מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate, Quantity: 345.396 mg (Equivalent: quetiapine, Qty 300 mg)
Dr Reddys Laboratories Australia Pty Ltd
Quetiapine fumarate
Tablet, film coated
Excipient Ingredients: lactose monohydrate; povidone; calcium hydrogen phosphate dihydrate; sodium starch glycollate type A; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400
Oral
60 tablet
(S4) Prescription Only Medicine
Bipolar disorder. Adults = 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.,Children/adolescents aged 10 to 17 years,= Monotherapy treatment of acute mania associated with bipolar I disorder,Schizophrenia. (Adults and adolescents aged 13 to 17 years) = Treatment of schizophrenia.
Visual Identification: White coloured, capsule shape, biconvex film coated tablets, debossed with 'QTP' on one side and '300' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2011-02-24
QUETIAPINE-DRLA CMI V3 1 QUETIAPINE-DRLA _Quetiapine fumarate_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about QUETIAPINE-DRLA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Your doctor may prescribe this medicine for another reason. It is not addictive. This medicine is available only with a doctor's prescription. If it has expired or is damaged, return it to your pharmacist for disposal. If you are not sure whether you should start taking QUETIAPINE-DRLA, talk to your doctor or pharmacist. _BEFORE YOU START TO TAKE IT_ TELL YOUR DOCTOR IF YOU HAVE ANY ALLERGIES TO: • any other medicines benefits. Your doctor will have • any other substances, such a weighed the risks of you taking it against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT QUETIAPINE- DRLA IS USED FOR QUETIAPINE-DRLA helps to correct chemical imbalances in the brain. It is used to treat conditions such as: • Schizophrenia, an illness with disturbances in thinking, feelings and behaviour • 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. QUETIAPINE-DRLA belongs to a group of medicines called antipsychotics. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ _ _ DO NOT TAKE QUETIAPINE- DRLA IF YOU HAVE AN ALLERGY TO • quetiapine, the active ingredient in the medicine • any of the other ingredients listed at the end of this leaflet. Some of the symptoms of an allergic rea קרא את המסמך השלם
QUETIAPINE-DRLA FILM COATED TABLETS 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. Quetiapine fumarate has no chiral centres and only one morphological entity has been detected throughout development. _Structural Formula:_ _ _ _ _ CAS: 111974-72-2 DESCRIPTION Quetiapine fumarate is a weak acid (pKa 3.3, 6.8) which exhibits moderate pH dependent solubility (94.3 to 2.37 mg/mL at pH values from 1 to 9) and lipophilicity 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 displays good solid state stability, has an aqueous solubility of 3.29 mg/mL at 25°C and exhibits suitable tableting properties when combined with appropriate excipients. Quetiapine-DRLA 25 mg, 100 mg, 150 mg, 200 mg, and 300 mg tablets contain quetiapine fumarate equivalent to 25 mg, 100 mg, 150 mg, 200 mg, and 300 mg quetiapine free base respectively. _EXCIPIENTS _ povidone, calcium hydrogen phosphate dihydrate, cellulose - microcrystalline, lactose, sodium starch glycollate, silica - colloidal anhydrous, magnesium stearate, hypromellose, macrogol 400, titanium dioxide, iron oxide yellow CI 77492 (25, 100 and 150 mg) and iron oxide red CI 77491 (25 mg) PHARMACOLOGY MECHANISM OF ACTION Quetiapine is an atypical antipsychotic agent. Quetiapine and the human plasma metabolite, norquetiapine, interact with a broad range of neurotransmitter Product Information_v3 Page 2 of 41 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. Additionally, norquetiapine has high affinity (higher than quetiapine) for the noradrenaline tra קרא את המסמך השלם