Ondansetron apollo Ondansetron apollo Ondansetron

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1 Ondansetron apollo Ondansetron apollo Ondansetron CAS Number : Molecular Formula : C18H19N3O Molecular Weight : g/mol Systematic (IUPAC) : 9-methyl-3-[(2-methyl-1H- imidazol-1-yl)methyl]-2,3,4,9-tetrahydro-1h-carbazol- 4-one Type : small molecule

2 Description A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. Categories Anti-anxiety Agents Antiemetics Antipsychotics Serotonin Antagonists Antipruritics Antipsychotic Agents Taxonomy Kingdom : Organic Classes Carbazoles Tryptamines and Derivatives Substructures Indoles and Indole Derivatives Carbazoles Pyrroles Benzene and Derivatives Tryptamines and Derivatives Imidazoles Heterocyclic compounds Aromatic compounds Imines

3 Cyanamides Cyclohexenes and Derivatives Ketones Pharmacology Indication : For the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, postoperation, and radiation. Also used for the treatment of postoperative nausea and vomiting. Pharmacodynamics : Ondansetron is a highly specific and selective serotonin 5-HT3 receptor antagonist, not shown to have activity at other known serotonin receptors and with low affinity for dopamine receptors. The serontonin 5-HT3 receptors are located on the nerve terminals of the vagus in the periphery, and centrally in the chemoreceptor trigger zone of the area postrema. The temporal relationship between the emetogenic action of emetogenic drugs and the release of serotonin, as well as the efficacy of antiemetic agents suggest that chemotherapeutic agents release serotonin from the enterochromaffin cells of the small intestine by causing degenerative changes in the GI tract. The serotonin then stimulates the vagal and splanchnic nerve receptors that project to the medullary vomiting center, as well as the 5-HT3 receptors in the area postrema, thus initiating the vomiting reflex, causing nausea and vomiting. Mechanism of action : Ondansetron is a selective serotonin 5-HT3 receptor antagonist. The antiemetic activity of the drug is brought about through the

4 inhibition of 5-HT3 receptors present both centrally (medullary chemoreceptor zone) and peripherally (GI tract). This inhibition of 5-HT3 receptors in turn inhibits the visceral afferent stimulation of the vomiting center, likely indirectly at the level of the area postrema, as well as through direct inhibition of serotonin activity within the area postrema and the chemoreceptor trigger zone. Absorption : Ondansetron is well absorbed after oral administration and undergoes limited first-pass metabolism. Protein binding : 70%-76% (Plasma protein binding) Metabolism : Hepatic Half life : 5.7 hours Clearance 0.38 L/h/kg [Normal Adult Volunteers (19-40 yrs)] 0.32 L/h/kg [Normal Adult Volunteers (61-74 yrs)] 0.26 L/h/kg [Normal Adult Volunteers (>=75 yrs)] Toxicity : Low blood pressure and fainting, sudden blindness, severe constipation Affected organisms : Humans and other mammals Uses This medication is used alone or with other medications to prevent nausea and vomiting caused by cancer drug

5 treatment (chemotherapy) and radiation therapy. It is also used to prevent and treat nausea and vomiting after surgery. It works by blocking one of the body's natural substances (serotonin) that causes vomiting. How To Use? To prevent nausea from chemotherapy, take this medication by mouth usually within 30 minutes before treatment begins. To prevent nausea from radiation treatment, take this medication by mouth 1 to 2 hours before the start of your treatment. To prevent nausea after surgery, take ondansetron by mouth 1 hour before the start of surgery. This medication may be taken with or without food. However, your doctor may tell you not to eat before chemotherapy, radiation, or surgery.if you are using the liquid form of this medication, use a special measuring spoon or device to measure out your prescribed dose. Do not use a household spoon because you may not get the correct dose.take any other doses as directed by your doctor. Ondansetron may be taken up to 3 times a day for 1 to 2 days after your chemotherapy or radiation treatment is finished. If you are taking this medication on a prescribed schedule, take it regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.dosage is based on your medical condition and response to therapy. The dosage for children may also be based on age and weight. The usual maximum dose in patients with severe liver problems is 8 milligrams in 24 hours. Take this medication exactly as directed. Do not take more medication or take it more often than prescribed. Ask your doctor or pharmacist if you have

6 questions.inform your doctor if your condition does not improve or if it worsens. Drug interactions Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.this drug should not be used with the following medication because a very serious interaction may occur: apomorphine.if you are currently using the medication listed above, tell your doctor or pharmacist before starting ondansetron.before using this medication, tell your doctor of all nonprescription and prescription medication you may use, especially of: tramadol.ask your doctor or pharmacist for more details.this document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Why is this medication prescribed? Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron is in a class of medications called serotonin 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.

