البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
pramipexole dihydrochloride monohydrate
Generic Health Pty Ltd
pramipexole dihydrochloride monohydrate
Pramipexole GH CMI v2 Page 1 of 5 CONSUMER MEDICINE INFORMATION PRAMIPEXOLE GH pramipexole dihydrochloride monohydrate What is in this leaflet This leaflet answers some common questions about PRAMIPEXOLE GH. It does not contain all the information and does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you taking PRAMIPEXOLE GH against the benefits they expect it will have for you. Talk to your doctor or pharmacist if you have any concerns about taking this medicine. Keep this leaflet with the medicine. You may need to read it again. What PRAMIPEXOLE GH is used for PRAMIPEXOLE GH is used in the treatment of Parkinson's disease. 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. When too little dopamine is produced, this results in Parkinson's disease. PRAMIPEXOLE GH works by having a similar effect as dopamine in the brain. PRAMIPEXOLE GH contains the active ingredient Pramipexole hydrochloride. Pramipexole hydrochloride belongs to a group of medicines known as "dopamine agonists". Ask your doctor if you have any questions about why PRAMIPEXOLE GH has been prescribed for you. Your doctor may have prescribed PRAMIPEXOLE GH for another reason. Before you take PRAMIPEXOLE GH When not to take it Only use PRAMIPEXOLE GH if it has been prescribed for you by a doctor. Never give it to someone else even if their symptoms seem to be the same as yours. Do not take PRAMIPEXOLE GH if you are allergic to pramipexole or any of the other ingredients listed at the end of this leaflet. If you are not sure if you have these allergies, you should raise those concerns with your doctor. Signs of an allergic reaction may include itching of skin, shortness of breath and swelling of the tongue or face. You should not use PR اقرأ الوثيقة كاملة
1501 Pramipexole GH PI v1 Page 1 of 18 PRODUCT INFORMATION PRAMIPEXOLE GH _PRAMIPEXOLE HYDROCHLORIDE MONOHYDRATE_ _ _ NAME OF THE M ED ICI NE Pramipexole hydrochloride monohydrate. The chemical name of pramipexole is (_S_)-2-amino-4,5,6,7-tetrahydro-6-propylamino- benzothiazole, [C 10 H 17 N 3 S], CAS registry number 104632-26-0, molecular weight 211.33. Pramipexole tablets contain C 10 H 17 N 3 S.2HCl.H 2 O, molecular weight 302.3, CAS registry number 191217-81-9 for which the Australian Approved Name is pramipexole hydrochloride monohydrate. The structural formula is: DESC RIPTI ON Pramipexole hydrochloride monohydrate is a white to off-white crystalline powder, freely soluble (>20% w/v) in water. PRAMIPEXOLE GH tablets also contain the following excipients: mannitol, pregelatinised maize starch, silicon dioxide, povidone and magnesium stearate. PHARMACOLOGY PHARMACODYNAMICS Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the dopamine D 2 subfamily receptors and has a preferential affinity to D 3 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. 1501 Pramipexole GH PI v1 Page 2 of 18 PHARMACOKINETICS _ABSORPTION: _ Pramipexole is rapidly absorbed, reaching peak concentrations in approximately two hours. The absolute bioavailability of pramipexole is greater than 90%, indicating that it is well absorbed and undergoes little presystemic metabolism. Food does not affect the extent of pramipexole absorption, although the time of maximum plasma concentration (Tmax) is increased by about one hour when t he drug is taken with a meal. _DISTRIBUTION: _ Pramipexole is extensively distributed, having a volume of distribution of about 500 L (coefficient of variation [CV] = 20%). It is about 15% bound to plasma proteins. Pramipexole distributes into red blood cells as indicated by an erythrocyte-to اقرأ الوثيقة كاملة