Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DOMPERIDONE MALEATE
ABIOTIDE SDN. BHD.
DOMPERIDONE MALEATE
100 Tablets
HOVID BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ AETOS DOMPERIDONE TABLET 10 MG Domperidone 10 mg 1 WHAT IS IN THIS LEAFLET 1. What Aetos Domperidone is used for 2. How Aetos Domperidone works 3. Before you use Aetos Domperidone 4. How to use Aetos Domperidone 5. While you are using it 6. Side effects 7. Storage and Disposal of Aetos Domperidone 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT AETOS DOMPERIDONE IS USED FOR Aetos Domperidone is used for the relief of the symptoms of nausea and vomiting from various causes (including chemotherapy, radiotherapy or other medicines). HOW AETOS DOMPERIDONE WORKS Aetos Domperidone 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 YOUR USE AETOS DOMPERIDONE _ _ _- When you must not use it_ You should not use Aetos Domperidone if: • You know you are allergic (hypersensitive) to domperidone and other ingredients listed at the end of the leaflet. • You suffer from a tumour of the pituitary gland called prolactinoma. • Have bleeding, obstruction and hole in the stomach and bowel (e.g. severe stomach cramps or persistent black stools). • Have moderate to severe liver disease. • Have abnormal potassium level, low magnesium level in the blood. • Have or had heart problems including heart failure or heart rhythm disorders including a slow or irregular heartbeat. Do not take Aetos Domperidone if you are taking any of the following medications: clarithromycin (antibiotic). If in doubt, ask your pharmacist or doctor for advice. Stop taking Aetos Domperidone and contact your doctor immediately if you experience abnormal heartbeat. _Pregnancy_ If you are pregnant or think you may be, tell your doctor, who will decide if you can take Aetos Domperidone. _Breast-feeding_ Small amounts of Aetos Domperidon Preberite celoten dokument
DESCRIPTION Round, 6.0 mm in diameter, white to off-white coated tablet with shallow convex faces. COMPOSITION Each film-coated tablet contains Domperidone Maleate 12.73mg, equivalent to Domperidone 10 mg. PHARMACODYNAMICS Domperidone is a dopamine antagonist with anti-emetic properties. Domperidone does not readily cross the blood-brain barrier. In domperidone users, especially adults, extrapyramidal side effects are very rare, but domperidone promotes the release of prolactin from the pituitary. Its anti-emetic effect may be due to a combination of peripheral (gastrokinetic) effects and antagonism of dopamine receptors in the chemoreceptor trigger zone, which lies outside the blood-brain barrier in the area postrema. Studies in man have shown oral domperidone to increase lower oesophageal pressure, improve antroduodenal motility and accelerate gastric emptying. There is no effect on gastric secretion. PHARMACOKINETICS ABSORPTION In fasting subjects, domperidone is rapidly absorbed after oral administration, with peak plasma concentrations at 30 to 60 minutes. The low absolute bioavailability of oral domperidone (approximately 15%) is due to an extensive first-pass metabolism in the gut wall and liver. Although domperidone's bioavailability is enhanced in normal subjects when taken after a meal, patients with gastro-intestinal complaints should take domperidone 15-30 minutes before a meal. Reduced gastric acidity impairs the absorption of domperidone. Oral bioavailability is decreased by prior concomitant administration of cimetidine and sodium bicarbonate. The time of peak absorption is slightly delayed and the AUC somewhat increased when domperidone is taken after a meal. DISTRIBUTION Domperidone is 91 - 93% bound to plasma proteins. METABOLISM Domperidone undergoes rapid and extensive hepatic metabolism by hydroxylation and N-dealkylation. In vitro metabolism experiments with diagnostic inhibitors revealed that CYP3A4 is a major form of cytochrome P-450 involved in the N-dealkylation of domperidone, whereas C Preberite celoten dokument