Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Amisulpride
APO-AMISULPRIDE _Contains the active ingredient: amisulpride_ 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 amisulpride. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. 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- Amisulpride. It contains the active ingredient amisulpride. It is used to treat: • symptoms of schizophrenia Schizophrenia is a condition which affects the way you think, feel and/or act. Schizophrenia may cause symptoms such as hallucinations (e.g. hearing, seeing or sensing things which are not there), delusions, unusual suspiciousness, emotional and social withdrawal. People with schizophrenia may also feel depressed, anxious or tense. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. _USE IN CHILDREN_ This medicine must not be taken by children up to the age of puberty. There is limited information on the use of amisulpride in adolescents, therefore the use of ami Read the complete document
Product Information – Australia APO-Amisulpride tablets Page 1 APO-AMISULPRIDE TABLETS NAME OF THE MEDICINE Amisulpride. Chemical Name: (R, S)-4-Amino-N-[1-ethyl-2-pyrrolidinyl)methyl]-5-ethylsulfonyl-2-methoxybenxamide Structural Formula: Molecular Formula: C 17 H 27 N 3 O 4 S Molecular Weight: 369.48 CAS Registry Number: 71675-85-9 DESCRIPTION Amisulpride is a white or almost white crystalline powder which is practically insoluble in water, freely soluble in methylene chloride, and sparingly soluble in anhydrous ethanol. PHARMACOLOGY CLASS Neuroleptic of the benzamide class PHARMACOKINETICS In man, amisulpride shows two absorption peaks: one which is attained rapidly, one hour post- dose and a second between 3 and 4 hours after administration. Corresponding plasma concentrations are 39±3 and 54±4 ng/mL after a 50 mg dose. The volume of distribution is 5.8 L/kg. As plasma protein binding is low (16%), drug interactions due to displacement are unlikely. The absolute bioavailability of amisulpride tablets is 48%. Amisulpride tablets are not interchangeable with amisulpride solution. Amisulpride is weakly metabolised: two inactive metabolites, accounting for approximately 4% of the dose, have been identified. The elimination half-life of amisulpride is approximately 12 hours after an oral dose. Fifty percent of an intravenous dose is excreted via the urine, the majority as unchanged drug. Ninety percent of the intravenous dose is eliminated in the first 24 hours. Renal clearance is in the order of 20 L/h or 330 mL/min. Following a single intravenous dose, about 20% of the dose was recovered from the faeces, about 70% of which was as unchanged amisulpride. Hepatic metabolism has a limited role in healthy pati Read the complete document