Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
quetiapine fumarate
Amneal Pharma Australia Pty Ltd
Quetiapine fumarate
Registered
_Quetiapine AN tablets – Consumer Medicine Information _ _ _ _Doc ID: 91.AN.M.1.0 _ _ _ _ _ _Page 1 _ QUETIAPINE AN TABLETS _Quetiapine fumerate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about Quetiapine AN. 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 benefits. Your doctor will have weighed the risks of you taking Quetiapine AN 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 AN IS USED FOR Quetiapine AN 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 own (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 AN belongs to a group of medicines called antipsychotics. 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. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE _ _QUETIAPINE AN: _ _ _ DO NOT TAKE QUETIAPINE AN IF YOU HAVE AN ALLERGY TO QUETIAPINE, THE ACTIVE INGREDIENT IN QUETIAPINE AN ANY OF THE OTHER INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin or you may feel faint. DO NOT GIVE QUETIAPINE Прочитать полный документ
_Quetiapine AN tablets Product Information _ _ _ _ Amneal Pharma Australia Pty Ltd _ QUETIAPINE AN _ _ _(QUETIAPINE FUMARATE TABLETS) _ _ _ PRODUCT INFORMATION NAME OF THE MEDICINE The name of the medicine is quetiapine fumarate CHEMICAL NAME :- Bis[2-[2-[4-(dibenzo[b,f][1,4]-thiazepin-11-yl)piperazin-1-yl] ethoxy] ethanol] fumarate. MOLECULAR FORMULA : C 46 H 54 N 6 O 8 S 2 MODULAR WEIGHT : 883.1 CAS NUMBER : [ _111974-72-2_ ] DESCRIPTION Quetiapine fumarate is white to off white powder. It is a weak acid (pKa 3.3, 6.8) which exhibits moderate pH dependent solubility 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 no chiral centres and only one morphological entity has been detected throughout development. Quetiapine fumarate displays good solid state stability, has moderate aqueous solubility at 25°C and exhibits suitable tableting properties when combined with appropriate excipients. Quetiapine AN 25 mg tablets, 100 mg tablets, 200 mg tablets and 300 mg tablets contains quetiapine fumarate equivalent to 25 mg, 100 mg, 200 mg and 300 mg quetiapine free base respectively. The inactive ingredients are: Lactose, sodium starch glycollate (Type A), calcium hydrogen phosphate, povidone, microcrystalline cellulose, magnesium stearate and film- coating contains: OPADRY complete film coating system 03B84929 PINK (ARTG Quetiapine AN PI v2.0 Page 1 _Quetiapine AN tablets Product Information _ _ _ _ Amneal Pharma Australia Pty Ltd _ No.106711) [25 mg], OPADRY complete film coating system 03B52117 yellow (ARTG No.106712) [100 mg], hypromellose, macrogol 400 and titanium dioxide [200 mg, 300 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 receptors. Quetiapine and norquetiapine exhibit affinity for brain serotonin (5HT 2 ) and dopamine D 1 and D 2 receptors; this combination of receptor Прочитать полный документ