Drug Interaction:
5-HT3 Receptor Antagonists include-
Alosetron, Dolasetron, Ondansetron, Palonosetron, Granisetron, Hydrolastron
Refer - 5-HT3 Receptor Antogonists
Dexamethasone enhances the effect of the drug.
Cisplatin, 5FU,carboplatin, etoposide, cyclophosphamide, ceftazidine, doxorubicin & dexamethasone
can be administered via the Y-site of infusion set. Dilution with normal saline,5% glucose
10% manitol I.V.infusion. Ringers I.V.infusion,potassium chloride 3% w/v with normal saline can also
be done.
Indication:
LIST OF DRUGS DURING 2007
Sr.No- 1
Name of the Drug- R-Ondansetron (as HCL dihydride)
(1mg/ml ) injection
Pharmacological Classification- Chemotherapy induced nausea & vomiting
Date of Approval- 12-01-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
LIST OF DRUGS DURING 2007
Sr.No- 136
Name of the Drug- Ondansetron orally disintegrating tablet
(4mg/8mg) (addl.dosage form) Pharmacological Classification- For chemotherapy induced nausea and
vomiting
Date of Approval- 28-09-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
Prevention of nausea and vomiting associated with cancer therapy.
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Ondansetron Hcl Antiemetic February 1994
Dihyrate
2.Ondansetron Hcl Oral Spray 08-11-2012
2mg (each spray delivers
Ondansetron 2mg)
For chemotherapeutic induced nausea and vomiting
3.Ondansetron orally 28-09-2007
Disintegrating tablet
4mg/8mg
Addl.Dosage Form
For Chemotherapy induced nausea and vomiting
4.R-Ondansetron Hcl dihydrate 12-01-2007
1mg/ml injection
Chemotherapy induced nausea and vomiting
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Ondansetron Gastrointestinal Glaxo Wellcome 09-05-2005
INFORMATION UP DATE-
ONDANSETRON- RISKY IN QT PROLONGATION, CCF-
The antinausea drug ondansetron should not be used in patients with long QT syndome,
as they are at particular risk for developing Torsade de Pointes while taking the drug,
according to U.S. Food Drug Administration.
Also at risk are patients with congestive heart failure or bradyarrhythmias, those predisposed
to low potassium and magnesium levels, and those taking other drugs that can lead to
QT prologation.
Accodingly ECG monitoring is now recommended for such patients using ondanseteron. ( MIMS )
Adverse Reaction:
Adverse reactions-
Ondansetron -Oral-
CNS - Extrpyrimidal symptoms ( rare )
Hepatic - AST 1%, ALT 2% ( exceed twice the upper limit )
Miscellaneous- rash 1%, anaphylaxis , angina, bronchospasm, ECG alterations,
grand mal seizures, hypokalemia, vascular ocular events ( rare )
Dermatologic - urticaria
Ophthalmic- cases of transcient blindness, predominently administration reported
Ondansetron- Injection-
Cardiovascular - angina ( chest pain ) ECG alterations, hypotension, tachcardia ( rare )
GI - Constipation 10%
Miscellaneous - Rash 1% hypkalemia ( rare )
Contra-Indications:
5-HT3 Receptor Antagonists include-
Alosetron, Dolasetron, Ondansetron, Palonosetron, Granisetron, Hydrolastron
Refer - 5-HT3 Receptor Antogonists
Dosages/ Overdosage Etc:
Date of Approval- February 1994
Indications:
Prevention of Nausea and vomiting associated with cancer therapy.
Dosage: Injection
Recommended IV dose is 0.15mg/kg .The first dose is infused over 15 minutes
beginning 30 minutes before the start of the therapy. Subsequent doses are administered
4 and 8 hours after the first dose. Dilute in 50ml of 5% dextrose injection or 0.9%
sodium chloride solution.
Dosage- Oral-
8mg orally 3 times a day
8mg orally administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours
after the first dose for each day radiotherapy is given
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
ONDANSETRON - systemic
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
ondansetron or granisetron. Also tell your healthcare care professional
if you are allergic to any other substances such as foods. preservatives
or dyes.
2.Pregnancy-
Ondensetron has not been studied in pregnant women. However, this medicine
has not been shown to cause birth defects or other problems in animal studies
3. Breast-feeding-
It is not known whether ondansetron passes into breast milk.
Mothers who are taking this medicine and who wish to breast feed should
discuss this with their doctor.
4.Children-
This medicine has been tested in a limited number of children with cancer
4 years and older. In effective doses the medicine has not been shown
to cause different side effects or problems than it does in adults.
5.Older adults-
This medicine has been tested in a limited number of cancer patients
65 years and older and has not caused different side effects or problems
in older people than it does in younger adults.
6. Other medicines-
Tell your doctor if you any other prescription or non-prescription
(Over-the counter) OTC medicine.
7. Other medical problems-
Make sure you tell your doctor if you have any other medical problems
especially-
Abdominal surgery- use of ondansteron may cover up stomach problems
Liver disease- patients with liver disease may have an increased chance
of side effects.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Ondansteron is a selective 5-HT3 receptor antagonist, serotonin receptors are present both peripherally on the vagal nerve terminals and centrally in the CTZ of the area posterma. Ondansteron blocks serotonin 5-HT 3 receptors with little or no effect on dopamine receptors.
Unlike metoclopramide, ondansetron does not affect GI motility or lower esophageal sphincter tone.
Pharmacokinetics:
Following an oral dose of ondansetron peak plasma concentrations are acheived in approximately 1 - 1.5 hrs. Oral bioavailability in healthy volunteers has been reported as 59%.
The plasma clearance averages to 0.45 1/h/kg systemic clearance is markedly reduced with prolonged elimination half-life in patients with severe hepatic impairment.
Ondansetron is extensively metabolised with approximately 5% of a radiolabelled dose recovered as the parent compound from urine. The plasma protein binding is 470- 76% and the volume of distribution is 1.8 L/kg.
Interaction with Food:
5-HT3 Receptor Antagonists include-
Alosetron, Dolasetron, Ondansetron, Palonosetron, Granisetron, Hydrolastron
Refer - 5-HT3 Receptor Antagonists
Pregnancy and lactation:
5-HT3 Receptor Antagonists include-
Alosetron, Dolasetron, Ondansetron, Palonosetron, Granisetron, Hydrolastron
Refer - 5-HT3 Receptor Antagonists
Manufacturer Details