Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DOMPERIDONE
DUOPHARMA (M) SDN. BHD.
DOMPERIDONE
500 Tablet Tablets; 500Tablet Tablets; 100Tablet Tablets; 500Tablet Tablets
DUOPHARMA (M) SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 MOTIDONE TABLET Domperidone (10mg) WHAT IS IN THE LEAFLET 1. What MOTIDONE is used for 2. How MOTIDONE works 3. Before you use MOTIDONE 4. How to use MOTIDONE 5. While you are using it 6. Side effects 7. Storage and Disposal of MOTIDONE 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT MOTIDONE IS USED FOR The indigestion symptom complex that is often associated with delayed gastric emptying, gastro-oesophageal reflux and oesophagus inflammation: • epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain; • bloating, burping, flatulence • nausea and vomiting; • heartburn with or without back flow of gastric contents in the mouth. HOW MOTIDONE WORKS MOTIDONE is an antiemetic and a prokinetic medicine. It works by blocking the action of a chemical messenger in the brain which causes the feeling of nausea and vomiting, as well as increasing the movement or contractions of the stomach and intestines, allowing food to move more easily through the stomach. BEFORE YOU USE MOTIDONE - _When you must not use it_ Do not take MOTIDONE if: • you have an allergy to MOTIDONE or any of the ingredients at the end of this leaflet. • you have a tumour of the pituitary gland called prolactinoma • bleeding, obstruction or perforation in the stomach and intestines. • prevention of post-operative vomiting or for long term usage • you have cardiac diseases such as heart failure due to increased risk of abnormal heart beat Do not take MOTIDONE if you are taking any of the following medicines: clarithromycin (antibiotic). - _Before you start to use it_ You must tell your doctor if: • you are pregnant or planning to become pregnant. This medicine should be used during pregnancy only if clearly needed. • you have or have had liver disease. • you had breast cancer. • you have experience any cardiac symptoms. If you have not told your doctor or pharmacist about any of the above, Baca dokumen lengkap
[DUOPHARMA (M) SDN BHD] Page 1 of 2 [REVISION DATE: 01.02.2021] MOTIDONE TABLET 10MG DESCRIPTION: An oblong shaped tablet, pink in colour with marking "DUO". COMPOSITION: Each tablet contains Domperidone 10 mg. PHARMACODYNAMICS: Pharmacologically, domperidone is a dopamine antagonist with antiemetic properties similar to those of metoclopramide and certain neuroleptic drugs. Unlike these drugs, however, domperidone does not readily cross the blood brain barrier. It seldom causes extra-pyrimidal side effects, but does cause a rise in prolactin levels. Its antiemetic effect may be due to a combination of peripheral (gastro- kinetic) effects and antagonism of central dopamine receptors in the chemo-receptor trigger zone which lies in the area postrema and is regarded as being outside the blood brain barrier. Animal studies have shown that domperidone has no effect on plasma concentrations of homovanillic acid, a metabolite of dopamine. It also antagonises the behavioural effects of dopamine much more effectively when administered intracerebrally than when given systemically. These findings, together with the low concentrations found in the brain, indicate a predominantly peripheral effect of domperidone on dopamine receptors. Studies in humans have shown intravenous and oral domperidone to increase the duration of antral and duodenal contractions, to increase the gastric emptying of liquids and semi solids in healthy subjects and in patients in whom, it was delayed, and to increase lower oesophageal sphincter pressure in healthy subjects. Domperidone has no effect on gastric secretion. PHARMACOKINETICS: Domperidone is rapidly absorbed following intramuscular and oral administration with peak plasma concentrations occurring at approximately 10 and 30 minutes respectively. Systemic bioavailability of oral domperidone is 13 to 17%. The low oral bioavailability is probably due to "first-pass" gut wall and hepatic metabolism. Oral bioavailability is decreased by prior administration of cimetidine or sodium bicarbonate. T Baca dokumen lengkap