Eden (ETHICARE) blocks the actions of chemicals in the body that can trigger nausea and vomiting.
Eden (ETHICARE) is used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy or radiation).
Eden (ETHICARE) is not for preventing nausea or vomiting that is caused by factors other than cancer treatment or surgery.
Eden (ETHICARE) may be used for purposes not listed in this medication guide.
Eden (ETHICARE) indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Prevention of Nausea and Vomiting Associated with Highly Emetogenic Cancer Chemotherapy
Eden (ETHICARE) (Eden (ETHICARE)) oral soluble film is indicated for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2.
Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy
Eden (ETHICARE) is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Prevention of Nausea and Vomiting Associated with Radiotherapy
Eden (ETHICARE) is indicated for the prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Prevention of Postoperative Nausea and/or Vomiting
Eden (ETHICARE) is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, Eden (ETHICARE) is recommended even where the incidence of postoperative nausea and/or vomiting is low.
How should I use Eden (ETHICARE)?
Use Eden (ETHICARE) soluble film as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Eden (ETHICARE) soluble film. Talk to your pharmacist if you have questions about this information.
Do not remove the film strip from the foil pouch until you are ready to take Eden (ETHICARE) soluble film. Use the film strip immediately after opening the pouch. Do not store the removed film strip for future use.
Make sure that your hands are dry when you open the foil pouch.
To use Eden (ETHICARE) soluble film, fold the pouch along the dotted line and tear it along the edge. Remove the film strip and place it on the top of your tongue. Once the strip dissolves, it can be swallowed with saliva. Eden (ETHICARE) soluble film may be taken with or without liquid.
Do not chew or swallow Eden (ETHICARE) soluble film whole.
Wash your hands after you use Eden (ETHICARE) soluble film.
It is important to take Eden (ETHICARE) soluble film as directed to prevent nausea and vomiting. If you forget to take a dose of Eden (ETHICARE) soluble film, take it when you remember as directed by your doctor. If you are not sure what to do, contact your doctor or pharmacist.
Ask your health care provider any questions you may have about how to use Eden (ETHICARE) soluble film.
Uses of Eden (ETHICARE) in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Eden (ETHICARE) is used for preventing nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy or radiation).
Eden (ETHICARE) 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. [PubChem]
Eden (ETHICARE) dosage
Eden (ETHICARE) Dosage
Generic name: Eden (ETHICARE) HYDROCHLORIDE 4mg in 5mL
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Instructions for Use/Handling Eden (ETHICARE) ODT
Orally Disintegrating Tablets:
Do not attempt to push Eden (ETHICARE) ODT Tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the Eden (ETHICARE) ODT Tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.
Prevention of Nausea and Vomiting Associated with Highly Emetogenic Cancer Chemotherapy:
The recommended adult oral dosage of Eden (ETHICARE) is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24-mg dosage has not been studied.
Pediatric Use:
There is no experience with the use of a 24-mg dosage in pediatric patients.
Geriatric Use:
The dosage recommendation is the same as for the general population.
Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy:
The recommended adult oral dosage is one 8-mg Eden (ETHICARE) Tablet or one 8-mg Eden (ETHICARE) ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of Eden (ETHICARE)) of Eden (ETHICARE)
Oral Solution given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg Eden (ETHICARE) Tablet or one 8-mg Eden (ETHICARE) ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of Eden (ETHICARE)) of Eden (ETHICARE)
Oral Solution should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric Use:
For pediatric patients aged 12 years and older, the dosage is the same as for adults. For pediatric patients aged 4 through 11 years, the dosage is one 4-mg Eden (ETHICARE) Tablet or one 4-mg Eden (ETHICARE) ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of Eden (ETHICARE)) of Eden (ETHICARE)
Oral Solution given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg Eden (ETHICARE) Tablet or one 4-mg Eden (ETHICARE) ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of Eden (ETHICARE)) of Eden (ETHICARE)
Oral Solution should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Geriatric Use:
The dosage is the same as for the general population.
Prevention of Nausea and Vomiting Associated with Radiotherapy, Either Total Body Irradiation, or Single High-dose Fraction or Daily Fractions to the Abdomen:
The recommended oral dosage is one 8-mg Eden (ETHICARE) Tablet or one 8-mg Eden (ETHICARE) ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of Eden (ETHICARE)) of Eden (ETHICARE)
Oral Solution given 3 times a day.
