Ondem (Ondansetron Hydrochloride Tablets)

Ondem (Ondansetron Hydrochloride Tablets) is used for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy and 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. It is also used for prevention of postoperative nausea and/or vomiting.

1. Ondansetron HCl Tablets
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Ondem (Ondansetron Hydrochloride Tablets) is used for the
prevention of nausea and vomiting associated with highly
emetogenic cancer chemotherapy, prevention of nausea and
vomiting associated with initial and repeat courses of moderately
emetogenic cancer chemotherapy and 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. It is also used for prevention of
postoperative nausea and/or vomiting.

2. Ondem Tablets
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Ondem Tablets are manufactured by
Alkem Laboratories Ltd., India.
(Website: www.alkemlabs.com)

3. Ondansetron Hydrochloride Tablets – Brand Names
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Ondansetron Hydrochloride are
available as Zofran, Zofer, Ondem,
Osetron ,Emeset, Oncoden,
Speronden, Vomikind, Vomiz,
Vorast, , Dotson, Edeset and
Nausehext.

4. Active Ingredient
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The active ingredient contained in Ondem
tablets is Ondansetron Hydrochloride.

5. Chemical Structure
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The structure of Ondansetron Hydrochloride
is given below:

6. Uses of Ondem Tablets
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Ondem tablets (Ondansetron Hydrochloride)
is used alone or with other medicines to
prevent nausea and vomiting caused by
cancer drug treatment (chemotherapy) and
radiotherapy (radiation therapy). It is also
used to prevent and treat nausea and
vomiting after surgery. It works by stopping
the effects one of the body's natural
substances (serotonin) that causes vomiting.

7. Ondem Dosage

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➢Highly Emetogenic Cancer Chemotherapy : A
single 24-mg dose administered 30 minutes before
the start of single-day highly emetogenic
chemotherapy, including cisplatin greater than or
equal to 50 mg/m2.
➢Moderately Emetogenic Cancer Chemotherapy: 8
mg administered 30 minutes before the start of
chemotherapy, with a subsequent 8-mg dose 8
hours after the first dose. Then administer 8 mg
twice a day (every 12 hours) for 1 to 2 days after
completion of chemotherapy.
The dosage of Ondem tablets (Ondansetron
Hydrochloride) is given below:

8. Ondansetron Hydrochloride Tablets - Dosage

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➢Radiotherapy: For total body irradiation: 8 mg administered
1 to 2 hours before each fraction of radiotherapy each day.
For single high-dose fraction radiotherapy to the abdomen: 8
mg administered 1 to 2 hours before radiotherapy, with
subsequent 8-mg doses every 8 hours after the first dose for
1 to 2 days after completion of radiotherapy. For daily
fractionated radiotherapy to the abdomen: 8 mg
administered 1 to 2 hours before radiotherapy, with
subsequent 8-mg doses every 8 hours after the first dose for
each day radiotherapy is given.
➢Postoperative: 16 mg administered 1 hour before induction
of anesthesia
The dosage of Ondem (Ondansetron Hydrochloride
Tablets) is given below:

9. Storage Instructions

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Ondem (Ondansetron Hydrochloride
Tablets) have to be stored at controlled
room temperature i.e. from 2°C to 30°C
(36°F to 86°F).
Protect from light. Dispense in tight,
light-resistant container.
Keep this as well as all other medicines
away from children and pets.

10. Warnings

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Hypersensitivity reactions including anaphylaxis and
bronchospasm: Discontinue Ondem in case suspected.
Monitor and treat immediately per standard of care until
signs and symptoms resolve.
QT interval prolongation and Torsade de Pointes: Avoid in
patients with congenital long QT syndrome; monitor with
electrocardiograms (ECGs) if concomitant electrolyte
abnormalities, cardiac failure or arrhythmias, or use of other
QT prolonging drugs.
Serotonin syndrome: Reported with 5-HT3 receptor
antagonists alone but particularly with concomitant use of
serotonergic drugs. In case such symptoms occur, stop
Ondem and start supportive treatment. In case
concomitant use of Ondem with other serotonergic drugs is
clinically warranted, patients should be made aware of a
potential increased risk for serotonin syndrome.

11. Warnings

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Masking of progressive ileus and/or gastric
distention following abdominal surgery or
chemotherapy-induced nausea and vomiting:
Monitor for decreased bowel activity,
particularly in patients with risk factors for
gastrointestinal obstruction.
Phenylketonuria: Patients should be informed
that Ondem MD orally disintegrating tablets
contain phenylalanine (a component of
aspartame). Each 4 mg and 8 mg orally
disintegrating tablet contains less than 0.03 mg
phenylalanine.

12. Ondem Tablets
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Contraindications
Ondem tablets are contraindicated in patients
with a hypersensitivity to Ondansetron
Hydrochloride or any other component of this
medication. Concomitant use of apomorphine
is also contraindicated.

13. Ondem Side Effects
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➢The most common Ondem (Ondansetron
Hydrochloride Tablets) side effects for the treatment of
various indications are:
➢Prevention of chemotherapy-induced (greater than or
equal to 5%) are headache, malaise/fatigue,
constipation, diarrhea.
➢Prevention of radiation-induced nausea and vomiting
(greater than or equal to 2%) are: headache,
constipation, and diarrhea.
➢Prevention of postoperative nausea and vomiting
(greater than or equal to 9%) are: headache and hypoxia.
➢Get emergency medical assistance in case you have
signs of an allergic reaction to Ondansetron: rash, hives;
fever, chills, difficult breathing; swelling of your face, lips,
tongue, or throat.

14. Ondem Overdose
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In addition to the side effects listed earlier, the following
adverse reactions have been described in the setting of
ondansetron overdose: “Sudden blindness” (amaurosis) of
2 to 3 minutes’ duration plus severe constipation occurred
in one patient that was administered 72 mg of
Ondansetron intravenously as a single dose.
Other symptoms of an Ondansetron overdose of may
include Fainting and Irregular heartbeat.
Hypotension (and faintness) occurred in a patient that took
48 mg of Ondansetron tablets.
Following infusion of 32 mg over only a 4-minute period, a
vasovagal episode with transient second-degree heart
block was observed.
In all instances, the adverse reactions resolved
completely.

15. Ondansetron Hydrochloride
Overdose
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There is no specific antidote for ondansetron
overdose. Patients must be managed with
appropriate supportive therapy.

16. Ondem During Pregnancy
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Ondansetron Hydrochloride (Ondem
tablets) has been classified by the US FDA
as Pregnancy Category B.
Animal reproduction studies have
revealed no evidence of impaired fertility or
harm to the fetus due to Ondansetron.
There are, however, no adequate and well-
controlled studies in pregnant women.
Because animal reproduction studies are
not always predictive of human response,
this drug should be used during pregnancy
only if clearly needed.

17. Ondem Tablets
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Ondem Tablets click here
© Clearsky Pharmacy
Ondem (Ondansetron Hydrochloride Tablets)
by Alkem Laboratories Limited, India .