Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
ondansetron hydrochloride
Arrow Pharma Pty Ltd
Ondansetron hydrochloride
Registered
APO-ONDANSETRON 1 APO-ONDANSETRON _Contains the active ingredient, ondansetron (as hydrochloride dihydrate) _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about ondansetron. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: if there is anything you do not understand in this leaflet, if you are worried about taking your medicine, or to obtain the most up-to-date information. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Ondansetron. It contains the active ingredient, ondansetron. It is used to help stop the nausea and vomiting which can occur after some medical treatments. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed ondansetron for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS _ Ondansetron belongs to a group of medicines called serotonin receptor - 3 antagonists. There is no evidence that this medicine is addictive. _USE IN CHILDREN _ There is not enough information to recommend the use of this medicine in children four years of age and under. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF: YOU ARE TAKING APOMORPHINE (USED TO TREAT PARKINSON'S DISEASE) YOU ARE HYPERSENSITIVE TO, OR HAVE HAD AN ALLERGIC Baca dokumen lengkap
Product Information APO-ONDANSETRON Page 1 of 11 APO-ONDANSETRON NAME OF THE MEDICINE Ondansetron (as hydrochloride dihydrate). Chemical Name: (3_RS_)-9-Methyl-3-[(2-methyl-1_H_-imidazol-1-yl)methyl]-1,2,3,9-tetrahydro-4_H_- carbazol-4-one hydrochloride dihydrate Structural Formula: Molecular Formula: C 18 H 20 ClN 3 O,2H 2 O Molecular Weight: 365.9 CAS Number: 99614-01-4 DESCRIPTION Ondansetron hydrochloride dihydrate is a white to off-white powder with a melting point of 177 ⁰ C. It is sparingly soluble in water and alcohol, soluble in methanol and slightly soluble in methylene chloride. It is soluble in saline (0.9% w/v) to about 8 mg/mL. The pKa of ondansetron hydrochloride dihydrate as determined by a solubility procedure is 7.4. The distribution coefficient between n-octanol and water is pH dependent with log D = 2.2 at a pH of 10.6 and log D = 0.6 at a pH of 5.95. Apo-Ondansetron tablets come in two strengths and contain either 4 mg or 8 mg of ondansetron (as hydrochloride dihydrate). The tablets also contain the following excipients: lactose, microcrystalline cellulose, maize starch, magnesium stearate and Opadry Y-1-7000 White. The tablets are gluten free. PHARMACOLOGY Ondansetron is a potent, highly selective 5HT 3 -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 5HT 3 - 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 due to antagonism of 5HT 3 -receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in postoperative nause Baca dokumen lengkap