For total body irradiation, one 8-mg Eden (ETHICARE) Tablet or one 8-mg Eden (ETHICARE) ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of Eden (ETHICARE)) of Eden (ETHICARE)
Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen, one 8-mg Eden (ETHICARE) Tablet or one 8-mg Eden (ETHICARE) ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of Eden (ETHICARE)) of Eden (ETHICARE)
Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen, one 8-mg Eden (ETHICARE) Tablet or one 8-mg Eden (ETHICARE) ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of Eden (ETHICARE)) of Eden (ETHICARE)
Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Pediatric Use:
There is no experience with the use of Eden (ETHICARE) Tablets, Eden (ETHICARE) ODT Tablets, or Eden (ETHICARE)
Oral Solution in the prevention of radiation-induced nausea and vomiting in pediatric patients.
Geriatric Use:
The dosage recommendation is the same as for the general population.
Postoperative Nausea and Vomiting:
The recommended dosage is 16 mg given as two 8-mg Eden (ETHICARE) Tablets or two 8-mg Eden (ETHICARE) ODT Tablets or 20 mL (4 teaspoonfuls equivalent to 16 mg of Eden (ETHICARE)) of Eden (ETHICARE)
Oral Solution 1 hour before induction of anesthesia.
Pediatric Use:
There is no experience with the use of Eden (ETHICARE) Tablets, Eden (ETHICARE) ODT Tablets, or Eden (ETHICARE)
Oral Solution in the prevention of postoperative nausea and vomiting in pediatric patients.
Geriatric Use:
The dosage is the same as for the general population.
Dosage Adjustment for Patients with Impaired Renal Function:
The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of Eden (ETHICARE).
Dosage Adjustment for Patients with Impaired Hepatic Function:
In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
Eden (ETHICARE) does not appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Eden (ETHICARE) is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of Eden (ETHICARE). On the basis of limited available data, no dosage adjustment is recommended for patients on these drugs.
Apomorphine
Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with Eden (ETHICARE), the concomitant use of apomorphine with Eden (ETHICARE) is contraindicated.
Phenytoin, Carbamazepine, And Rifampin
In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of Eden (ETHICARE) was significantly increased and Eden (ETHICARE) blood concentrations were decreased. However, on the basis of available data, no dosage adjustment for Eden (ETHICARE) is recommended for patients on these drugs.
Tramadol
Although there are no data on pharmacokinetic drug interactions between Eden (ETHICARE) and tramadol, data from two small trials indicate that concomitant use of Eden (ETHICARE) may result in reduced analgesic activity of tramadol. Patients on concomitant Eden (ETHICARE) self administered tramadol more frequently in these trials, leading to an increased cumulative dose in patient-controlled administration (PCA) of tramadol.
Serotonergic Drugs
Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs).
Chemotherapy
In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of Eden (ETHICARE).
In a crossover trial in 76 pediatric patients, intravenous Eden (ETHICARE) did not increase blood levels of high-dose methotrexate.
Temazepam
The coadministration of Eden (ETHICARE) had no effect on the pharmacokinetics and pharmacodynamics of temazepam.
Alfentanil And Atracurium
Eden (ETHICARE) does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. Interactions with general or local anesthetics have not been studied.
Drug Abuse And Dependence
Animal studies have shown that Eden (ETHICARE) is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.
The following have been reported as adverse events in clinical trials of patients treated with Eden (ETHICARE), the active ingredient of Eden (ETHICARE). A causal relationship to therapy with Eden (ETHICARE) has been unclear in many cases.
Chemotherapy-Induced Nausea and Vomiting
The adverse events in Table 5 have been reported in ≥ 5% of adult patients receiving a single 24-mg Eden (ETHICARE) Tablet in 2 trials. These patients were receiving concurrent highly emetogenic cisplatin-based chemotherapy regimens (cisplatin dose ≥ 50 mg/m ).
Table 5: Principal Adverse Events in US Trials: Single Day Therapy With 24-mg Eden (ETHICARE) Tablets (Highly Emetogenic Chemotherapy)
Event
Eden (ETHICARE) 24 mg q.d.
n = 300
Eden (ETHICARE) 8 mg b.i.d.
n = 124
Eden (ETHICARE) 32 mg q.d.
n = 117
Headache
33 (11%)
16 (13%)
17 (15%)
Diarrhea
13 (4%)
9 (7%)
3 (3%)
The adverse events in Table 6 have been reported in ≥ 5% of adults receiving either 8 mg of Eden (ETHICARE) Tablets 2 or 3 times a day for 3 days or placebo in 4 trials. These patients were receiving concurrent moderately emetogenic chemotherapy, primarily cyclophosphamide-based regimens.
