(on dan' se tron)
P / L : Caution - pregnancy & lactation (breast feeding)
|| See TERMINOLOGY & ABBREVIATIONS ||
|Indication(s) & Dosage||
Nausea and vomiting associated with cancer chemotherapy or radiotherapy
Hepatic impairment: Moderate or severe hepatic impairment: Max: 8 mg daily.
Hepatic impairment: Moderate or severe hepatic impairment: Max: 8 mg daily.
|Administration||Should be taken with food.
|Overdose||Sudden transient blindness, severe constipation, hypotension, and vasovagal episode with transient secondary heart block. Treatment is supportive.|
|Contraindications||Use with apomorphine (profound hypotension).|
|Special Precautions||May cause QT prolongation; caution when used in cardiac diseases, patients who are on medications that can prolong QT or patients with electrolyte abnormalities. Severe hepatic impairment. May mask progressive ileus and/or gastric distension. Pregnancy, lactation.|
|Adverse Drug Reaction(s)||Headache, malaise/fatigue, constipation; drowsiness, fever, dizziness, anxiety, cold sensation; pruritus, rash; diarrhoea; gynaecological disorder, urinary retention; elevated transaminase; local inj site reaction (pain, redness, burning); paresthesia; hypoxia. Rarely: Anaphylaxis, angina, bronchospasm, ECG changes, extrapyramidal symptoms, grand mal seizure, hypokalaemia, tachycardia, vascular occlusive events.|
|Drug Interactions||Rifampicin and other CYP3A4 inducers reduce levels/effects of ondansetron.
Potentially Fatal: Concurrent use may increase the hypotensive effect of apomorphine; avoid concurrent use. Please consult detailed drug interactions before prescribing.
|Food Interaction||Extent of absorption increased with food. St John's wort may reduce serum levels of ondansetron.|
|Pregnancy Category (US FDA)||Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).|
|Storage||Oral: Oral solution: Store at 15-30°C. Protect from light. Tablet: Store at 2-30°C. Parenteral: Vial: Store at 2-30°C. Protect from light. Stable with D5W or normal saline for 48 hr at room temperature.|
|Pharmacology||Ondansetron antagonises 5-HT3 receptor, blocking serotonin, both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone.
Onset: Approx 30 minutes.
Absorption: Peak plasma concentrations: Oral: 1.5 hr; rectal: 6 hr.
Distribution: Extensively distributed. Protein-binding: 70-75%.
Metabolism: Hepatic via multiple enzymatic pathways.
Excretion: Via urine (44-60% as metabolites, 5-10% as unchanged), faeces (approx 25%). Terminal elimination half-life: Oral/parenteral: 3 hrs; rectal: 6 hrs; elderly/renal impairment: prolonged, approx 5 hr; severe hepatic impairment: 15-32 hr.
|ATC Classification||A04AA01 - ondansetron; Belongs to the class of serotonin (5HT3) antagonists. Used for the prevention of nausea and vomiting.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|ANSET||Opsonin Pharma Limited||Ondansetron as hydrochloride 4mg & 8mg||Film Coated Tablet||30's each: 135.00 & 300.00 MRP|
|ANSET Injection||Opsonin Pharma Limited||Ondansetron hydrochloride dihydrate 8mg/4ml||Injection||5's: 125.00 MRP|
|ANSET Solution||Opsonin Pharma Limited||Ondansetron hydrochloride dihydrate 4mg/5ml||Solution||50ml: 30.00 MRP|
|EMISTAT||Healthcare Pharmacuticals Ltd.||Ondansetron Hydrochloride USP equivalent to Ondansetron 8mg||Tablet||30's MRP 300 Tk|
|EMISTAT FT||Healthcare Pharmacuticals Ltd.||Ondansetron Hydrochloride USP equivalent to Ondansetron 4mg||Tablet||30's MRP 180 Tk|
|EMISTAT Injection||Healthcare Pharmacuticals Ltd.||Ondansetron Hydrochloride USP equivalent to Ondansetron 8 mg/4ml||Injection||10's: 300.00 MRP|
|EMISTAT SYRUP||Healthcare Pharmacuticals Ltd.||Ondansetron Hydrochloride Dihydrate BP equivalent to Ondansetron 4mg/5ml||Syrup||50ml, MRP 45 Tk|
|EMISTON-8||IBN SINA Pharmaceutical Industry Ltd.||Ondansetron hydrochloride dihydrate 8mg||Film Coated Tablet||30's: 300.00 IP|
|OFRAN 8||Square Pharmaceuticals Ltd.||Ondansetron 8mg||Tablet||3x10's: 302.10 MRP|
|OFRAN INJ||Square Pharmaceuticals Ltd.||Ondansetron 8mg/4 ml||IV Injection||3x2's: 180.60 MRP|
|OFRAN O-SOLN||Square Pharmaceuticals Ltd.||Ondansetron 4mg/5 ml||Oral Solution||50 ml: 40.13 MRP|
|OFRAN SUPP||Square Pharmaceuticals Ltd.||Ondansetron 16mg||Suppository||2x5's: 200.60 MRP|
|ONASECRON Solution||Incepta Pharmaceuticals Limited||Ondansetron Hydrochloride Dihydrate BP equivalent to Ondansetron 4mg/5ml||Solution||1's: 40.00 MRP|
|Onaseron||Incepta Pharmaceuticals Limited||Ondansetron Hydrochloride Dihydrate BP 9.977 mg equivalent to Ondansetron 8 mg||Film Coated Tablet||10x3's:MRP 300 Tk|
|Onaseron Injection||Incepta Pharmaceuticals Limited||Ondansetron Hydrochloride Dihydrate BP 2.49 mg equivalent to Ondansetron 2 mg||Injection||1x5's:MRP 125 Tk|
|ONASIA||Orion Pharma Ltd.||Ondansetron hydrochloride dihydrate equivalent ondensetron 8mg||Film Coated Tablet||30's: 150.00 MRP|
