Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
trifluoperazine hydrochloride
Amdipharm Mercury Australia Pty Ltd
Registered
Stelazine (trifluoperazine hydrochloride) Page 1 of 10 CONSUMER MEDICINE INFORMATION STELAZINE ® _TRIFLUOPERAZINE HYDROCHLORIDE _ _ _ Film-coated tablets 1 mg, 2 mg and 5 mg WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Stelazine. This leaflet answers some common questions about Stelazine. It does not contain all the available information. Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Stelazine against the benefits this medicine is expected to 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 want to read it again. WHAT STELAZINE IS USED FOR Stelazine contains trifluoperazine hydrochloride as the active ingredient. It belongs to a group of medicines called phenothiazine neuroleptics. It helps to correct chemical imbalances in the brain, which may cause mental illness. These chemicals may also affect the parts of the brain which control nausea and vomiting. Stelazine is used to treat mental illnesses with disturbances in thinking, feelings and behaviour. It may also be used to treat nausea and vomiting, or used short term in patients with severe anxiety, tension and agitation. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Stelazine is available only with a doctor's prescription. Stelazine is not addictive. Stelazine (trifluoperazine hydrochloride) Page 2 of 10 BEFORE YOU TAKE STELAZINE Stelazine is not suitable for everyone. _WHEN YOU MUST NOT TAKE IT _ STELAZINE MUST NOT BE GIVEN TO ANYONE WHO HAS REDUCED CONSCIOUSNESS DUE TO MEDICATION, IS UNCONSCIOUS OR IN A COMA. DO NOT TAKE STELAZINE IF YOU HAVE AN ALLERGY TO IT OR TO: any other medicine containing trifluoperazine any of the ingredients listed at the end of this leaflet other similar medicines kn Přečtěte si celý dokument
1 PRODUCT INFORMATION STELAZINE ® (TRIFLUOPERAZINE) NAME OF THE MEDICINE Trifluoperazine hydrochloride Molecular formula: C 21 H 24 F 3 N 3 S.2HCl MW: 480.4 Chemical structure: .2HCl CAS Registry Number: 440-17-5 DESCRIPTION Trifluoperazine is a white to pale yellow, crystalline powder, hygroscopic, freely soluble in water, soluble in alcohol, practically insoluble in ether, which melts at approx. 242°C, with decomposition. Trifluoperazine is a phenothiazine tranquilliser with potent antipsychotic, anxiolytic and antiemetic activity. Stelazine tablets 1 mg, 2 mg and 5 mg contains excipients: calcium sulfate, sucrose, maize starch, gelatin, purified talc, stearic acid, purified water and Opadry OY-S-4492. Stelazine capsules contain excipients: gelatin, maize starch, purified talc, kaolin, sucrose, titanium dioxide, microcrystalline wax, glyceryl distearate, quinoline yellow, indigo carmine, docusate sodium, shellac and iron oxide black. Stelazine Liquid Forte contains excipients: sodium benzoate, saccharin sodium, sodium chloride, sodium citrate, citric acid monohydrate, glycerol, sorbitol, purified water, sunset yellow FCF, Natural Soluble Orange Flavour, Sweet No 1 07-2241 and 65359 Quassia Q5 Soluble Essence. PHARMACOLOGY Antagonism of dopamine-mediated synaptic neurotransmission is an important action of neuroleptic drugs including trifluoperazine and is believed to contribute to their antipsychotic action. The 2 antidopaminergic effects are also considered to be responsible for the diverse extrapyramidal manifestations. INDICATIONS CHRONIC THERAPY In higher doses for the management of psychotic disorders, such as acute and chronic schizophrenia, psychosis due to organic brain damage, toxic psychosis, manic depressive psychosis, senile psychosis and psychosis associated with mental deficiency. SHORT TERM THERAPY For the relief of delusions, hallucinations and confusion, and for the control of tremulousness and aggressive behaviour in alcoholic patients. In low doses to control excessive anxiety, tension and Přečtěte si celý dokument