Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)

Ondem (Generic Ondansetron Hydrochloride Tablets) is a serotonin 5-HT3 receptor antagonist, which is used mainly as an anti-emetic (to treat nausea and vomiting), often following chemotherapy or radiotherapy. It is also used for prevention of postoperative nausea and/or vomiting.
Its effects are thought to be on both peripheral and central nerves. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone.
Ondem tablets are manufactured by Alkem Laboratories Limited, India in the strengths of 4 mg and 8 mg.

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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)

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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Ondem (Generic Ondansetron Hydrochloride Tablets) is
a serotonin 5-HT3 receptor antagonist, which is used
mainly as an anti-emetic (to treat nausea and vomiting),
often following chemotherapy or radiotherapy. It is also
used for prevention of postoperative nausea and/or
vomiting.
Its effects are thought to be on both peripheral and
central nerves. Ondansetron reduces the activity of the
vagus nerve, which deactivates the vomiting centre in the
medulla oblongata, and also blocks serotonin receptors in
the chemoreceptor trigger zone.

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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Active Ingredient
The active ingredient present in Ondem
tablets is Ondansetron Hydrochloride. Each
film coated Ondem tablet contains
Ondansetron Hydrochloride equivalent to
Ondansetron 4 mg or Ondansetron 8 mg
respectively.

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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Chemical Structure
The structure of Ondansetron Hydrochloride is given below:

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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Ondem Tablets (Generic Ondansetron Hydrochloride
Tablets) are manufactured by Alkem Laboratories
Limited, India in the strengths of 4 mg and 8 mg.
(Website: https://www.alkemlabs.com/ )
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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Ondansetron Hydrochloride Tablets – Brand Names
Ondansetron Hydrochloride tablets are
available under various Drug trade names
that include Zofran, Zofer, Ondem,
Osetron ,Emeset, Oncoden, Speronden,
Vomikind, Vomiz, Vorast, Dotson, Edeset
and Nausehext.

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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Uses of Ondem Tablets
Ondem (Generic Ondansetron Hydrochloride Tablets) is a 5-HT3 receptor
antagonist indicated for the prevention of nausea and vomiting associated
with highly emetogenic cancer chemotherapy, including cisplatin greater
than or equal to 50 mg/m2. This medicine is also used to treat nausea and
vomiting associated with initial and repeat courses of moderately
emetogenic cancer chemotherapy and 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.
Also used to treat postoperative nausea and/or vomiting.
Ondansetron works in the stomach to block the signals to the brain that
cause nausea and vomiting.
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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Ondem Tablets Dosage

You should only take Ondem exactly as directed by your doctor. The
dosage of Ondem tablets (Generic Ondansetron Hydrochloride tablets)
is given below:
Emetogenic Chemotherapy and Radiotherapy:The recommended oral dose
of is 8 mg one to two hours before treatment, followed by 8 mg orally 12
hours later. The recommended oral dose is 8 mg to be taken twice daily.
To protect against delayed or prolonged emesis after the first 24 hours,
oral treatment with Ondansetron should be continued for up to 5 days
after a course of treatment.
Post-Operative Nausea and Vomiting: For prevention of post-operative
nausea and vomiting, the recommended oral dose is 16 mg given one hour
prior to anaesthesia.
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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Ondem Tablets Contraindications
Ondem tablets are contraindicated in persons with a
hypersensitivity (allergy) to Ondansetron Hydrochloride or
any of the other ingredients of this medicine. Concomitant use of
Apomorphine is also contraindicated.
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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Storage Instructions

Ondem Tablets (Generic Ondansetron
Hydrochloride Tablets) have to be stored at
controlled room temperature i.e. from 20°C to
25°C (68°F to 77°F) with excursions
permitted between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away
from children and pets.
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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Warnings

Hypersensitivity reactions including anaphylaxis and bronchospasm: Ondem
must be discontinued in case in case Hypersensitivity reactions are suspected.
Monitor and treat immediately per standard of care until signs and symptoms
resolve.
QT interval prolongation and Torsade de Pointes: Avoid administration of this
medicine 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 tablets 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.

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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Warnings

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.
Based on reports of profound hypotension and loss of consciousness
when Apomorphine was administered with Ondansetron, concomitant
use of Apomorphine with ondansetron is contraindicated.

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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Side Effects
The most common side effects of Ondansetron Hydrochloride (Ondem tablets)
in adults for the Prevention of chemotherapy-induced (greater than or equal to
5%) are headache, malaise/fatigue, constipation, diarrhea.
The most common side effects of Ondansetron tablets in adults forPrevention
of radiation-induced nausea and vomiting (greater than or equal to 2%) are:
headache, constipation, and diarrhea.
The most common side effects of Ondansetron tablets in adults for Prevention
of postoperative nausea and vomiting (greater than or equal to 9%) are:
headache and hypoxia.
Get emergency medical help if you have signs of an allergic reaction to
ondansetron: rash, hives; fever, chills, difficult breathing; swelling of your face,
lips, tongue, or throat.
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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Side Effects
Call your doctor at once if you have: severe constipation, stomach
pain, or bloating; headache with chest pain and severe dizziness,
fainting, fast or pounding heartbeats; fast or pounding heartbeats;
jaundice (yellowing of the skin or eyes); blurred vision or
temporary vision loss (lasting from only a few minutes to several
hours); high levels of serotonin in the body--agitation,
hallucinations, fever, fast heart rate, overactive reflexes, nausea,
vomiting, diarrhea, loss of coordination, fainting
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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Ondem Tablets Overdose
In addition to the side effects listed earlier, other symptoms of an
overdose of Ondansetron Hydrochloride tablets (Ondem) may include
Sudden and temporary blindness, Severe constipation, 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.
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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
Ondem Tablets During Pregnancy
Ondansetron Hydrochloride (Ondem tablets) has been classified by the
US FDA as Pregnancy Category B.
Published epidemiological studies on the association between Ondansetron and
fetal outcomes have reported inconsistent findings and have important
methodological limitations hindering interpretation. Reproductive studies in rats
and rabbits did not show evidence of harm to the fetus when ondansetron was
administered during organogenesis at approximately 6 and 24 times the
maximum recommended human oral dose of 24 mg/day, based on body surface
area, respectively.
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.
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Ondem Tablets (Generic Ondansetron Hydrochloride Tablets)
For more details on
Ondem Tablets click here
Ondem Tablets (Generic Ondansetron Hydrochloride Tablets) by
Alkem Laboratories Limited, India.
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