Table 6: Principal Adverse Events in US Trials: 3 Days of Therapy With 8-mg Eden (ETHICARE) Tablets (Moderately Emetogenic Chemotherapy)
Event
Eden (ETHICARE) 8 mg b.i.d.
n = 242
Eden (ETHICARE) 8 mg t.i.d.
n = 415
Placebo
n = 262
Headache
58 (24%)
113 (27%)
34 (13%)
Malaise/fatigue
32 (13%)
37 (9%)
6 (2%)
Constipation
22 (9%)
26 (6%)
1 ( < 1%)
Diarrhea
15 (6%)
16 (4%)
10 (4%)
Dizziness
13 (5%)
18 (4%)
12 (5%)
Central Nervous System: There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving Eden (ETHICARE).
Hepatic: In 723 patients receiving cyclophosphamide-based chemotherapy in US clinical trials, AST and/or ALT values have been reported to exceed twice the upper limit of normal in approximately 1% to 2% of patients receiving Eden (ETHICARE) Tablets. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. The role of cancer chemotherapy in these biochemical changes cannot be clearly determined.
There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear.
Integumentary: Rash has occurred in approximately 1% of patients receiving Eden (ETHICARE).
Other: Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures have been reported. Except for bronchospasm and anaphylaxis, the relationship to Eden (ETHICARE) was unclear.
Radiation-Induced Nausea and Vomiting
The adverse events reported in patients receiving Eden (ETHICARE) Tablets and concurrent radiotherapy were similar to those reported in patients receiving Eden (ETHICARE) Tablets and concurrent chemotherapy. The most frequently reported adverse events were headache, constipation, and diarrhea.
Postoperative Nausea and Vomiting
The adverse events in Table 7 have been reported in ≥ 5% of patients receiving Eden (ETHICARE) Tablets at a dosage of 16 mg orally in clinical trials. With the exception of headache, rates of these events were not significantly different in the Eden (ETHICARE) and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications.
Table 7: Frequency of Adverse Events From Controlled Studies With Eden (ETHICARE) Tablets (Postoperative Nausea and Vomiting)
Adverse Event
Eden (ETHICARE) 16 mg
(n = 550)
Placebo
(n = 531)
Wound problem
152 (28%)
162 (31%)
Drowsiness/sedation
112 (20%)
122 (23%)
Headache
49 (9%)
27 (5%)
Hypoxia
49 (9%)
35 (7%)
Pyrexia
45 (8%)
34 (6%)
Dizziness
36 (7%)
34 (6%)
Gynecological disorder
36 (7%)
33 (6%)
Anxiety/agitation
33 (6%)
29 (5%)
Bradycardia
32 (6%)
30 (6%)
Shiver(s)
28 (5%)
30 (6%)
Urinary retention
28 (5%)
18 (3%)
Hypotension
27 (5%)
32 (6%)
Pruritus
27 (5%)
20 (4%)
Preliminary observations in a small number of subjects suggest a higher incidence of headache when Eden (ETHICARE) ODT
Orally Disintegrating Tablets are taken with water, when compared to without water.
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of oral formulations of Eden (ETHICARE). Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Eden (ETHICARE).
Cardiovascular: Rarely and predominantly with intravenous Eden (ETHICARE), transient ECG changes including QT interval prolongation have been reported.
General: Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylaxis/anaphylactoid reactions, angioedema, bronchospasm, shortness of breath, hypotension, laryngeal edema, stridor) have also been reported. Laryngospasm, shock, and cardiopulmonary arrest have occurred during allergic reactions in patients receiving injectable Eden (ETHICARE).
Hepatobiliary: Liver enzyme abnormalities
Lower Respiratory: Hiccups
Neurology: Oculogyric crisis, appearing alone, as well as with other dystonic reactions
Skin: Urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Special Senses: Eye Disorders: Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours.
Drug Abuse And Dependence
Animal studies have shown that Eden (ETHICARE) is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.
You should not use this medication if you are allergic to Eden (ETHICARE) or to similar medicines such as dolasetron (Anzemet), granisetron (Kytril), or palonosetron (Aloxi). Do not take Eden (ETHICARE) if you are also using apomorphine (Apokyn).
Before taking Eden (ETHICARE), tell your doctor if you have liver disease, or a personal or family history of Long QT syndrome.
Eden (ETHICARE) orally disintegrating tablets may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).
The serious side effects of this medication include blurred vision or temporary vision loss (lasting from only a few minutes to several hours), slow heart rate, trouble breathing, anxiety, agitation, shivering, feeling like you might pass out, and urinating less than usual or not at all. Stop taking Eden (ETHICARE) and call your doctor at once if you have any of these side effects.
Eden (ETHICARE) may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
DailyMed. "ONDANSETRON: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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