Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ONDANSETRON HYDROCHLORIDE DIHYDRATE
AVERROES PHARMACEUTICALS SDN. BHD.
ONDANSETRON HYDROCHLORIDE DIHYDRATE
12tablet Tablets
PT NOVELL PHARMACEUTICAL LABORATORIES.
_Consumer Medication Information Leaflet (RiMUP)_ ONDANOV TABLET ONDANSETRON (4MG, 8MG) WHAT IS IN THIS LEAFLET 1. What ONDANOV Tablet is used for 2. How ONDANOV Tablet works 3. Before you use ONDANOV Tablet 4. How to use ONDANOV Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of ONDANOV Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ONDANOV TABLET USED FOR ONDANOV Tablet is used to manage of nausea (feeling sick) and vomiting (being sick) induced by cytotoxic chemotherapy and radiotherapy and for the prevention and treatment of postoperative nausea and vomiting. HOW ONDANOV TABLET WORKS This medicine contains ondansetron, which belongs to a group of medicines called anti- emetics, which help to stop you feeling or being sick. BEFORE YOU USE ONDANOV TABLET _When you must not use it _ • Do not take if you are hypersensitivity to any component of ONDANOV Tablet. • Do not take if you are taking Parkinson;s disease medicine (Apomorphine hydrochloride) ONDANOV is not recommended for use during pregnancy. • Tell your doctor if you are pregnant or planning to become pregnant. • ONDANOV may harm your unborn baby. • If you do become pregnant during treatment with ONDANOV, tell your doctor. If you are a woman of childbearing age, your doctor will check if you are pregnant and perform a pregnancy test if necessary before starting treatment with ONDANOV. If you may become pregnant, you should use effective birth control during treatment and for at least 2 days after stopping ONDANOV. Ask your doctor about options of effective birth control. _ _ _Before you start to take it _ _ _ Ondansetron is known to increase large bowel transit time if you have a blockage of your intestines or constipation, as you will need to be closely monitored by your doctor. _ _ _Taking other medicines _ _ _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop Les hele dokumentet
ONDANOV 4MG TABLET ONDANOV 8MG TABLET Ondansetron DESCRIPTION _ONDANOV 4mg Tablet:_ Orange, round, shallow, convex, 6.80 – 7.20 mm in diameter and 2.80 – 3.80 mm in thickness film coated tablet with break line on one side. _ONDANOV 8mg Tablet:_ Orange, round, shallow, convex, 7.80 – 8.20 mm in diameter and 4.05 – 5.05 mm in thickness film coated tablet with no break line on one side. COMPOSITION _ONDANOV 4mg Tablet:_ Each film-coated tablet contains 5mg Ondansetron Hydrochloride Dihydrate equivalent to 4mg of Ondansetron. _ONDANOV 8mg Tablet:_ Each film-coated tablet contains 10mg Ondansetron Hydrochloride Dihydrate equivalent to 8mg of Ondansetron. PHARMACODYNAMICS Ondansetron is a potent, highly selective 5HT3 receptor antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the 4th ventricle, and this may promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3-receptors on neurons located both in the peripheral and central nervous system. The mechanisms of actions in postoperative nausea and vomiting are not known but there may be common pathways with cytotoxic-induced nausea and vomiting. Ondansetron does not alter plasma protein concentrations. PHARMACOKINETICS Following oral administration, ondansetron is passively and completely absorbed from the gastrointestinal tract and undergoes first-pass metabolism. Peak plasma concentrations are attained approximately 1.5 hrs after dosing. For doses >8 mg, the increase in ondansetron systemic exposure with dose is greater than proportional; this may refl Les hele dokumentet