국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
pramipexole dihydrochloride monohydrate
Apotex Pty Ltd
pramipexole dihydrochloride monohydrate
APO-PRAMIPEXOLE TABLETS _Contains the active ingredient pramipexole (as pramipexole hydrochloride monohydrate)_ 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 pramipexole. 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. You can also download the most up to date leaflet from www.apotex.com.au. 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- Pramipexole Tablets. It contains the active ingredient pramipexole (as pramipexole hydrochloride monohydrate). It is used to treat Parkinson's disease. 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. _HOW IT WORKS_ It belongs to a group of medicines known as "dopamine agonists". Parkinson's disease is a disease of the brain that affects body movement. The symptoms of Parkinson's disease are caused by a lack of dopamine, a naturally occurring chemical produced by certain brain cells. Dopamine relays messages in the part of the brain that controls movement. Pramipexole works by having a similar effect to dopamine in the 전체 문서 읽기
Product Information – Australia APO-Pramipexole tablets Page 1 APO-PRAMIPEXOLE TABLETS NAME OF THE MEDICINE Pramipexole Hydrochloride Monohydrate Chemical Name: (S)-2-amino-6-propylamino-4,5,6,7-tetrahydrobenzothiazole dihydrochloride monohydrate Structural Formula: Molecular Formula: C 10 H 17 N 3 S . 2HCl . H 2 O Molecular Weight: 302.26 (monohydrate) 211.33 (free base) 284.25 (anhydrous) CAS Registry Number: 191217-81-9 DESCRIPTION Pramipexole Hydrochloride Monohydrate is a white to off-white crystalline powder, freely soluble in water (>20% w/v). Each tablet contains 0.125 mg, 0.25mg or 1mg pramipexole hydrochloride monohydrate as the active ingredient. In addition, each tablet contains the following inactive ingredients: mannitol, pregelatinised maize starch, colloidal anhydrous silica, povidone and magnesium stearate. PHARMACOLOGY PHARMACOLOGICAL ACTIONS Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the dopamine D2 subfamily receptors and has a preferential affinity to D3 receptors. It has full intrinsic activity. Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum. Animal studies have shown that pramipexole inhibits dopamine synthesis, release and turnover. In human volunteers a dose-dependent decrease in prolactin was observed. PHARMACOKINETICS Pramipexole displays linear pharmacokinetics over the clinical dosage range with peak to trough fluctuations (C max , C min ) of approximately 55%. Absorption Pramipexole is rapidly absorbed following oral administration. The absolute bioavailability of pramipexole is greater than 90%, indicating that it is well absorbed and undergoes little presystemic metabolism. Generally, concomitant administration with food does not affect the bioavailability of pramipexole. Following administration of pramipexole tablets, maximum plasma concentrations (C max ) are reached in approximately 2 hours. Food does not affect the extent of pramipexole absorption, although the time to maximum 전체 문서 읽기