EMITOFF-MD Tablets

EMITOFF-MD Tablets

EMITOFF-MD is used for the management of nausea and vomiting induced by cancer treatment through anticancer drugs and radiation in adults and children. This medicine works by blocking the release of serotonin, a natural substance which may cause vomiting and nausea.
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COMPOSITION

Ondansetron 4mg Mouth Dissolving

DESCRIPTION

Ondansetron is a selective antagonist of the serotonin receptor subtype, 5-HT3.
Cytotoxic chemotherapy and radiotherapy are associated with the release of serotonin (5-HT) from enterochromaffin cells of the small intestine, presumably initiating a vomiting reflex through stimulation of 5-HT3 receptors located on vagal afferents. Ondansetron may block the initiation of this reflex. Activation of vagal afferents may also cause a central release of serotonin from the chemoreceptor trigger zone of the area postrema, located on the floor of the fourth ventricle. Thus, the antiemetic effect of ondansetron is probably due to the selective antagonism of 5-HT3 receptors on neurons located in either the peripheral or central nervous systems, or both.

HOW TO USE:

Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens.

INDICATION

• Nausea and vomiting
• Chemotherapy induced nausea and vomiting
• Post operative nausea and vomiting

Side Effects

• agitation
• constipation
• diarrhea
• dizziness
• fatigue
• fever
• flushing
• headache
• inability to urinate
• intravenous injection site reaction
• local burning sensation
• low level of oxygen in the blood (hypoxia)

PRECAUTIONS:

Before you use EMITOFF-MD, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Discuss with your doctor if you are allergic to granisetron, dolasetron, alosetron, or palonosetron. Before you use EMITOFF-MD Tablet, tell your doctor of your medical history including irregular heart beat, heart failure, low blood levels of magnesium, low blood levels of potassium, prolonged heartbeat (long QT syndrome), liver problems, genetic birth defect causing the build-up of an amino acid in the body (phenylketonuria), or severe constipation. Before having any surgery, discuss with your doctor and dentist about medicines you use including prescription medicines, non-prescription medicines, and herbal supplements. The use of EMITOFF-MD Tablet may change Electrocardiogram (ECG) monitoring. Electrocardiogram (ECG) changes including QT interval prolongation have been seen in patients receiving EMITOFF-MD. EMITOFF-MD Tablet is not safe for use in women who are pregnant. If you are pregnant or planning to become pregnant, you should discuss the impact on the fetus with your doctor before you start using this medicine. There is no appropriate data available on the safety of EMITOFF-MD during pregnancy. EMITOFF-MD Tablet is not safe for use in women who are breastfeeding. If you are breastfeeding, discuss with your doctor if you should either discontinue breastfeeding, or stop using this medicine during this period. Consult with your doctor on the use of EMITOFF-MD Tablet, if you are trying to conceive. EMITOFF-MD is known to be safe while drinking alcohol. EMITOFF-MD can make you feel sleepy. Be careful, especially while driving, while using heavy machinery, or when doing any activity that needs you to be completely alert. The consumption of alcohol with EMITOFF-MD can worsen the sleepiness. EMITOFF-MD may cause seizures in some people. Hence, you should discuss with your doctor before performing any activities where a loss of consciousness may cause harm to you or others.

DRUG INTERACTIONS:

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
EMITOFF-MD Tablet may interact with serotonergic drugs, which are used to treat depression. The use of EMITOFF-MD with serotonergic drugs may cause a life-threatening condition caused by the use of serotonergic drugs (serotonin syndrome). Such patients may experience symptoms like mental status changes, autonomic instability (e.g., high blood pressure, neuromuscular symptoms (e.g., tremor, rigidity), seizures, stomach and intestine symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the exposure of serotonin syndrome. If any of these symptoms occur, discontinue the use of EMITOFF-MD and provide supportive treatment. There may be an interaction of EMITOFF-MD with drugs affecting cytochrome P-450 enzymes (cyto3A4, cyto2D6, cyto1A2), which helps in the metabolism of the drug. The use of EMITOFF-MD with cytochrome P3A4 inducers such as (phenytion, carbamazepine, rifampin) may decrease the level of EMITOFF-MD in the blood. There is no requirement for dosage adjustment of EMITOFF-MD in such patients. EMITOFF-MD Tablet interacts with tramadol, which is used to help relieve moderate to adequately severe pain. When EMITOFF-MD is used in combination with tramadol, EMITOFF-MD may reduce the pain-relieving effect of tramadol. Such patients should be monitored to ensure adequate pain control. Special instructions need to be followed while taking this medicine along with apomorphine, which is used to treat Parkinson's disease. The use of EMITOFF-MD with apomorphine may cause low blood pressure and loss of consciousness in the patients. The use of EMITOFF-MD with apomorphine is not recommended. Your doctor's guidelines may need to be followed while taking this medicine along with drugs that cause prolonged heartbeat (QT prolonging drugs). When EMITOFF-MD is used with QT-prolonging drugs (such as doxorubicin, daunorubicin, trastuzimab, erythromycin, ketoconazole, amiodarone, atenolol or timolol) may increase the risk of irregular heartbeat. Take necessary precautions while taking EMITOFF-MD with QT-prolonging drugs in such patients. This page does not contain all the possible interactions of EMITOFF-MD Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

OVERDOSE:

Do not use more than prescribed dose. Taking more medication will not improve your symptoms; rather they may cause poisoning or serious side-effects. If you suspect that you or anyone else who may have overdosed of EMITOFF-MD Tablet, please go to the emergency department of the closest hospital or nursing home. Bring a medicine box, container, or label with you to help doctors with necessary information.

STORAGE:

Store medicines at room temperature, away from heat and direct light. Do not freeze medicines unless required by package insert. Keep medicines away from children and pets.

MISSED DOSE:

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

NOTES:

Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection. A different medication may be necessary in those cases.With prolonged treatment, laboratory and/or medical tests (e.g., kidney and liver function, complete blood counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Report Problems to the Central Drugs Standard Control Organization

You are encouraged to report negative side effects of prescription drugs to the CDSCO. Visit the CDSCO website.