XR cause problems?

Constipation, drowsiness, upset stomach, tiredness, weight gain, blurred vision, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor promptly. Dizziness or lightheadedness may occur, especially when you first start or increase your dose of this drug. Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.

Tell your doctor right away if you have any serious side effects, including: restlessness/constant need to move, shakiness (tremor), mental/mood changes (such as increased anxiety, depression, thoughts of suicide), difficulty swallowing, constipation with persistent abdominal pain, persistent nausea/vomiting, loss of appetite, yellowing eyes/skin, interrupted breathing during sleep, trouble urinating.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor.

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).

Quetiapine may increase a certain natural substance (prolactin) made by your body. For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

MARKETING AUTHORISATION HOLDER: manufactured by Al Rowad Pharmaceutical industries company for Inspire pharmaceutical co.(IPC Pharma).

QUETIAZIC XR – Information Leaflet

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