Granisetron hcl - @ - 5-HT3 Receptor Antagonists - Antiemetic/Antivertigo agents- (Dec 1993)
Drug Interaction:
5-HT3 Receptor Antagonists include-
Alosetron, Dolasetron, Ondansetron, Palonosetron, Granisetron, Hydrolastron
Refer - 5-HT3 Receptor Antogonists
Indication:
Prevention of nausea/vomiting ssociated with chemotherapy
Approved by FDA on December 29,1993
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Granisetron Anti-emetic 05-07-2000
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Granisteron Gastrointestinal GlaxoSmithKline 29-12-2007
Adverse Reaction:
Adverse reactions-
Granisetron - Oral-
Cardiovascular- hypertension 1% angina,pectoris, atrial fibrilation, hypotension,
syncope ( rare )
CNS- Asthenia 13% headache 20%, dizziness, insomnia 5% anxiety 2%
extrapyrinidal symptoms ( rare )
GI - Nausea 20% Constipation 17% Vomiting 11%diarrhea 7%
abdominal pain 5% dyspepsia 4%
Hepatic - Elevation of ALT and AST , 5% , ( greater than 2 times the upper limit
of normal ULN
Hypersensitivity - hypersensitivity reactions eg anaphylaxis, shortness of breath,
hypotension, urticaria ( rare )
Miscellaneous- Leukopenia 8% , decreased appetite 5%, fever 4%, anemia 3%,
alopecia 2%, thrombocytopenia 2%
Granisetron- injection-
CNS - Asthenia 4% headache 13% somnolence 4% agitation, anxiety,
( less than 2% )
GI - Constipation 3% diarrhea 4%
Cardovascular - hypotension 2% arrhthmias eg sinus braycardia, atrial fibrilation,
AV block, ventricular ectopy, ECG abnormalites
Hepatic - Elevation of ALT and AST 2%, ( greater than 2 times the ULN )
Hypersensitivity - hypersensitivity reactions eg anaphylaxis, hypotension, shortness of
breath, urticaria ( rare )
Miscellaneous- Fever 3%, taste disorder 2%, skin rashes 1%
Contra-Indications:
5-HT3 Receptor Antagonists include-
Alosetron, Dolasetron, Ondansetron, Palonosetron, Granisetron, Hydrolastron
Refer - 5-HT3 Receptor Antogonists
Dosages/ Overdosage Etc:
Approved by FDA on December 29,1993
Indicatons:
Prevention of nausea/vommiting ssociated with chemotherapy
Dosage: Injection
IV- recommended dosage- 10mcg/kg infused IV over 5 minutes, beginning within 30 minutes
before initiation of chemotherapy, and only on the days of chemotherapy is given.
Dosage - Oral-
2mg once daily ( 1 hour before chemotherapy ) or 1mg twice daily ( give the first 1mg dose
upto 1 hour before chemotherapy and the second 1mg dose 12 hours after the first dose.
Either regimen is administered only on the days of chemotherapy is given
Patient Information:
5-HT3 Receptor Antagonists include-
Alosetron, Dolasetron, Ondansetron, Palonosetron, Granisetron, Hydrolastron
Refer - 5-HT3 Receptor Antogonists
5-HT3 Receptor Antagonists include-
Alosetron, Dolasetron, Ondansetron, Palonosetron, Granisetron, Hydrolastron
Refer - 5-HT3 Receptor Antogonists
Ref - USP PDI Vol II 17th Edition (1997)
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
granisetron. Also tell your healthcare care professional if you are allergic to any other
substances such as foods. preservatives or dyes.
2.Pregnancy-
Studies have not been done in humans. However, Granisetron has not shown to cause
birth defects or other problems in animal studies.
3. Breast-feeding-
Mothers who are taking this medicine and who wish to breast feed should discuss this
with their doctor.
4.Children-
In effective doses the medicine has not shown to cause different side effects or
problems than it does in adults.
5.Older adults-
This medicine has not shown to cause side effects or problems in older people
than in younger adults.
6. Other medicines-
Tell your doctor if you are using any of the following or /other prescription or
non-prescription (Over-the counter) OTC medicine.
7. Other medical problems-
The presence of other medical problems may affect the use of granisetron.
Make sure you tell your doctor if you have any other medical problems
Pharmacology/ Pharmacokinetics:
Pharmacology:
Granisteron , an antinauseant and antiemetic agent is a selective 5 hydroxy tryptamine (5-HT3) receptor antagonist, with little or no affinity for other serotinin, alpa or beta adrenergic, dopamine receptors.
Interaction with Food:
5-HT3 Receptor Antagonists include-
Alosetron, Dolasetron, Ondansetron, Palonosetron, Granisetron, Hydrolastron
Refer - 5-HT3 Receptor Antogonists
Pregnancy and lactation:
5-HT3 Receptor Antagonists include-
Alosetron, Dolasetron, Ondansetron, Palonosetron, Granisetron, Hydrolastron
Refer - 5-HT3 Receptor Antogonists
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