Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ONDANSETRON HYDROCHLORIDE DIHYDRATE
MYLAN HEALTHCARE SDN. BHD.
ONDANSETRON HYDROCHLORIDE DIHYDRATE
1vial Vials
Mylan Laboratories Limited [Specialty Formulation Facility}
MYLAN ONDANSETRON CONCENTRATE FOR SOLUTION FOR INFUSION OR INJECTION 2MG/ML PRODUCT DESCRIPTION: Mylan Ondansetron Concentrate Solution for Infusion or Injection 2mg/mL is a clear colour less solution free from visible particles. The reconstituted solution is a clear colourless solution. Ondansetron injection should only be mixed with those infusion solutions which are recommended: • Sodium chloride 0.9%w/v • Dextrose 5.0%w/v • Sodium chloride 0.9%w/v and Dextrose 5.0%w/v • Sodium chloride 0.45%w/v and Dextrose 5.0%w/v • Sodium chloride 3.0%w/v COMPOSITION: EACH ML CONTAINS: Ondansetron hydrochloride equivalent to Ondansetron 2 mg PHARMACOLOGY: Ondansetron is a highly selective 5 HT 3 receptor antagonist, which inhibits nausea and vomiting caused by cytotoxic agents and radiation. Its precise mode of action is not known but believed to be mediated via antagonism of 5-hydroxytryptamine receptors located in the chemoreceptor trigger zone in the area postrema of the brain and possibly on vagal afferents in the upper gastrointestinal tract. It is used in the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, particularly where this is severe or unresponsive to other therapy. It has also been given for postoperative nausea and vomiting. PHARMACOKINETICS: It is extensively distributed in the body and about 70-75% of the drug in plasma is protein bound. It is cleared from the systemic circulation predominantly by hepatic metabolism through multiple enzymatic pathways, with less than 5% of a dose being excreted unchanged in urine. The disposition of ondansetron following IM or IV dosing is similar with a terminal elimination half-life of about 3 hours and steady-state volume of distribution of about 140L. Special Patient Populations: _Elderly: _ Studies in healthy elderly volunteers have shown prolonged elimination half-life (5hrs). _Children: _ Studies in children (above 2 years) also showed reduced clearance and volume of distribution, which is age-related; use of weight-bas Read the complete document