Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ondansetron Hydrochloride
PHARMAFORTE (MALAYSIA) SDN. BHD.
Ondansetron Hydrochloride
10Tablet Tablets; 30Tablet Tablets
APOTEX INC. - ETOBICOKE SITE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ APO-ONDANSETRON TABLET Ondansetron hydrochloride (4mg, 8mg) 1 WHAT IS IN THIS LEAFLET 1. What Apo-Ondansetron is used for 2. How Apo-Ondansetron works 3. Before you use Apo-Ondansetron 4. How to use Apo-Ondansetron 5. While you are using it 6. Side Effects 7. Storage and Disposal of Apo- Ondansetron 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT APO-ONDANSETRON IS USED FOR It is used to prevent and manage nausea (feeling sick) and vomiting (being sick), which can occur: • during treatment for cancer (chemotherapy or radiotherapy) • after an operation HOW APO-ONDANSETRON WORKS Apo-Ondansetron belongs to a group of medicines called anti-emetics. It works by blocking the action of a natural substance called serotonin that may cause nausea and vomiting. BEFORE YOU USE APO-ONDANSETRON _-When you must not use it _ Do not take Apo-Ondansetron if you are allergic (hypersensitive) to ondansetron or any other ingredients of Apo-Ondansetron. If you think this applies to you, do not use Apo- Ondansetron until you have checked with your doctor. _-Before you start to use it _ Before you use Apo-Ondansetron your doctor needs to know: • if you are allergic to medicines similar to Apo-Ondansetron, such as medicines containing granisetron or palonosetron • if you have bowel obstruction problems • if you have electrolytes abnormalities • if you have liver disease, your doctor may lower your dose of Apo-Ondansetron Check with your doctor if you think any of these may apply to you. Apo-Ondansetron is not recommended for use during pregnancy. • Tell your doctor if you are pregnant or planning to become pregnant. • If you do become pregnant during treatment with Apo- Ondansetron, tell your doctor. Breast-feeding is not recommended during treatment with Apo- Ondansetron. The ingredients can pass into your breast milk, and may affect your baby. Talk to your doctor about this. If you are a woman of childbearing age, your do read_full_document
APO‐ONDANSETRON TABLET 4MG AND 8MG ANTIEMETIC Ondansetron 4mg (as ondansetron HCl): Yellow, oval, unscored, film‐coated tablets, imprinted “APO” on one side and “OND4” on the other side, blister pack in a box of 10 tablets Ondansetron 8mg (as ondansetron HCl): Yellow, oval, unscored, film‐coated tablets, imprinted “APO” on one side and “OND8” on the other side, blister pack in a box of 10 tablets. 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 fourth ventricle, and this may also 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 action in post‐operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting. Ondansetron does not alter plasma prolactin concentrations. PHARMACOKINETICS Following oral administration, ondansetron is passively and completely absorbed from the gastrointestinal tract and undergoes first pass metabolism. Peak plasma concentrations of about 30ng/ml are attained approximately 1.5 hours after an 8mg dose. For doses above 8mg the increase in ondansetron systemic exposure with dose is greater than proportional; this may reflect some reduction in first pass metabolism at higher oral doses. Bioavailability, following oral administration, is slightly enhanced by the presence of food but unaffected by antacids. Studies in hea read_full_document