Odanostin Hydrochlor >
Zofran . Research Triangle Park, NC: GlaxoSmithKline;2011 September.
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Getting the most from your treatment
- Odanostin should start to work within an hour or so. If you are taking tablets or liquid medicine and you are sick within one hour of taking a dose, you should take the same dose again. This does not apply, however, if you are using suppositories or if you have been given an injection, as being sick will not prevent these from being absorbed by your body.
- Even if you do not feel like eating or drinking, try to sip water regularly to prevent you from becoming lacking in fluids (dehydrated). Also, rather than trying to eat three main meals a day, try eating small, simple but nourishing snacks, every few hours.
- You can take Odanostin with or without food.
- Take this drug at the time(s) recommended by your doctor.
- Do not cut or crush the orally disintegrating tablets.
Before taking Odanostin,
Odanostin can cause a severe allergic reaction. Symptoms can include:
- trouble breathing
- swelling of your throat or tongue
If you develop these symptoms, call 911 or go to the nearest emergency room.
Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).
Odanostin mechanism of action
Odanostin is a serotonin-3 (5-hydroxytryptamine-3, 5-HT3) receptor antagonist, have been shown to have a good antiemetic effect in patients receiving chemotherapy and in situations with vomiting after surgery 1) . Odanostin is one of the best known 5-HT3 receptor antagonists, blocking receptors at vagal and sympathetic nerves and the chemoreceptor triggering zone 2) . However, 5-HT3 receptor antagonists not only inhibit transmission of signals to the CNS, they also decrease intestinal motility, presumably by interfering with serotonergic neurotransmission within the enteric nervous system (ENS) and blocking the initiation of reflexes 3) . Odanostin effects are thought to be on both peripheral and central nerves. One part is to reduce the activity of the vagus nerve, which is a nerve that activates the vomiting center in the medulla oblongata, the other is a blockage of serotonin receptors in the chemoreceptor trigger zone.
Before taking Odanostin, tell your doctor or pharmacist if you are allergic to it; or to other anti-nausea serotonin blockers (e.g., granisetron); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: irregular heartbeat, liver disease, stomach/intestinal problems (e.g., recent abdominal surgery, ileus, swelling).
Odanostin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using Odanostin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using Odanostin safely.
This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
This medicine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist regarding the safe use of this medicine.
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Pediatric Dose for Nausea/Vomiting – Postoperative
- Use: Prevention of postoperative nausea and vomiting
- 1 month to 12 years
- Less than 40 kg: Recommended dose: 0.1 mg/kg IV over 2 to 5 minutes immediately prior to/following anesthesia induction or postoperatively (nausea and/or vomiting occurring shortly after surgery)
- 40 kg and greater: Recommended dose: 4 mg IV over 2 to 5 minutes immediately prior to/following anesthesia induction or postoperatively (nausea and/or vomiting occurring shortly after surgery)
What Are Warnings and Precautions for Odanostin?
- This medication contains Odanostin. Do not take Zofran, Zofran ODT, or Zuplenz if you are allergic to Odanostin or any ingredients contained in this drug
- Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately
- Coadministration with apomorphine; combination reported to cause profound low blood pressure and loss of consciousness
Effects of Drug Abuse
- Odanostin may mask progressiveileus or gastricdistention in patients who are undergoing abdominal surgery or experiencing chemotherapy-induced nausea and vomiting; monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction
- See also "What Are Side Effects Associated with Using Odanostin?”
- See also "What Are Side Effects Associated with Using Odanostin?”
- Hypersensitivity reactions including anaphylaxis and bronchospasm may occur: discontinue therapy if suspected; monitor and treat promptly per standard of care until signs and symptoms resolve
- Reduce dose with severe hepatic impairment
- Use according to schedule, not as needed
- Odanostin may mask progressive ileus or gastric distention in patients who are undergoing abdominal surgery or experiencing chemotherapy-induced nausea and vomiting; monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction
- Odanostin is not a drug that stimulates gastric or intestinal peristalsis; should not be used instead of nasogastric suction
- Serotonin syndrome reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs including SSRIs, SNRIs, MAO inhibitors, lithium, tramadol, methylene blue IV, and mirtazapine; if concomitant use with other serotonergic drugs is clinically warranted, patients should be made aware of potential increased risk for serotonin syndrome
- Cross-sensitivity among selective serotonin antagonists may occur
- Zofran ODT contains phenylalanine (caution for phenylketonurics)
- Dose-dependent QT prolongation; avoid in patients with congenitallong QT syndrome; ECG monitoring recommended in patients who have electrolyte abnormalities, chronicheart failure, or bradyarrhythmias or who are also receiving other medications that cause QT prolongation
Pregnancy and Lactation with Odanostin
- Available data do not reliably inform of association with adverse fetal outcomes when Odanostin is used during pregnancy; published epidemiological studies on the association between Odanostin and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation
- It is not known whether Odanostin is present in human milk; there are no data on effects of Odanostin on breastfed infant or effects on milk production; the developmental and health benefits of breastfeeding should be considered along with mother's clinical need for Odanostin and any potential adverse effects on breastfed infant from therapy or from the underlying maternalcondition