Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
Moclobemide
Apotex Pty Ltd
Medicine Registered
TERRY WHITE CHEMISTS MOCLOBEMIDE _Contains the active ingredient, moclobemide_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about moclobemide. 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 Terry White Chemists Moclobemide. It contains the active ingredient moclobemide. It is used to treat depression. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed moclobemide for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS_ There are many different types of medicines used to treat depression. Moclobemide belongs to a group of antidepressant medicines called reversible inhibitors of monoamine oxidase A (RIMA). Antidepressants are used to treat depression and work on the central nervous system. They are thought to work by their action on brain chemicals called amines, which are involved in controlling mood. 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 Pročitajte cijeli dokument
Product Information – Australia Terry White Chemists Moclobemide Tablets Page 1 TERRY WHITE CHEMISTS MOCLOBEMIDE TABLETS NAME OF THE MEDICINE Moclobemide. Chemical Name: p-chloro-N-(2-morpholinoethyl)benzamide. Structural Formula: H O N CH 2 CH 2 N C O Cl Molecular Formula: C 13 H 17 O 2 N 2 Cl Molecular Weight: 268.74 CAS Registry Number: 71320-77-9 DESCRIPTION Moclobemide is a white to slightly reddish crystalline powder. It contains no crystal water and is not hygroscopic. It is soluble in water at 0.4 g/100 mL. The pKa is approximately 6.2. PHARMACOLOGY PHARMACOKINETICS Absorption After oral administration, moclobemide is completely absorbed from the gastrointestinal tract into the portal blood. A hepatic first-pass effect reduces the systemically available dose fraction (bioavailability: F). This reduction is more pronounced after single (F: 60%) than after multiple (F: > 80%) doses. Following the administration of a 300 mg single dose of moclobemide to healthy subjects, peak plasma concentrations ranged from 1.0 to 3.4 μg/mL (mean C max 2.2 μg/mL) and were reached in 0.8 to 4.0 hours (median T max 1.75 hours). Studies using other moclobemide-containing formulations have shown that during the second week of a 100mg t.i.d. dosing regimen in healthy subjects, the steady- state trough concentrations of moclobemide ranged between 114 ng/mL and 517 ng/mL. An increase in the dose to 150 mg t.i.d. resulted in a greater than proportional increase in moclobemide steady- state trough concentrations, namely to concentrations ranging between 346 ng/mL and 1,828 ng/mL. Distribution Due to its lipophilic nature, moclobemide is extensively distributed in the body with an apparent volume of distribution (V ss ) of Pročitajte cijeli dokument