|ONASIA Injection||Orion Pharma Ltd.||Ondansetron hydrochloride dihydrate 8mg/4ml (I/V)||Injection||4ml x5's: 125.00 MRP|
|ONASIA Solution||Orion Pharma Ltd.||Ondansetron hydrochloride dihydrate equivalent ondensetron 4mg/5ml||Oral Solution||50ml: 30.00 MRP|
|ONCODEX-4||Jayson Pharmaceuticals Ltd.||Ondansetron hydrochloride dihydrate 4mg||Film Coated Tablet||30's: 135.60 IP|
|ONCODEX-8||Jayson Pharmaceuticals Ltd.||Ondansetron hydrochloride dihydrate 8mg||Film Coated Tablet||30's: 240.90 IP|
|ONCODEX-8 Injection||Jayson Pharmaceuticals Ltd.||Ondansetron hydrochloride dihydrate 8mg/4ml||Injection||4ml x5's: 125.50 IP|
|ONDANOV-4||Novus Pharmaceuticals Ltd.||Ondansetron hydrochloride dihydrate 4mg||Film Coated Tablet||30's: 90.00 MRP|
|ONDANOV:8||Novus Pharmaceuticals Ltd.||Ondansetron hydrochloride dihydrate 8mg||Film Coated Tablet||30's: 150.00 MRP|
|ONDASON-8||Drug International Ltd||Ondansetron hydrochloride dihydrate 8mg||Film Coated Tablet||30's: 300.00 MRP|
|ONSAT 8||Beximco Pharmaceuticals Ltd||Ondansetron Hydrochloride USP eq. to Ondansetron 8mg||Tablet||30's: 300.00 MRP|
|ONSAT INJECTION||Beximco Pharmaceuticals Ltd||Ondansetron Hydrochloride USP eq. to Ondansetron 8mg/4ml||Injection||5's: 125.00 MRP|
|OSETRON||ACI Ltd.||Ondansetron hydrochloride dihydrate 8mg||Film Coated Tablet||30's: 300.00 MRP|
|OSETRON Injection||ACI Ltd.||Ondansetron hydrochloride dihydrate 8mg/4ml||Injection||4ml x5's: 125.45 MRP|
|OSETRON Syrup||ACI Ltd.||Ondansetron hydrochloride dihydrate 4mg/5ml||Syrup||50ml: 30.11 MRP|
|SETON 8||Delta Pharma Limited||Ondansetron hydrochloride dihydrate 8mg||Film Coated Tablet||30's: 240.00 MRP|
|SETRONAX 8||Monico Pharma Limited||Ondansetron hydrochloride dihydrate 8mg||Film Coated Tablet||30's: 300.00 MRP|
|ZOFER MD 4||Sun Pharmaceutical (Bangladesh) Ltd.||Ondansetron hydrochloride dihydrate 4m||Film Coated Tablet||30's: 135.00 MRP|
|ZOFRA||Eskayef Bangladesh Ltd||Ondansetron Hydrochloride Dihydrate BP equivalent to Ondansetron 4mg/5ml||Syrup||50ml MRP: 30.00|
|ZOFRA Injection||Eskayef Bangladesh Ltd||Ondansetron Hydrochloride USP equivalent to Ondansetron 8mg/4ml||Injection||5's MRP: 150.00|
|ZOFRA ODT 4||Eskayef Bangladesh Ltd||Ondansetron Hydrochloride USP equivalent to Ondansetron 4mg||Film Coated Tablet||20's & 30's MRP: 80.00 & 120.00|
|ZOFRA ODT 8||Eskayef Bangladesh Ltd||Ondansetron Hydrochloride USP equivalent to Ondansetron 8mg||Film Coated Tablet||20's & 30's MRP: 160.00 & 240.00|
Why is Ondansetron 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.
How should Ondansetron 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 Ondansetron
Ondansetron may be prescribed for other uses. Ask your doctor for more information.
What special precautions to follow?
Before taking ondansetron,
- inform your doctor if you are allergic to ondansetron, alosetron, dolasetron, granisetron, palonosetron any other medications, or any of the ingredients in ondansetron tablets or liquid.
- inform your doctor if you are receiving apomorphine. Your doctor will probably inform you not to take ondansetron if you are receiving Ondansetron.
- inform your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention clarithromycin; erythromycin; medications for irregular heart beat; medications for mental illness; moxifloxacin and tramadol.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 inform your doctor about all the medications you are taking, even those that do not appear on this list.
- inform 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.
- inform 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 orally disintegrating tablets contain aspartame that forms phenylalanine.
What special dietary instructions to follow?
Unless your doctor informs you otherwise, continue your usual diet.
What to 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 Ondansetron cause?
Ondansetron may cause side effects. inform your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
blurred vision or vision loss
swelling of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
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 Ondansetron.
What to know about storage and disposal of Ondansetron?
Keep Ondansetron 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.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
Symptoms of overdose may include:
sudden loss of vision for a short time
dizziness or lightheadedness
irregular heart beat
What other information to know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Ondansetron.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
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 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.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
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