7 How should this medicine be used? Ondansetron comes as a tablet, a rapidly disintegrating (dissolving) tablet, and an oral solution (liquid) to take by mouth. The first dose of ondansetron is usually taken 30 minutes before the start of chemotherapy, 1 to 2 hours before the start of radiation therapy, or 1 hour before surgery. Additional doses are sometimes taken one to three times a day during chemotherapy or radiation therapy and for 1 to 2 days after the end of treatment. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ondansetron exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If you are taking the rapidly disintegrating tablet, remove the tablet from the package just before you take your dose. To open the package, do not try to push the tablet through the foil backing of the blister. Instead, use dry hands to peel back the foil backing. Gently remove the tablet and immediately place the tablet on the top of your tongue. The tablet will dissolve in a few seconds and can be swallowed with saliva. Other uses for this medicine This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. What special precautions should I follow? Before taking ondansetron, tell your doctor and pharmacist if you are allergic to ondansetron, alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), palonosetron (Aloxi),

8 any other medications, or any of the ingredients in ondansetron tablets or liquid. Ask your pharmacist for a list of the ingredients. tell your doctor if you are receiving apomorphine (Apokyn). Your doctor will probably tell you not to take ondansetron if you are receiving this medication. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention clarithromycin (Biaxin, in Prevpac); erythromycin (E.E.S., Erythrocin, others); medications for irregular heart beat; medications for mental illness; moxifloxacin (Avelox);and tramadol (Ultram, in Ultracet).Your doctor may need to change the doses of your medications or monitor you more carefully for side effects. Many other medications may also interact with ondansetron, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. tell your doctor if you or anyone in your family has or has ever had long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death), or another type of irregular heart beat or heart rhythm problem, or if you have or have ever had low blood levels of magnesium or potassium in your blood, congestive heart failure (CHF; condition in which the heart cannot pump enough blood to other parts of the body),or liver disease. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ondansetron, call your doctor. if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the

9 orally disintegrating tablets contain aspartame that forms phenylalanine. What special dietary instructions should I follow? Unless your doctor tells you otherwise, continue your usual diet. What should I do if I forget a dose? Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. What side effects can this medication cause? Ondansetron may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: diarrhea headache constipation weakness tiredness dizziness Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:blurred vision or vision loss rash hives itching swelling of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs hoarseness difficulty breathing or swallowing

10 shortness of breath noisy, high pitched breathing Ondansetron may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication. What storage conditions are needed for this medicine? Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets and rapidly disintegrating tablets away from light, at room temperature or in the refrigerator. Store the solution in the bottle upright at room temperature and away from light, excess heat, and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication. Symptoms of overdose may include sudden loss of vision for a short time dizziness or lightheadedness fainting constipation irregular heart beat What other information should I know? Keep all appointments with your doctor. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such

11 as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies. apollo asia Division APOLLO Pharmaceuticals API Manufacturers INDIA [P] Ltd. asia Division Mr.Vipin Saxena CEO Cellular: Cellular: Direct : FAX : Wireline Purchase HELPDESK: Wireline Sales HELPDESK: Wireless 24x7 HELPDESK: Blackberry Pin : 32E6500D 32E C58 apollo@hotmail.co.in Sales@apollopharma.in Export@apollopharma.in purchase@apollopharma.in

12 Chat: MSN Hotmail:VipinrSaxena Skype NAME:VipinrSaxena Rocketmail:VipinrSaxena Google mail:vipinrsaxena BlackBerry:28415C58 Regd. Office :- 1104, Maker Chamber V, Nariman Point Mumbai, INDIA Pin: Industrial Office D-62, OIC India Oshiwara Industrial Centre, New Link Road, Goregoan West, Mumbai, INDIA Pin: Manufacturing Unit Address: Plot No. 117A, Village: Chamble Near MonaTona Limited.Wada, Maharashtra, PIN : INDIA apollo@hotmail.co.in Sales@apollopharma.in Export@apollopharma.in purchase@apollopharma.in

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