Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate
Medis Pharma Pty Ltd
Quetiapine fumarate
Registered
APO-Quetiapine XR Tablet 1 APO-QUETIAPINE XR _Contains the active ingredient Quetiapine (as fumarate) _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about APO-QUETIAPINE XR. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- QUETIAPINE XR Tablet. It contains the active ingredient quetiapine fumarate. It helps to correct chemical imbalances in the brain. It is used to treat conditions such as: • Bipolar disorder, an illness in which there are sustained mood swings either up (mania) or down (depression). During mania, patients experience episodes of overactivity, elation or irritability. During depression, patients may feel depressed or guilty, lack energy, lose their appetite and have trouble sleeping. • Recurrent major depressive disorder, an illness where depression is longer lasting and/or more severe than the "low moods" everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing. • Generalised anxiety disorder, where patients have excessive anxiety and worry. • Schizophrenia, an illness with disturbances in thinking, feelings and behaviour. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this med Read the complete document
1 APO-QUETIAPINE XR quetiapine fumarate PRODUCT INFORMATION NAME OF THE MEDICINE Quetiapine fumarate Chemical Name: Bis[2-(2-[4-(dibenzo[b,f][1,4]-thiazepin-11-yl)piperazin-1-yl] ethoxy) ethanol] fumarate. The chemical structure of quetiapine fumarate is: CAS number: 111974-72-2 DESCRIPTION Quetiapine fumarate is a weak acid (pKa 3.3, 6.8) which exhibits moderate pH dependent solubility (94.3 mg/mL to 2.37 mg/mL at pH values from 1 to 9) and lypophilicity characteristics (Log P) which vary with pH (0.45 in water, 1.37 at pH 5, 2.65 at pH 7 and 2.59 at pH 9). Quetiapine fumarate has an aqueous solubility of 3.29 mg/mL at 25°C. APO-QUETIAPINE XR 50 mg 200 mg, 300 mg and 400 mg are modified release tablets which are pink (50 mg), yellow (200 mg), light yellow (300 mg) or white (400 mg) in colour. Each tablet contains quetiapine fumarate equivalent to 50 mg, 200 mg, 300 mg or 400 mg of quetiapine free base. The tablets also include the following excipients – lactose, hypromellose, sodium chloride, povidone, talc, magnesium stearate, microcrystalline cellulose (50mg), Opadry II 85F540003 Pink – PI no. 109248 (50mg), Opadry 03B52117 Yellow – PI No. 106712 (200mg), Opadry 03B82929 Yellow – PI No. 106295 (300mg) and Opadry 03B58900 White- PI No. 106176 (400mg). APO- QUETIAPINE XR tablets do not contain gluten. 2 PHARMACOLOGY MECHANISM OF ACTION Quetiapine is an atypical antipsychotic agent. Quetiapine and the human plasma metabolite, norquetiapine, interact with a broad range of neurotransmitter receptors. Quetiapine and norquetiapine exhibit affinity for brain serotonin (5HT 2 ) and dopamine D 1 and D 2 receptors; this combination of receptor antagonism with a higher selectivity for 5HT 2 relative to D 2 receptors is believed to contribute to the clinical antipsychotic properties and low extrapyramidal side effects (EPS) liability of quetiapine compared to typical antipsychotics. Quetiapine has no affinity for the norepinephrine transporter (NET) and low affinity for the serotonin 5HT 1A receptor, whereas norqu Read the complete document