Quetiapine STELLA 200 mg

Rx

Indications:

• Treatment of schizophrenia.
• Treatment of bipolar disorder including manic episodes associated with bipolar disorder; Major depressive episodes in bipolar disorder; Preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment.

Dosage:

• Schizophrenia: Initial dosage 25 mg twice daily, increased in increments of 25 – 50 mg, 2 or 3 times daily on the second or third day, to a target dosage of 300 – 400 mg daily in 2 or 3 divided doses by the fourth day. From day 4 onwards, the usual effective dose range of 300 – 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.
• Manic episodes associated with bipolar disorder: 100 mg on the first day, 200 mg on the second day, 300 mg on the third day and 400 mg on the fourth day; in 2 divided doses. Further dose increases to 800 mg daily by the sixth day should be made in steps of no greater than 200 mg daily. The dose may then be adjusted according to response and tolerance to a usual range of 400 to 800 mg daily, although, in some patients, 200 mg may be adequate.
• Depressive episodes in bipolar disorder: The initial dose is 50 mg once daily at bedtime on the first day, 100 mg on the second day, 200 mg on the third day and 300 mg on the fourth day. The dose may be further increased to 400 mg on the fifth day and 600 mg on the eighth day, if necessary.
• Preventing recurrence in bipolar disorder: Continue therapy at the same dose. The dose may then be adjusted depending on clinical response and tolerability of the individual patient, within the range of 300 to 800 mg/day administered twice daily. It is important that the lowest effective dose is used for maintenance therapy

Patients with hepatic impairment: The initial dose is 25 mg daily. The dosage should be increased by 25 – 50 mg daily according to clinical response and tolerability until an effective dosage is reached.

Usage:

Quetiapine STELLA 200 mg is administered orally, without regard to meals.

• Hypersensitivity to quetiapine fumarate or to any of the excipients.
• Concomitant administration of cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin and nefazodone.

• Very common: Decreased haemoglobin; elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL-cholesterol), decreases in HDL-cholesterol, weight gain; dizziness, somnolence, headache; dry mouth.
• Common: Leucopenia, decreased neutrophil count, eosinophils increased. Increased appetite, blood glucose increased to hyperglycaemic levels. Extrapyramidal symptoms, dysarthria, syncope. Tachycardia, palpitations. Vision blurred. Orthostatic hypotension. Dyspnoea, rhinitis. Constipation, dyspepsia, vomiting. Elevations in serum transaminases alanine aminotransferase (ALT, AST), elevations in gamma-GT levels.

Quetiapine STELLA 200 mg should be given with caution when used for:

• Patients with a history of suicide related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment should receive careful monitoring during treatment.
• Patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension.
• Patients with a history of seizures.
• Patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control. Weight should be monitored regularly.
• Patients at risk for aspiration pneumonia.
• Patients with cardiovascular disease or family history of QT prolongation. Also, caution should be exercised when quetiapine is prescribed either with medicines known to increase QT interval, or with concomitant neuroleptics, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.

Treatment with Quetiapine STELLA 200 mg should be discontinued in case:

• If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of quetiapine should be considered. The symptoms of tardive dyskinesia can worsen or even arise after discontinuation of treatment.
• Neuroleptic malignant syndrome may occur with clinical manifestations including hyperthermia, altered mental status, muscular rigidity, autonomic instability and increased creatine phosphokinase.
• In patients with a neutrophil count < 1.0 x 10⁹/L.
• Jaundice develops.

Moreover, the following reactions should be taken into account:

• Extrapyramidal symptoms.
• Orthostatic hypotension, somnolence and dizziness has onset usually during the initial dose-titration period. This could increase the occurrence of accidental injury (fall), especially in the elderly population.
• Increases in triglycerides, LDL- and total cholesterol, decreases in HDL-cholesterol have been observed in clinical trials with quetiapine. Lipid changes should be managed as clinically appropriate.
• Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs.

Gradual withdrawal over a period of at least one to two weeks is advisable.

Elderly patients with dementia-related psychosis: Not use.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take Quetiapine STELLA 200 mg.

Quetiapine STELLA 200 mg should only be used during pregnancy if the benefits justify the potential risks. Avoid breast feeding while taking Quetiapine STELLA 200 mg.

Patients should be advised not to drive or operate machinery while using Quetiapine STELLA 200 mg.