AURO-QUETIAPINE 100 MG — DIN 02390213

What is AURO-QUETIAPINE?

AURO-QUETIAPINE 100 MG contains QUETIAPINE (QUETIAPINE FUMARATE) : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02390213, held by AURO PHARMA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 18-Oct-2012. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is AURO-QUETIAPINE used for?

AURO-QUETIAPINE (quetiapine fumarate) is indicated for: • the management of the manifestations of schizophrenia. Bipolar Disorder AURO-QUETIAPINE is indicated as monotherapy for the: • acute management of manic episodes associated with bipolar disorder. • acute management of depressive episodes associated with bipolar I and bipolar II disorder.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Schizophrenia The usual starting dose of AURO-QUETIAPINE (quetiapine fumarate) is 25 mg b.i.d., titrated with increments of 25-50 mg b.i.d. per day, as tolerated, to a target dose of 300 mg/day given b.i.d. within four to seven days. Further dosage adjustments may be indicated depending on the clinical response and tolerability in the individual patient. Dosage adjustments should generally occur at intervals of not less than 2 days, as steady state for AURO-QUETIAPINE would not be achieved for approximately 1-2 days in the typical patient. When adjustments are necessary, dose increments/decrements of 25-50 mg b.i.d. are recommended. Clinical trials suggest that the usual effective treatment dose will be in the range of 300-600 mg/day. However, some patients may require as little as 150 mg/day. In schizophrenia, the safety of doses above 800 mg/day has not been evaluated. Bipolar Mania: The titration rate, based on clinical trials, is shown in a table with daily BID doses increasing from 100 mg/day on Day 1 to up to 800 mg/day on Day 6. Dosage adjustments should be made depending on clinical response and tolerability. The safety of doses above 800 mg/day has not been evaluated. Bipolar Depression: The titration rate, based on clinical trials, is shown in a table with daily Once Daily doses increasing from 50 mg/day on Day 1 to 300 mg/day on Day 4. A usual target dose of 300 mg/day is recommended. The safety of doses above 600 mg/day has not been evaluated. AURO-QUETIAPINE should be administered once daily at bedtime. Administration: AURO-QUETIAPINE is for oral use only and can be administered with or without food. Missed Dose: If a dose is missed by only a few hours, take it as soon as possible. If most of the day has passed, skip that dose and wait until the next scheduled dose. Never take two doses at once.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

AURO-QUETIAPINE (quetiapine fumarate) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. AURO-QUETIAPINE is not to be used if you are elderly and have dementia.

Warnings and precautions

Serious Warnings and Precautions: • Increased Mortality in Elderly Patients with Dementia: Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Most deaths appeared to be cardiovascular or infectious in nature. • Body Temperature Regulation: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Caution is advised for patients experiencing conditions that may contribute to an elevation of core temperature (e.g., strenuous exercise, extreme heat, anticholinergic medication, dehydration). • Dependence / Tolerance: Reports of quetiapine misuse, abuse, tolerance, and/or physical dependence exist. Caution is needed for patients with a history of alcohol or drug abuse. Patients should be observed for signs of misuse or abuse. • Acute Withdrawal (discontinuation) Symptoms: Insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability have been described after abrupt cessation. Gradual withdrawal over 1-2 weeks is advisable. • Hypotension and Syncope: Quetiapine may induce orthostatic hypotension, tachycardia, dizziness, and syncope, especially during initial dose titration. Risk may be reduced by gradual titration. Caution in patients with cardiovascular disease, cerebrovascular disease, or conditions predisposing to hypotension. • QT Prolongation: Cases of QT prolongation have been reported, especially in patients with concomitant illness, electrolyte imbalance, or taking drugs known to increase QT interval. Caution in patients with cardiovascular disease, family history of QT prolongation, or increased risk factors. • Cardiomyopathy and Myocarditis: Reported in clinical trials and post-marketing experience. Treatment should be reassessed if suspected. • Worsening of More than one Metabolic Parameter (among Cholesterol and Triglyceride Elevations; Hyperglycemia; Weight Gain): Changes in these parameters should be managed as clinically appropriate. • Hyperglycemia: Rare reports of hyperglycemia and diabetes mellitus (including fatal cases) in post-marketing experience. Patients should have baseline and periodic monitoring of blood glucose. • Weight Gain: Observed in clinical trials. Patients should have baseline and periodic monitoring of body weight. • Hyperprolactinemia: Elevation in prolactin levels observed in clinical trials. Possible manifestations include amenorrhea, galactorrhea, and menorrhagia. • Hypothyroidism: Dose-related decreases in thyroid hormone levels observed. Monitoring for TSH and T4 levels is recommended. • Antiemetic Effect: Quetiapine may mask signs of toxicity or symptoms of disease. • Dysphagia and Aspiration Pneumonia: Dysphagia and aspiration have been reported. Caution in patients at risk for aspiration pneumonia. • Constipation and Intestinal Obstruction: Constipation and intestinal obstruction have been reported, including fatal cases. Risk factors include concomitant medications that decrease intestinal motility or known gastrointestinal obstruction. • Priapism: Rare cases reported. • Leukopenia, Neutropenia and Agranulocytosis: Events reported. CBC should be tested prior to and periodically throughout treatment. Severe neutropenia (<0.5 x 10^9/L) has been uncommonly reported. • Venous Thromboembolism: Reported with antipsychotic drugs. All potential risk factors should be identified and preventative measures undertaken. • Hepatic Impairment: Decreased clearance observed. Caution in patients with mild hepatic impairment. No pharmacokinetic data for moderate to severe impairment. Hepatic failure, including fatalities, reported rarely post-marketing. • Pancreatitis: Reported in clinical trials and post-marketing experience. Many cases had risk factors. • Rhabdomyolysis: May cause rhabdomyolysis. Discontinue if markedly elevated creatine kinase concentrations or myopathy is suspected. • Neuroleptic Malignant Syndrome (NMS): Potentially fatal symptom complex repor